MONO-SWIFT

K030786 · Cp Medical · NEW · May 6, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030786
• Device Name: MONO-SWIFT
• Applicant: Cp Medical
• Product Code: NEW · General, Plastic Surgery
• Decision Date: May 6, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MonoSwift™ is intended to be used for surgical wound closure.

Device Story

MonoSwift™ is a synthetic absorbable monofilament surgical suture. Composed of polydioxanone, trimethylene-carbonate, and caprolactone copolymers. Used by surgeons for soft tissue approximation and ligation. Device provides wound closure support during healing process; material eventually absorbs. Operates as a mechanical fixation device. No electronic or software components.

Clinical Evidence

Bench testing only. Device meets recognized consensus standards for surgical sutures (United States Pharmacopoeia) and ISO 10993 biocompatibility requirements.

Technological Characteristics

Synthetic absorbable monofilament suture. Materials: polydioxanone, trimethylene-carbonate, and caprolactone copolymers. Complies with USP standards and ISO 10993 for biocompatibility. Manufacturing follows QSR and ISO quality standards.

Indications for Use

Indicated for soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgery, or ophthalmic surgery.

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

• CP Medical's polydioxanone surgical suture
• CP Medical's collagen suture material

Submission Summary (Full Text)

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K03 0786

MAY 0 6 2003

## SAFETY AND EFFECTIVENESS SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with Volume 21 of the Code of Federal Regulations, this is to serve as a Summary of Safety and Effectiveness for the proposed CP Medical synthetic absorbable monofilament surgical suture.

| Manufacturer: | CP Medical, Inc.<br>836 NE 24th Avenue<br>Portland, OR 97232<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Ann Greenawalt, VP Legal & Regulatory Affairs |
| Device Name:<br>Classification: | MonoSwift™ - synthetic absorbable monofilament suture<br>Class II |
| Date Prepared: | March 5, 2003 |
| Device Description: | The proposed device is a synthetic absorbable monofilament surgical<br>suture comprised of polydioxanone, trimethylene-carbonate and<br>caprolactone copolymers. These polymers, individually, and as co-<br>formulated herein, are substantially equivalent to other synthetic<br>absorbable monofilament sutures in commercial distribution today. |
| Predicate Devices: | The proposed device is substantially equivalent to CP Medical's<br>polydioxanone surgical suture and is similar in absorption rates to CP<br>Medical's collagen suture material. |
| Indications: | MonoSwift™ is indicated for use in soft tissue approximation and/or<br>ligation but not for use in cardiovascular or neurological surgery,<br>microsurgery or ophthalmic surgery. |
| Intended Use: | MonoSwift™ is intended to be used for surgical wound closure. |
| Summary of Clinical and Non-Clinical Studies: | Meets recognized consensus standards for surgical suture, United States<br>Pharmacopoeia and ISO 10993 biocompatibility. |
| Comparison of Technological Characteristics: | The device has similar characteristics (chemistry, material and<br>composition) as the predicate devices. Manufacture of this device,<br>including QC testing, is in substantial compliance with current QSR and<br>ISO quality standards. |

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head and body are formed by the silhouettes of the human faces.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Ann Greenawalt Vice President, Legal and Regulatory Affairs CP Medical, Inc. 836 NE 24th Avenue Portland, Oregon 97232

MAY 0 6 2003

Re: K030786

Trade/Device Name: Monofilament-Synthetic Absorbable Monofilament Surgical Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: II Product Code: NEW Dated: March 10, 2003 Received: March 12, 2003

Dear Ms. Greenawalt:

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. Iisting 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. Mary Ann Greenawalt

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained from the Division of Small Manufacturers, v 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. Provost

tol 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

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510(k) (if known):

K934786

DEVICE Name: Monofilament -Synthetic Absorbable Monofilament Surgical Suture

Indications for Use:

CP Medical's synthetic absorbable monofilament is indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use the image is of a form with the following content:

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Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030786