The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.

Device Description

The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is a triegersqueeze mechanical device with a curved cannula, pre-loaded with 20 absorbable straps. The ETHICON SECURESTRAP™ Fixation Device straps are made of a blend of polydioxanone dyed with D&C Violet No. 2 and a L(-)-Lactide/glycolide copolymer. The inserted length of the strap is 6.7 mm.

AI/ML Overview

The provided text describes a 510(k) summary for the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device. It outlines the device's characteristics, intended use, and a performance testing program to demonstrate its safety and effectiveness compared to a predicate device.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table format. Instead, it describes a testing program designed to show that the new device "meets the device requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1 standards	Biocompatibility testing was conducted in accordance with the tests recommended in the ISO 10993-1 standard. (Implied: Device met these standards).
Physical/Performance Measurements: Function as intended	Bench top physical/performance measurements including mesh fixation force and mesh compatibility testing in an animal tissue model were conducted. (Implied: Device performed as intended, demonstrating satisfactory mesh fixation force and compatibility, and meeting user specifications). The device uses the same fundamental scientific technology and principles of operation.
Substantial Equivalence: To predicate device	Performance data (from biocompatibility and physical/performance measurements) "demonstrates that the device is as safe and as effective as the predicate device for the intended use." Minor delivery system differences raised no new issues of safety or effectiveness.

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

The document does not specify exact sample sizes for the "bench top physical/performance measurements" or the "animal tissue model." It mentions "Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard," which typically involves specific sample sizes per test, but these are not detailed here.

Sample Size (Test Set): Not explicitly stated.
Data Provenance: Not explicitly stated. The testing includes "bench top" (laboratory) and "animal tissue model" experiments, indicating controlled experimental settings rather than human clinical data. It is prospective in nature as these tests were performed to evaluate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable (N/A) to this study. The tests described are laboratory-based (benchtop and animal model) and assess physical and material properties, as well as functional performance (e.g., mesh fixation force). They do not involve expert interpretation for 'ground truth' in the way a diagnostic AI study would (e.g., radiologists reviewing images). The "ground truth" here is objective measurement against defined specifications or comparison to the predicate device's performance.

4. Adjudication Method for the Test Set

This is not applicable (N/A). Adjudication methods are typically employed in studies where human reviewers or interpreters make judgments (e.g., clinical trials, AI diagnostic studies) and discrepancies need to be resolved. The studies mentioned (biocompatibility, benchtop, animal tissue model) are objective measurements and comparisons, not subjective interpretations requiring adjudication.

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

This is not applicable (N/A). The device is a physical fixation device for surgical procedures (hernia repairs). It is not an AI diagnostic or assistive tool, so an MRMC study comparing human reader performance with or without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable (N/A). As stated in point 5, the device is a physical surgical tool and does not involve AI or an algorithm that would operate in a standalone manner.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance data in this context refers to:

Pre-defined material and functional specifications: For biocompatibility (ISO 10993-1 standards) and physical performance (e.g., mesh fixation force).
Performance of the predicate device: The new device's performance is compared against the known, established performance of the ETHICON SECURESTRAP™ 5 mm Absorbable Strap Fixation Device (K093845) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable (N/A). This product is a medical device, not an AI or machine learning model that requires a "training set." The product's design and manufacturing processes are likely informed by prior engineering principles, material science, and iterative design, but not a data-driven "training set" in the context of AI.

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

This is not applicable (N/A), as there is no "training set" for this type of device.

Summary

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5 510(K) SUMMARY

Applicant:

Ethicon Inc. P.O. Box 151 Route 22 West Somerville, NJ 08876 USA Phone: +1-908-218-2256 Fax: +1-908-218-2595

Contact Person:

Fixation Device

Implantable Staple

September 28, 2012

Susan Lin

Date:

Trade Device Name:

Class II, 21CFR 878.4750, Product Code: GDW

Common Device Name:

Classification:

Predicate Devices:

ETHICON SECURESTRAP™ 5 mm Absorbable Strap Fixation Device (K093845)

ETHICON SECURESTRAPTM Open Absorbable Strap

Manufacturer:

Ethicon LLC Guaynabo, Puerto Rico 00969 USA

Description of the Device Subject to Premarket Notification;

Indications for Use:

The ETHICON SECURESTRAPTM Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.

FEB

5 2013

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23114 2002

Summary of Technological Characteristics of New Device to Predicate Devices:

The principle of operation and fundamental scientific technology of the proposed device are equivalent to the predicate device. Both the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device and the ETHICON SECURESTRAP™ 5 mm Absorbable Strap Fixation Device function in the same manner - they are designed for fixation of prosthetic material to soft tissues in surgical procedures, such as hernia repairs. They perform this function by delivering absorbable straps into the tissue of the abdominal wall. The strap delivery system in the proposed device is specifically designed for open surgical repair procedures and consists of a newly designed ergonomic handle and trigger, modified lockout counter, modified mesh positioning tip, and includes 20 preloaded absorbable straps.

Performance Data:

The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device underwent an extensive safety and performance testing program, including bench and animal testing, to support that the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device meets the device requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device. The tests conducted include:

Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard .
Bench top physical/performance measurements including mesh fixation force and mesh . compatibility testing in animal tissue model

Conclusion:

The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device has the same intended use, fundamental scientific technology, and principles of operation as its predicate device. Performance data demonstrates that the device is as safe and as effective as the predicate device for the intended use. The minor delivery system differences between the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device and the ETHICON SECURESTRAPTM Fixation Device raise no new issues of safety or effectiveness as verified by performance data.

Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure, composed of three overlapping profiles, symbolizing the department's focus on people and their well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role within the United States government.

Public Health Service

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

February 5, 2013

Ethicon, Incorporated % Ms. Susan Lin Manager, Regulatory Affairs Route 22 West P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K123114

Trade/Device Name: ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 14, 2013 Received: January 16, 2013

Dear Ms. Lin:

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 - Ms. Susan Lin

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/ucm115809.htm forthe 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,

Peter D. Rumm -S

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

Enclosure

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INDICATIONS FOR USE STATEMENT 4

510(k) No (if known): __K123114

Device Name: ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device

Indications for Use:

The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

David Krause

Page 1 of 1

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123114

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.