Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

K201639 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · GDW · May 27, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201639
• Device Name: Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
• Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, side-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoid disease. The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue. The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

Device Story

Manual surgical staplers; used in open and laparoscopic procedures; alimentary tract, abdominal, thoracic, gynecological, and pediatric applications. Devices place titanium staples (double or triple staggered rows) to compress and join tissue; integrated circular or linear knives simultaneously resect excess tissue or divide tissue between staple rows. Operated by surgeons; manual activation via handles/firing mechanisms. Safety features include insurance/locking mechanisms to prevent misfiring. Benefits include efficient tissue closure, resection, and anastomosis creation. Devices are single-use, sterile, and disposable.

Clinical Evidence

No clinical data. Bench testing only. Testing included ISO 10993 biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity), ASTM F88/F1929 packaging/seal integrity, and ex-vivo porcine tissue performance testing (pressure, staple formation, force-to-fire).

Technological Characteristics

Manual surgical staplers; unalloyed titanium staples; stainless steel and various polymers (ABS, PC, PPA, POM, PA-757, PE, AL6063). Sterilization: Ethylene Oxide. Endotoxin limit: 20EU. Configurations: Circular, Linear, Linear Cutter, and Endoscopic Linear Cutter. Staple heights: 2.5mm to 4.8mm. Connectivity: None (mechanical).

Indications for Use

Indicated for patients undergoing abdominal, thoracic, gynecological, or pediatric surgical procedures requiring tissue transection, resection, or anastomosis, and for the surgical treatment of hemorrhoid disease.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• PANTHER Group of Surgical Staplers (K103470)
• Panther Endo Linear Cutter Staplers with Single Use Loading Unit (K142577)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 27, 2021

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: K201639

Trade/Device Name: Disposable Circular Stapler, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: June 2, 2020 Received: June 16,2020

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/cdrl/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 medical devices and radiation -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.

for Cindy Chowdhury, Ph.D., MBA Assistant Director DHT4B: Division of Infection Control and Plastic 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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# Indications for Use

510(k) Number (if known) K210639

### Device Name

Disposable Circular Stapler; Disposable Hemorrhoidal Stapler and Reloads; Disposable Linear Cutter Stapler and Reloads; Disposable Endoscopic Linear Cutter Stapler and Reloads

### Indications for Use (Describe)

The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, sideto-side anastomoses in both open and laparoscopic surgeries.

The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoid disease.

The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.

The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 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: K201639

- 1. Date of Preparation: 05/27/2021
- 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: RA Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (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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#### Identification of Proposed Device 4.

### Trade Name:

Disposable Circular Stapler Disposable Hemorrhoidal Stapler Disposable Linear Stapler and Reloads Disposable Linear Cutter Stapler and Reloads Disposable Endoscopic Linear Cutter Stapler and Reloads Common Name: Stapler, Implantable

Regulatory Information Classification Name: Implantable Stapler; Classification: II; Product Code: GDW; Regulation Number: 21CFR 878.4750 Review Panel: General & Plastic Surgery;

### Indications for Use:

The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease.

The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.

The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

## Device Description:

Disposable Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 28mm, 29mm and 32mm five

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specifications. The staple is available in 4.5mm and 4.8mm two different heights.

Disposable Endoscopic Linear Cutter Stapler and Unit places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three specifications. Reloads are available in 2.5mm, 4.0mm and 4.8mm four staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.

Disposable Hemorrhoidal Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 32mm, 33mm three specifications. The staple size is 3.8mm. It cannot be reloaded.

Disposable Linear Cutter Staplers and Reload places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm five specifications. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 8 times in a single procedure.

The Disposable Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm four specifications for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 8 times in a single procedure.

#### ર . Identification of Predicate Devices

Predicate Device 1 510(k) Number: K103470 Product Name: PANTHER Group of Surgical Staplers

Predicate Device 2 510(k) Number: K142577 Product Name: Panther Endo Linear Cutter Staplers with Single Use Loading Unit

#### 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 test results demonstrated that the proposed device complies with the following standards:

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- > ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
- > ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and > delayed-type hypersensitivity
- USP42-NF37 <85> Bacterial Endotoxins Tests >
- > ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials;
- > ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ▲ ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Rest, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for 2.5mm staple height. Burst pressure, closed staple height and staple formation were evaluated in jugular vein test.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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

