(80 days)
The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.
The subject device is designed to deliver fixation springs via a minimally invasive sterile disposable instrument that is for single patient use. The fixation springs are made of nitinol and are composed of 3 coils that are approximately .18 inches in diameter. The spring is held within the lumen of a needle is inserted through the tissue or prosthetic material to be approximated or fixated and the spring is pushed out so that approximately 1 coil of the spring is released. The needle is then withdrawn from the tissue or prosthetic material while the remainder of the spring is pushed out thereby deploying at least one coil on the proximal surface of the tissue or prosthetic material. Because the spring is manufactured such that the coils are naturally pre-compressed against each other, the distal and proximal coils place a compression force on the tissue or prosthetic material that holds them together.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details.
The document is a 510(k) summary for a medical device (Coil Fixation Device) and focuses on describing the device, its intended use, and claiming substantial equivalence to a predicate device. It does not include the detailed study results or performance metrics you requested.
{0}------------------------------------------------
DEC 2 7 2002
510(k) Summary
K02 3372
page lofl
10/4/2002
| Company: | Onux Medical, Inc5 Merrill DriveHampton, NH 03842 |
|---|---|
| Contact Person: | Ruthann R. DePietro, Vice President, Quality Assurance andRegulatory Assurance |
| Trade or Proprietary Name: | Not available |
| Common or Usual Name: | Endoscopic stapler and staple |
| Classification Name: | Endoscopic and/or Accessory, Implantable Staple |
Devices to Which Equivalence is Claimed
The subject device has equivalency to the EndoANCHOR produced by Ethicon Endo-Surgery, Inc. (K013749).
Description of Subject Device
The subject device is designed to deliver fixation springs via a minimally invasive sterile disposable instrument that is for single patient use. The fixation springs are made of nitinol and are composed of 3 coils that are approximately .18 inches in diameter. The spring is held within the lumen of a needle is inserted through the tissue or prosthetic material to be approximated or fixated and the spring is pushed out so that approximately 1 coil of the spring is released. The needle is then withdrawn from the tissue or prosthetic material while the remainder of the spring is pushed out thereby deploying at least one coil on the proximal surface of the tissue or prosthetic material. Because the spring is manufactured such that the coils are naturally pre-compressed against each other, the distal and proximal coils place a compression force on the tissue or prosthetic material that holds them together.
Intended Use of Subject Device
Both the subject device and the EndoANCHOR are indicated for fixation of prosthetic mesh material and approximation of tissue in endoscopic and open surgical procedures.
Comparison of Technical Aspects
The subject device and the EndoANCHOR use an elastic deformation force from nitinol fixation constructs to produce a holding force on the tissue or prosthetic material being approximated or fixated. The subject device uses a spring to compress and hold material that is between its coils while the EndoANCHOR uses opposing pairs of flexible tabs that push against and compress the material held between them.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like design connecting them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ruthann DePietro Vice President Quality Assurance and Regulatory Assurance Onux Medical, Inc. 5 Merrill Drive Hampton, New Hampshire 03842
Re: K023372
Trade/Device Name: Coil Fixation Device Regulation Number: 21 CFR 878.4495; 21 CFR 876.1500 Regulation Name: Stainless Steel Suture; Endoscope and Accessories Regulatory Class: II Product Code: NJU; GCJ Dated: October 4, 2002 Received: October 8, 2002
Dear Ms. DePietro:
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. This letter will allow you to begin marketing your device as described in your Section 510(k)
DEC 2 7 2002
{2}------------------------------------------------
Page 2 - Ms. Ruthann DePietro
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). 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 N. Mellema
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
{3}------------------------------------------------
Page 1 of 1
| 510(k) Number (if known): | K023372 |
|---|---|
| Device Name: | Coil Fixation Device |
| Indications For Use: |
and the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the country of the
The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use__________
(Optional Formal 1-2-96)
Mark N. Millerson
on-Remoral Restorative and Neurological Devices
510(k) Number K023372
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.