BLUE ORTHOCORD SUTURE

K043298 · Depuy Mitek · NEW · Dec 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K043298
• Device Name: BLUE ORTHOCORD SUTURE
• Applicant: Depuy Mitek
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Dec 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

Device Story

Blue ORTHOCORD suture is a synthetic, sterile, braided composite suture; composed of dyed (D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene; coated with a copolymer of 90% caprolactone and 10% glycolide. Used by surgeons in clinical settings for soft tissue approximation and ligation during orthopedic and general surgical procedures. The device provides mechanical tissue support during healing.

Clinical Evidence

Bench testing only. Device performance verified through non-clinical laboratory testing demonstrating conformance to USP monograph for absorbable sutures.

Technological Characteristics

Braided composite suture; materials: polydioxanone (absorbable) and polyethylene (non-absorbable); coating: 90% caprolactone and 10% glycolide copolymer; dyed with D&C Blue #6. Sterile, synthetic construction.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including orthopedic surgeries, in patients requiring surgical suture.

Regulatory Classification

Identification

An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for the 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

• Violet ORTHOCORD suture (K040004)
• PDS II suture (N18331)

Submission Summary (Full Text)

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## DEC 1 0 2004

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## 510(k) SUMMARY

## Blue ORTHOCORD suture

| Submitter's Name and<br>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: [phone]<br>Facsimile: 781-278-9578<br>e-mail: [e-mail] | |
| Name of Medical Device | Classification Name:<br>Common/Usual Name:<br>Proprietary Name: | Non-absorbable poly(ethylene terephthalate)<br>surgical suture; and<br>Suture, Surgical, Absorbable, Polydioxanone<br>Suture<br>Blue ORTHOCORD suture |
| Substantial Equivalence | Blue ORTHOCORD suture is substantially equivalent to:<br>Violet ORTHOCORD suture (K040004) manufactured by Mitek; and<br>PDS II suture (N18331) manufactured by Ethicon, Inc. | |
| Device Classification | Sutures, classified by the FDA, are Class II Medical Devices.<br>PDS Suture carries an FDA product code NEW, and is classified as<br>absorbable surgical suture, polydiaxanone under 21 CFR 878.4840.<br>Polyethylene suture carries an FDA product code GAT, and is classified<br>under 21 CFR 878.5000. | |
| Device Description | Blue ORTHOCORD suture is a synthetic, sterile, braided composite<br>suture composed of dyed (D&C Blue #6) absorbable polydioxanone<br>(PDS) and un-dyed non-absorbable polyethylene. The partially<br>absorbable suture is coated with a copolymer of 90% caprolactone and<br>10% glycolide. | |
| Indications for Use | Blue ORTHOCORD suture is indicated for use in general soft tissue<br>approximation and/or ligation, including use in orthopedic surgeries. | |
| Safety and Performance | The determination of substantial equivalence for this device was based<br>on a detailed device description, and conformance to consensus and<br>voluntary standards. Non-clinical laboratory testing was performed<br>demonstrating that the device conformed to the USP monograph for<br>absorbable sutures. | |
| | Based on the indications for use, technological characteristics, and<br>comparison to predicate devices, the blue ORTHOCORD suture has<br>been shown to be substantially equivalent to predicate devices under the<br>Federal Food, Drug and Cosmetic Act. | |

510(k) Premarket Notification: Special Blue ORTHOCORD suture

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2004

Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K043298

Trade/Device Name: Blue Orthocord Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: November 29, 2004 Received: November 30, 2004

Dear Ms. Forstadt:

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 10 mmerce 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 ou may, attress, and see 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.

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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) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provoost

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): Ko 43298

Device Names: Blue ORTHOCORD suture

Indications for Use:

Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

Prescription Use V (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

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**and Neurological Devices**

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510(k) Premarket Notificatios TO(ki) Number___________________________________________________________________________________________________________________________________