SHARPOINT PDO (POLYDIOXANONE) SUTURES

K063680 · Surgical Specialties Corp · NEW · May 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063680
• Device Name: SHARPOINT PDO (POLYDIOXANONE) SUTURES
• Applicant: Surgical Specialties Corp
• Product Code: NEW · General, Plastic Surgery
• Decision Date: May 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sharpoint® PDO Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Story

Sharpoint® PDO Suture is a synthetic, absorbable, monofilament surgical suture; dyed D&C violet No.2; attached to 400 series stainless steel needles. Used by surgeons for soft tissue approximation and ligation. Device provides temporary wound support during healing; material undergoes absorption in vivo. Performance verified through tensile strength and mass loss studies.

Clinical Evidence

No clinical data. Evidence based on bench testing to USP 29 standards (suture diameter, attachment, tensile strength) and animal studies for biocompatibility (ISO 10993) and implant performance (tensile/mass loss).

Technological Characteristics

Material: Polydioxanone (synthetic, absorbable, monofilament). Needle: 400 series stainless steel. Performance standards: USP 29, ISO 10993. Form factor: Suture with attached needle.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgical, or ophthalmic procedures.

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's PDS II (N18331)

Submission Summary (Full Text)

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K063680

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MAY - 9 2007

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY

| Submitter: | Surgical Specialties Corporation dba Angiotech |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 100 Dennis Drive<br>Reading, PA 19606 |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth Lazaro<br>Regulatory Affairs Specialist |
| Date Prepared: | December 6, 2006 revised May 07, 2007 |
| Name of Device: | Sharpoint® PDO ( Polydioxanone) Synthetic,<br>Absorbable, Monofilament Sutures |
| Common / Usual<br>Classification Name: | Surgical Suture.<br>Absorbable Polydioxanone Surgical Suture. |
| Regulation Number: | 878.4840 |
| Device Classification: | Class II Device |
| Predicate Device: | Ethicon's PDS II<br>Submission Number N18331 |
| Device Description | The Sharpoint® (Polydioxanone) PDO Suture is a<br>synthetic, absorbable, monofilament surgical suture<br>available dyed D&C violet No.2. The PDO Sutures<br>are attached to various size needles made of 400<br>series stainless steel |

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

| Intended Use: | The Sharpoint® PDO Sutures are indicated for use<br>in general soft tissue approximation and/or ligation,<br>but not for use in cardiovascular or neurological<br>tissues, microsurgery or ophthalmic surgery. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polydioxanone material is well characterized<br>through absorption studies and biocompatibility<br>studies.<br>Bench testing has demonstrated the device to be<br>safe and effective. Its performance is equivalent to<br>the predicate device, Ethicon PDS II. |
| Performance Data: | Physical testing was performed on PDO<br>(Polydioxanone) Synthetic, Absorbable sutures to<br>USP 29, including <861> Suture Diameter, <871><br>Suture Attachment, <881> Tensile Strength. Animal<br>testing was performed for conformance to ISO<br>10993 for Biocompatibility and Implant studies to<br>demonstrate rates of tensile and mass loss. |
| Substantial Equivalency: | The Sharpoint® PDO sutures are equivalent to the<br>predicate device PDS II in material composition,<br>intended use, absorption profile and bench testing. |

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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 symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Specialties Corporation dba Angiotech % Ms. Elizabeth Lazaro Regulatory Affairs Specialist 100 Dennis Drive Reading, Pennsylvania 19606

MAY - 9 2007

Re: K063680

Trade/Device Name: Sharpoint® PDO Sutures Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: April 19, 2007 Received: April 20, 2007

Dear Ms. Lazaro:

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 – Ms. Elizabeth Lazaro

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.

Fa
Mark N. Melkerson

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

Enclosure

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K063680

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## Indications for Use

510(k) Number (if known):

Device Name: Sharpoint® PDO Sutures

Indications For Use;

Sharpoint® PDO sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular, or neurological tissues, microsurgery or ophthalmic surgery.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ |
|-------------------------------------------------|------------------------------------------------|
| AND/OR | Over-The-Counter Use<br>(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

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