(186 days)
The PerFix ™ Light Plug with HydroLight™ Onlay is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
The PerFix™ Light Plug with HydroLight™ Onlay (also referenced as "PerFix™ Light Plug HL" and "PerFix™ Light HL" in the submission) is a permanent, tissue contacting implant.
The PerFix™ Light Plug with HydroLight™ Onlay is comprised of two components: the BARD® PerFix™ Light Plug (hereon referred to as "plug") cleared in K092032; and the onlay, a Lightweight Large Pore Mesh (LLPM) with HydroLight™ hydrogel technology. The HydroLight™ hydrogel coating is a 90:1 mixture of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG).
The provided text describes the regulatory clearance (K153236) for a medical device called the "PerFix™ Light Plug with HydroLight™ Onlay." It does not describe an AI/ML device or a study involving acceptance criteria for an AI/ML algorithm's performance.
Therefore, most of the requested information regarding AI device acceptance criteria, performance, sample sizes, ground truth, expert consensus, and MRMC studies is not applicable to the provided document.
However, I can extract information related to the device's performance testing and the studies conducted to support its substantial equivalence.
Here's the relevant information based on the document provided:
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "All samples tested met the established acceptance criteria." and "The PerFix™ Light Plug with HydroLight™ Onlay passed all test requirements and demonstrated substantial equivalence to the test results of the predicate device." However, it does not provide specific numerical acceptance criteria or detailed numerical results for each test. Instead, it lists the types of performance tests conducted.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Indicated device is biocompatible per referenced standards (FDA Blue Book Memorandum #G95-1, ISO 10993-1) | Met criteria. Specific tests conducted: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Genotoxicity, Implantation (Subcutaneous at 4, 8, and 13 weeks), Toxicological Assessment. Results indicate the subject device is biocompatible. |
| Bench Testing (Physical/Performance Characteristics) | Established acceptance criteria (specifics not detailed) | Met criteria. Specific tests conducted: Mesh Thickness, Mesh Weave Characteristics, Monofilament Diameter, Pore Size, Device Weight, Mesh Density (Linear), Tensile Strength, Device Stiffness, Suture Pull Out Strength, Burst Strength, Tear Resistance, Material Interaction Testing. Performance demonstrates the Onlay component does not adversely affect safety/effectiveness and shows substantial equivalence to the predicate. |
| Animal Study (In-vivo) | Established acceptance criteria (specifics not detailed) | Met criteria. Specific studies conducted: |
| - Histological Characterization Comprehensive Rat GLP Study: Evaluated host inflammatory/fibrotic response and presence/absence of hydrogel coating following subcutaneous implantation over a simulated abdominal surgical defect in the rat. | ||
| - Acute GLP Porcine Study: Determined tissue plane conformance and positioning aid properties following placement in the subcutaneous muscular abdominal tissue plane in the porcine model. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility Testing: Not specified for each test, but generally involves specific sample counts per test.
- Bench Testing: "All samples tested met the established acceptance criteria." The specific number of samples for each bench test is not provided.
- Animal Studies:
- Rat GLP Study: "Comprehensive Rat GLP Study," specific number of rats not provided.
- Porcine Study: "Acute GLP Porcine Study," specific number of pigs not provided.
- Clinical Studies (referenced as supporting data, not primary performance studies):
- Champault et al. (2011): Not specified in this document, but the citation indicates a "prospective, multicenter study" on inguinal hernia repair.
- Tollens et al. (2014): "100 Consecutive Patients." "Prospective, Single Center, Single Surgeon's Experience."
- Adhesix™ Intraoperative Handling Characteristics Data: "EU Clinical Experience."
- Testimonials: Dr. Millikan's preclinical evaluation, Dr. Tollens' testimonial.
- Data Provenance: For the clinical data, one study mentions "EU Clinical Experience." The animal studies are assumed to be conducted in a controlled lab environment, likely in the US, but the country of origin is not explicitly stated. The bench testing is also implicitly from the manufacturer's lab. All studies appear to be prospective for their specific designs (e.g., animal studies, clinical trial).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the device is a surgical mesh, not an AI/ML diagnostic or image analysis tool. There is no concept of "ground truth" expert consensus in the same way an AI algorithm would have. The performance is assessed through laboratory tests, animal studies, and referenced clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's not an AI/ML device requiring expert adjudication of results.
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 as the device is a surgical mesh, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a surgical mesh, not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As this is not an AI/ML device, the concept of "ground truth" for algorithmic performance isn't directly applicable. However, for the various tests:
- Biocompatibility: Standards (ISO 10993) and established biological responses.
