(113 days)
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of a reusable circular stapler handle, a disposable reload (containing the anvil, knife, washer, and staples), and accessory set (consisting of the circular anal dilator, pursestring anoscope, anal introducer, and suture threader).
The provided 510(k) summary for the "Reusable PPH Circular Stapler, Disposable Reload & Accessory Set" describes performance data from bench testing and animal tissue testing. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and a study proving a medical AI device meets those criteria. The provided document is for a traditionally mechanical surgical stapler, not an AI device.
Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established, are not applicable or not provided in the context of this document.
However, I can extract the available information and state where details are missing or not relevant to the provided document.
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | "bench testing acceptance criteria were met." (Specific criteria not detailed.) |
| Animal (Tissue) Testing (Leak Pressure) | "leak pressure acceptance criteria." (Specific criteria not detailed, applied to anastomotic stoma created in porcine colon.) |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance: Not specified for bench testing or animal testing. Data provenance is "porcine colon" for animal testing.
- Retrospective/Prospective: Not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified, as this is a mechanical device, and ground truth in this context would likely be physical measurements and observations, not expert interpretations of data like in AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not specified.
-
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: Not applicable, as this is not an AI device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For bench testing: Implied to be engineering specifications and measurement outcomes (e.g., staple formation, material integrity, handle function).
- For animal tissue testing: Measured leak pressure of anastomotic stoma.
-
The sample size for the training set: Not applicable, as this is not an AI device. (The concept of a "training set" is not relevant to the described testing of a mechanical device).
-
How the ground truth for the training set was established: Not applicable, as this is not an AI device.
Summary of Device Performance Studies:
The document states that:
- Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. The results indicated that the acceptance criteria were met.
- Animal (tissue) testing was conducted using porcine colon to evaluate the pressure tolerance of an anastomotic stoma. The results showed that the staple lines created by the device met the "leak pressure acceptance criteria."
Key Missing Information:
The document provides high-level statements but lacks specific details on:
- The exact numerical or qualitative "acceptance criteria" for both bench and animal testing.
- The specific methods and full results of these tests.
- The number of samples/tests performed in each study.
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K103672 page 1/2
510(k) Premarket Notification (Traditional) for Reusable PPH Circular Stapler, Disposable Reload & Accessory
510(k) Summary
APR - 8 2011
Ethicon Endo-Surgery, LLC Company: 475 Calle C Guaynabo, PR 00969
Contact: Dennis Hahn, RAC Director, Regulatory Strategic Initiatives Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3134 Fax: (513) 337-2134 Email: dhahn1@its.jnj.com
Date Prepared: December 16, 2010
Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set
Common or Usual Name: Circular Stapler
Classification Name: Staple, Implantable
Predicate Device: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (cleared under K051301)
Device Description: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of a reusable circular stapler handle, a disposable reload (containing the anvil, knife, washer, and staples), and accessory set (consisting of the circular anal dilator, pursestring anoscope, anal introducer, and suture threader).
Indications for Use: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
Contraindications for use:
- . Do not use where the combined compressed tissue thickness is less than 0.75 mm or greater than 1.5 mm, or where the internal diameter of the rectum will not accommodate the instrument and accessories. If the instrument is used on tissue less than 0.75mm or greater than 1.5 mm in thickness, an inadequate mucosal repair and inadequate hemostasis could result.
- Do not use the instrument on ischemic or necrotic tissue. .
- Do not use the instrument for full rectal wall thickness resection. ●
- Do not use the instrument for the Stapled Transanal Rectal Resection (STARR). ●
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K103672 page 2/2
510(k) Premarket Notification (Traditional) for Reusable PPH Circular Stapler, Disposable Reload & Accessory Set
Technological Characteristics: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of three components: the reusable handle, the disposable reload, and the accessory set. The handle can be used for 200 applications. An adjustable knob on the handle adjusts the device for use on compressed tissue from 0.75 mm to 1.5 mm. The reload, which is designed for a single use, is made up of an anvil head with a diameter of 32.5 mm and two staggered rows of staples. Contained within the same sterile packaging as the reload, the disposable accessory set consists of a circular anal dilator, purse-string anoscope, anal introducer, and suture threader.
Performance Data: Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. Test results demonstrated the bench testing acceptance criteria were met.
Animal (tissue) testing was conducted to evaluate the pressure tolerance of an anastomotic stoma created in porcine colon. Testing results demonstrated that staple lines created by the stapler device met the leak pressure acceptance criteria.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Mr. Dennis Hahn, RAC 4545 Creek Road Cincinnati, Ohio 45242
APR - 8 2011
Re: K103672
Trade/Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 6, 2011 Received: April 7, 2011
Dear Mr. Hahn:
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 - Mr. Dennis Hahn, RAC
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 faor the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alo, 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/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 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 vours.
Aing B. De. ter
for
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
510(k) Number (if known): K103672
Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set
Indications for Use: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Moore for MKM
Page 1 of 1
(Division Sig Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103672
§ 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.