(41 days)
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The PROXIMATE PPH 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, from which the name of the modified device is derived.
The provided text describes a 510(k) submission for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (PPH03). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be seen in a de novo or PMA application.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to cut and staple intraluminal tissue in a manner similar to the predicate device. | Preclinical testing demonstrated the ability of the PPH device to cut and staple intraluminal tissue in a manner similar to the predicate, thus meeting all the requirements of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Preclinical testing," which typically refers to bench testing or animal studies, not human clinical trials. No specific sample size for a "test set" (human subjects) is mentioned. No data provenance in terms of country of origin or retrospective/prospective human data is provided since human clinical studies are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" in this context would likely be based on technical specifications and performance metrics aligned with the predicate device, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process for a "test set" of human data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical stapler, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on the functional equivalence to the predicate device in terms of its ability to cut and staple intraluminal tissue. This would likely be assessed through engineering specifications, material testing, and potentially animal model performance mimicking the predicate's known capabilities.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a mechanical device, not an AI model.
Summary from the provided text:
The submission for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories is a 510(k) application, which primarily aims to demonstrate substantial equivalence to an existing predicate device (PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories, K991030). The "study" mentioned is "Preclinical testing," which focused on demonstrating that the new device could perform its intended function (cutting and stapling intraluminal tissue) in a manner similar to the predicate device. The acceptance criteria essentially align with the functional performance of the predicate device. No human clinical trials, expert reviews for ground truth, or AI-related performance metrics are detailed in this 510(k) summary.
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PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (PPH03)
510(k) Summary of Safety and Effectiveness
MAR 2 0 2003
Company:
Ethicon Endo-Surgery. Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact:
Name: Carol Sprinkle Title: Regulatory Affairs Specialist
Date Prepared:
February 6, 2003
Name of Device:
Trade Name: PROXIMATE® PPH 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:
The PROXIMATE PPH 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, from which the name of the modified device is derived.
Indications for Use:
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Technological Characteristics:
The PROXIMATE PPH Hemorrhoidal Circular Stapler is similar to the predicate device, in that it is a single-use sterile device with the same intended use and basic technology.
Performance Data
Preclinical testing demonstrated the ability of the PPH device to cut and staple intraluminal tissue in a manner similar to the predicate, thus meeting all the requirements of substantial equivalence.
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Public Health Service
MAR 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K030411
Trade/Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: February 6, 2003 Received: February 7, 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,
Mark A. Mulkeran
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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510(k) Number (if known): KO30411
Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories
Indications for Use:
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Mark N. Milken
Division Sign-Off Division of General, I revocative and Neurological Devices
510(k) Number -
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
§ 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.