The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hemia repairs.

Device Description

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is a 5mm laparoscopic device for hernia repair. It is a multi-fire, single-use device pre-loaded with 25 absorbable straps. The straps are composed of a blend of polydioxanone and L(-)-lactide and glycolide dyed with D&C Violet No. 2.

AI/ML Overview

The provided text describes a 510(k) summary for the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device. This is a submission to demonstrate substantial equivalence to a predicate device, not necessarily a study proving acceptance criteria for a novel device's performance in a clinical setting. Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory document.

However, I will extract the information that is available and indicate where information is not provided.

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

The document states that the new device is "substantially equivalent" to the predicate device. For 510(k) submissions, the acceptance criteria are generally that the new device performs "as intended" and is "substantially equivalent" to the predicate device in terms of safety and effectiveness, based on comparison with the predicate and performance data. Specific numerical acceptance criteria are not typically detailed in the public 510(k) summary for devices like this.

Acceptance Criteria	Reported Device Performance
Intended Use	Same intended use as predicate device (fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repair).
Indications for Use	Similar indications for use as predicate device.
Technological Characteristics	Similar technological characteristics and principles of operation as predicate device. Minor technological differences raise no new issues of safety or effectiveness.
Material Biocompatibility	Materials used have been evaluated in accordance with ISO 10993-1:2003 and are equivalent to the predicate device.
Overall Safety & Effectiveness	"Fulfills the device requirements as defined in used specifications, functions as intended, and is substantially equivalent to the predicate device."

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

The document mentions "bench and animal" testing as part of the performance data.

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin). The testing type ("bench and animal") indicates prospective data generation for the purpose of this submission, rather than retrospective clinical data.

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)

This type of information is not applicable for this 510(k) submission. The evaluation is based on engineering performance, material compatibility, and comparison to a predicate device, not on expert-adjudicated clinical ground truth from a test set.

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

Not applicable for this type of regulatory submission. There is no mention of human adjudication of results in the context of clinical outcomes or diagnostic accuracy.

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 device is a surgical fixation device, not an AI-assisted diagnostic tool or imaging system. Therefore, an MRMC study is irrelevant to its evaluation.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

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

For this device, the "ground truth" for demonstrating substantial equivalence would be based on:

Engineering specifications and functional testing results.
Comparison to the established performance characteristics and safety profile of the predicate device.
Biocompatibility testing against ISO standards.
Animal study results (though specifics are not provided).

There is no mention of expert consensus, pathology, or specific clinical outcomes data as "ground truth" in this summary, which primarily focuses on bench and animal testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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Traditional 510(k) — ETHICON

5 page 1/2

510(K) SUMMARY 5

Applicant:	Ethicon Inc.P.O. Box 151Route 22 WestSomerville, NJ 08876USAPhone: +1-908-218-2954Fax: +1-908-218-2595	APR - 7 2010
Date:Contact Person:	November 25, 2009Joseph Kiceina
Proprietary Device Name:	ETHICON SECURESTRAP™ 5mm Absorbable StrapFixation Device
Common Device Name:	Implantable staple; 21CFR 878.4750
Classification:	GDW; Class II
Predicate Devices:	AbsorbaTack™ Absorbable Fixation Device (K091900)
Manufacturer:	Ethicon LLCGuaynabo, Puerto Rico 00969USA

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5.1 Substantially Equivalent To:

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is substantially equivalent to the Covidien AbsorbaTack™ Absorbable Fixation Device (K091900).

The ETHICON SECURESTRAPTM 5mm Absorbable Strap Fixation Device has the same intended use, and similar indications for use, technological characteristics, and principles of operation as its predicate device.

The minor technological differences between the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device and the AbsorbaTack™ Absorbable Fixation Device raise no new issues of safety or effectiveness as verified by performance data.

5.2 Description of the Device Subject to Premarket Notification:

5.3 Indications for Use:

5.4 Performance Data:

An appropriate and complete performance testing program, including bench and animal, supports that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device fulfills the device requirements as defined in used specifications, functions as intended, and is substantially equivalent to the predicate device.

5.5 Overall Performance Conclusion:

An appropriate and complete performance testing program, including bench and animal testing was performed. Results support that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device meets the device requirements as defined in user specifications, functions as intended, and is substantially equivalent to the predicate device. The materials that are used in the manufacturing of this device have been evaluated in accordance with ISO 10993-1:2003, Biological Evaluation of Medical Devices - Part 1 Evaluation and Testing and are equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 7 2010

Ethicon Inc. % Mr. Joseph Kiceina Manager, Regulatory Affairs · P.O. Box 151, Route 22 West Somerville, New Jersey 08876

Re: K093845

Trade/Device Name: Ethicon SECURESTRAP™ 5mm Absorbable Strap Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 31, 2010 Received: April 01, 2010

Dear Mr. Kiceina:

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. 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

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Page 2 - Mr. Joseph Kiceina

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.

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/ucm11.5809.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/MedicalDevices/Safety/ReportaProblem/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.

Sincerely yours,

For

N. Melkerson

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) No (if known):

Device Name: ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device

Indications for Use:

The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation-of-prosthetic-material-to-soft-tissues-in-various-minimally-invasive-and-open surgical procedures such as hernia repair.

Prescription Use V (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)

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Daniel Kane for MxM

Division Blue-Off

(Division Slun-Of Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K093845

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.