PANTHER Endo Linear Cutter Staplers with Single Use Loading Units

K142577 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · GDW · Jun 11, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142577
• Device Name: PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
• Applicant: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Manual surgical instrument for endoscopic procedures; used in abdominal, gynecologic, pediatric, and thoracic surgery. Device utilizes single-use loading units (SULU) to place two triple-staggered rows of titanium staples while simultaneously dividing tissue between rows via linear knife. Available in straight or articulating configurations with various cartridge lengths (30mm, 45mm, 60mm) and staple sizes. Operated by surgeons in clinical settings; device is reloaded and fired up to 25 times per procedure. Safety mechanism includes green button to prevent misfiring. Provides tissue transection and anastomosis creation; benefits include standardized staple formation and efficient tissue management.

Clinical Evidence

Bench testing only. Testing included physical performance, endotoxin levels, package integrity, shelf life, and biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993). No clinical data provided.

Technological Characteristics

Manual surgical stapler; titanium staples (ISO 5832-2); stainless steel knife; polymeric body materials. Straight or articulating SULU configurations. EtO sterilized (SAL 10^-6). 36-month shelf life. Manual operation principle.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, or thoracic surgery requiring resection, transection, or anastomosis, including liver, hepatic vasculature, and biliary structures.

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

• Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement (K080898)

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

June 11, 2015

B.j.z.h.f. Panther Medical Equipment Co. Ltd. % Chu Xiaoan Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, CN 102200

Re: K142577

Trade/Device Name: Panther Endo Linear Cutter Staplers With Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: September 12, 2014 Received: September 12, 2014

Dear Mr. Chu Xiaoan,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

# David Krause -S

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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# Indications for Use

510(k) Number (if known) K142577

#### Device Name

PANTHER Endo Linear Cutter Staplers with Single Use Loading Units

Indications for Use (Describe)

PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary (per 2.1 CFR 807.92)

## 1. Applicant

| B.J.ZH.F. Panther Medical Equipment Co. Ltd. | | |
|-------------------------------------------------|--|--|
| ROM 805, Ruichuang Mansion, NO.9 Wangjing East, | | |
| Beijing, 102200, China | | |
| Ms. Liu Yu | | |
| 8610-6970402-8039 | | |
| 9/9/2014 | | |
| | | |

## 2. Device Name

Trade or Proprietary Name: PANTHER Endo Linear Cutter Stapler with Single Use Loading Units

Common/Usual Name: Surgical Stapler with Implantable Staple Classification Name: Implantable Staple Regulation Number: 878.4750 Product Code: GDW Classification: II Panel: General & Plastic Surgery

### 3. Predicate Device

### 3.1 Device

Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units with Staple Line Reinforcement (K 080898)

### 3.2 Manufacture

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)

### 4. Intended Use

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.

### 5. Description of the Devices

The proposed device. PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (SULU) is sterile (ETO), single-patient-use surgical instruments, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two triple-staggered rows. The Endo Linear Cutter Stapler will accommodate any of the reloading unit with staple cartridge lengths of 30mm, 45mm,

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and 60mm and come in long or compact shaft lengths, and they may be reloaded and fired up to 25 times in a single procedure. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm SULU.

The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.

### 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. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.

### 7. Substantially Equivalent (SE) Conclusion

The following table compares the proposed-device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Features & Description | Subject Device | Predicate Device |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | GDW | Same |
| Regulation Number: | 878.4750 | Same |
| Class | II | Same |
| Intend for use | PANTHER Endo Linear Cutter Stapler<br>with Single Use Loading Units (SULU)<br>has applications in abdominal,<br>gynecologic, pediatric and thoracic<br>surgery for resection, transaction and<br>creation of anastomosis. They may be<br>used for transection and resection of liver<br>substance, hepatic vasculature and biliary<br>structures. | Same |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Green button for preventing from<br>miss-firing. | Same |
| Staple shape | B-Shaped | Same |
| Closed staple height(mm) | 0.75,1.0, 1.5, 2.0 | Same |
| material | Staple<br>ISO 5832-2: Implants for surgery -<br>Metallic materials - Part 2: Unalloyed<br>titanium | Same |

#### .Table 1 Product Comparison Table

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| Kinife | Stainless steel | Same |
|------------------|---------------------------------------------------------------------------------------|----------------|
| Stapler | Polymeric materials,<br>surgical grade stainless steels,<br>adhesives, and lubricants | Very Similarly |
| Sterilization | EtO sterilized , SAL: 10-6 | Same |
| Packaging | PET shrink plastic tray and Tyvek<br>®.dialyzed paper | Same |
| Shelf life | 36 months | Same |
| Biocompatibility | Cytotoxicity Compliance with ISO 10993-5 | Same |
| | Irritation Compliance with ISO 10993-10 | Same |
| | Sensitization Compliance with ISO<br>10993-10 | Same |

Although there is a little different from the Predicate Device, the staple line reinforcement material (the synthetic absorbable film) on the ENDO GIA TM UNIVERSAL Single Use Loading Units (SULUs), but there are no substantial differences between the PANTHER Endo Linear Cutter Stapler with Single Use Loading Units (SULU) and the predicate devices. They have the same or similar indications for use. In addition, the minor differences in the technological characteristics do not raise issues of safety and effectiveness.

### 8. Conclusion

The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units, is determined to be Substantially Equivalent (SE) to the predicate device. Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units with Staple Line Reinforcement (K 080898), in respect of safety and effectiveness.