(33 days)
Not Found
No
The 510(k) summary describes a surgical mesh made of polypropylene and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for hernioplasty and repair of other fascial defects, which are procedures aimed at treating or alleviating a medical condition, thus classifying it as a therapeutic device.
No
Explanation: The device is described as a synthetic implantable sheet used for the reinforcement of connective tissue structures in hernioplasty and repair of other fascial defects. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a synthetic implantable sheet made of monofilament polypropylene, which is a physical material, 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 "hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result." This describes a surgical implant used in vivo (within the body) to repair tissue.
- Device Description: The device is described as a "synthetic implantable sheet for the reinforcement of connective tissue structures." This further confirms its use as an implantable surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in vitro (outside the body) for these purposes.
Therefore, the Optilene Meshes are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle
610-984-9274 (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
1
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.
2
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.
3
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
4
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