The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Device Description

The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired.

AI/ML Overview

The provided text describes a 510(k) submission for the PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories. However, it does not contain information about acceptance criteria, device performance, sample size for testing or training, expert qualifications for ground truth, or adjudication methods.

The submission is primarily focused on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and clinical evidence in the form of published clinical data and other information, rather than a new clinical study with specific performance metrics and acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified for this submission. The device is stated to be "identical to the predicate device" with only changes in "Indications for Use statement and Instructions for Use." Clinical evidence is cited as "Published clinical data and other information demonstrat[ing] the general utility of the HCS device to staple and resect anorectal tissue..."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The submission refers to "Published clinical data and other information" without detailing specific studies or sample sizes.
Data Provenance: Not specified.

3. 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)

Not applicable/Not specified. The submission relies on existing clinical data and the substantial equivalence principle, not a new test set with expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified.

5. 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, this is not an AI-based device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical stapler, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated for this 510(k) submission itself. For the "Published clinical data" referenced, it would typically involve clinical outcomes data from surgical procedures where the device was used.

8. The sample size for the training set

Not applicable/Not specified. This is a hardware device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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MAY 15 2003

K0309225

PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories (PPH01)

510(k) Summary of Safety and Effectiveness

Company:

Date Prepared: March 21, 2003

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

Contact:

Name: Carol Sprinkle Title: Regulatory Affairs Specialist

Name of Device:

Trade Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories Common Name: Intraluminal Stapler (ILS) Classification Name: Implantable Staple, General & Plastic Surgery Surgical Device

Predicate Device:

PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories (K991030).

Device Description:

Indications for Use:

Technological Characteristics:

The PROXIMATE HCS Hemorrhoidal Circular Stapler is identical to the predicate device. The only changes are in the Indications for Use statement and Instructions for Use.

Clinical Evidence:

Published clinical data and other information demonstrate the general utility of the HCS device to staple and resect anorectal tissue in various procedures similar to the previously cleared Indications for Use for surgical treatment of hemorrhoidal disease, thus meeting all the requirements of substantial equivalence.

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Image /page/1/Picture/1 description: The image is the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles embedded within the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2003

Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K030925

Trade/Device Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 21, 2003 Received: March 24, 2003

Dear Ms. Sprinkle :

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 such 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); 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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Page 2 - Ms. Carol Sprinkle

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page | of _ of _(

510(k) Number (if known): _ K D30925

Device Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories

Indications for Use:

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030925

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)

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.