DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

K082097 · Demetech Corp. · NEW · Jan 8, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K082097
• Device Name: DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
• Applicant: Demetech Corp.
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

Device Story

Demetech Polydioxanone (PDO) Suture is a sterile, synthetic, absorbable monofilament surgical suture composed of poly(p-dioxanone) polyester. It is supplied in various lengths and diameters, with or without attached needles, and is available un-dyed or dyed with D&C Violet No. 2. Used by surgeons for soft tissue approximation, the suture provides extended wound support for up to six weeks. Absorption occurs via hydrolysis, characterized by a gradual loss of tensile strength without significant mass loss; strength retention is approximately 85% at 120 days and 25% at 180 days, with complete absorption by 220 days. The device is intended for clinical use in surgical settings.

Clinical Evidence

Bench testing only. The device meets or exceeds USP 31 performance requirements for absorbable surgical sutures, including diameter, tensile strength, and needle attachment. Implantation studies in animals were referenced to characterize the absorption profile and tensile strength retention over time.

Technological Characteristics

Synthetic monofilament absorbable suture composed of poly(p-dioxanone). Meets USP 31 standards for diameter, tensile strength, and needle attachment. Supplied sterile, un-coated, in various lengths/diameters. Colorant: D&C Violet No. 2 (21 CFR 74.3602).

Indications for Use

Indicated for soft tissue approximation in pediatric cardiovascular tissue (where growth is expected) and ophthalmic surgery. Contraindicated for adult cardiovascular, 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

• CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture (K013274)
• Ethicon PDS II Synthetic Absorbable Monofilament Suture (N 18331)

Submission Summary (Full Text)

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510(K) Summary

Polydioxanone Synthetic Absorbable Monofilament Suture

JAN - 8 2010

This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed.

| Applicant: | Demetech Corporation, |
|----------------------|--------------------------------------------------------------------------|
| | 8935 NW 27th Street, Miami FL. 33172 |
| Contact Person: | A. J. Dimercurio<br>[e-mail] |
| Date Revised: | September 27, 2009 |
| Device Names: | |
| Trade Name: | DemeTECH Polydioxanone Synthetic Monofilament<br>(PDO) Absorbable Suture |
| Common Name: | DemeTECH Synthetic PDO Monofilament Absorbable<br>Suture |
| Classification Name: | Absorbable Polydioxanone Surgical Suture |

Predicate Devices:

Demetech Polydioxanone (PDO) Synthetic Absorbable Suture is substantially equivalent to these predicate devices:

- . CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture 510K Number K013274, CP Medical Portland Oregon
- . Ethicon PDS II Synthetic Absorbable Monofilament Suture Polydioxanone Suture PMA Number N 18331, Ethicon Inc

#### Device Description:

Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.

> 8935 NW 27 Street, Miami, Florida, 33172- USA Tel [phone] · Toll Free [phone] · Fax: [phone] Web: www.demetech.us · Email [e-mail]

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Image /page/1/Picture/1 description: The image shows the logo for DemeTECH. The logo consists of a circular icon on the left and the word "DemeTECH." on the right. The icon contains a triangular shape inside the circle. The text is in a bold, sans-serif font.

510(K) Summary Polydioxanone Synthetic Absorbable Monofilament Suture

- A. Intended Use:
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

# Technological Comparison to Predicate Devices:

# COMPARISON TABLE DEMETECH POLYDIOXANONE TO PREDICATE DEVICES

| Suture Material is a synthetic monofilament absorbable<br>surgical suture composed of polyester polymers poly (p-<br>dioxanone) | Same | Same | Same |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|--------------------|
| Suture material is offered un-dyed and dyed with the FDA listed<br>colorant, D&C Violet No. 2 (21 CFR 74.3602) | Same | Same | Same |
| Suture Material is supplied un-coated | Same | Same | Same |
| Suture Material is designed being a sterile, flexible, monofilament<br>thread offered in a variety of lengths and a range of diameters with<br>or without various needles attached. | Same | Same | Same |
| Suture material absorption begins as a loss of tensile strength<br>without appreciable loss of mass. Implantation studies in animals<br>indicate that Polydioxanone retains approximately 85% of its<br>original tensile strength at 120 days post implantation, with<br>approximately 25% remaining at 180 days. Absorption<br>polydioxanone surgical suture is essentially complete at 220 days. | Same | Same | Same to<br>Similar |
| The Suture Material is "Intended for Use" in general soft tissue<br>approximation including pediatric cardiovascular tissue where<br>growth is expected to occur and ophthalmic surgery, but not<br>for use in adult cardiovascular, microsurgery and neural<br>tissue. These sutures are useful where absorbable suture with<br>extended wound support (up to six weeks) is desirable. | Same | Same | Same |
| Suture Material meets or exceeds the performance requirements for<br>"Absorbable Surgical Suture" as defined in the Official Monograph<br>of the United States Pharmacopeia 31. | Same | Same | Same |

