The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.

Device Description

The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the "PANTHER Cutter Stapler". It is a regulatory document and does not contain information about a study that proves the device meets specific acceptance criteria in the manner of an AI/algorithm-based medical device.

Instead, this document describes the device, its intended use, and states that no clinical or animal studies were included in the submission. The manufacturer relies on bench testing to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information in the format of an AI/algorithm study. However, I can provide the available information regarding the bench tests mentioned:

Acceptance Criteria and Device Performance (Bench Tests)

The document mentions that bench tests were conducted to confirm substantial equivalence to a predicate device, not to meet specific quantitative performance metrics against clinical ground truth. The acceptance criteria for these bench tests would typically be defined by engineering specifications and comparative performance to the predicate device. The document does not provide the specific numerical acceptance criteria or the reported performance values for each test.

Acceptance Criteria Category (Implied by Test Name)	Reported Device Performance (No specific values provided in document)
Physical Specification	"perform as intended and are substantially equivalent"
Closed Staple Height Dimensions	"perform as intended and are substantially equivalent"
Pressure Resistance	"perform as intended and are substantially equivalent"
Maximum Tensile Strength	"perform as intended and are substantially equivalent"
Force Required to Fire Stapler	"perform as intended and are substantially equivalent"

Since this is a submission for a surgical stapler and not an AI/algorithm device, the following points are not applicable or the information is not provided in the document:

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/algorithm study. For the bench tests, the sample sizes are not provided in this regulatory summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench test results are typically measured against engineering specifications or compared directly to a predicate device's performance, not expert consensus as ground truth.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical study is included in this submission."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not an AI/algorithm device.
The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and the performance of the predicate device.
The sample size for the training set: Not applicable, as no AI model is being trained.
How the ground truth for the training set was established: Not applicable.

Summary

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

November 12, 2015

B. J. Zh. F. Panther Medical Equipment Company, Ltd % Ms. Diana Hong Mid-link Consulting Company, Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K152618

Trade/Device Name: PANTHER Cutter Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: September 1, 2015 Received: September 14, 2015

Dear Ms. 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. 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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation 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)

K152618

Device Name PANTHER Cutter Stapler

Indications for Use (Describe)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

Form Approved: OMB No. 0910-0120

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510(k) Summary

510(k) Submitter

B. J. ZH. F. Panther Medical Equipment Co., Ltd Room 3305A, Floor 3, Building 3, No.208 Block 2 Liza Park, Wangjing Industrial District, Chaoyang District, 100102 Beijing, China Tel: +86-010-80789058 Fax: +86-510-80789028 Email: lina.yun@pantherhealthcare.com

Date Prepared: 10/08/2015

Device Names/Classification

Trade Name: PANTHER Cutter Stapler Common Name: Cutter stapler and reloads

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

Classification Name: Stapler, Surgical; Classification: II; Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4880 Review Panel: General & Plastic Surgery

Predicate Devices

510(k) Number: K091322 Product Name: CONTOUR™ Curved Cutter Stapler and Reloads

Device Description

It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously

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between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.

Indications for Use

Differences in Technological Characteristic

The PANTHER Cutter Stapler is identical to the CONTOUR™ Curved Cutter Stapler and Reloads marketed device with respect to technological characteristics. The PANTHER Cutter Stapler has the same intended use, configuration, operation principle, staple height, patient-contact material, sterilization as the predicate device.

Summary of Performance Testing

Pre-Clinical No study is included in this submission. Bench Bench tests including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance, Maximum Tensile Strength and Force Required to Fire Stapler were conducted to confirm that the proposed devices perform as intended and are substantially equivalent to the predicate devices. Animal No animal study is included in this submission. Clinical No clinical study is included in this submission.

Conclusion

Based on performance data, the proposed devices is substantially equivalent to the predicate devices CONTOUR™ Curved Cutter Stapler and Reloads cleared in K091322.

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.