Single Use Curved Intraluminal Circular Stapler
The CHEX™ Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.
Circular Stapler for Rectal Prolapse and Hemorrhoid
The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.
Single Use Reloadable Linear Stapler
The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Single Use Reloadable Linear Cutter Stapler
The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.

Device Description

The Chex™ Staplers were 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:

The Chex™ Single Use Curved Intraluminal Circular Stapler places a circular, double staqqered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 25mm, 28mm, or 32mm stapler.

The Chex™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal mucosa above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal mucosa. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.

The Chex™ Disposable Reloadable Linear Stapler places a double staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. The Linear Stapler is available in 30mm, 45mm, 60mm, and 90mm 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.

The Chex™ Linear Cutter Disposable Reloadable Stapler delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 100mm). 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. The use of the instrument with stable buttressing materials, or across a previous staple line, may reduce the number of firings.

AI/ML Overview

This FDA 510(k) summary (K090821) is for surgical staplers, which are mechanical devices. The acceptance criteria and "device performance" in this context refer to the physical and mechanical properties of the staplers, not to performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices. Therefore, the questions related to AI/software performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable.

Here's an analysis of the provided information regarding the acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't provide a specific table of "acceptance criteria" with numerical targets in the way an AI/software device submission would. Instead, it states that the devices were tested and "passed all required" testing, and in some cases, "produced superior results." The acceptance criteria are implicitly defined by compliance with a set of international standards and by demonstrating substantial equivalence to predicate devices, and sometimes superior clinical outcomes compared to manual suturing.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility	Cytotoxicity, skin irritation, and delayed contact sensitization tests were conducted in accordance with ISO 10993. Result: "Passed all required biocompatibility testing."
Physical Characteristics	Appearance, dimensions, stapler compatibility with cartridge, and sterility per ISO 11737 and EN 552 were tested. Result: "Passed all required [...] testing."
Performance Characteristics (Mechanical)	Strength and closure performance were tested. Result: "Passed all required [...] testing."
Substantial Equivalence (Mechanical Performance Comparison)	A performance test was conducted comparing the Chex™ Single Use Curved Intraluminal Circular Stapler and the Chex™ Disposable Reloadable Linear Stapler to analogous Ethicon staplers. Result: "Based on this test, the design and construction of the Frankenman and Ethicon staplers were determined to be substantially equivalent."
Clinical Performance (Comparison to Manual Suturing/Competitors)	Clinical testing of each stapler line. Result: "produced superior results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices." This implies that the staplers met performance criteria for these clinical outcomes at least as well as, or better than, the comparators. Specific acceptance thresholds for "superior" are not quantified in this summary.

Regarding AI/Software specific questions:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This is not applicable as the submission is for a physical surgical stapler, not an AI/software device. The "test set" in this context would refer to tested units of the stapler.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable for a physical surgical stapler. "Ground truth" in this context could refer to accurate measurements of physical properties or expert assessment of clinical outcomes, but the submission does not detail the number or qualifications of individuals involved in these aspects beyond generic statements about "clinical testing."
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for a physical surgical stapler.
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
- This is not applicable for a physical surgical stapler. The closest equivalent is the comparison of the staplers' clinical performance to manual suturing and competitors' devices, which is not an MRMC study for AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable for a physical surgical stapler. The "standalone" performance here refers to the stapler's mechanical and clinical function without human intervention in its design or manufacturing, but its use inherently involves a surgeon.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical/mechanical tests, the "ground truth" would be established by validated measurement techniques and adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11737 and EN 552 for sterility).
- For the clinical performance, the "ground truth" was based on "post-operative healing, pain management, anastomotic leakage, and bleeding" outcomes, which are typical clinical outcome measures derived from patient data.
The sample size for the training set
- This is not applicable for a physical surgical stapler.
How the ground truth for the training set was established
- This is not applicable for a physical surgical stapler.

