The Davol Absorbable Fastener 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 Davol Absorbable Fastener System is designed to deliver an absorbable fastener into I ho Da vir reberration ing general surgery procedures such as hernia repair. The fastener system consists of an ergonomic handle with trigger, shaft and penetrating tip. The shaft is available in either a 36 cm length for laparoscopic use or an 18 cm length for open surgical procedures. The device is preloaded with 5, 15, or 30 absorbable fasteners. Each absorbable fastener contains threads for mesh and tissue delivery.

AI/ML Overview

The provided text describes a 510(k) summary for the Davol Absorbable Fastener System. This documentation is for a medical device that delivers absorbable fasteners during general surgery procedures like hernia repair. The request asks for details related to acceptance criteria and the study proving the device meets these criteria. However, a 510(k) summary for a medical device like this, particularly one from 2008, does not typically contain the detailed information requested regarding clinical trial design, acceptance criteria tables, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies with AI assistance.

The provided text focuses on demonstrating substantial equivalence to a predicate device, which is the primary goal of a 510(k) submission. It briefly mentions performance data but does not specify "acceptance criteria" in the format of a table of metrics or provide detailed study designs that would typically be found in a clinical trial report or a more comprehensive performance study summary.

Therefore, many of the requested fields cannot be directly extracted from the provided document. I will fill in the information that can be inferred or directly stated, and indicate where the information is not available in the given text.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility (non-toxic, non-sensitizing)	"The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use."
Mechanical strength of repair (over time, compared to predicate)	"The Davol Absorbable fasteners were tested in vitro in a hernia repair model and in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device." (Specific results not detailed)
Material degradation characteristics (over time)	"Additional in vitro laboratory tests were conducted to characterize material degradation over time." (Specific results not detailed)
Meeting established specifications for consistent performance	"All test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Davol Absorbable Fastener System met the established specifications necessary for consistent performance during its intended use."

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 specified in the document. The studies mentioned are "in vitro in a hernia repair model" and "in vivo in an animal model."
Data provenance: Not specified. "In vivo in an animal model" suggests animal data, not human patient data from a specific country. The study design (retrospective/prospective) is not detailed.

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)

Number of experts: Not applicable. This device is a surgical fastener system, not an AI diagnostic tool that would require expert-established ground truth for image interpretation or similar tasks. The "ground truth" for its performance would be objective measurements from mechanical tests and animal studies.
Qualifications of experts: Not applicable.

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

Adjudication method: Not applicable. This is not an AI diagnostic or interpretive device where adjudication of readings would be necessary. Performance is based on physical and biological testing.

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

MRMC comparative effectiveness study: No, this device is a physical surgical fastener, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant.

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

Standalone performance: Not applicable. This is a physical medical device (fastener system), not an algorithm or AI. Its performance is inherent to its design and material properties, tested in a lab or animal setting.

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

Type of ground truth: For biocompatibility, the ground truth is established through standard biological tests (e.g., cytotoxicity, sensitization assays). For mechanical strength, the ground truth would be objective measurements of force, displacement, or tear resistance; for degradation, it would be material property changes over time. These are all objective, laboratory-derived measurements rather than interpretive ground truths like expert consensus or pathology.

8. The sample size for the training set

Sample size for training set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

How ground truth for training set was established: Not applicable. This is not an AI/machine learning device.

Summary

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(082396

JAN - 2 2009

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 7.0

Submitter Information A.

Submitter's Name: Address:

Telephone: Fax: Contact Person: Date of Preparation:
Davol Inc. Subsidiary of C. R. Bard, Inc. 100 Crossing Boulevard Warwick, RI 02886 (401) 825-8588 (401) 825-8765 Stephanie Baker August 18, 2008

Davol Absorbable Fastener System Staple, Implantable . Staple, Implantable

C. Predicate Device Name

Common/Usual Name:

Classification Name:

Trade name:

Device Name

Trade Name:

Permasorb Disposable Fixation Device (K060494)

D. Device Description

E. Intended Use

The Davol Absorbable Fastener 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.

PREMARKET NOTIFICATION FOR THE DAVOL ABSORBABLE FASTENER SYSTEM

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F Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The Davol Absorbable Fastener System and the currently marketed Permasorb Disposable Fixation Device are both indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

In addition, both products are similar in technological characteristics and performance. Both devices have the same basic components including a handle and shaft designed to deliver a fastener. Both devices use similar fixation technology to deliver the fasteners by compressing a trigger. The fasteners are manufactured from the same polymer material, poly (D, L) lactide.

The proposed device and the predicate device differ in the details of the device design. The proposed device has a gun shaped handle and fasteners that are screw-like while the predicate device has a T-shaped handle and fasteners that are tack-like.

Performance Data G.

Biocompatibility testing on the Davol Absorbable Fastener System fastener has been completed. The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use.

The Davol Absorbable fasteners were tested in vitro in a hernia repair model and in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device.

Additional in vitro laboratory tests were conducted to characterize material degradation over time.

All test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Davol Absorbable Fastemer System met the established specifications necessary for consistent performance during its intended use.

PREMARKET NOTIFICATION FOR THE DAVOL ABSORBABLE FASTENER SYSTEM

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH" at the bottom left and "USA" at the top right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Davol Inc. % C.R. Bard Inc. Ms. Stephanie Baker Senior Regulatory Affairs Associate 100 Crossing Boulevard Warwick, Rhode Island

Re: K082396

Trade/Device Name: Davol Absorbable Fastener System Regulation Number: 21 CFR 878.4750 Device Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: December 16, 2008 Received: December 17, 2008

Dear Ms. Baker:

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.

JAN - 2 2009

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. Stephanie Baker

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

Mark N. Melkerson 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

510(k) Number (if known):

Device Name:

Indications for Use:

782396

procedures, such as hernia repair.

Davol Absorbable Fastener System

The Davol Absorbable Fastener System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

FOR M. MELKERSON

Division of General, Restorative, and Neurological Devices

510(k) Number K082396

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.