(161 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is used for soft tissue approximation and fixation of surgical mesh, which is a structural and mechanical function, not a therapeutic one that treats or cures a disease.
No
Explanation: The device is indicated for "approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures," which describes a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a "sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft" and includes physical components like a "316L Stainless steel helical coil and polyetheretherketone (PEEK) cap". This indicates a physical medical device, not a software-only one.
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 procedure performed directly on the patient's body.
- Device Description: The device is a "sterile single use device that delivers either 15 or 30 permanent fasteners." This is a surgical instrument used for mechanical fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The CapSure™ Permanent Fixation System is a surgical device used in vivo (within the living body) during surgical procedures, not an in vitro (in glass/outside the body) 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 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, surgical mesh (for 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: In accordance with FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1. Tests included: Cytotoxicity, Sensitization, Irritation, Pyrogen Testing for the device, and for implant materials: 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. All samples tested met the acceptance criteria.
Mechanical testing: Non-clinical tests were completed for the subject and predicate devices. Tests included: Trigger Force, Mesh Compatibility, Deployment Reliability, MR Compatibility, Burst Testing. CapSure™ passed all test requirements and showed substantial equivalence to the predicate device - ProTack™.
Animal Studies: Porcine implantation strength study. CapSure™ passed all test requirements and showed substantial equivalence to the predicate device - ProTack™.
Clinical Studies: Clinical studies were not performed for this device nor for the predicate device, as they were not deemed necessary to adequately assess safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle with three human profiles incorporated into its design.
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
1
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
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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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
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.
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
4
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 of | |
| soft tissue and fixation of surgical | ||
| mesh to tissues during open or | ||
| laparoscopic surgical procedures, | ||
| such as hernia repair. | Fixation of prosthetic material and | |
| approximation of tissue in various | ||
| surgical specialties, such as the | ||
| repair of hernial defects. | ||
| Mesh/Tissue | ||
| Retention Feature | ||
| Material | Polyetheretherketone (PEEK) cap | |
| (injection molded) | Titanium (metal wire fabrication) | |
| Fastener Material | 316L Stainless Steel (metal wire | |
| fabrication) | Titanium (metal wire fabrication) | |
| Fastener Body | ||
| Contact | Same as predicate | Long term implant (>30 days) |
| contacting tissue and/or bone | ||
| Fastener | ||
| Shape/Design | Helical Coil/Screw with retention | |
| feature (proximal cap) | Helical Coil/Screw with retention | |
| feature (proximal tab) | ||
| Fastener | ||
| Dimensions | 4.2 mm overall fastener length | |
| 4.0 mm overall body diameter | 4.0 mm overall fastener length | |
| 3.8 mm overall body diameter | ||
| Fastener Quantity | ||
| per Device | 15 & 30 fasteners | 30 fasteners |
| Deployment | ||
| component -Shaft | ||
| Length | 37 cm length | 35.5 cm length |
| Deployment | ||
| component Handle | ||
| design | Same as predicate | Handle |
| actuated-level | ||
| delivery | ||
| device | ||
| Fastener Delivery | ||
| System | Same as predicate | Rotational - driven by inner shaft |
| assembly | ||
| Device | ||
| Sterilization | 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.