PANTHER Circular The Panther Circular staplers and accessories have application Stapler throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

PANTHER The PANTHER Hemorrhoidal Circular Stapler and accessories Hemorrhoidal have application throughout the anal to perform surgical Circular Stapler treatment of hemorrhoidal disease.

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

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

Device Description

The PANTHER Staplers were sterile(ETO), single-patient-use instruments which designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go. Specifics for each stapler include:

PANTHER Circular Stapler: The PANTHER Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. PANTHER Circular Stapler includes 4 series: FCSM, FCSME, FCSMF, and FCSLWBE.

PANTHER Hemorrhoidal Circular Stapler: The PANTHER Hemorrhoidal Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. The Hemorrhoidal Circular Stapler set includes a Hemorrhoidal Circular Stapler, Suture Threader, Circular Anal Dilator and Purse-string Suture Anoscope. PANTHER Hemorrhoidal Circular Stapler includes 4 series: FCSS, FCSSME, FCSSWAE and FCSSWBE.

PANTHER Linear Stapler: The PANTHER Linear Stapler places a double or triple staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. and is available in 30 mm, 45 mm, 60 mm, 75 mm and 90 mm staple line lengths for use in various applications. The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Stapler includes 2 series: FLSL, FLSLE

PANTHER Linear Cutter Stapler: The PANTHER Linear Cutter Staplers place two double staggered rows of titanium staples in organs and tissues to anastomose the internal tissues and simultaneously cut and divide between the two rows during surgical procedures. The PANTHER Linear Cutter Staplers is available in six staple line lengths (55, 60, 75, 80, 100 or110mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Cutter Stapler includes 2 series: SSAA, SSAB.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PANTHER Group of Surgical Staplers:

The provided 510(k) summary for the PANTHER Group of Surgical Staplers describes a premarket notification for devices that are "substantially equivalent" to predicate devices. This type of submission relies on demonstrating similarity to already legally marketed devices, rather than establishing entirely new performance criteria through extensive clinical trials.

Therefore, the acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices, and the "study" is a bench testing comparison, not a human clinical trial.

Here's the breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices (AutosutureTM EEA surgical Stapler, PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories, AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER, AUTO SUTURE DISPOSABLE GIA SURG. STAPLER)	"Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the PANTHER Stapler is substantially equivalent to the predicate devices.""There are no substantial differences between the PANTHER Group of Surgical Stablers 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."
Performance to Internal Specifications	"Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications."

Acceptance Criteria

Reported Device Performance

Substantial Equivalence to Predicate Devices (AutosutureTM EEA surgical Stapler, PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories, AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER, AUTO SUTURE DISPOSABLE GIA SURG. STAPLER)

"Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the PANTHER Stapler is substantially equivalent to the predicate devices.""There are no substantial differences between the PANTHER Group of Surgical Stablers 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."

Performance to Internal Specifications

"Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Notionally, a "test set" and "training set" as understood in machine learning are not applicable here. This application is for physical surgical staplers, and the "testing" refers to bench testing (laboratory-based performance evaluation). The document does not specify the number of stapler units or specific test configurations used in the bench testing.
- Data Provenance: The bench testing was performed by "B.J.ZH.F. Panther Medical Equipment Co. Ltd" in China. The data's provenance is therefore the manufacturer's internal testing facilities. It is retrospective in the sense that it evaluates the manufactured device's performance against pre-defined specifications and predicate device performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of expert consensus in clinical imaging or diagnosis is not relevant for this type of device and submission. The "ground truth" for the bench testing would be objective measurements according to engineering and performance standards, and comparison to the predicate device specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies, which is not described for this bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study is not relevant here. This is a surgical stapler, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical, mechanical surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" would be objective engineering and performance metrics (e.g., staple formation consistency, staple line strength, cutting efficiency, deployment force, biocompatibility of materials, etc.) as evaluated against internal specifications and the known performance characteristics of the predicate devices. This does not involve expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.
The sample size for the training set:
- Not applicable. The concept of a "training set" is typically used in machine learning. For this device, there is no AI algorithm being trained. The design and manufacturing process would involve iterative development and testing, analogous to "training" in a broad sense, but not with a specified "training set" of data as in AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI sense. The design specifications and performance objectives for the stapler would have been established based on engineering principles, industry standards for surgical staplers, and the characteristics of the predicate devices.

In summary, the K103470 submission is a traditional 510(k) based on substantial equivalence. The "study" mentioned refers to bench testing that verified the device met internal specifications and demonstrated equivalence to the identified predicate devices in terms of function and safety. It did not involve human subjects, AI, or expert consensus in the manner one would see for a diagnostic device.

