Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

K182476 · Fengh Medical Co., Ltd. · GDW · Dec 18, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K182476
• Device Name: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
• Applicant: Fengh Medical Co., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Disposable Powered Articulating Endosopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Device Story

Disposable, battery-powered, articulating endoscopic linear cutter stapler; used in open or minimally invasive surgery. Device delivers six staggered rows of staples while simultaneously cutting tissue. Features include rotating shaft, articulation mechanism for lateral access, and empty-reload safety protection. Operated by surgeons in clinical settings. Powered by internal 12V DC supply. Provides mechanical tissue transection and stapling; output is a stapled, divided tissue line. Benefits include facilitated access to operative sites and consistent staple delivery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included mechanical performance (anastomosis/cutting, articulation, firing current), biocompatibility (ISO 10993 series), electrical safety (AAMI/ANSI ES60601-1), and EMC (IEC60601-1-2).

Technological Characteristics

Powered endoscopic stapler; 12V DC internal battery. Materials: Stainless steels (SUS420, SUS630, SUS440, SUS304), Aluminum (2A12-T4), LCP, PC, PU, and Titanium alloy (Ti-3AL-2.5V). Articulating shaft; IPX4 (shaft) and IPX0 (body) water ingress rating. Sterilization: Irradiation (SAL 10^-6). Standards: ASTM F1980-16, ASTM F88/F-15, ASTM F1929-15, ASTM F3039-15, ASTM D3078-2002, DIN 58953-6-2010, ISO 10993, AAMI/ANSI ES60601-1, IEC60601-1-2.

Indications for Use

Indicated for transection, resection, and/or creation of anastomoses in open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

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

• Echelon Flex Powered Articulating Endoscopic Linear Cutters (K130653)

Submission Summary (Full Text)

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December 18, 2019

Fengh Medical Co., Ltd. Jiao Liu RA Manager D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, 214437 Cn

Re: K182476

Trade/Device Name: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 13, 2019 Received: November 18, 2019

Dear Jiao Liu:

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.

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

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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,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K182476

#### Device Name

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads, Model include 30mm series and 60mm series

#### Indications for Use (Describe)

The Disposable Powered Articulating Endosopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><span style="border: 1px solid black; padding: 1px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><span style="border: 1px solid black; padding: 1px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="border: 1px solid black; padding: 1px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="border: 1px solid black; padding: 1px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| <span style="border: 1px solid black; padding: 1px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="border: 1px solid black; padding: 1px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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## 510(k) SUMMARY

(As Required by 21 CFR 807.92)

### 1. Date Prepared [21 CFR 807.92(a)(1)]

Jan 29th, 2019

### 2. Submitter's Information [21 CFR 807.92(a)(1)]

| Company Name: | Fengh Medical Co., Ltd. |
|------------------|--------------------------------------------------------------------------------------|
| Company Address: | D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone, 214437 Jiangsu, China |
| Contact Person: | Jiao Liu |
| Phone: | 0086-13815132106 |
| Email: | [e-mail] |

### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | Disposable Powered Articulating Endoscopic Linear Cutter<br>Stapler & Reloads, Model include 30mm series, 45mm<br>series and 60mm series |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Implantable staple |
| Product Code: | GDW |
| Regulation Number: | 21 CFR 878.4750 |
| Device Class: | II |

### 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification of predicates within this submission is as follow:

| Manufacturer: | Ethicon Endo-Surgery, LLC |
|----------------------|----------------------------------------------------------------|
| Trade Name: | Echelon Flex Powered Articulating Endoscopic Linear<br>Cutters |
| Common Name: | Cutter/Stapler |
| Product Code: | GDW |
| Classification Name: | Staple, Implantable; Stapler, Surgical |
| Regulation Number: | 21 CFR 878.4750 |
| Classification: | Class II |

## Page 1 of 8

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K130653 (K130653 is a modification to their original FDA 510 (k) #: product cleared under K110385)

### 5. Description of the Device [21 CFR 807.92(a)(4)]

The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line.

The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.

Model 30mm series include FSMS30, FSMM30, FSML30; 45mm series include FSMS45, FSMM45, FSML45; 60mm series include FSMS60, FSMM60, FSML60. The difference between the three series lies in the different anatomized lengths.

