Disposable Specimen Retrieval Bag

K201243 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · GCJ · Jul 10, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201243
• Device Name: Disposable Specimen Retrieval Bag
• Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

Device Story

Disposable Specimen Retrieval Bag used during general and laparoscopic surgery; functions as a receptacle for tissue, organ, and calculi collection. Device consists of a retracted bag, introducer handles, sleeves, and a tightening line. Operated by surgeons in clinical settings; device is inserted into the surgical site to capture specimens; the bag is then closed via the tightening line and withdrawn. Provides a secure container for specimen removal, minimizing contamination risk during extraction. Single-use, sterile device.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via peeling force, tensile strength, push/withdraw force, penetration force, and leak tests. Biocompatibility confirmed via cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, and pyrogen testing. Sterilization validated to SAL 10^-6.

Technological Characteristics

Materials: TPU (bag), PVC (shafts/rod), 304 Stainless Steel (sheet), ABS (plug/joint), Nylon (line). Mechanical actuation via pull ring and tightening line. Sterile, single-use. EO sterilization (SAL 10^-6).

Indications for Use

Indicated for patients undergoing general and laparoscopic surgical procedures requiring the collection and extraction of tissue, organs, and calculi.

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

• Specimen Retrieval Bag (K172789)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

July 10, 2020

Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K201243

Trade/Device Name: Disposable Specimen Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 22, 2020 Received: May 8, 2020

Dear Diana Hong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K201243

Device Name

Disposable Specimen Retrieval Bag

Indications for Use (Describe)

The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Tab #6 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: __

- 1. Date of Preparation: 04/22/2020
- 2. Sponsor Identification

## Beijing Biosis Healing Biological Technology Co., Ltd.

No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600 Beijing, China

Establishment Registration Number: 3016668451

Contact Person: Jiali Zhou Position: Regulatory Affair Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Disposable Specimen Retrieval Bag Common Name: Specimen Retrieval Bag Models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-350, RJRB-420

#### Regulatory Information

Classification Name: Laparoscope, General& Plastic Surgery; Classification: II; Product Code: GCJ; Regulation Number: 21CFR 876.1500 Review Panel: General & Plastic Surgery;

Indication for Use:

The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

### Device Description

The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use

- ਟ. Identification of Predicate Device
510(k) Number: K172789 Product Name: Specimen Retrieval Bag

#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

The performance tests were performed on both proposed device and predicate device. The test items include follow items

- A Retracted Bag Peeling Force Test

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- > Tightening Line Tensile Strength Test
- > Force to Push out Retracted Bag Test
- > Force to Withdraw Retracted Bag Test
- > Penetration Force Test
- > Leak Test

Sterile Barrier Packaging Testing performed on the proposed device:

- > Visual Inspection
- > Seal strength
- > Dye penetration

Sterilization and Shelf Life Testing performed on the proposed device:

- > EO residue
- > ECH residue
- > Shelf Life Evaluation

### Biocompatibility testing

The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA guidance document "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" June, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The proposed device was evaluated for the following tests:

- > Cytotoxicity,
- > Sensitization,
- > Intracutaneous reactivity,
- > Systemic Toxicity,
- > Pyrogen
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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#### Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device | Predicate Device |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K172789 |
| Product Code | GCJ | GCJ |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 |
| Class | Class II | Class II |
| Indication for Use | The specimen retrieval bag is<br>indicated for use as a receptacle for<br>the collection and extraction of<br>tissue, organs and calculi during<br>general and laparoscopic surgical<br>procedures. | The specimen retrieval bag is<br>indicated for use as a receptacle for<br>the collection and extraction of<br>tissue, organs and calculi during<br>general and laparoscopic surgical<br>procedures. |
| Configuration | Retracted bag | Retracted Bag |
| | Steel sheet | Outer Introducer Shaft |
| | Plug | Outer Introducer Handle |
| | Inner sleeve | Inner Introducer Shaft |
| | Outer sleeve | Inner Introducer Handle |
| | Pull ring | String |
| | Outer introducer handle | Opening Support |
| | Joint | Pull loop |
| | Tightening line | |
| | Pick rod | |
| | Inter introducer handle | |
| Single Use | Single Use | Single Use |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 |
| Retracted Bag<br>Size | Available in 90mm×100mm, 90mm<br>×120mm, 90mm×140mm, 90mm<br>×160mm, 90mm×180mm, 110mm<br>×120mm, 110mm×150mm, 110mm<br>×180mm, 130mm×150mm,<br>130mm×180mm | Available in 40 × 130mm, 60 ×<br>150mm, 80 × 200mm, 100 ×<br>220mm, 130×250mm, 40×150mm,<br>60×180mm, 80 × 220mm, 100×<br>275mm, 130× 320mm |
| Retracted Bag<br>Volume | Available in 50ml, 100ml, 120ml,<br>150ml, 200ml, 250ml, 300ml, 320ml,<br>350ml, 420ml | Available in 50ml, 100ml, 200ml,<br>300ml, 350ml, 400ml, 500ml, 600ml |
| Patient -contact material | | |
| Retracted Bag | Thermoplastic Polyurethane (TPU) | Thermoplastic Polyurethane (TPU) |
| Outer Introducer<br>Shaft | Polyvinyl chloride (PVC) | Polycarbonate (PC) |
| Inner<br>Introducer<br>Shaft | Polyvinyl chloride (PVC) | Polycarbonate (PC) |
| Steel sheet | 304 Stainless Steel | / |
| Plug | Acrylonitrile Butadiene styrene<br>(ABS) | / |
| Joint | Acrylonitrile Butadiene styrene<br>(ABS) | / |
| Ttightening line | Nylon | / |
| Pick rod | Polyvinyl chloride (PVC) | / |
| Biocompatibility | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity |
| Skin Sensitization | No skin Sensitization | No skin Sensitization |
| Irritation | No irritation | No irritation |
| Systemic Toxicity | No systemic Toxicity | No systemic Toxicity |
| Pyrogen | No pyrogen | No pyrogen |
| Sterilization | | |
| Method | EO sterilization | EO sterilization |
| SAL | 10-6 | 10-6 |

# Table 1 Comparison of Technology Characteristics

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- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.