PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP

K041806 · Depuy Mitek, A Johnson & Johnson Company · GAM · Aug 3, 2004 · General, Plastic Surgery

Device Facts

Record IDK041806
Device NamePASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP
ApplicantDepuy Mitek, A Johnson & Johnson Company
Product CodeGAM · General, Plastic Surgery
Decision DateAug 3, 2004
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4493
Device ClassClass 2
AttributesTherapeutic

Intended Use

Passing Needle with PANACRYL, ETHIBOND, or ORTHOCORD 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 Loop 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.

Device Story

Suture and needle assembly for in vivo soft tissue passage during surgical procedures; designed for use with Mitek Suture Passer; may be used with other Mitek anchor products. Device packaged with colored clips for identification. Used by surgeons in orthopedic procedures; facilitates tendon and ligament reconstruction. Provides mechanical means for suture placement; enables tissue approximation and ligation. Benefits patient by allowing minimally invasive arthroscopic repair.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by the predicate status of the constituent suture materials (PANACRYL, ETHIBOND, ORTHOCORD) which have been previously cleared or approved by the FDA.

Technological Characteristics

Suture and needle assembly. Materials: ETHIBOND (poly(ethylene terephthalate)), PANACRYL (polydiaxanone), ORTHOCORD (polydiaxanone). Form factor: Suture/needle assembly with colored clips. Intended for use with Mitek Suture Passer. Sterilization method not specified.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in orthopedic procedures, specifically arthroscopic Bankart and rotator cuff procedures involving tendon and ligament reconstruction.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ AUG - 3 2004 K041806 Page 1/2 # SECTION 2 – 510(k) SUMMARY ### Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture; and Passing Needle with ETHIBOND Loop | Submitter's Name and Address: | DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Ruth C. Forstadt<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Telephone: 781-251-3188<br>Facsimile: 781-278-9578<br>e-mail: rforstad@dpyus.jnj.com | | Name of Medical Device | Classification Name: ETHIBOND<br>Non-absorbable poly(ethylene terephthalate)<br>suture under 21 CFR 878.5000.<br>PANACRYL<br>Absorbable surgical suture, polydiaxanone<br>under 21 CFR 878.4493.<br>ORTHOCORD<br>PDS Suture carries an FDA product code<br>NEW, and is classified as absorbable surgical<br>suture, polydiaxanone under 21 CFR<br>878.4840.<br>Polyethylene sutures carries an FDA product<br>code GAT, and is classified under 21 CFR<br>878.5000.<br>Common/Usual Name: Suture<br>Proprietary Name: Passing Needle with ETHIBOND,<br>PANACRYL or ORTHOCORD suture; and<br>Passing Needle with ETHIBOND Loop | Premarket Notification: Traditional Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture Passing Needle with ETHIBOND Loop {1}------------------------------------------------ K041806 page 2/2 | Substantial Equivalence | PANACRYL sutures have been cleared by FDA - K964345;<br>ETHIBOND sutures have been approved by FDA - NDA 17-804 &<br>17-809;<br>ORTHOCORD sutures have been cleared by FDA- K040004 | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification | Sutures are Class II devices. | | Device Description | Mitek Passing Needle with ETHIBOND, PANACRYL or<br>ORTHOCORD suture is a suture and needle assembly to be used in<br><i>vivo</i> for suture passage through soft tissue during the surgical<br>procedure. It is packaged with two colored clips and is designed to be<br>used with the Mitek Suture Passer. The Passing Needle with<br>PANACRYL, ETHIBOND or ORTHOCORD suture may also be used<br>with other Mitek anchor products.<br><br>Mitek Passing Needle with ETHIBOND Loop is a <i>utility</i> suture and<br>needle assembly that is used in <i>vivo</i> for suture passage of operative<br>suture through soft tissue during the surgical procedure. It is<br>packaged with a colored clip and is designed to be used with the Mitek<br>Suture Passer. | | Indications for Use | Passing Needle with PANACRYL, ETHIBOND, or<br>ORTHOCORD suture is indicated for use in general soft tissue<br>approximation and/or ligation in orthopedic procedures. Specifically<br>Arthroscopic Bankart and Rotator Cuff Procedures encompassing<br>tendon and ligament reconstruction.<br><br>Mitek Passing Needle with ETHIBOND Loop is indicated for use in<br>general soft tissue approximation and/or ligation in orthopedic<br>procedures. Specifically Arthroscopic Bankart and Rotator Cuff<br>Procedures encompassing tendon and ligament reconstruction. | | Safety | These sutures have been cleared through K964345 (PANACRYL),<br>NDA 17-804 & 17-809 (ETHIBOND) and K040004<br>(ORTHOCORD). Safety data may be referenced in these documents. | Image /page/1/Picture/3 description: The image is completely black. There are no discernible shapes, patterns, or objects within the frame. The entire image is filled with a uniform black color, creating a solid, dark void. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of an organization or agency, possibly related to health or human services. The symbol in the center consists of three stylized lines or curves, resembling a bird or a flowing design. The logo has a simple, monochrome design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 UG = 3 2004 Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062 Re: K041806 Trade/Device Name: Passing Needle with Ethibond, Panacryl or Orthocord suture; and Passing Needle with Ethibond Loop Regulation Number: 21 CFR 878.4493, 21 CFR 878.4840, 21 CFR 878.5000 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture; Absorbable polydioxanone surgical suture; Nonabsorbable poly(ethylene terephthalate) surgical suture. Regulatory Class: II Product Code: GAM, NEW, GAT Dated: June 30, 2004 Received: July 6, 2004 Dear Ms. Forstadt: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) of the enactment date of the Medical Device Amendments, or to eoniner of the been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetre Prov (100) and the device, subject to the general controls provisions of the Act. The I va may, increrere, 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 n your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a submitted and 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 r rease be arrison a determination that your device complies with other requirements of the Act that I Dr Haal statutes and regulations administered by other Federal agencies. You must {3}------------------------------------------------ # Page 2 - Ms. Ruth C. Forstadt comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR Fart 807), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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) This letter whit anow you to begin mailing of substantial equivalence of your device to a legally prematication. The PDF Intellig sification 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 If you ucsire specific acries ion 100 - 301) 594-4659. Also, please note the regulation entitled, Comaci the Office of Council cation" (21CFR Part 807.97). You may obtain Missuranting of telefonoe to premation on your the Act from the Division of Small other general informational 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 {4}------------------------------------------------ # Indications for Use # 510(k) Number (if known): KOY (806 #### Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture; Device Name:__________________________________________________________________________________________________________________________________________________________________ and Passing Needle with ETHIBOND Loop Indications For Use: Passing Needle with ETHIBOND, PANACRYL or ORTHCORD subure is indicated for use in Passing Needle With ETHIBOND, I ANTICA I D Chrosedic procedures. Specifically Arthroscopic general soft tissue approximation and/or ligation in orthopedia.organstration general son thsue approximation and of inguited in consisted on and ligament reconstruction. Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstructi Passing Needle with ETHIBOND Loop is indicated for use in general soft issue approximation and/or Passing Needle will ETHIDOND Evop is marcated for as a good and 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 | | | 510(k) Number | K041806 | | Page 1 of | | Premarket Notification: Traditional Passing Needles with ETHIBOND, PANACRYL or ORTHOCORD suture Passing Needle with ETHIBOND Loop
Innolitics
510(k) Summary
Decision Summary
Classification Order
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