(41 days)
Passing Needle with ETHIBOND, PANACRYL or ORTHCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.
The provided document is a 510(k) Pre-market Notification for a medical device: "Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with acceptance criteria for a novel device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.
The document explicitly states:
- "Substantial Equivalence: PANACRYL sutures have been cleared by FDA - K964345; ETHIBOND sutures have been approved by FDA - NDA 17-804 & 17-809; ORTHOCORD sutures have been cleared by FDA- K040004"
- "Safety: These sutures have been cleared through K964345 (PANACRYL), NDA 17-804 & 17-809 (ETHIBOND) and K040004 (ORTHOCORD). Safety data may be referenced in these documents."
This indicates that the current submission relies on the safety and effectiveness data of the predicate sutures themselves, and not a new study on the "Passing Needle" device that would establish new performance criteria. The "Passing Needle" likely refers to the delivery mechanism for these pre-existing sutures.
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K042233 page1/2
SEP 2 8 2004
SECTION 2 – 510(k) SUMMARY
Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 | |
|---|---|---|
| Contact Person | Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-3188Facsimile: 781-278-9578e-mail: rforstad@dpyus.jnj.com | |
| Name of Medical Device | Classification Name: | ETHIBONDNon-absorbable poly(ethylene terephthalate)suture under 21 CFR 878.5000.PANACRYLAbsorbable surgical suture, polydiaxanoneunder 21 CFR 878.4493.ORTHOCORDPDS Suture carries an FDA product codeNEW, and is classified as absorbable surgicalsuture, polydiaxanone under 21 CFR878.4840.Polyethylene sutures carries an FDA productcode GAT, and is classified under 21 CFR878.5000. |
| Common/Usual Name: | Suture | |
| Proprietary Name: | Passing Needle with ETHIBOND,PANACRYL or ORTHOCORD suture | |
| Substantial Equivalence | PANACRYL sutures have been cleared by FDA - K964345;ETHIBOND sutures have been approved by FDA - NDA 17-804 &17-809;ORTHOCORD sutures have been cleared by FDA- K040004 | |
| Premarket Notification: Traditional | Confidential | |
| Passing Needle with ETHIBOND, PANACRYL or ORTHOCORDsuture has been cleared by the FDA - K041806. | ||
| Device Classification | Sutures are Class II devices. | |
| Device Description | Mitek Passing Needle with ETHIBOND, PANACRYL orORTHOCORD suture is a suture and needle assembly to be used invivo for suture passage through soft tissue during the surgicalprocedure. It is packaged with colored clips and is designed to beused with the Mitek Suture Passer. The Passing Needle withPANACRYL, ETHIBOND or ORTHOCORD suture may also be usedwith other Mitek anchor products. | |
| Indications for Use | Passing Needle with PANACRYL, ETHIBOND, orORTHOCORD suture is indicated for use in general soft tissueapproximation and/or ligation in orthopedic procedures. SpecificallyArthroscopic Bankart and Rotator Cuff Procedures encompassingtendon and ligament reconstruction. | |
| Safety | These sutures have been cleared through K964345 (PANACRYL),NDA 17-804 & 17-809 (ETHIBOND) and K040004(ORTHOCORD). Safety data may be referenced in these documents. |
Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture
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K042233 page2/2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol consisting of three abstract shapes that resemble human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2004
Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K042233
Trade/Device Name: Passing Needle with Ethibond, Panacryl, or Orthcord suture Regulation Number: 21 CFR 878.4493 Regulation Name: Polyglycolic acid suture Regulatory Class: II Product Code: GAM, NEW, GAT Dated: August 17, 2004 Received: August 18, 2004
Dear Ms. Forstadt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve rowed for a we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 197 are 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 r ca may) and 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 If your de rise 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.
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Page 2 - Ms. Ruth C. Forstadt
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in Journe FDA finding of substantial equivalence of your device to a legally premanted 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 conact 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 other general 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
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):
Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Passing Needle with ETHIBOND, PANACRYL or ORTHCORD suture is indicated for use in I worning in tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.,
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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
Page 1 of
510(k) Number K042233
Premarket Notification: Traditional
Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). 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.