8935 NW 27 Street, Miami, Florida, 33172- USA Tel [phone] · Toll Free [phone] · Fax: [phone] Web: www.demetech.us · [e-mail]

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K082097

Image /page/2/Picture/1 description: The image shows the logo for "DemeTECH". The logo consists of a circular icon on the left and the company name on the right. The icon features a triangle inside a circle, and the company name is written in a bold, italicized font.

# 510(K) Summary Polydioxanone Synthetic Absorbable Monofilament Suture

# Technological Comparison to Predicate Devices (continued)

| COMPARISON TABLE TO PREDICATE DEVICES | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------|-------------------|
| Comparison Items | Demetech<br>Polydioxanone<br>Suture | CP Medical Mono-<br>Dox | Ethicon<br>PDS II |
| Suture Materials meet the performance<br>requirements for Diameter as defined in the<br>United States Pharmacopeia 31 | Same | Same | Same |
| Suture Material meets or exceeds the performance<br>requirements defined in the United States<br>Pharmacopeia 31 for "Tensile Strength" < 881 > | Same | Same | Same |
| Suture Material meets or exceeds the performance<br>requirements defined in the United States<br>Pharmacopeia 31 and the current edition USP 31<br>for "Needle Attachment" < 871 > | Same | Same | Same |
| Suture Material meets or exceeds the performance<br>requirements defined in the United States<br>Pharmacopeia 31 for "Suture Length<br>Requirement" (95% of stated label length) | Same | Same | Same |
| Suture Material is packaged in a same or equivalent<br>manner with sterile single or double package<br>having labeling conforming to 21 CFR and USP<br>XXXI. | Same | Same | Same |

Demetech Polydioxanone Suture is composed of the same material, as are the predicated devices and having the same design being a sterile, flexible, monofilament threads meeting all the requirements of the United States Pharmacopeia. Demetech Polydioxanone Synthetic Monofilament Absorbable Suture is manufactured in the same manner as the predicate devices, being composed of polyester polymers poly (p-dioxanone) and produced in operations considered standard in the fiber industry to form the finished suture fiber. The manufacturer supplies to Demetech the same suture materials as it does to other suture manufacturers including some of those listed above.

The information and the results of the performance testing presented demonstrate the substantial equivalence of Demetech's Polydioxanone Synthetic Monofilament Absorbable Suture to that of the predicate devices. It further demonstrates Demetech suture is safe and effective for its intended purpose.

> 8935 NW 27 Street, Miami, Florida, 33172- USA Tel [phone] · Toll Free [phone] · Fax: [phone] Web: www.demetech.us · Email [e-mail]

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

#### JAN - 8 2010

DemeTECH Corporation % Mr. Anthony Dimercurio Vice President of Manufacturing 8935 NW 27" Street Miami, Florida 33172

Re: K082097

Trade/Device Name: DemeTECH Polydioxanone Synthetic Monofilament (PDO) Absorbable Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: December 21, 2009 Received: January 06, 2010

Dear Mr. Dimercurio:

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 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); medical device reporting (reporting of medical

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Page 2 - Mr. Anthony Dimercurio

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

urs,
fur

lkerson

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

Enclosure

ﻢ ﺗ

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K082097

হবে

ార్లు

Image /page/5/Picture/1 description: The image shows the logo for "DemeTECH." The logo consists of a circular graphic to the left of the company name. The graphic contains a triangular shape inside of the circle. The company name is written in a stylized font, with the "T" in "TECH" being larger than the other letters. There is a registered trademark symbol to the right of the company name.

Intended Use Statement

# Indication for use

510K Number:

Device Name: Demetech Absorbable Polydioxanone Surgical Suture. As per 21CFR 878.4840

Indication for Use:

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Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft . tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ And/Or Over the-Counter Use_ (Part 21 CFR 801; Subpart D) (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)

David Keane

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082097