(90 days)
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.
The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments that deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications. The nitinol anchors are 5.9 mm long and 6.7 mm wide. The EndoANCHOR fixation device is designed for endoscopic surgical use with a trocar or for oven surgical use. Two sizes of the EndoANCHOR Fixation Device are offered: a 3 mm and 5 mm diameter shaft. Both instrument shafts are 301 mm long and contain 20 nitinol anchors. The OpenANCHOR Fixation Device is designed for open surgical use. The instrument has a 132mm long, 3 mm diameter shaft and contains 10 nitinol anchors.
Here's an analysis of the provided text regarding the EndoANCHOR and OpenANCHOR fixation devices' acceptance criteria and supporting study, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance | Study Type |
|---|---|---|---|
| Safety | Safe for intended use | "Preclinical testing was performed to ensure the device performs as intended" and "demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures." | Bench and animal testing |
| Effectiveness/Functionality | Performs as intended | "Preclinical testing was performed to ensure the device performs as intended when used I roomling to the instructions for use." and "demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures." | Bench and animal testing |
| Material Compatibility | Biocompatible (implied by material type and intended use) | Nitinol anchors used; no adverse events reported, suggesting compatibility. | N/A (implied by general safety) |
| Sterility | Sterile for single patient use | "The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments." | N/A (implied by device description) |
| Fixation/Approximation | Achieves fixation of prosthetic material and approximation of soft tissue | "deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications." and "demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures." | Bench and animal testing |
Explanation of Inferred Criteria: The document is a 510(k) summary, which often focuses on substantial equivalence rather than explicit, quantified acceptance criteria. Therefore, the "specific criteria" are inferred from the stated purpose of the preclinical testing and the nature of medical device approval for devices of this type. The statement "ensure the device performs as intended" broadly encapsulates these inferred criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated. The document refers to "bench and animal testing" but does not provide specific numbers of animals or test configurations.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective relative to the 510(k) submission, as the testing was already completed when the summary was prepared.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The summary focuses on preclinical performance data rather than human expert evaluation of test results.
4. Adjudication Method for the Test Set
- Adjudication method is not applicable and therefore not mentioned, as the study involves bench and animal testing, not human readers interpreting data that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The preclinical testing comprised bench and animal studies to assess the device's performance, not to evaluate human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a mechanical surgical instrument, not an algorithm or AI. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- The ground truth for the preclinical testing was established through direct observation and measurement of device function and biological response in bench and animal models. This would include:
- Mechanical performance: (e.g., anchor deployment success, tensile strength of fixation)
- Biological response: (e.g., tissue integration, inflammatory response, absence of adverse events in animal models)
- Clinical outcomes in animal models: (e.g., successful approximation of tissue, durable fixation over time).
8. The Sample Size for the Training Set
- Not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML model, there is no training set or associated ground truth establishment method.
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EndoANCHOR and OpenANCHOR 510(k) Summary of Safety and Effectiveness
Company:
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati. OH 45242
FEB 1 1 2002
1/2
Contact:
Name: Doug Kentz Title: Regulatory Affairs Associate II
Date Prepared:
November 12, 2001
Name of Device:
Trade Name: EndoANCHOR and OpenANCHOR Fixation Devices Classification Name: Stapler, General & Plastic Surgery
Predicate Devices:
- Ethicon Endo-Surgery, Inc. ENDOPATH EMS cleared under K913469 on September . 30 1991.
- United States Surgical Corp. AutoSuture™ ProTack™ cleared under K963999 on . November 27, 1996.
Device Description:
The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments that deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications. The nitinol anchors are 5.9 mm long and 6.7 mm wide. The EndoANCHOR fixation device is designed for endoscopic surgical use with a trocar or for oven surgical use. Two sizes of the EndoANCHOR Fixation Device are offered: a 3 mm and 5 mm diameter shaft. Both instrument shafts are 301 mm long and contain 20 nitinol anchors. The OpenANCHOR Fixation Device is designed for open surgical use. The instrument has a 132mm long, 3 mm diameter shaft and contains 10 nitinol anchors.
Intended Use:
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.
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Technological Characteristics:
The EndoANCHOR and OpenANCHOR Fixation devices are similar to the predicate I ho Endor INON of the same intended use however these devices deploy an anchor shaped implant made of nitinol for fixation and approximation purposes.
Performance Data
Preclinical testing was performed to ensure the device performs as intended when used I roomling to the instructions for use. Bench and animal testing demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Doug Kentz, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K013749
Trade/Device Name: EndoANCHOR and OpenANCHOR Fixation Devices Regulation Number: 878.4750, 876.1500 Regulation Name: Implantable staple Endoscope and accessories Regulatory Class: II
Product Code: GDW, GCJ Dated: November 12, 2001 Received: November 13, 2001
Dear Mr. Kentz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 accordance with the provisions of the Federal Food, Drug, de nees that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, clerelore, mains 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 11 your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a saterial 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 I lease of devices and i Drimination that your device complies with other requirements of the Act than I Dr Haral statutes and regulations administered by other Federal agencies. You must or any 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 form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Doug Kentz, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in you've FDA finding of substantial equivalence of your device to a legally prematicated 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 and If you dosille specific advices and vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (201) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information turers, 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,
Muriam C. Provost
for 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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Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by a zero with a diagonal line through it, then the numbers '13749'. The characters are written in a simple, clear style, making them easily readable.
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510(k) Number (if known): Kol 3749
Device Name: EndoANCHOR and OpenANCHOR Fixation Devices
Indications for Use:
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material I he EndoALVCHON Pradion between various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material t he Open in Croxia of soft tissue in various open general surgical procedures, such as hernia repair.
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)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013749
§ 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.