PREMICRON NONABSORBABLE PET SURGICAL SUTURE

K012201 · Aesculap, Inc. · GAT · Sep 19, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012201
• Device Name: PREMICRON NONABSORBABLE PET SURGICAL SUTURE
• Applicant: Aesculap, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PremiCron® Nonabsorbable PET Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue.

Device Story

PremiCron is a sterile, braided multifilament surgical suture composed of 100% poly(ethylene terephthalate) (PET). It is used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. The device is available in various lengths and diameters, with or without stainless steel needles, and may include a silicone coating to improve handling and reduce tissue drag. Some versions include polytetrafluoroethylene (PTFE) pledgets. The suture is applied manually by the clinician during surgery to secure tissue or vessels. It provides mechanical support for tissue healing through its high tensile strength and nonabsorbable nature. The device is provided sterile to the clinical environment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical testing, including sterilization validation, evaluation of sterilant residues, shelf-life testing, and in vitro/in vivo biocompatibility assays.

Technological Characteristics

Material: 100% poly(ethylene terephthalate) (PET). Construction: Braided multifilament. Coating: Optional silicone. Accessories: Optional stainless steel needles and PTFE pledgets. Standards: Conforms to USP XXIV (Monograph for Nonabsorbable Surgical Suture, <861>, <871>, <881>). Sterilization: Sterile.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures in patients requiring nonabsorbable suture support.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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

• SURGIDAC® Nonabsorbable Surgical Suture (U. S. Surgical Corp.)
• ETHIBOND® Nonabsorbable Surgical Suture (Ethicon, Inc.)
• TI-CRON® Nonabsorbable Surgical Suture (Sherwood Davis & Geck)
• Synthofil® Nonabsorbable Surgical Suture (AESCULAP®)

Submission Summary (Full Text)

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## AESCULAP®, Inc.

#### VII. 510(k) Summary

SEP 1 9 2001

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

#### Submitted for A.

AESCULAP®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Telephone: [phone] Contact: Joyce Thomas, Director of Regulatory Affairs & Quality Assurance Date Prepared: July 9, 2001

#### Device Name B.

| Trade or Proprietary Name: | PremiCron® Nonabsorbable PET Surgical<br>Suture |
|----------------------------|---------------------------------------------------------------|
| Common or Usual Name: | NonabsorbablePolyester Surgical Suture |
| Classification Name: | Nonabsorbable Poly(Ethylene terephthalate)<br>Surgical Suture |

#### C. Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

- SURGIDAC® Nonabsorbable Surgical Suture (U. S. Surgical Corp.) ●
- ETHIBOND® Nonabsorbable Surgical Suture (Ethicon, Inc.) .
- TI-CRON® Nonabsorbable Surgical Suture (Sherwood Davis & Geck) .
- Synthofil® Nonabsorbable Surgical Suture (AESCULAP®) .

#### Device Description D.

The subject device is an mutlifilament, nonabsorbable, sterile, flexible thread composed of 100% poly(ethylene terephthalate), or PET, and is indicated for soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue. It is available uncolored, or colored with D&C Green No. 6. It is available uncoated, or with a silicone coating. It is available with or without standard or detachable stainless steel needles.

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#### E. Intended Use

PremiCron® Nonabsorbable PET Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue.

#### F. Comparison to Predicate Devices

The subject device is composed of 100% poly(ethylene terephthalate) polymer, as is true of the predicate ETHIBOND®, TI-CRON®, SURGIDAC®, and Synthofil® sutures. As is also true of these predicate devices, the subject device is offered uncolored, or colored with D&C Green No. 6 at a concentration that conforms to the requirements of Title 21 CFR, §74.3206. Like TI-CRON® and other sutures, the subject device is offered with a silicone coating.

The subject device has the same design as do the ETHIBOND®, TI-CRON®, SURGIDAC®, and Synthofil® predicate devices, being a sterile, flexible braided multifilament thread.

As is true of the predicate sutures, the subject suture is offered in a variety of lengths and a range of diameters, and is offered with or without one of a selection of standard or detachable stainless steel needles. Further, as is the case with the predicate devices, the subject device conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIV, including <861> Sutures -- Diameter, <871> Sutures -- Needle Attachment, and <881> Tensile Strength.

The subject device is manufactured in a manner typical of the industry and equivalent to that used to produce the predicate devices, wherein the poly (ethylene terephthalate) polymer is synthesized, and polymer is then melt extruded (colorant is added if desired) and spun to form fine filaments of specified diameter. These filaments are then "drawn" to enhance tensile properties, braided to form a fiber of the desired diameter, and where appropriate, coated with a lubricant to enhance handling properties and reduce tissue drag. The fibers are then cut to length and attached to needles.

As is true of the predicate ETHIBOND® sutures, PremiCron® sutures are offered with small "pledgets" of 100% TEFLON® polytetrafluoroethylene.

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The subject device is packaged and sterilized in the same or equivalent manner, and has the same or equivalent labeling claims as do the predicate devices, including indications, contraindications, warnings, cautions and precautions.

### Summary of Non-Clinical Tests G.

Non-clinical testing conducted on the subject device sterilization validation and evaluation of sterilant residues, shelf-life testing, and a series of state-of-the-art in vitro and in vivo assays to establish biocompatibility and in vivo behavior.

#### H. Summary of Clinical Tests

(Not applicable)

#### Conclusions of Non-Clinical and Clinical Tests I.

The results of testing demonstrated the substantial equivalence of the subject device in terms of its biocompatibility and in vivo behavior.

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SEP 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. c/o Mr. Steve Reitzler, RAC Regulatory Consulting Services 13221 Maricotte Place San Diego, California 92130

Re: K012201

K012201
Trade/Device Name: PremiCron® Nonabsorbable PET Surgical Suture Regulation Number: 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: July 9, 2001 Received: July 13, 2001

Dear Mr. Reitzler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Security pro(x) premainer's substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosule) to regally manatiment date of the Medical Device Ameral Food. Days commerce prior to May 28, 1770, the encordance with the provisions of the Federal Food. Drug. devices that have been recalise in assess approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl alle Cosment Act (Act) that to not requence subject to the general controls provisions of the Act. The You may, merefore, market the do received be requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classified (socrative) also Existing major regulations affecting your device can may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Oods acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe advised allat 1 Dri blocation of our device complies with other requirements of the Act that I DA has made a actorinations administered by other Federal agencies. You must or any it catal statutes and regularents, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements, and manufacturing practice requirements as set CFR Part 807); adoming (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Mr. Steve Reitzler, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally promation in a classification for your device and thus, permits 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 31 31 3 594-4659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 + + the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Suse Walk, us

Image /page/4/Picture/5 description: The image contains a handwritten symbol that resembles a cursive letter 'f' with a loop at the top. The symbol is bold and slightly tilted to the right. It is the only element in the image, set against a plain white background.

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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#### V. Draft Labeling

#### Indications for Use A.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AESCULAP®, Inc, Monosyn® Synthetic Absorbable Suture

Indications for Use:

PremiCron® Nonabsorbable Surgical Suture is indicated for use in I reneral soft tissue approximation and/or ligation, including use in Echeral soft itsins appscular, ophthalmic and neurological procedures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109)

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(Division Sign-Off) Division of General, Restorative and Ney

510(k) Number_Ko1220