| Item | Proposed Device | Predicate Device 1 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K103470 |
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Circular Stapler has<br>application throughout the alimentary<br>tract to create end-to-end, end-to-side<br>and side-to-side anastomoses in both<br>open and laparoscopic surgeries | The Panther circular staplers and<br>accessories have application<br>throughout the alimentary tract to<br>create end-to-end, end-to-side and<br>side-to-side anastomoses in both<br>open and laparoscopic surgeries |
| | Anvil | Anvil |
| | Cartridge | Cartridge |
| | Drivepipe | Drivepipe |
| | Firing Handle | Firing Handle |
| Main Configuration | Insurance | Insurance |
| | Rating Nut | Rating Nut |
| | Staple | Staple |
| | Circular Knife | Circular Knife |
| | Cartridge Cover | Cartridge Cover |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Circular Knife | Circular Knife |
| Safety Mechanism | Insurance is used for preventing from<br>mis-firing | Insurance is used for preventing<br>from mis-firing |
| Specification | 25, 26, 28, 29 and 32mm | 24, 26, 29, 32 and 34mm |
| Staple Height | 4.5 and 4.8mm | 4.5 and 4.8mm |
| Row number of Staple | 2 | 2 |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contact<br>material of stapler | Stainless Steel<br>ABS<br>AL6063 | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Item | Proposed Device | Predicate Device 1<br>K103470 |
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease | The PANTHER Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical Treatment of hemorrhoidal disease. |
| Main Configuration | Anvil<br>Cartridge Cover<br>Cartridge<br>Fixed handle<br>Firing Handle<br>Rating Nut<br>Insurance<br>Staple<br>Circular Knife | Anvil<br>Cartridge Cover<br>Cartridge<br>Fixed handle<br>Firing Handle<br>Rating Nut<br>Insurance<br>Staple<br>Circular Knife |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Circular Knife | Circular Knife |
| Safety Mechanism | Insurance is used for preventing from mis-firing | Insurance is used for preventing from mis-firing |
| Specification | 32, 33 and 34mm | 31, 32, 33 and 34mm |
| Staple Height | 3.8mm | 3.8mm |
| Row number of Staple | 2 | 2 |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contact material of stapler | Stainless Steel<br>PE<br>ABS<br>PC | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Sterilization | Ethylene Oxide | Ethylene Oxide |

# Table 1 Comparison of Disposable Circular Stapler

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| | | | Table 2 Comparison of Disposable Hemorrhoidal Stapler | |
|--|--|--|-------------------------------------------------------|--|
|--|--|--|-------------------------------------------------------|--|

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| Item | Proposed Device | Predicate Device 1<br>K103470 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Linear Stapler and<br>Reloads can be applied in<br>abdominal, thoracic and pediatric<br>surgical procedures for transection<br>or resection of tissue. | The PANTHER Linear Stapler<br>can be applied in abdominal,<br>thoracic and pediatric surgical<br>procedures for transection or<br>resection of tissue. |
| Main Configuration | Anvil<br>Reloading Unit<br>Left and right slider<br>Rest knob<br>Fixed handle<br>Firing handle | Anvil<br>Reloading Unit<br>Left and right slider<br>Rest knob<br>Fixed handle<br>Firing handle |
| Operate Principle | Manual | Manual |
| Suture length | 30 mm, 45 mm, 60 mm and 90 mm | 30mm, 45mm, 60mm, 75mm and<br>90mm |
| Staple Height | 3.5mm and 4.8mm | 2.5mm, 3.5mm and 4.8mm |
| Row number of<br>Staple | Double staggered rows | Double staggered rows |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contact<br>material of stapler | PC<br>Stainless Steel<br>PA-757 | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Item | Proposed Device | Predicate Device 1 |
| | | K103470 |
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Linear Cutter Stapler<br>and Reloads can be applied in<br>abdominal, gynecological, pediatric<br>and thoracic surgical procedures<br>for resection, transection and creation<br>of anastomosis | The PANTHER Linear Cutter<br>Stapler can be applied in<br>abdominal, gynecological,<br>pediatric and thoracic surgical<br>procedures for resection,<br>transection and creation of<br>anastomosis. |
| Main Configuration | Push Button<br>Rotating pin<br>Cutting knife<br>Cartridge cover<br>Cartridge | Push Button<br>Rotating pin<br>Cutting knife<br>Cartridge cover<br>Cartridge |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Linear knife | Linear knife |
| Suture length | 55mm, 60 mm, 75mm, 80 mm and<br>100 mm | 55mm, 60mm, 75mm, 80mm,<br>100mm and 110mm |
| Staple Height | 3.8mm and 4.8mm | 3.8mm and 4.8mm |
| Row<br>number<br>of<br>Staple | two double staggered mows | two double staggered mows |
| Closed Staple form | B-shape | B-shape |
| Staple material | Titanium | Titanium |
| Patient-contact<br>material of stapler | Stainless Steel<br>PC<br>ABS<br>POM<br>PPA | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Item | Proposed Device | Predicate Device 2 |
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis. | PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. |
| Main Configuration | Firing rod<br>Barrel shell<br>Rotary knob<br>Insurance button<br>Left and right shell<br>Cartridge | Firing rod<br>Barrel shell<br>Rotary knob<br>Insurance button<br>Left and right shell<br>Cartridge |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Linear Knife | Linear Knife |
| Safety Mechanism | Insurance button for preventing from miss-firing | Insurance button for preventing from miss-firing |
| Suture length | 30mm, 45mm and 60mm | 30mm, 45mm and 60mm |
| Staple Height | 2.5, 3.5, 4.0 and 4.8mm | 2.0, 2.5, 3.5, 4.0 and 4.8mm |
| Row number of Staple | Two, triple-staggered rows | Two, triple-staggered rows |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contact material of stapler | PPA<br>Stainless Steel | Stainless steel<br>Polymeric materials<br>Adhesives<br>lubricants |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |

Table 3 Comparison of Disposable Linear Stapler and Reloads

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Table 4 Comparison of Disposable Linear Cutter Stapler and Reloads

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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.