The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair

Device Description

Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.

AI/ML Overview

Here's an analysis of the provided text regarding the Absorbatack™ Absorbable Fixation Device. It appears this documentation describes a 510(k) submission for a medical device and not a study demonstrating the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the US. It does not contain information on a study with acceptance criteria and reported device performance in the context of, for example, diagnostic accuracy or treatment efficacy.

Therefore, many of the requested sections about study design, sample size, ground truth, and expert evaluation are not applicable in this context.

Analysis of Absorbatack™ Absorbable Fixation Device (K091900)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable (N/A) - This document does not specify performance-based acceptance criteria in the way a clinical or algorithm performance study would. The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a predicate device.	Substantially Equivalent to the predicate device (Absorbatack™ Absorbable Fixation Device, K071920). The device is identical in design, materials, and intended use.

Explanation: In a 510(k) pathway, the "acceptance criteria" are typically regulatory requirements for demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing identical technological characteristics, intended use, and materials, or by conducting performance testing to demonstrate equivalence if there are differences. This document explicitly states "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device." Therefore, no new performance data comparing it against specific quantitative acceptance criteria is presented for this particular submission.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No test set (in the context of clinical or algorithm performance evaluation) is described.
Data Provenance: Not applicable. The document relies on the identical nature of the device to its predicate, rather than new performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method

Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. No such study is described or referenced.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Not applicable. This device is a physical surgical tack, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. The ground for this submission is the established safety and effectiveness of the predicate device (K071920) through its prior clearance, and the assertion that the current device is identical.

8. Sample Size for the Training Set

Sample Size: Not applicable. As this device is not an algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable.

Summary of the Document's Content:

The provided documents detail a 510(k) premarket notification for the "Absorbatack™ Absorbable Fixation Device." The core of this submission is the claim that the device is substantially equivalent to a previously cleared predicate device (K071920), also named "Absorbatack™ Absorbable Fixation Device."

Key points from the submission:

Identity to Predicate: The submitter explicitly states: "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device."
Materials Evaluation: The materials were evaluated according to ISO 10993-1: 2003, "Biological Evaluation of medical devices - Part I Evaluation and Testing," and again, stated to be identical to the predicate device.
Performance Data: The document states, "The modified labeling for the subject device is based on performance testing obtained for the predicate device." This indicates that no new performance testing for the subject device itself was conducted for this specific 510(k) submission; rather, it leveraged the existing data from the identical predicate.
Intended Use: Fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures (e.g., hernia repair), which is consistent with the predicate.

In essence, this is a regulatory filing asserting that a device, which remains unchanged from a previously cleared version, is still substantially equivalent to that predicate. Therefore, it bypasses the need for new, extensive performance studies with specific acceptance criteria that would typically be seen for a novel device or a device with significant modifications.

Summary

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ട്. 510(k) SUMMARY:

510(K) Summary of Safety and Effectiveness:

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

DEVICE DESCRIPTION:

Note: There are no modifications

to the previously cleared devices.)

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473

K091900

JUL 1 6 2009

1881

Rebecca Ronner Associate, Regulatory Affairs Phone: (203) 492-5346 Fax: (203) 492-5029

June 24, 2009

Absorbatack™ Absorbable Fixation Device

Absorbable Tack and Applicator

Implantable Staple

K071920 - Absorbatack™ Absorbable Fixation Device

Absorbatack™ Absorbable Fixation Devices are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures such as hernia repair.

Absorbatack™ Absorbable Fixation Device is identical to the predicate device.

Absorbatack™ Absorbable Fixation Devices is comprised of materials which have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices - Part I Evaluation and Testing and is identical to the predicate device

There has been no change to the Absorbatack ™ Absorbable Fixation Device. The modified labeling for the subject device is based on performance testing obtained for the predicate device.

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

MATERIALS: CHARACTERISTICS:

PERFORMANCE DATA: CHARACTERISTICS:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image contains the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the logo. The caduceus symbol is depicted with three intertwined snakes and a staff.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2009

Covidien LP % Ms. Rebecca Ronner 60 Middletown Avenue North Haven. Connecticut 06473

Re: K091900

Trade/Device Name: Absorbatack™ Absorbable Fixation Device Regulation Number: 21 CFR 878:4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 24, 2009 Received: June 25, 2009

Dear Ms. Ronner:

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 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 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. Rebecca Ronner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Poe Dhlson
Mark N. Melen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT:

510(k) Number (if known): K091900

Device Names:

Indications For Use

Absorbatack™ Absorbable Fixation Device

The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daind Krome for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number KD91900

Page 1 of

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.