The CapSure ™ Permanent 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 CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The CAPSURE™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the CapSure™ Permanent Fixation System, a medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Conforms to FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." Specific tests to include Cytotoxicity, Sensitization, Irritation, Pyrogen Testing (for device); Cytotoxicity, Maximization Sensitization Study, Intracutaneous Study, Acute Systemic Toxicity Study, Pyrogenicity, Hemolysis, Complement Activation Assay, Intramuscular Implant (12 weeks), Rabbit Femoral Bone Implant (12 & 26 weeks), Bacterial Reverse Mutation (Ames) Assay, In Vitro Mouse Lymphoma Mutation Assay, Mouse Peripheral Blood Micronucleus Test, Subacute (14-Day) Intraperitoneal Toxicity Study Mice, Subchronic (14-Day) Intravenous Toxicity Study Mice, Subchronic (13-Week) Toxicity Study in Rats, In Vivo Neurotoxicity, Non-Volatile Residue, Residue on Ignition, Turbidity, UV Absorption (for implant materials). Implantable fastener material conforms to ASTM F138 (316L Stainless Steel) and ASTM F2026 (PEEK).	All samples tested met the acceptance criteria.
Mechanical Testing	Not explicitly stated in quantitative terms but implied to demonstrate substantial equivalence to the predicate device (ProTack™). Specific tests include Trigger Force, Mesh Compatibility, Deployment Reliability, MR Compatibility, Burst Testing.	CapSure™ passed all the test requirements and showed substantial equivalence to the results of the predicate device - ProTack™.
Animal Studies	Not explicitly stated in quantitative terms but implied to demonstrate substantial equivalence to the predicate device. Specific study: Porcine implantation strength study.	CapSure™ passed all the test requirements and showed substantial equivalence to the results of the predicate device - ProTack™.

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

The document does not explicitly state the sample sizes for the mechanical and animal studies. For biocompatibility, it refers to "All samples tested," but the specific number is not provided. The data provenance is from internal company testing conducted by Davol Incorporated. It is retrospective in the sense that it's reported after the tests were performed to support the 510(k) submission. No information about the country of origin of the data is specified beyond "the company."

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

This information is not applicable as the studies described are performance and safety tests (biocompatibility, mechanical, animal studies) for a medical device that performs a mechanical function, not an AI or diagnostic device that requires expert-established ground truth from images or clinical data.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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. The device is a surgical fixation system, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant.

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

This is not applicable. The device is a physical surgical tool; there is no "algorithm only" performance to be evaluated.

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

The "ground truth" for the tests performed can be characterized as follows:

Biocompatibility: Established by adherence to ISO 10993 standards and the expected biological responses (e.g., absence of cytotoxicity, irritation, sensitization).
Mechanical Testing: Established by engineering specifications, physical measurements, and comparison to the performance of the legally marketed predicate device (ProTack™).
Animal Studies: Established by anatomical and physiological assessment in the animal model, and comparison to the performance of the predicate device.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This is not applicable as there is no training set for this type of device.

Summary

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

March 9, 2015

Davol Incorporated Mr. Andrew Harrell Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K142808

Trade/Device Name: CapSure™ Permanent Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 3, 2015 Received: February 5, 2015

Dear Mr. Harrell:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/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.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 Industry and Consumer Education 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,

David Krause -S

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

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Indications for Use

510(k) Number: K142808

Device Name: CapSure™ Permanent Fixation System

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

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) Page 1 of 1

PREMARKET NOTIFICATION FOR CAPSURE™ PERMANENT FIXATION SYSTEM

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510(k) Summary

I. SUBMITTER

Davol Inc. 100 Crossings Boulevard Warwick, RI 02886 Contact Person: Andrew Harrell Regulatory Affairs Specialist Phone: (401) 825-8472 Fax: (401) 825-8447 Andrew.Harrell@crbard.com

Date Prepared: March 7, 2015

II. DEVICE

e-Mail:

Name of Device:	CapSure™ Permanent Fixation System (product code GDW)
Common or Usual Name:	Staple Implantable/Implantable Staple
Classification Name:	Implantable staple (21 CFR §878.4750)
Regulatory Class:	II
Product Code:	GDW

III. PREDICATE DEVICE

K090470 ProTack™ Permanent Fastener System (Covidien Plc) - Cleared May 14, 2009 This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The CapSure™ Permanent 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.

