MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE

K031216 · Aesculap · NEW · Jul 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031216
• Device Name: MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
• Applicant: Aesculap
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

MonoPlus Poly-p-dioxanone absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in pediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.

Device Story

MonoPlus is a synthetic, absorbable, flexible monofilament surgical suture composed of Poly(p-dioxanone). It is designed for soft tissue approximation and ligation, particularly when extended wound support exceeding 4 weeks is required. The device is supplied sterile, available in undyed or dyed (D&C Violet No. 2) forms, and may be provided with or without attached needles. It is intended for use by surgeons in clinical settings. The suture provides mechanical wound closure, gradually losing tensile strength as it is absorbed by the body. It offers a therapeutic benefit by maintaining tissue approximation during the healing process in pediatric cardiovascular and general surgical applications.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and material properties.

Technological Characteristics

Synthetic monofilament absorbable suture; material: Poly(p-dioxanone); colorant: D&C Violet No. 2 (21 CFR 74.3602); form factor: thread with optional attached needles; sterilization: sterile; energy source: none; connectivity: none.

Indications for Use

Indicated for general soft tissue approximation and ligation requiring extended wound support (>4 weeks) and pediatric cardiovascular surgery. Contraindicated for adult cardiovascular tissue, microsurgery, and neural tissue.

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

• Ethicon, Inc.; PDS II Polydioxanone Suture (N18331)

Submission Summary (Full Text)

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KΦ312/6

Page 1 of 1

# C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

[in Accordance with SMDA of 1990]

# MonoPlus Poly-p-dioxanone absorbable suture

April 18, 2003

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller<br>800-258-1946 x 5073 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | MonoPlus Poly-p-dioxanone monofilament absorbable surgical suture |
| COMMON NAME: | Synthetic Absorbable Surgical Suture |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 79NEW |
| CLASSIFICATION: | 878.4840 - Suture, surgical, absorbable , polydioxanone |
| REVIEW PANEL: | General & Plastic Surgery |

# INDICATIONS FOR USE

MonoPlus Poly-p-dioxanone absorbable suture are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.

### DEVICE DESCRIPTION

The subject device is an absorbable, flexible monofilament suture thread which is supplied sterile. It is composed of a synthetic Poly (p-dioxanone), and it is indicated for soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue. It will be offered undeyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3602. It is available uncoated, and will be available with or without standard needles attached.

#### PURPOSE FOR SUBMISSION

This submission seeks marketing clearance for Aesculap's MonoPlus Poly-p-dioxanone absorbable suture.

### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

### SUBSTANTIAL EQUIVALENCE

Aesculap® Inc. believes that MonoPlus Poly-p-dioxanone monofilament absorbable surgical suture is substantially equivalent to:

- Ethicon, Inc.; PDS II Polydioxanone Suture (N18331) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUL 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K031216

Trade/Device Name: MonoPlus Poly-p-dioxanone absorbable suture Regulation Number: 21 CFR 878.4840 Regulation Name: Suture, surgical, absorbable, polydioxanone Regulatory Class: II Product Code: NEW Dated: April 16, 2003 Received: May 6, 2003

Dear Mr. Keller:

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. Georg Keller

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, 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

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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#### B. INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number:

φ3/2/6

Device Name:

MonoPlus Poly-p-dioxanone absorbable suture

Indication for Use:

MonoPlus Poly-p-dioxanone absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in pediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*****_** or Over-the-C

(per 21 CFR 801.109)

or Over-the-Counter Use

Miriàm C. Provost

ral. Restorative and Neurological Dev

510(k) Number K031216