K Number
K160900
Device Name
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
Manufacturer
Date Cleared
2016-05-31

(60 days)

Product Code
Regulation Number
878.4750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.

Yes.
Explanation: The device is used for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair, which are therapeutic interventions.

No

The device is described as a "Permanent Fixation System" for the "approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair." This indicates its function is surgical fixation, not diagnosis. The "Summary of Performance Studies" also focuses on biocompatibility, mechanical testing, and animal studies related to fixation, not diagnostic accuracy.

No

The device description clearly states it is a sterile single-use device that delivers permanent fasteners via a straight shaft, indicating it is a physical medical device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair." This describes a surgical device used directly on the patient's body during a procedure.
  • Device Description: The description details a mechanical device that delivers fasteners. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples.
    • Providing diagnostic information about a disease or condition.
    • Using reagents or assays.

Therefore, the CapSure™ Permanent Fixation System is a surgical device, not an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GDW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, for procedures such as hernia repair.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility testing: The evaluation for the CapSure™ Permanent Fixation System was reported in K142808, 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 assays for Cytotoxicity, Sensitization, Irritation, Pyrogen Testing (Device Testing), and 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 (Implant Materials Testing). 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™. Tests included Trigger Force, Mesh Compatibility, Deployment Reliability, MR Compatibility, and Burst Testing. All samples tested met the acceptance criteria.

Animal Studies: A Porcine implantation study was completed for this premarket submission. Key result: As compared to the control, CapSure™ had significantly (p

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine. The symbol is composed of three figures in profile, representing health and human services.

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

1

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

2

Indications for Use

510(k) Number: K160900

Device Name: CapSure™ Permanent Fixation System

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.

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

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.

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.

4

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Device Comparison
Device FeaturesCapSureTM
(Subject Device)CapSureTM
(Predicate - K142808)
Intended UseIdentical to predicatePermanent soft tissue fixation
Indication For useIdentical to predicateIndicated for the approximation of
soft tissue and fixation of surgical
mesh to tissues during open or
laparoscopic surgical procedures,
such as hernia repair.
Mesh/Tissue
Retention Feature
MaterialIdentical to predicatePolyetheretherketone (PEEK) cap
(injection molded)
Fastener MaterialIdentical to predicate316L Stainless Steel (metal wire
fabrication)
Fastener Body
ContactIdentical to predicateLong term implant (>30 days)
contacting tissue and/or bone
Fastener
Shape/DesignIdentical to predicateHelical Coil/Screw with retention
feature (proximal cap)
Fastener
DimensionsIdentical to predicate4.2 mm overall fastener length
4.0 mm overall cap diameter
Fastener Quantity
per DeviceIdentical to predicate15 & 30 fasteners
Deployment
component -Shaft
LengthIdentical to predicate37 cm length
Deployment
component Handle
designIdentical to predicateHandle
actuated-level
delivery
device
Fastener Delivery
SystemIdentical to predicateRotational - driven by inner shaft
assembly
Device
SterilizationIdentical to predicateEtO

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

5

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

6

  • . 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