Summary

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K09 0821
Page 1 of 3

510(k) Summary (per 21 CFR 807.92(c))

1. Applicant

JUN 1 0 2009

Frankenman International Limited Suite B, 13/F Wing Tat Commercial Building 121 - 125 Winq Lok Street Sheung Wan, Hong Kong China

Contact Person: Lee Edwards, President-International Business Tel: 852 3106 3035 Fax: 852 3585 0519 E-mail: lee.edwards@frankenman.hk

Date Prepared: March 1, 2009

2. Device Name

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

3. Predicate Devices

The Chex™ Family of Surgical Staplers, which include:

Single Use Curved Intraluminal Circular Stapler, .
. Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids,
Single Use Reloadable Linear Stapler and Reloads, and .
Single Use Reloadable Linear Cutter Stapler and Reloads ♥ are substantially equivalent to:

Subject Device	Predicate Device
	Name	Company	510(k) Number
Chex™ Single UseCurved IntraluminalCircular Stapler	Endopath ILS EndoscopicCircular Stapler	Ethicon	K920752
Chex™ Single UseCurved IntraluminalCircular Stapler	Autosuture™ Circular EEASurgical Staplers	United StatesSurgical Corp.(USSC)	K062850
	Autosuture™ Premium PlusCEEA Disposable Staplers		K024275
	Autosuture™ Premium PlusCEEA Disposable Staplers		K020804 K001895
Chex™ Single UseCircular Stapler forRectal Prolapse andHemorrhoids	Proximate PPH HemorrhoidalCircular Stapler and	Ethicon Endo-Surgery, Inc.	K051301

Accessories

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Subject Device	Predicate Device		510(k)Number
	Name	Company
	Hemorrhoidal Circular Staplerand Accessories		K991030
	Hemorrhoidal Circular Staplerand Accessories		K030925
Chex™ Single UseReloadable LinearStapler and Reloads	Disposable Linear Stapler(LSF)	Ethicon	K822345
	Auto Suture™ TA premium™	USSC	K905106
Chex™ LinearCutter DisposableReloadable Stapler	Auto Suture™ DisposableGIA™ Surgical Stapler	USSC	K801590
	Proximate Linear Cutters andStapler (not Endopath)	Ethicon Endo-Surgery, Inc.	K951546

4. Intended Use

The Chex Family of Staplers and there intended uses are as follows:

Single Use Curved Intraluminal Circular Stapler .

The CHEX™ Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.

Circular Stapler for Rectal Prolapse and Hemorrhoid

The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surqical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.

Single Use Reloadable Linear Stapler

The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

Single Use Reloadable Linear Cutter Stapler

The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.

5. Description of the Devices

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K0'90821
Page 3 of 3

6. Summary of Performance Data

Each of the four Chex™ Staplers were tested and passed all required biocompatibility testing. Specifically, cytotoxcity, skin irritation, and delayed contact sensitization were conducted in accordance with ISO 10993. Secondly, Frankenman tested each stapler to validate both physical (i.e., appearance, dimensions, stapler compatibility with cartridge, sterility per ISO 11737 and EN 552) and performance characteristics (strength, closure performance). Thirdly, a performance test was conducted comparing the Chex™ Sinqle Use Curved Intraluminal Circular Stapler and the Chex™ Disposable Reloadable Linear Stapler to analogous Ethicon staplers. Based on this test, the design and construction of the Frankenman and Ethicon staplers were determined to be substantially equivalent. Finally, clinical testing of each stapler line produced superior results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices.

7. Safety & Effectiveness

There are no substantial differences between the Chex™ Family of Staplers defined in this 510(k) submission and the predicate devices. They have the same or similar Indications for Use. In addition, the minor differences in technological characteristics do not raise issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2009

Frankenman International Limited % Emergo Group. Incorporated Ms. Jean Asquith Senior Consultant, Regulatory Affairs 1705 South Capitol of Texas Highway, Suite 500 Austin, Texas 78746

Re: K090821

Trade/Device Name: CHEX™ Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: March 6, 2009 Received: March 30, 2009

Dear Ms. Asquith:

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.

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

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Page 2-Ms. Jean Asquith

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

510(k) Number (if known): K090821

Device Name: CHEX™ Surgical Staplers

Indications for Use:

The Chex Family of Staplers and there intended uses are as follows:

1. Single Use Curved Intraluminal Circular Stapler

2. Circular Stapler for Rectal Prolapse and Hemorrhoid

The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.

3. Single Use Reloadable Linear Stapler

The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

4. Single Use Reloadable Linear Cutter Stapler

The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K990821

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.