Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
The proposed Composix™ L/P Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon). The mesh, Composix™ L/P, is a low profile, nonabsorbable, sterile prosthesis designed for the reconstruction of soft tissue deficiencies, previously cleared under K061754. It is constructed of one layer of large pore polypropylene mesh and one layer of expanded polytetrafluoroethylene (ePTFE) stitched together with PTFE monofilament. The Composix™ L/P Mesh described above will be preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K092726. The positioning system is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Composix™ L/P Mesh. Additionally, all sizes of the proposed product will be packaged with an Introducer Tool. The Introducer Tool consists of a metal tines/T-cap assembly which is used to roll the proposed device in order to facilitate laparoscopic introduction. The Introducer Tool is identical to that included and cleared under the Composix® L/P Mesh K061754.
The provided 510(k) summary (K102766) describes a medical device, the Composix™ L/P Mesh with Echo PSTM Positioning System, which is a combination of two previously cleared devices. It is important to note that this submission is for a combination device and relies heavily on the substantial equivalence to its predicate devices rather than a de novo study demonstrating novel performance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standards; material recognized as biocompatible (for Introducer Tool) | Biocompatibility testing in accordance with ISO 10993-1 standards was conducted on the proposed device (mesh and positioning system), and the results indicate it is biocompatible. No biocompatibility testing was conducted on the Introducer Tool as 304 Stainless Steel is a recognized biocompatible material (ASTM F899-09e1). |
| Functional Performance | Meet product specifications and intended uses, demonstrating safe and effective deployment and positioning. | Bench testing and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses. |
| Material Equivalence | Materials of the mesh, positioning system, and introducer tool must be equivalent or have recognized biocompatibility to predicates. | Composix™ L/P Mesh: same physical attributes, performance characteristics, and materials as predicate Bard Composix™ L/P Mesh (K061754). Echo PSTM Positioning System: maintains same intended use, physical attributes, performance characteristics, and materials as Mesh GPSTM Deployment Balloon (K092726), with minor shape and inflation mechanism changes. Introducer Tool: identical to previous version (K061754) made of 304 Stainless Steel (recognized biocompatible). |
| Intended Use Equivalence | Intended use should be equivalent to predicate devices. | Composix™ L/P Mesh: same indication as predicate mesh (reconstruction of soft tissue deficiencies, repair of hernias and chest wall defects). Echo PSTM Positioning System: intended to facilitate delivery of soft tissue prosthetics during laparoscopic hernia repair (same as predicate deployment balloon). |
| Safety and Effectiveness | Overall demonstration of safety and effectiveness, leading to substantial equivalence. | All test results support the safety and effectiveness of the device for its intended use and demonstrate substantial equivalence to its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for a "test set" in the context of a clinical performance study. The studies mentioned are:
- Biocompatibility testing: Conducted on the proposed device (mesh and positioning system).
- Bench testing: Conducted on the proposed device design.
- In vivo simulated use experiments: Conducted on the proposed device design.
The nature of these tests suggests they are laboratory or animal-based, not human clinical trials with a specific "test set" of patients.
Data Provenance: The data provenance is not specified in terms of country of origin or retrospective/prospective. Given the type of tests described (bench, in vivo simulated use), it is safe to assume these are prospective experiments/tests conducted for the purpose of this submission, likely within a laboratory or controlled setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies performed (biocompatibility, bench, in vivo simulated use) do not typically involve human expert "ground truthing" in the way a diagnostic AI device would. The "ground truth" for material biocompatibility is based on ISO standards, and for functional performance, it's against design specifications and intended use.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the described studies are not clinical trials or diagnostic performance studies that would involve expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh system, not an AI-assisted diagnostic tool where human readers would assess images with and without AI assistance. The document focuses on the physical and functional performance of the medical device itself and its equivalency to existing products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (surgical mesh and deployment system), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- International Standards: For biocompatibility (ISO 10993-1, ASTM F899-09e1).
- Product Specifications: For bench testing and in vivo simulated use experiments, the device performance is measured against pre-defined product specifications and intended use requirements.
- Predicate Device Performance/Characteristics: A significant part of the "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The new device demonstrates "substantial equivalence" to these known safe and effective devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided as there is no training set for this type of medical device submission.
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K102766
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is provided per the requirements of section 807.92(c).
