CYTOPLAST PTFE SUTURE

K072076 · Osteogenics Biomedical, Inc. · NBY · Oct 31, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072076
• Device Name: CYTOPLAST PTFE SUTURE
• Applicant: Osteogenics Biomedical, Inc.
• Product Code: NBY · General, Plastic Surgery
• Decision Date: Oct 31, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5035
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Device Story

Cytoplast PTFE Suture is a nonabsorbable surgical suture composed of expanded polytetrafluoroethylene (ePTFE). Used by surgeons for soft tissue approximation and ligation across various specialties including dental and cardiovascular procedures. Device provides mechanical closure of tissues; functions as a standard surgical suture. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Classification: Nonabsorbable surgical suture (21 CFR 878.5035). Class II. Product Code: NBY. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, dental, and general surgeries, and dura mater repair. Contraindicated for ophthalmic surgery, microsurgery, and peripheral neural tissue.

Regulatory Classification

Identification

Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osteogenics Biomedical, Inc. % Mr. Dustyn Webb Regulatory/Quality Manager 4620 71st Street, Building 78-79 Lubbock, Texas 79424

OCT 3 1 2007

Re: K072076

Trade/Device Name: Cytoplast PTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluoroethylene surgical suture Regulatory Class: II Product Code: NBY Dated: October 9, 2007 Received: October 9, 2007

Dear Mr. Webb:

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.

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Page 2 - Mr. Dustyn Webb

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/industry/support/index.html.

Sincerely yours,
Mark A. Mellersen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## on 2019

## Indications for Use

510(k) Number (if known): _ K072076

Device Name: Cytoplast PTFE Suture

Indications For Use:

The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number L62016