[Product description]

The Disposable Pulmonary Nodules Localization Needle is composed of a protective sleeve, an anti-releasing buckle, an anti-backout buckle, an introducer needle, a propelling part and a localization string with a localization hook. The protective sleeve is composed of a protective sleeve tubing and a protective sleeve tap. The introducer needle is composed of a needle tube, which has only one tip shape, and an introducer needle handle. The propelling part is composed of a propelling tube and a propelling handle. The localization string with localization hook is composed of a localization string with scale marks and a localization hook.

[Intended Use]

The Disposable Pulmonary Nodules Localization Needle is used for the CT-guided percutaneous assisted preoperative localization and intraoperative marking of pulmonary nodule.

[Intended User]

This product may only be used by radiologist or thorax surgeon before surgical operation and by thorax surgeon during the surgical operation.

[Intended Environment]

Computed tomography suite and operating room.

[Indications for Use]

Pulmonary nodules or small pulmonary nodules.

[Patient Population]

Adults.

[Intended Benefits]

The localization success rate is 71.4%-100%, which ensures the complete removal of the pulmonary nodule, while preserving more normal lung parenchyma to the maximum extent.

[Contraindications]

Absolute contraindications: 1. increased bleeding propensity;

                                            2. no suitable puncture site localizable;

                                            3. not suitable candidates for segmentectomy or wedge resection.

Relative contraindications: 1. intake of anticoagulants;

2. insufficient lung reserve;

3. cardiac insufficiency;

4. pulmonary hypertension;

5. pronounced emphysema;

6. chronic respiratory insufficiency;

7. severe dyspnoea;

8. severe pleural adhesions;

9. preoperative CT findings suggestive of possible distant metastasis;

10. pulmonary nodules for which thoracic surgeons deem unsuitable for puncture and localization.

[Potential Risks]

Bleeding, hemoptysis, dislodgement/shedding, hemorrhage, migration, pain, pneumothorax, pulmonary hemorrhage, unplanned thoracotomy.

[Specification]

Table 1 Specification of Disposable Pulmonary Nodules Localization Needle (Unit: mm)

[Warnings]

1. This product was expressly manufactured for single use and may not be reused after its initial use. The manufacturer declines any responsibility in the case of product resterilization or reuse. The product is not designed for the essential cleaning and sterilization processes. Sterility of the reprocessed single-use product is therefore not guaranteed. In addition, the quality of the material may be impaired, with safe use no longer be guaranteed. The risk of unintended injuries and infection, particularly cross-infection in patients and medical personnel, increases disproportionately in this case.

2. The localization string and localization hook are meant to be guides only. DO NOT use them as retractors.

3. If the buckle of the introducer needle is dislodged before surgery, the localization hook may not be released in the expected position during the operation.

4. The localization hook can only be released after the introducer needle reaches the edge of the pulmonary nodule, and it is strictly prohibited to release it in advance.

5. The localization hook and localization string should only be retained in the body less than 24h.

6.This device is not intended for use except as indicated in the Intended Use.

7. After use, the product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations related to product contamination by blood.

[Precautions]

1. The intended users shall be experienced in percutaneous lung puncture and receive product training before operation.

2. To reduce the possibility of unwanted complications (pain, pneumothorax, hook dislocation) the period of time up to resection of the lesion should be minimized.

3. The depth of the pulmonary nodule shall not be more than the maximum insertion depth of the product.

4. The patient shall be instructed to inhale and hold his/her breath while the needle is inserted.

5. If a lobectomy or pneumonectomy is being considered by the surgeon, preoperative localization using this product is not required; therefore, no restriction is placed on the depth of the nodule.

6. Once deployed, the localization hook of this product cannot be retracted and is intended for single use only.