(182 days)
Not Found
No
The summary describes a mechanical clip and delivery system with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
Explanation: The device is intended to assist in the creation of anastomoses and for the surgical approximation of tissue; it does not treat or cure a disease or condition.
No
The device is described as assisting in the creation of anastomoses and surgical approximation of tissue, indicating it is an interventional or therapeutic device rather than one used for diagnosis.
No
The device description explicitly states it consists of an implantable clip (hardware) and a delivery system (hardware). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for assisting in surgical procedures (creating anastomoses, approximating tissue). This is a direct surgical intervention on the patient's body.
- Device Description: The description details an implantable clip and a delivery system, which are physical tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during a surgical procedure.
N/A
Intended Use / 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.
Product codes
FZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Appropriate product testing was conducted to evaluate conformance to riproprise specification and substantial equivalence to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K032896 page 1/2
MAR 1 7 2004
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Refix Clip |
| Manufacturer | Anson Medical |
| 67 Milton Park, | |
| ABINGDON, | |
| Oxfordshire, | |
| United Kingdom. | |
| OX14 4RX | |
| Contact | Ian Quirk |
| Commercial Clinical and Regulatory Affairs | |
| Manager |
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.
2
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.
3
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
4
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
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510(k) Number_KG32896_