There are total 18 models of reloads within the proposed device, three stapler line length: 35.2±2.0mm,49.3±2.0mm and 61.3±2.0mm; six staple heights: Gray (0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), Black (2.3mm).

Power type: internal power supply; DC voltage 12V, rated power 40W Applied parts: Type CF Mode of operation: Non-Continuous Operation

Degree of safety when used in the presence of flammable anesthetic gas mixed with flammable anesthetic gas or nitrous oxide mixed with air: Flammable anesthetic gas that cannot be mixed with flammable anesthetic gas or nitrous oxide mixed with air .

The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0.

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Image /page/5/Figure/1 description: The image shows a medical instrument with two labels, IPX4 and IPX0, indicating different sections of the device. IPX4 is positioned above the long, slender part of the instrument, while IPX0 is located above the handle. The instrument appears to be a type of surgical tool, possibly used for grasping or cutting tissue during medical procedures. The design includes a handle for manual operation and an extended arm with a specialized tip.

### 6. Indications For Use [21 CFR 807.92(a)(5)]

The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

### 7. Technological Characteristics [21 CFR 807.92(a)(6)]

The technological characteristics are the same or very similar to the predicate device.

Surgical stapling is the technological principle for both the subject and predicate device. It is based on the use of endoscopic instrumentation for transection, resection, and/or creation of anastomoses.

The subject and predicate staplers and reloads share the following features:

- Intended Use
- Technological characteristics
- Operational principles
- Sterilization Method

### 8. Non-Clinical and Clinical Tests

The device passed the following tests.

| Non-Clinical Test | Appearance |
|------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Flexibility |
| | Assembling capacity |
| | Hardness |
| | Anastomosis and cutting performance |
| | Resistance to Pressure |
| | Safety Device |
| | Sharpness |
| | Surface Roughness |
| | Package Seal |
| | Rotation and Articulation |
| | Firing Electric Current |
| | Battery Voltage |
| | Motor Rotate Speed |
| | Size |
| | Sterility Test |
| | Accelerated Aging Test (ASTM F1980-16) |
| | Seal Strength Test (ASTM F 88/F-15) |
| | Dye Penetration Test (ASTM F1929-15, ASTM<br>F3039-15) |
| | Vacuum Leak Test(ASTM D3078-2002(2013)) |
| | Packaging Resistance Bacteria Performance Test(DIN<br>58953-6-2010) |
| Biocompatibility Test | In Vitro Cytotoxicity Test (ISO 10993-5: 2009) |
| | Skin Sensitization Test (ISO 10993-10:2010) |
| | Intracutaneous reactivity Test (ISO 10993-10:2010) |
| | Acute Systemic Toxicity (ISO 10993-11:2006) |
| | Pyrogen Test (ISO 10993-11:2006) |
| | Subchronic Systemic Toxicity (ISO 10993-11:2006) |
| | Ames test (ISO 10993-3: 2014) |
| | In vitro Mammalian Chromosome Aberration Test<br>(ISO 10993-3:2014) |
| | In Vivo Mammalian Erythrocyte Micronucleus Test<br>(ISO 10993-3:2014) |
| | Muscle Implantation Test (ISO 10993-6: 2016) |
| Electrical Safety Test | Electrical Safety Test (AAMI / ANSI ES60601-<br>1:2005/(R)2012 and A1:2012,c1:2009/(r)2012 and<br>a2:2010/(r)2012) |
| EMC Test | EMC Test (IEC60601-1-2:2014) |

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## 9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