The Indications for Use statement for the subject device is essentially identical to the predicate device. Both the subject and predicate devices have the same intended use for the

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approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

	VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
DEVICE

Device Comparison
Device Features	CapSure™(Subject Device)	ProTack™(K090470)
Intended Use	Permanent soft tissue fixation	Permanent soft tissue fixation
Indication For use	Indicated for the approximation ofsoft tissue and fixation of surgicalmesh to tissues during open orlaparoscopic surgical procedures,such as hernia repair.	Fixation of prosthetic material andapproximation of tissue in varioussurgical specialties, such as therepair of hernial defects.
Mesh/TissueRetention FeatureMaterial	Polyetheretherketone (PEEK) cap(injection molded)	Titanium (metal wire fabrication)
Fastener Material	316L Stainless Steel (metal wirefabrication)	Titanium (metal wire fabrication)
Fastener BodyContact	Same as predicate	Long term implant (>30 days)contacting tissue and/or bone
FastenerShape/Design	Helical Coil/Screw with retentionfeature (proximal cap)	Helical Coil/Screw with retentionfeature (proximal tab)
FastenerDimensions	4.2 mm overall fastener length4.0 mm overall body diameter	4.0 mm overall fastener length3.8 mm overall body diameter
Fastener Quantityper Device	15 & 30 fasteners	30 fasteners
Deploymentcomponent -ShaftLength	37 cm length	35.5 cm length
Deploymentcomponent Handledesign	Same as predicate	Handleactuated-leveldeliverydevice
Fastener DeliverySystem	Same as predicate	Rotational - driven by inner shaftassembly
DeviceSterilization	Same as predicate	EtO

VII. PERFORMANCE DATA

Performance Standards

No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

The following performance data are provided in support of the substantial equivalence determination.

PREMARKET NOTIFICATION FOR CAPSURE™ PERMANENT FIXATION SYSTEM

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Biocompatibility testing

The biocompatibility evaluation for the CapSure™ Permanent Fixation System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by

FDA. The battery of testing included the following tests:

Device Testing

. Cytotoxicity
Sensitization ●
. Irritation

. Pyrogen Testing

Implant Materials Testing
- . Cytotoxicity
- Maximization Sensitization Study .
- . Intracutaneous Study
- . Acute Systemic Toxicity Study
- Pyrogenicity
- Hemolysis
- Complement Activation Assay
- . Intramuscular Implant - 12 Weeks
- Rabbit Femoral Bone Implant - 12 Weeks
- . Rabbit Femoral Bone Implant - 26 Weeks
- Bacterial Reverse Mutation (Ames) Assay
- In Vitro Mouse Lymphoma Mutation Assay
- . Mouse Peripheral Blood Micronucleus Test
- Subacute (14-Day) Intraperitoneal Toxicity Study Mice ●
- Subchronic (14-Day) Intravenous Toxicity Study Mice
- . Subchronic (13-Week) Toxicity Study in Rats
- In Vivo Neurotoxicity
- . Non-Volatile Residue
- . Residue on Ignition
- Turbidity
- . UV Absorption

The deployment device of the CapSure™ Permanent Fixation System is determined to be tissue contacting for duration of less than 24 hours, while the fasteners are determined to be permanent implants. The implantable fastener material conforms to ASTM F138 (316L Stainless Steel) and ASTM F2026 (PEEK).

All samples tested met the acceptance criteria.

Mechanical testing

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

PREMARKET NOTIFICATION FOR CAPSURE™ PERMANENT FIXATION SYSTEM

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. Trigger Force
Mesh Compatibility ●
. Deployment Reliability
MR Compatibility
. Burst Testing

All samples tested met the acceptance criteria.

Animal Studies

The following Animal in vivo studies were completed

. Porcine implantation strength study
CapSure™ passed all the test requirements and showed substantial equivalence to the results of the predicate device - ProTack™.

Clinical Studies

Clinical studies were not performed for this device nor were clinical studies performed for the predicate device, as they are not necessary to adequately assess the safety and effectiveness of the products.

VIII. CONCLUSIONS

The CapSure™ Permanent Fixation System is substantially equivalent to the legally marketed predicate device for the following reasons:

A) The same intended use and indications for use as the predicate device.
B) All devices use a similar fixation technology to deliver the fasteners by compressing an actuation lever.
C) Similar metallic coil fastener design that includes a feature to support mesh or tissue retention made of an inert, non-absorbable, biocompatible material.
D) Similar materials with long history of biocompatible use in medical instrumentation and implantation with appropriate testing data.
E) Similar technological characteristics to the predicate device such as: trigger handle, penetration depth, rotary delivery mechanism and shaft length.
F) Same principle of operation.

As demonstrated in the completed battery of bench and preclinical tests that were conducted by the company, minor technological differences between the CapSure™ Permanent Fixation System and the predicate device do not raise new questions of safety and effectiveness. The minor differences in technological characteristics have been tested and results demonstrate that the differences do not adversely affect the safety, effectiveness, or intended performance of the device. Testing included laboratory bench testing, biocompatibility testing, animal testing, and reliability testing, which result in the conclusion that the CapSure™ Permanent Fixation System is substantially equivalent to the legally marketed predicate device.

PREMARKET NOTIFICATION FOR CAPSURE™ PERMANENT FIXATION SYSTEM

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.