PLIASURE Polyglycolide Synthetic Absorbable Suture

K142822 · ETHICON, Inc. · GAM · Mar 26, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142822
• Device Name: PLIASURE Polyglycolide Synthetic Absorbable Suture
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Mar 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

PLIASURE Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

Device Story

PLIASURE is a synthetic, absorbable, braided, bicolored surgical suture composed of polyglycolide (PGA) homopolymer, coated with a mixture of polyglactin 370 and calcium stearate. Used by surgeons for soft tissue approximation and ligation. Device provides mechanical wound closure; material is absorbed by the body over time. Biocompatible, nonpyrogenic, and elicits minimal tissue reaction. Supplied sterile.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation). Physical performance testing per USP standards for diameter, needle attachment, and tensile strength. In vivo evaluation of tensile strength retention and absorption profile provided.

Technological Characteristics

Synthetic absorbable braided suture; material: polyglycolide (PGA) homopolymer; coating: polyglactin 370 and calcium stearate; bicolored (D&C Violet #2 and natural); sterile; meets USP standards for synthetic absorbable sutures (except diameter).

Indications for Use

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

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

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.

Predicate Devices

• VICRYLTM Coated Suture (K022269)
• DEXON/DEXON II Braided Suture (K972566)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2015

Ethicon Incorporated Ms. Susan Lin, RAC Manager, Regulatory Affairs P.O. Box 151 Route 22 West Somerville, New Jersey 08876

Re: K142822

Trade/Device Name: PLIASURE™ Polyglycolide Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: February 19, 2015 Received: February 23, 2015

Dear Ms. Lin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K142822

Device Name

PLIASURE™ Polyglycolide Synthetic Absorbable Suture

Indications for Use (Describe)

PLIASURE Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| I. SUBMITTER: | Ethicon |
|-----------------|----------------------|
| | P.O. Box 151 |
| | Route 22 West |
| | Somerville, NJ 08876 |
| | USA |
| | Phone: [phone] |
| | Fax: [phone] |
| Date: | September 29, 2014 |
| Contact Person: | Susan Lin |

# II. DEVICE

| Name of Device: | PLIASURE™ Polyglycolide Synthetic Absorbable Suture |
|----------------------|------------------------------------------------------|
| Common Device Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Classification Name: | Absorbable Poly(glycolide/L-lactide) Surgical Suture |
| Regulatory Class: | Class II, 21 CFR 878.4493 |
| Product Code: | GAM |

# III. PREDICATE DEVICES:

VICRYLTM Coated Suture (K022269) DEXON/DEXON II Braided Suture (K972566)

# IV. DEVICE DESCRIPTION:

PLIASURE Suture is a synthetic absorbable sterile surgical suture composed of the homopolymer of glycolide (PGA). PLIASURE Suture is prepared by coating PGA suture material with a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate. The polymers used in this product have been found to be nonpyrogenic and elicit minimal tissue reaction during absorption. The sutures are braided bicolored with a combination of dyed (D&C Violet #2) and undyed (natural) yarns. PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter.

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# V. INDICATION FOR USE

PLIASURE Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

PLIASURE Suture has same materials as the predicate devices. Like the currently marketed predicate devices, PLIASURE Suture is a sterile, braided synthetic absorbable suture intended for the soft tissue approximation and/or ligation. It conforms to the USP Monograph for absorbable surgical sutures, except for diameter,

### VII. PERFORMANCE DATA

Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Suture. The following performance data was provided in support of the substantial equivalence determination:

#### Biocompatibility Evaluation

PLIASURE Suture is considered a permanent (>30 days) tissue contact implant device.

The biocompatibility evaluation for PLIASURE Suture was conducted in accordance with International Standard ISO 10993-1"Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, " as recognized by FDA, and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.""May 1, 1995. The battery of testing included the following tests:

- Cytotoxicity
- Irritation and Sensitization
- Acute Systemic Toxicity ●
- Pyrogenicity
- Genotoxicity
- Implantation (for Tissue Reaction and Absorption) ●

#### Physical/Performance Characteristics

USP performance testing including Suture – Diameter <861>. Suture – Needle Attachment <871>, and Tensile Strength <881> was conducted on the sterilized suture samples in finished form. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vivo tensile strength retention profile and absorption profile.

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#### VIII. CONCLUSIONS

PLIASURE Suture has the same intended use as the predicate devices. The main technological characteristics of PLIASURE Suture are the same as the predicate devices. The performance data including biocompatibility testing, physical performance testing, and in vivo evaluation of tensile strength and absorption profile demonstrate that PLIASURE Suture is substantially equivalent to the predicate devices.