- Bench Testing: Mechanical and physical properties measured against established engineering specifications.
- Animal Studies: Histopathological findings, observations of tissue conformance and positioning aid properties.
- Clinical Data (supporting only): Patient outcomes from surgical repair procedures (e.g., hernia repair).
8. The sample size for the training set:
This is not applicable as the device is a hardware implant (surgical mesh), not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable as the device is a hardware implant (surgical mesh), not an AI/ML model.
{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 symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
C.R. Bard, Inc. Ms. Shweta Conner Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K153236
Trade/Device Name: Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay. Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh
Regulatory Class: Class II Product Code: FTL Dated: April 12, 2016 Received: April 13, 2016
Dear Ms. Conner:
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 device
{1}------------------------------------------------
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/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,
David Krause -S
- 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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K153236
Device Name
PerFixTM Light Plug with HydroLight™ Onlay
Indications for Use (Describe)
The PerFix ™ Light Plug with HydroLight™ Onlay is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Patilishing Services (301) 443-6780 EF
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
Section 5 510(k) Summary
I. SUBMITTER
Davol Inc. 100 Crossings Boulevard Warwick, RI 02886
| Contact Person: | Shweta Conner |
|---|---|
| Regulatory Affairs Specialist | |
| Phone: | (401) 825-8303 |
| Fax: | (401) 825-8763 |
| E-mail: | shweta.conner@crbard.com |
Date Prepared: May 11, 2016
II. DEVICE
| Name of Device: | PerFix™ Light Plug with HydroLight™ Onlay |
|---|---|
| 510(k) number: | K153236 |
| Product Code | 0117450, 0117460, 0117470, 0117480 |
| Common or Usual Name: | Mesh, Surgical, Polymeric/ Surgical Mesh |
| Classification Name: | 21 CFR §878.3300 – Surgical Mesh |
| Regulatory Class: | II |
| Product Code: | FTL |
III. PREDICATE DEVICE
The predicate device for this submission is the BARD® PerFix™ Light Plug, cleared in K092032, marketed by Davol Inc., a subsidiary of CR Bard, Inc. This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The PerFix™ Light Plug with HydroLight™ Onlay (also referenced as "PerFix™ Light Plug HL" and "PerFix™ Light HL" in the submission) is a permanent, tissue contacting implant.
The PerFix™ Light Plug with HydroLight™ Onlay is comprised of two components: the BARD® PerFix™ Light Plug (hereon referred to as "plug") cleared in K092032; and the onlay, a Lightweight Large Pore Mesh (LLPM) with HydroLight™ hydrogel technology. The HydroLight™ hydrogel coating is a 90:1 mixture of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG).
{4}------------------------------------------------
V. INDICATIONS FOR USE
The PerFix™ Light Plug with HydroLight™ Onlay is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
The Indications for Use statement for the subject PerFix™ Light Plug with HydroLight™ Onlay is identical to that of the predicate BARD® PerFix™ Light Plug.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Device Features | Subject devicePerFix™ Light Plug withHydroLight™ Onlay | Predicate deviceBARD® PerFix™ Light Plug(K092032) |
|---|---|---|
| Indications for Use | Identical to predicate device:Indicated for reinforcement of softtissue, where weakness exists, inprocedures involving soft tissue repair,such as groin hernia defects. | Indicated for reinforcement of softtissue, where weakness exists, inprocedures involving soft tissue repair,such as groin hernia defects. |
| DeviceSterilization | Identical to predicate device:ETO SAL 10-6 | ETO SAL 10-6 |
| Plug Material | Identical to predicate device:Co-knitted using polypropyleneCo-knitted using polypropylene | Co-knitted using polypropyleneCo-knitted using polypropylene |
| Onlay Material | Hydrogel coating- Blend ofpolyvinylpyrrolidone (PVP) andpolyethylene glycol (PEG) | No coating |
| Shape of Plug | Identical to predicate device:Pre-formed cone shapeAvailable sizes- small, medium, largeand extra large | Pre-formed cone shapeAvailable sizes- small, medium, largeand extra large |
| Shape of Onlay | Flat pre-shaped mesh with key holeAvailable size- 6 x 13.5 cm | Flat pre-shaped mesh with no keyholeAvailable size- 5.8 x 13.7 cm |
| Packaging | PlugIdentical to predicate device:Blister tray with Tyvek lid | Blister tray with Tyvek lid |
| OnlayTyvek/Mylar pouch in blister tray withTyvek lid | Blister tray with Tyvek lid |
Table 5-1: Device Substantial Equivalence – General Characteristics
{5}------------------------------------------------
VII. PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
Performance standards
No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
Biocompatibility testing
The biocompatibility evaluation for the PerFix™ Light Plug with HydroLight™ Onlay 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 following tests were conducted and the results indicate that the subject device is biocompatible per the referenced standards:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity
- Pyrogenicity
- Genotoxicity
- Implantation: Subcutaneous Implantation (4 week)
- Implantation: Subcutaneous Implantation (8 week)
- Implantation: Subcutaneous Implantation (13 week) ●
- Toxicological Assessment ●
Electrical safety and electromagnetic compatibility (EMC)
The subject PerFix™ Light Plug with HydroLight™ Onlay is not an electro-mechanical medical device nor is it a medical system; therefore this section does not apply.