DEC 1 6 2010
Submitter Information:
| Submitter's Name:Address: | Davol, Inc., Subsidiary of C. R. Bard, Inc.100 Crossings BoulevardWarwick, RI 02886 |
|---|---|
| Telephone: | (401) 825-8575 |
| Fax: | (401) 825-8763 |
| Contact Person: | Keti Sino |
| Device Name: | |
| Trade Namc: | Composix™ L/P Mesh with Echo PSTMPositioning System |
| Common/Usual Name: | - Surgical Mesh- Endoscope & Accessories- Mesh Deployment Balloon |
| Classification Name: | - Mesh, Surgical, Polymeric- Mesh Deployment Balloon- Laparoscope, General & Plastic Surgery |
| Classification Code: | - Class II, § 878.3300, Product Code FTL- Class II, § 878.3300, Product Code OQL- Class II, § 876.1500, Product Code GCJ |
Predicate Device Names:
- Bard Composix® L/P Mesh, K061754 (Davol Inc.), FDA cleared on . 10/23/2006
- Surgical Structures Mesh GPS™ Deployment Balloon, K092726, FDA . cleared on 03/15/2010
PREMARKET NOTIFICATION FOR THE COMPOSIX™ L/P MESH WITH ECHO PSTM POSITIONING SYSTEM
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Device Description:
The proposed Composix™ L/P Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon).
The mesh, Composix™ L/P, is a low profile, nonabsorbable, sterile prosthesis designed for the reconstruction of soft tissue deficiencies, previously cleared under K061754. It is constructed of one layer of large pore polypropylene mesh and one layer of expanded polytetrafluoroethylene (ePTFE) stitched together with PTFE monofilament.
The Composix™ L/P Mesh described above will be preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K092726. The positioning system is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Composix™ L/P Mesh. Additionally, all sizes of the proposed product will be packaged with an Introducer Tool. The Introducer Tool consists of a metal tines/T-cap assembly which is used to roll the proposed device in order to facilitate laparoscopic introduction. The Introducer Tool is identical to that included and cleared under the Composix® L/P Mesh K061754.
Intended Use:
The Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The Composix™ L/P Mesh and the predicate mesh have the same indication: reinforce soft tissue, i.e., repair of hernias and chest wall defects. The proposed product has the same intended use, physical attributes, performance characteristics, and materials as the predicate Bard Composix™ L/P Mesh.
The proposed Composix™ L/P Mesh with Echo PSTM Positioning System simply combines two previously cleared devices: K061754 (which included the Introducer Tool) and K092726, the predicate mesh positioning system. However, for optimal functionality in combination with the Composix™ Mesh that is part of the proposed product, two changes have been made to the positioning system. These modifications include a change to the shape of the positioning system and a change to the type of inflation assembly that is to be used with the positioning system. Similar to its predicate device, the Echo PSTM
PREMARKET NOTIFICATION FOR THE COMPOSIX™ L/P MESH WITH ECHO PSTM POSITIONING SYSTEM
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K102766
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Positioning System has an inflatable channel or tubular structure. However, the predicate device shape was based on a universal design concept in order for it to be compatible with currently marketed mesh devices from various manufacturers, whereas the proposed product is provided in an oval shaped to better match the shape and configuration of the Composix™ L/P Mesh. The second change addresses the positioning system inflation assembly which has been updated to a syringe inflation apparatus, replacing the original bulb type inflation apparatus, as used for the predicate device positioning system. The Echo PSTM Positioning System maintains the same intended use, physical attributes, performance characteristics, and materials as the Mesh GPSTM Deployment Balloon (K092726).
The Introducer Tool that will be packaged with all size configurations of the proposed device is the same as the Introducer Tool currently provided in the predicate Composix™ L/P Mesh device, as cleared in K061754.
Performance Data:
Biocompatibility testing in accordance to ISO 10993-1 standards was conducted on the proposed device (mesh and positioning system) and the results indicate that the device is biocompatible per these standards.
No biocompatibility testing was conducted on the Introducer Tool to be packaged with the proposed device as the 304 Stainless Steel material used for the rolling tines is a recognized biocompatible material as per ASTM F899 - 09e1 Standard Specification for Wrought Stainless Steels for Surgical Instruments. In addition. the polymer handle attached to the rolling tines and the T-cap are non patient contacting material, and therefore, not subject to biocompatibility testing requirements.
Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses.
All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate devices.
PREMARKET NOTIFICATION FOR THE COMPOSIX™ L/P MESH WITH ECHO PSTM POSITIONING SYSTEM
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC I 6 2010
C. R. Bard, Inc. Davol. Inc. % Keti Sino 100 Crossing Boulevard Warwick, Rhode Island 02886
Re: K102766
Trade/Device Name: Composix" L/P Mesh with Echo PS™ Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OQL, GCJ Dated: September 23, 2010 Received: September 24, 2010
Dear Keti Sino:
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
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Page 2 – Keti Sino
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.78001 html far the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/default.hum 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 Small Manufacturers, International and Consumer Assistance 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,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Composix™ L/P Mesh with Echo PSTM Positioning System
Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Usc (21 CFR 801 Subpart C)
(PLËASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kumefa MXM
(Division Sign Off)
(Division Sign-Oil) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102766
20
§ 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.