(33 days)
Optilene Meshes (Standard, Universal, and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Optilene® Mesh is a synthetic implantable sheet for the reinforcement of connective tissue structures. It consists of monofilament polypropylene, which is knitted into a dimensionally stable, thin, and flexible net that is cut into various sizes and shapes.
The provided text is a 510(k) summary for the Optilene® Mesh Line Extension. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically requested for AI/ML-based medical devices.
The document primarily focuses on establishing substantial equivalence based on technological characteristics and bench testing. It does not provide performance metrics like sensitivity, specificity, or reader improvement for a human-in-the-loop scenario.
Here's a breakdown of the requested information based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not present in the document.
The document states that "Sufficient bench testing was conducted in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' to show that Aesculap's Optilene® Meshes are comparable to the predicate surgical mesh." However, it does not detail specific acceptance criteria (e.g., tensile strength, pore size, biocompatibility metrics) or the quantitative results from these bench tests.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device.
This information is typically relevant for studies involving data analysis, such as imaging or diagnostic devices. For a surgical mesh, the "test set" would refer to the materials used in bench testing. The document does not specify the sample size of meshes or materials used for the bench tests, nor does it provide details on the provenance of such materials (e.g., country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable for this type of device.
This concept is for devices where human experts interpret data to establish a ground truth (e.g., radiologists labeling images). For a surgical mesh, ground truth is established through physical properties testing, not expert interpretation of data relevant to a "test set" of cases.
4. Adjudication Method for the Test Set
Not applicable for this type of device.
Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth from data. This is not relevant to the bench testing of a surgical mesh.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done.
MRMC studies are typically performed for diagnostic devices where human readers interpret medical cases. This device is a surgical mesh, which does not involve human readers interpreting cases in the context of device performance. The document does not mention any human reader involvement in evaluating the mesh's effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable in the context of AI/ML algorithms.
This device is a physical surgical mesh, not an algorithm. The performance of the mesh is evaluated through bench testing of its physical and mechanical properties, not through an algorithm's standalone performance.
7. The Type of Ground Truth Used
For the Optilene® Mesh, the "ground truth" for demonstrating substantial equivalence is based on:
- Technological Characteristics: Comparison of material (monofilament polypropylene), structure (knitted, dimensionally stable, thin, flexible net), and forms (various sizes and shapes) to the predicate device.
- Bench Testing Results: The document states that "Sufficient bench testing was conducted... to show that Aesculap's Optilene® Meshes are comparable to the predicate surgical mesh." This implies that the ground truth for "comparability" would be established by measuring various physical and mechanical properties (e.g., tensile strength, burst strength, pore size, material composition) and confirming they fall within acceptable ranges or are similar to the predicate device. The specific methods and criteria for this "comparability" are not detailed.
8. The Sample Size for the Training Set
Not applicable for this type of device.
A training set is relevant for AI/ML algorithms that learn from data. This device is a physical surgical mesh.
9. How the Ground Truth for the Training Set Was Established
Not applicable for this type of device.
As above, this concept pertains to AI/ML devices.
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Optilene® Mesh Line Er
JUL 1 9 2006
Page 1 of 1
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Optilene® Mesh Line Extension June 14, 2006
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Lisa M. Boyle610-984-9274 (phone)610-791-6882 (fax) |
| TRADE NAME: | Optilene® Mesh |
| COMMON NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| REGULATION NUMBER: | 878.3300 |
| PRODUCT CODE: | FTL |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Optilene® Mesh is substantially equivalent to:
- Aesculap Optilene® Mesh LP (K053158) .
DEVICE DESCRIPTION
Optilene® Mesh is a synthetic implantable sheet for the reinforcement of connective tissue structures. It consists of monofilament polypropylene, which is knitted into a dimensionally stable, thin, and flexible net that is cut into various sizes and shapes.
INDICATIONS FOR USE
The Optilene® Meshes (Standard, Universal and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s)}
All meshes are woven from monofilament polypropylene nonabsorbable suture material. Optilene® Meshes and Optilene® Mesh LP are also marketed in similar shapes and sizes that are packaged as sterile single use devices.
3
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PERFORMANCE DATA
Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" to show that Aesculap's Optilene® Meshes are comparable to the predicate surgical mesh.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The words "U.S. Department of Health and Human Services" are arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2006
Aesculap®, Inc. % Ms. Lisa M. Boyle Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K061704
Trade/Device Name: Optilene® Mesh Line Extension Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 14, 2006 Received: June 22, 2006
Dear Ms. Boyle:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prarketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Optilene® Mesh Line Extension
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number: K06/704
Device Name: Optilene® Mesh Line Extension
Indications for Use:
Optilene Meshes (Standard, Universal, and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
and/or Over-the-Counter Use Prescription Use (per 21 CFR 801 Subpart D) (per 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)
houbare Buchim
Division of General, Restorative, and Neurological Devices
510(k) Number K061704
§ 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.