Summary

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K103470
page 1/3

510(k) Summary (per 2.1 CFR 807.92.(c))

JAN 1 1 2011

1. Applicant

B.J.ZH.F. Panther Medical Equipment Co. Ltd · Room 806, Peking Times Square B, No.103 Huizhongli, Chaoyang District, Beijing, 100101; China

Date Prepared: 11/22/2010

2. Device Name

Trade Name: PANTHER Group of Surgical Staplers Common/Usual Name: Stapler, Implantable Classification Name: Implantable Staple Regulation Number: 878.4750 Product Code: GDW Classification: II Panel: General & Plastic Surgery

3. Predicate Device

The PANTHER Group of Surgical Staplers includes:

PANTHER Circular stapler *
PANTHER Hemorrhoidal Circular Stapler .
PANTHER Linear Stapler .
PANTHER Linear Cutter Stapler .

are substantially equivalent to:

Subject Device	Predicate Device
	Name	Company	510(k)Number
PANTHERCircular stapler	AutosutureTM EEATM surgicalStapler	United StatesSurgical Corp.(USSC)	K062850
PANTHERHemorrhoidalCircular Stapler	PROXIMATE PPH HemorrhoidalCircular Stapler and Accessories	EthiconEndo-Surgery, Inc	K030411
PANTHERLinear Stapler	AUTO SUTURE(R) TAPREMIUM(TM) UROLOGYSTAPLER	United StatesSurgical Corp.(USSC)	K905106
PANTHERLinear CutterStapler	AUTO SUTURE DISPOSABLEGIA SURG. STAPLER	United StatesSurgical Corp.(USSC)	K801590

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4. Intended Use

The PANTHER Surgical Staplers and there intended uses are as follows:

PANTHER Circular Stapler .

The Panther Circular staplers and accessories have application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

PANTHER Hemorrhoidal Circular Stapler .

The PANTHER Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

PANTHER Linear Stapler

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

PANTHER Linear Cutter Stapler .

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

5. Description of the Devices

PANTHER Circular Stapler

The PANTHER Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. PANTHER Circular Stapler includes 4 series: FCSM, FCSME, FCSMF, and FCSLWBE.

PANTHER Hemorrhoidal Circular Stapler

The PANTHER Hemorrhoidal Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. The Hemorrhoidal Circular Stapler set includes a Hemorrhoidal Circular Stapler, Suture Threader, Circular Anal Dilator and Purse-string Suture Anoscope. PANTHER Hemorrhoidal Circular Stapler includes 4 series: FCSS, FCSSME, FCSSWAE and FCSSWBE.

PANTHER Linear Stapler .

The PANTHER Linear Stapler places a double or triple staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. and is available in 30 mm, 45 mm, 60 mm, 75 mm and 90 mm staple line lengths for use in various applications. The instrument may be reloaded during a single procedure but

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cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Stapler includes 2 series: FLSL, FLSLE

PANTHER Linear Cutter Stapler .

The PANTHER Linear Cutter Staplers place two double staggered rows of titanium staples in organs and tissues to anastomose the internal tissues and simultaneously cut and divide between the two rows during surgical procedures. The PANTHER Linear Cutter Staplers is available in six staple line lengths (55, 60, 75, 80, 100 or110mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Cutter Stapler includes 2 series: SSAA, SSAB.

6. Summary of Performance Data

Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the PANTHER Stapler is substantially equivalent to the predicate devices.

7. Safety & Effectiveness

There are no substantial differences between the PANTHER Group of Surgical Stablers 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.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in black lines. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

B.J.ZH.F. Panther Medical Equipment Co., LTD % Chu Xiaoan Room 1606 Building 1, Jianxiang Yu, No. 209 Bei Si Huan Beijing, China 100083

JAN 1 1 2011

Re: K103470

Trade/Device Name: PANTHER Group of Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: November 15, 2010 Received: November 26, 2010

Dear 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

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Page 2 - Chu Xiaoan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

A. B. 21

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

JAN 1 1 2011

510(k) Number (if known):

Device Name: PANTHER Group of Surgical Staplers

Indications For Use

510(k) Number (if known):

PANTHER The PANTHER Hemorrhoidal Circular Stapler and accessories Hemorrhoidal have application throughout the anal to perform surgical Circular Stapler treatment of hemorrhoidal disease.

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

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF N.

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Concurrence of CDRH, Offeg as Ask SPACE

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103470

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.