BIOELAST 5-0 SUTURE, MODEL 500100

• K Number: K072470
• Device Name: BIOELAST 5-0 SUTURE, MODEL 500100
• Manufacturer: ENTRIGUE SURGICAL, INC.
• Date Cleared: 2007-11-16 ( 73 days)
• Product Code: NWJ
• Regulation Number: 878.4494
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K163013 , K913865
• Predicate For: N/A

Intended Use

BioElast™ 5-0 absorbable 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 Description

BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate. The BioElast™ 5-0 Sutures will be provided undyed at a 5-0 size.

AI/ML Overview

The provided text describes a 510(k) summary for the BioElast™ 5-0 Suture. It details the device, its indications for use, and a general statement about safety and performance, but it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Specifically, the document states: "Results of bench and in-vivo testing demonstrate that the BioElast™ 5-0 Suture is biocompatible and substantially equivalent in function to the predicate devices."

This statement indicates that testing was performed and that the device was found substantially equivalent to predicate devices (Tepha, Inc., TephaFLEX® Absorbable Suture and Ethicon, Inc., PDS*II). However, it does not provide:

1. A specific table of acceptance criteria and reported device performance. The document only gives a general statement of meeting certain benchmarks through substantial equivalence.
2. Details about sample sizes for test sets or data provenance.
3. Information on experts used to establish ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies. This is typically for AI-powered diagnostic devices, not sutures.
6. Information about standalone algorithm performance. Again, this is for AI-powered diagnostic devices.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Given the nature of the device (a surgical suture) and the context of a 510(k) summary for a Class II medical device, the "acceptance criteria" here are generally implied by the regulatory standard of substantial equivalence to existing legally marketed predicate devices. This means that the new device performs as intended and is as safe and effective as the predicate devices, based on comparative bench and in-vivo testing.

Therefore, I cannot populate the requested table and detailed information as the provided text does not contain that level of detail for a medical device study typical of AI/diagnostic tools.

Summary

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510(k) NumberKo72470

510(k) SUMMARY

Trade Name:	BioElast™ 5-0 Suture	NOV 16 2007
Sponsor:	ENTrigue Surgical, Inc.3463 Magic Drive, Suite 320San Antonio, Texas 78229Telephone: [phone]Fax: [phone]Contact Person: Gabriele G. Niederauer, Ph.D.
Date of Summary:	August 31, 2007
Device Classification Name:	21 CFR §878.4494Absorbable Poly(hydroxybutyrate) Surgical Suture
Classification:	According to Section 13 of the Federal Food, Drugand Cosmetic Act, the device classification is Class IIPerformance Standards.
Predicate Devices:	Tepha, Inc., TephaFLEX® Absorbable SutureEthicon, Inc., PDS*II
Device Description:	BioElast™ 5-0 Suture is a sterile, monofilament,absorbable surgical suture composed of poly-4-hydroxybutyrate. The BioElast™ 5-0 Sutures will beprovided undyed at a 5-0 size.
Indications for Use:	BioElast™ 5-0 absorbable sutures are indicated foruse in general soft tissue approximation and/orligation, but not for use in cardiovascular orneurological tissues, microsurgery or ophthalmicsurgery.
Safety and Performance:	Results of bench and in-vivo testing demonstrate thatthe BioElast™ 5-0 Suture is biocompatible andsubstantially equivalent in function to the predicatedevices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a symbol and surrounding text. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

NOV 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ENTrigue Surgical, Inc. % Gabriele G. Niederauer, PhD VP, Research & Development 3463 Magic Drive, Suite 320 San Antonio, Texas 78229

Re: K072470

Trade/Device Name: BioElast™ 5-0 Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Suture, recombinant technology Regulatory Class: II Product Code: NWJ Dated: August 13, 2007 Received: September 4, 2007

Dear Dr. Niederauer

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 - Gabriele G. Niederauer, PhD

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,

Mark N. Melkerson
Director

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

Enclosure

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Indications for Use Statement

Device Name: BioElast™ 5-0 Suture

Indications for Use:

BioElast™ 5-0 absorbable 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 区

AND/OR

Over-The-Counter Use □

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oil) Division of General, Restorative, and Neurological Devices

510(k) Number 10012470

Page 1 of 1

Regulation Number and Section

§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).