The OPTIFIX™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Device Description

The OPTIFIX™ Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners via a straight shaft. The shaft of the OPTIFIX™ Absorbable Fixation System is 39 cm in length. The fasteners are designed with a retention feature on the end and are manufactured from Poly (D, L)-lactide.

AI/ML Overview

The provided document describes the OPTIFIX™ Absorbable Fixation System, a medical device, and its substantial equivalence to a predicate device, SorbaFix™, based on non-clinical and animal studies. However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-driven device. It is a traditional medical device submission for a physical surgical fixation system.

Therefore, many of the requested fields related to AI/algorithm performance (e.g., test set, ground truth experts, MRMC studies, standalone performance, training set) are not applicable to this document.

Here's an attempt to extract relevant information from the provided text, acknowledging that the request is geared towards AI/algorithm studies, which isn't the subject of this 510(k) summary.

1. Table of acceptance criteria and the reported device performance

The document states that the OPTIFIX™ Absorbable Fixation System passed various non-clinical and animal test requirements, and "All samples tested met the acceptance criteria." However, the specific quantitative acceptance criteria values are not explicitly stated in the provided text. The performance is reported as meeting these (unstated) criteria.

Acceptance Criteria Category	Reported Device Performance
Non-Clinical Tests:
Shear strength testing	Met acceptance criteria
Mass loss determination	Met acceptance criteria
Dimensional changes	Met acceptance criteria
Inherent viscosity	Met acceptance criteria
Glass transition temperatures	Met acceptance criteria
Residual monomer content	Met acceptance criteria
Animal (In-vivo) Studies:
Contracture	Met acceptance criteria
Tissue Ingrowth	Met acceptance criteria
Histology	Met acceptance criteria
Ex-vivo Test:
Burst Strength on Pig wall	Met acceptance criteria

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for each test, but implied to be "All samples tested." The specific number of samples for each non-clinical or animal study is not provided.
Data Provenance: Not explicitly stated. The studies are described as "non-clinical tests," "animal in-vivo studies," and "Ex-vivo Burst Strength on Pig wall." Country of origin or retrospective/prospective nature is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This document describes the testing of a physical medical device. The "ground truth" for the performance metrics (e.g., shear strength, mass loss, burst strength) would be established by direct physical measurements and observations, not by human expert consensus or interpretation in the way it's done for AI models.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See explanation above. The assessment of physical and biological properties is based on experimental protocols and quantitative analysis, not expert adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical device, not an AI/algorithm. No human "readers" are involved in interpreting its output, and there's no AI assistance being evaluated.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the measured physical and biological properties of the device and its interaction with tissue. This includes:
- Direct measurements of shear strength, mass, dimensions, viscosity, glass transition temperatures, and residual monomer content.
- Observations from animal in-vivo studies (e.g., contracture, tissue ingrowth, histology) which are typically assessed by pathologists or researchers following established protocols.
- Measurements of burst strength on ex-vivo tissue (pig wall).

8. The sample size for the training set

Not Applicable. This is not an AI/algorithm-driven device; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. See explanation above.

Summary

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DEC

510(k) Summary

OPTIFIX™ Absorbable Fixation System			10 July, 2013
Submitter	Davol Inc.100 CrossingsBoulevardWarwick, RI 02886	Contact	Radhika PondicherrySenior Regulatory Affairs Specialistradhika.pondicherry@crbard.com(401) 825-8464(401) 825-8764 (fax)
Preparation Date	10 July, 2013
Trade NameCommon/ClassificationName	OPTIFIX™ Absorbable Fixation SystemStaple Implantable/Implantable Staple
Regulatory ClassProduct Code	Class II per 21 CFR §878.4750GDW
Legally MarketedPredicate Device(s)	K082396 Davol Absorbable Fastener System- SorbaFix™ - 02Jan2009
Device Description	The OPTIFIX™ Absorbable Fixation System is a sterile single use devicethat delivers either 15 or 30 synthetic absorbable fasteners via a straightshaft. The shaft of the OPTIFIX™ Absorbable Fixation System is 39 cmin length. The fasteners are designed with a retention feature on the endand are manufactured from Poly (D, L)-lactide.
Indications for Use	The OPTIFIX™ Absorbable Fixation System is indicated for theapproximation of soft tissue and fixation of surgical mesh to tissuesduring open or laparoscopic surgical procedures, such as hernia repair.
Predicate DeviceComparison	Device Comparison
	Device Features	OptiFix™(Subject Device)	SorbaFix(K082396)
	Tack Schematic	Image: Tack Schematic for OptiFix	Image: Tack Schematic for SorbaFix
	Indication For use	Identical to predicate	Indicated for theapproximation of soft tissueand fixation of surgicalmesh to tissues during openor laparoscopic surgicalprocedures, such as herniarepair.
	Fastener Material	Identical to predicate	Poly (D,L) Lactide

PREMARKET NOTIFICATION FOR OPTIFIX™ ABSORBABLE FIXATION SYSTEM

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Fastener VioletDye	Identical to predicate	D & C Violet No. 2
Fastener BodyContact	Identical to predicate	Long term implant (>30days) contacting tissueand/or bone
FastenerShape/Design	Push Tack with retentionfeature on end	Screw
Fastener Quantityper Device	15 & 30 fasteners	5,15& 30 fasteners
Deploymentcomponent - ShaftLength	39 cm in length	18cm and 36 cm in length
Deploymentcomponent Handledesign	Identical to predicate	Pistol/Gun shape
Device Sterilization	Identical to predicate	Gamma Irradiation (25 - 40kGy)

Non-Clinical Test Summary

The following non-clinical tests were completed for the subject and predicate devices. OptiFix™ passed all the test requirements and showed substantial equivalence to the results of the predicate device- SorbaFix™

. Shear strength testing
Mass loss determination .
Dimensional changes .
Inherent viscosity .
. Glass transition temperatures
Residual monomer content .

All samples tested met the acceptance criteria.

Animal Test Summary

The following Animal in-vivo studies were completed
- Contracture .
- Tissue Ingrowth ●
- Histology o

Ex-vivo Burst Strength on Pig wall

OptiFix™ passed all the test requirements and showed substantial equivalence to the results of the predicate device- SorbaFix™.

PREMARKET NOTIFICATION FOR OPTIFIX™ ABSORBABLE FIXATION SYSTEM

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Conclusions

・デ

The OPTIFIX™ Absorbable Fixation System is substantially equivalent to the predicate device. The device is as safe, as effective, and performs as well as the predicate device.

PREMARKET NOTIFICATION FOR OPTIFLX™ ABSORBABLE FIXATION SYSTEM

・

· September 1998

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

C.R. Bard Incorporated Radhika Pondicherry Senior Regulatory Affairs Specialist 100 Crossing Boulevard Warwick, Rhode Island 02886

December 2, 2013

Re: K132134

Trade/Device Name: OPTIFIX™ Absorbable Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 29, 2013 Received: October 30, 2013

Dear Pondicherry:

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. Ilsting 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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Page 2 - Radhika Pondicherry

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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.goy/MedicalDevices/Safety/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerely vours.

Joshua C. Nipper -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use-

510{k} Number (if known) K132134

Device Name

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OPTIFIX™ Absorbable Fixation System

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Indications for Use (Describe)

The OPTIFLY™ Absorbable Fixation System is indicated for the approximation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.