| Product Name | Disposable Powered Articulating Endoscopic<br>Linear Cutter Stapler & Reloads | Echelon Flex Powered Articulating Endoscopic<br>Linear Cutters (K130653)<br>K130653 is a modification to their original product<br>cleared under K110385 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II | II |
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Product Code | GDW | GDW |
| Intended Use | The Disposable Powered Articulating Endoscopic<br>Linear Cutter Stapler & Reloads are intended for<br>transection, resection, and/or creation of<br>anastomoses. The instruments have application in<br>multiple open or minimally invasive general<br>abdominal, gynecologic, thoracic, and pediatric<br>surgical procedures. | The Echelon families of endoscopic linear cutters<br>(articulating and straight) are intended for<br>transection, resection, and/or creation of<br>anastomoses. The instruments have application in<br>multiple open or minimally invasive general,<br>gynecologic, urologic, thoracic, and pediatric<br>surgical procedures. They can be used with staple<br>line or tissue buttressing materials. The<br>instruments may also be used for transection and<br>resection of liver parenchyma (hepatic vasculature<br>and biliary structures), pancreas, kidney and<br>spleen. |
| Cutting Mechanism | Stapler places two, triple staggered rows of staples<br>and simultaneously cuts and divides the tissue<br>between the two row. | Stapler places two, triple staggered rows of staples<br>and simultaneously cuts and divides the tissue<br>between the two row. |
| Manual/Powered | Powered | Powered |
| Safety Feature | Power stapler has empty-reload safety protection<br>mechanism. | Power stapler has empty-reload safety protection<br>mechanism. |
| Main Components | Closing Trigger, Red Firing Trigger Lock, Firing<br>Trigger, Anvil Release Button, Battery Pack,<br>Battery Pack Release Tab, Manual Override | Closing Trigger, Red Firing Trigger Lock, Firing<br>Trigger, Anvil Release Button, Battery Pack,<br>Battery Pack Release Tab, Manual Override |

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| | Access Panel, Knife Reverse Switch, Rotating<br>Knob, Articulation Fins, Reload(Cartridge),<br>Reload Gripping Surface, Reload Alignment Tab,<br>Reload Alignment Slot, Staple Retaining Cap,<br>Anvil Jaw, Cartridge Jaw, Staple Line, Cut Line,<br>Proximal Black Line , Knife Blade Indicator,<br>Indicator | Access Panel, Knife Reverse Switch, Rotating<br>Knob, Articulation Fins, Reload(Cartridge),<br>Reload Gripping Surface, Reload Alignment Tab,<br>Reload Alignment Slot, Staple Retaining Cap,<br>Anvil Jaw, Cartridge Jaw, Staple Line, Cut Line,<br>Proximal Black Line , Knife Blade Indicator | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Staple Line Length | 30mm | N/A | |
| | 45mm | 45mm | |
| | 60mm | 60mm | |
| Open Staple Height | 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.4mm | No Known | |
| Open Staple Picture | Image: Open Staple | Image: Open Staple | |
| Closed Staple Height | 0.75mm | 0.75mm | |
| | 1.0mm | 1.0mm | |
| | 1.5mm | 1.5mm | |
| | 1.8mm | 1.8mm | |
| | 2.0mm | 2.0mm | |
| | 2.3mm | 2.3mm | |
| Closed Staple Picture | Image: Closed Staple | Image: Closed Staple | |
| Number of Staples | 36 | N/A | |
| | 70 | 70 | |
| | 88 | 88 | |
| Staple Cross Section | 0.03 mm2 | No Known | |
| Patient-Contact Material | Contact<br>Material<br>Component | No Known | |
| | Anvil | SUS420(Stainless 20Cr13)<br>SUS630(Stainless<br>05Cr17Ni4Cu4Nb/0Cr17Ni4Cu4Nb) | |
| | Reload seat | SUS630(Stainless<br>05Cr17Ni4Cu4Nb/0Cr17Ni4Cu4Nb) | |
| | Cutting knife | SUS440(Stainless 85Cr17) | |
| | Aluminum<br>ring | 2A12-T4 | |
| | Left Pipe | SUS304(Stainless 06Cr19Ni10) | |
| | Right Pipe | SUS304 (Stainless 06Cr19Ni10) | |
| | Reload | LCP, PC | |
| | Pushing plate | RTP4007A | |
| | Bracket | SUS304(Stainless 06Cr19Ni10) | |
| | Cover | PU | |
| | Staple | Ti-3AL-2.5V(TA18) | |
| Sterilization | Sterilized by Irradiation | | Sterilized by Irradiation |
| SAL | 10-6 | | Not Known, but assumed to be 10-6 |

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### 10. Conclusion [21 CFR 807.92(b)(3)]

The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads device is substantially equivalent to the predicate device because both devices use the same or similar technology and have the same intended use. Testing to relevant standards demonstrate the device will perform as intended. The differences between the devices are insignificant and do not raise different questions of safety and effectiveness for the Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads device.