Software Verification and Validation Testing
The subject PerFix™ Light Plug with HydroLight™ Onlay does not contain software; therefore this section does not apply.
Performance Testing
Performance testing was completed for the subject PerFix™ Light Plug with HydroLight™ and predicate BARD® PerFix" Light Plug. In accordance with FDA's "Guidance for the
{6}------------------------------------------------
Preparation of a Premarket Notification for a Surgical Mesh" published March 2, 1999, testing included the following physical and performance characteristic evaluations.
Bench Testing:
- . Mesh Thickness
- Mesh Weave Characteristics ●
- Monofilament Diameter ●
- Pore Size ●
- Device Weight ●
- Mesh Density (Linear) .
- Tensile Strength ●
- Device Stiffness ●
- Suture Pull Out Strength ●
- Burst Strength ●
- Tear Resistance ●
- Material Interaction Testing ●
All samples tested met the established acceptance criteria. The PerFix™ Light Plug component of the subject device is identical to that of the predicate BARD® PerFix™M Light Plug (K092032). For the HydroLight™ Onlay which is the only difference between the subject and the predicate, performance testing demonstrates that the Onlay component does not adversely affect the safety and effectiveness of the proposed device. The subject PerFix™ Light Plug with HydroLight™ Onlay passed all test requirements and demonstrated substantial equivalence to the test results of the predicate device.
Animal Study:
The performance of the subject PerFix™ Light Plug with HydroLight™ Onlay was evaluated by animal study.
The following in-vivo animal studies were conducted:
- . Histological Characterization Comprehensive Rat GLP Study to histologically evaluate the host inflammatory/fibrotic response, and the presence or absence of hydrogel coating following subcutaneous implantation over a simulated abdominal surgical defect in the rat.
- Acute GLP Porcine Study to determine tissue plane conformance and ● positioning aid properties following placement in the subcutaneous muscular abdominal tissue plane in the porcine model.
All samples tested met the established acceptance criteria and demonstrated substantial equivalence to the test results of the predicate device.
Clinical Studies
Clinical studies were not performed for either the subject or the predicate device, however, the following clinical data was included to support the safety and effectiveness and demonstrate substantial equivalence to the predicate BARD® PerFix™ Light Plug (K092032)
{7}------------------------------------------------
- Champault G, Torcivia A, Paolino L, Chaddad W, Lacaine F, Barrat C. A self-● adhering mesh for inguinal hernia repair: preliminary results of a prospective, multicenter study. Hernia. 2011;15(6):635-41.
- Tollens T, Kennes J, Vermeiren K, Aelvoet C. Prospective, Single Center, Single ● Surgeon's Experience with an Atraumatic Self-Adhering Mesh in 100 Consecutive Patients. Surgical Technology Int. 2014;(24):178-82.
- . Adhesix™ Intraoperative Handling Characteristics Data from EU Clinical Experience
- Testimonial of Dr. Keith Millikan, MD FACS, Surgeon & Professor, Rush ● University.
- Based on his preclinical evaluation on the usability, interoperability, and o clinical utility of the coating.
- VIDEO 1 "Millikan Preclinical Lab Trimming" (1:26s) o
- o VIDEO 2 "Millikan Preclinical Lab Mesh Manipulation" (0:45s)
- Testimonial from Dr. Timothy Tollens, MD. ●
VII. CONCLUSIONS
The comparative analysis, performance testing results and clinical data demonstrate the subject PerFix™ Light Plug with HydroLight™ Onlay is substantially equivalent to the currently marketed predicate BARD® PerFix™ Light Plug (K092032).
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.