Well Lead Extraction Bag

K160801 · Well Lead Medical Co., Ltd. · GCJ · Nov 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160801
• Device Name: Well Lead Extraction Bag
• Applicant: Well Lead Medical Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

Device Story

Well Lead Extraction Bag is a single-use, sterile device for tissue specimen removal during laparoscopic surgery. It consists of a cylindrical sheath, a pusher, and a polyurethane bag. The device is inserted through a trocar; the bag is deployed to isolate and contain tissue specimens, minimizing spillage and intraoperative contamination. The transparent, high-strength polyurethane bag allows for visualization. Surgeons operate the device manually to enter, open, close, and exit the surgical site. Available in four types and various volumes (e.g., 200ml) to accommodate different laparoscopic procedures. The device facilitates efficient specimen retrieval, reducing the risk of contamination during extraction.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included leakage, rated volume, tensile strength, and dimensional analysis. Biocompatibility testing conducted per ISO 10993-1:2009, including cytotoxicity (ISO 10993-5:2009), irritation (ISO 10993-10:2010), and sensitization (ISO 10993-10:2010). All results met pre-determined acceptance criteria.

Technological Characteristics

Materials: Biocompatible high-strength polyurethane (PU). Form factor: Cylindrical sheath with pusher and retrieval bag. Operation: Manual deployment system. Sterilization: Supplied sterile. Single-use only.

Indications for Use

Indicated for use by qualified surgeons for tissue extraction during laparoscopic surgery.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Rüsch Memory Bag (K013872)
• GENICON Single-Use Specimen Retrieval Bag (K132375)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 29, 2016

Well Lead Medical Co., Ltd. c/o Huang Kaigen Regulatory Affairs Manager C-4 # Jinhu Industrial Estate, Hualong, Panyu Guangzhou, 511434 CN

Re: K160801

Trade/Device Name: Well Lead Extraction Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 28, 2016 Received: October 31, 2016

Dear Huang Kaigen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K160801 510(k) Number (if known):

Device Name: Well Lead Extraction Bag

Indications for Use:

The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | 2016/10/26 |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | WELL LEAD MEDICAL CO., LTD.<br>Address:C-4 # Jinhu Industrial Estate, Hualong,<br>Panyu,<br>Guangzhou, 511434, P.R. China |
| Contact Person: | Huang Kaigen<br>Regulatory Affairs Manager<br>WELL LEAD MEDICAL CO., LTD.<br>Email: [e-mail]<br>Tel: [phone]<br>Fax:[phone] |
| Device Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Product Code:<br>Regulatory Class: | Well Lead Extraction Bag<br>Extraction Bag, Retrieval Bag<br>21 CFR § 876.1500<br>Endoscope and accessories<br>GCJ<br>Class II |
| Predicate Device(s): | K013872-Rüsch Memory Bag<br>K132375-GENICON Single-Use Specimen Retrieval Bag |

#### 1. Intended Use

The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

### 2. Device Description

The Well Lead Extraction Bag is used for removal of tissue specimens during a suitable laparoscopic surgery.The device consists of a cylindrical sheath, a pusher and a polyurethane bag that minimizes spillage and intraoperative contamination by isolating and containing specimens. The bag is made of biocompatible high strength PU material, it is transparent and soft. which makes a qood visuality.

The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. It's easy to enter, open, close and exit, higher efficiency, and different type and size available. It is offerd in 4 types: Type B, Type C, Type D and range in bag volume from 200ml for different surgery needs. The well thought-out rang of types and sizes are suitable for all laparoscopic procedures. The main differences between all types are the deployment system and operation method.

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### 3. Substantial Equivalence-Comparison to Predicate Devices

### ※ Similarities Between Proposed and Predicate Devices

The proposed and predicate devices are both intended for tissue containment and removal during laparoscopic surgery. All devices are single use, sterile and offer two functional sections: a working section and a container section.

The proposed Well Lead Extraction Bag and the predicate devices, Rüsch Memory Bag, GENICON Single-Use Specimen Retrieval Bag, have the same intended use, principle of operation, patient population, performance characteristics and technological characteristics.

### ※ Differences Between Proposed and Predicate Devices

The following aspects involve slight differences between the proposed and predicate devices:

- Bag Volume
- · Materials
- · Deployment System
- · Mechanism of the bag opening

## ※ Summary and Conclusion

The Well Lead Extraction Bag described in this 510(k) has similar technological and performance characteristics to the predicate devices. The proposed device is substantially equivalent in intended use, principle of operation, patient population, performance characteristics and technological characteristics as to predicate devices. The differences in the device do not introduce new issues of safety and efficacy, or raise different questions of safety and effectiveness.

Therefore the proposed Well Lead Extraction Bag is substantially equivalent to Rüsch Memory Baq(K013872) and GENICON Single-Use Specimen Retrieval Bag(K132375).

### 4. Summary of Non-Clinical Performance Testing

The following performance testing was conducted for the Well Lead Extraction Bag:

- 1 ) General performance testing including:
- · Leakage
- Rated Volume
- · Tensile Strength
- · Determining the Dimensions

Testing datas and results are included in this submission, and demonstrated that the Well Lead Extraction Bag meets all the pre-determined testing and acceptance criteria.

2) Biocompatibility testing as per ISO 10993-1:2009 including:

- · Cytotoxicity as per ISO 10993-5:2009
- · Irritation as per ISO 10993-10:2010

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- · Sensitization as per ISO 10993-10:2010
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible.

#### 5. Conclusion

The Well Lead Extraction Bag is substantially equivalent to predicate devices Rüsch Memory Bag(K013872) and GENICON Single-Use Specimen Retrieval Bag(K132375). Based on the intended use, principle of operation, patient population, performance characteristics, and technological characteristics, the proposed Well Lead Extraction Bag is substantially equivalent to and as safe and as effective as the legally marketed predicate devices.