(182 days)
The Anson Refix tissue and vascular clip is intended:
- To assist in the creation of anastomoses in blood vessels, grafts, and, .
- For the surgical approximation of tissue to tissue, or tissue to woven graft . material for general and vascular surgery.
The Refix tissue and vascular clip consists of an implantable clip and a delivery system. The Anson Refix Clip is comprised of a single monofilament, Nitinol wire, which is sharpened at both ends. The arms of the device are curved as in a bow and are separated via a loop of wire in the center.
The provided text is a 510(k) summary for the Anson Refix Clip, a medical device. It describes the device's intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics and study methodologies (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).
The document states: "Appropriate product testing was conducted to evaluate conformance to riproprise specification and substantial equivalence to predicate devices." This is a general statement and does not provide the detailed information requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.
Here's a breakdown of why the information is missing and what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document only states "Appropriate product testing was conducted to evaluate conformance to riproprise specification." Specific performance metrics (e.g., clip strength, closure force, biocompatibility safety thresholds, failure rates, etc.) are not detailed. | Not provided in the document. As the acceptance criteria are not detailed, neither are the specific performance outcomes against those criteria. The document only concludes "The Anson Refix Clip is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document generally mentions "Appropriate product testing," but no specifics on sample sizes, test set composition, or data provenance.
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 provided. This device is a surgical clip, not a diagnostic imaging AI. "Ground truth" in the context of diagnostic AI refers to adjudicated diagnoses or pathology results. For a physical device like this, testing would involve engineering, material, and biocompatibility assessments, not "ground truth" established by experts in a diagnostic sense. Details about any clinical experts involved in performance testing are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. See explanation for #3.
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 a physical surgical clip, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant or applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical surgical clip, not an algorithm. Standalone performance as defined for AI (algorithm only) is not relevant. The device itself is "standalone" in the sense that it performs its intended function (clipping) without inherent "human-in-the-loop" AI decision-making.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided in detail. For a medical device like this, "ground truth" would relate to objective measurements of physical properties (e.g., tensile strength, corrosion resistance, biocompatibility standards, securement force), and potentially in vivo or ex vivo surgical outcomes in animal or cadaver models, or clinical observations for predicate device equivalence. The document only states "conformance to appropriate specification and substantial equivalence to predicate devices."
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See explanation for #8.
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K032896 page 1/2
MAR 1 7 2004
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Refix Clip |
| Manufacturer | Anson Medical67 Milton Park,ABINGDON,Oxfordshire,United Kingdom.OX14 4RX |
| Contact | Ian QuirkCommercial Clinical and Regulatory AffairsManager |
Intended Use
The Anson Refix tissuc and vascular clip is intended:
- To assist in the creation of anastomoses in blood vessels, grafts, . and,
- For the surgical approximation of tissue to tissue, or tissue to . woven graft material for general and vascular surgery.
Predicate Devices
The predicate device for the Refix™ device is the Coalescent Surgical U-Clip (K012317, K994160 and K971588). The Coalescent U Clip is classified as an Implantable Clip and Delivery System per 21CFR878.4300 and 21CFR878.4800.
Device Description
The Refix tissue and vascular clip consists of an implantable clip and a delivery system. The Anson Refix Clip is comprised of a single monofilament, Nitinol wire, which is sharpened at both ends. The arms of the device are curved as in a bow and are separated via a loop of wire in the center.
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K032896 Page 2/2
Materials
All materials used in the manufacture of the Anson Refix Clip are suitable for All matchals about in the main and in numerous previously cleared products. tills use and nave been assume with ISO 10993-1 to ensure appropriate biocompatibility of all materials.
Testing
Appropriate product testing was conducted to evaluate conformance to riproprise specification and substantial equivalence to predicate devices.
Summary of Substantial Equivalence
The Anson Refix Clip is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three wing feathers and a tail feather. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
MAR 1 7 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ian H.Quirk Commercial Clinical and Regulatory Affairs Manager Anson Medical Ltd. 67 Milton Park Nr. Abingdon Oxon, OX14 4RX
Re: K032896
Trade/Device Name: Anson Refix Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: February 2, 2004 Received: February 5, 2004
Dear Mr. Quirk:
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 10 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 docs 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 - Mr. Ian H.Quirk
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. 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 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
fol 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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Indications for Use
510(k) Number (if known): K032896
Device Name: Anson Refix Clip
Indications For Use:
The Anson Refix tissue and vascular clip is intended:
- To assist in the creation of anastomoses in blood vessels, grafts, and, .
- For the surgical approximation of tissue to tissue, or tissue to woven graft . material for general and vascular surgery.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mìriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_KG32896_
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.