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 shaft of 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 document is a 510(k) premarket notification for the CapSure™ Permanent Fixation System. It focuses on demonstrating substantial equivalence to a predicate device (K142808 CapSure™ Permanent Fixation System) rather than presenting a study for initial market approval. Therefore, the information typically requested for a device's initial acceptance criteria and its demonstration through a study (especially regarding algorithm performance, ground truth establishment, sample sizes for training/test sets, and expert involvement for AI/diagnostic devices) is largely not applicable in this context.

This submission is about minor changes to an already cleared device, asserting that no technological characteristics have changed and that updated instructions for use are supported by adequate performance data from the previous 510(k).

However, I can extract the information related to performance data and acceptance criteria as presented for the original clearance (K142808) and affirmed for this submission.

Here's a breakdown based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity	(Implicit: Meet ISO 10993 standards for non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, etc. for materials in contact duration categories)	All samples tested met the acceptance criteria. (Deployment device: tissue contacting < 24 hours; Fasteners: permanent implants adhering to ASTM F138 & ASTM F2026)
	Sensitization
	Irritation
	Pyrogen Testing
	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
Mechanical Testing	Trigger Force	(Implicit: Meet pre-defined functional specifications for device operation)	All samples tested met the acceptance criteria and showed substantial equivalence to the predicate device (ProTack™).
	Mesh Compatibility
	Deployment Reliability
	MR Compatibility
	Burst Testing
Animal Studies	Porcine implantation study	(Implicit: Device performance that is not inferior to control or demonstrates a specific benefit, i.e., minimizing tissue attachments to fasteners.)	CapSure™ had significantly (p<0.05) fewer tissue attachments to fasteners compared to the control, indicative of a role of the CapSure™ Device in minimizing tissue attachments to fasteners.

The following questions are largely N/A or cannot be answered from this document, as it focuses on demonstrating substantial equivalence for a mechanical/implantable device and not an AI/diagnostic algorithm.

2. Sample size used for the test set and the data provenance:

Biocompatibility: "All samples tested met the acceptance criteria." Specific sample sizes are not provided in this summary but would have been in the original K142808 submission. Data provenance is implied to be laboratory testing as per ISO 10993 standards.
Mechanical Testing: "All samples tested met the acceptance criteria." Specific sample sizes are not provided but would have been in the original K142808 submission. Data provenance is laboratory testing.
Animal Studies: A "Porcine implantation study" was conducted. The sample size (number of pigs, number of fasteners tested) is not specified in this summary. Data provenance is an animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This information is not relevant for biocompatibility, mechanical, or animal studies of a fixation device. Ground truth, in this context, relates to objective measurements or physiological responses, not expert interpretation.

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

N/A. Not applicable for the types of tests performed.

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:

No. This is a mechanical fixation device, not an AI/diagnostic device involving human readers.

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

N/A. Not applicable for this device.

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

Biocompatibility: Ground truth is defined by objective parameters according to ISO 10993 standards (e.g., cell viability, erythema scores, implant site reactions, toxicological endpoints).
Mechanical Testing: Ground truth is defined by engineering specifications and objective measurements (e.g., force values, successful deployment rate, MR compatibility measurements, burst pressure).
Animal Studies: Ground truth is objective pathological and physiological observations (e.g., presence/absence of tissue attachments, statistical significance of differences compared to control).

8. The sample size for the training set:

N/A. This is not an AI/machine learning device; there is no "training set."

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

N/A. Not applicable.

Summary

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

May 31, 2016

C.R. Bard Inc. Mr. Andrew Harrell Senior Regulatory Affairs Specialist 100 Crossings Blvd Warwick, Rhode Island 02886

Re: K160900

Trade/Device Name: Capsure Fixation System - Straight 5mm X 37 Cm - 30 Permanent Fasteners, Capsure Fixation System - Straight 5mm X 37 Cm - 15 Permanent Fasteners Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II

Product Code: GDW Dated: March 31, 2016 Received: April 1, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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: K160900

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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Section 5 510(k) Summary

SUBMITTER

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

Date Prepared: March 31, 2016

II. DEVICE

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

III. PREDICATE DEVICE

K142808 CapSure™ Permanent Fixation System (Davol Inc.) - Cleared March 9, 2015

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 unchanged as a result of this 510(k) and remains identical to the device cleared in K142808. Both the subject and predicate devices retain the identical intended use for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Device Comparison
Device Features	CapSureTM(Subject Device)	CapSureTM(Predicate - K142808)
Intended Use	Identical to predicate	Permanent soft tissue fixation
Indication For use	Identical to predicate	Indicated for the approximation ofsoft tissue and fixation of surgicalmesh to tissues during open orlaparoscopic surgical procedures,such as hernia repair.
Mesh/TissueRetention FeatureMaterial	Identical to predicate	Polyetheretherketone (PEEK) cap(injection molded)
Fastener Material	Identical to predicate	316L Stainless Steel (metal wirefabrication)
Fastener BodyContact	Identical to predicate	Long term implant (>30 days)contacting tissue and/or bone
FastenerShape/Design	Identical to predicate	Helical Coil/Screw with retentionfeature (proximal cap)
FastenerDimensions	Identical to predicate	4.2 mm overall fastener length4.0 mm overall cap diameter
Fastener Quantityper Device	Identical to predicate	15 & 30 fasteners
Deploymentcomponent -ShaftLength	Identical to predicate	37 cm length
Deploymentcomponent Handledesign	Identical to predicate	Handleactuated-leveldeliverydevice
Fastener DeliverySystem	Identical to predicate	Rotational - driven by inner shaftassembly
DeviceSterilization	Identical to 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.

Biocompatibility testing

The biocompatibility evaluation for the CapSure™ Permanent Fixation System was reported in K142808, in accordance with the FDA Blue Book Memorandum #G95-1 "Use of

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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
o Bacterial Reverse Mutation (Ames) Assay
In Vitro Mouse Lymphoma Mutation Assay
o 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 Neurotoxicitv
o 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 CapSure™ Permanent Fixation System in K142808 and passed all the test requirements and showed substantial equivalence to the results of the predicate device identified in K142808 – ProTack™

. Trigger Force
Mesh Compatibility ●
. Deployment Reliability

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. MR Compatibility
. Burst Testing

All samples tested met the acceptance criteria.

Animal Studies

The following in vivo study was completed for this premarket submission

. Porcine implantation study
As compared to the control. CapSure™ had significantly (p<0.05) fewer tissue attachments to fasteners, indicative of a role of the CapSure™ Device in minimizing tissue attachments to fasteners.

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 Class II products.

VIII. CONCLUSIONS

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

A) The intended use and indications for use are not changed from the predicate device.
B) No technological characteristics have changed related to this premarket notification.
C) The update to the instructions for use has been supported by adequate performance data.

As demonstrated in the completed tests that were conducted by the company in K142808 and this submission, the CapSure™ Permanent Fixation System is substantially equivalent to the legally marketed predicate device.

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.