(705 days)
Not Found
No
The summary describes a physical surgical mesh container and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a surgical mesh container intended to maintain the position of bone graft material, which is a supportive rather than a therapeutic function.
No
Explanation: The device, OptiMesh, is described as a surgical mesh container used to maintain the position of bone graft material. Its intended use is purely structural and does not involve detecting, monitoring, or identifying a medical condition.
No
The device description explicitly states it is a "sterile, three-dimensional surgical mesh container made of knitted polyester yarn," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of OptiMesh is to maintain the position of bone graft material within a vertebral body defect. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical mesh container made of knitted polyester yarn, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples. OptiMesh is used in vivo (in the body) during surgery.
N/A
Intended Use / Indications for Use
OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.
Product codes (comma separated list FDA assigned to the subject device)
EZX, KWQ
Device Description
OptiMcsh is a sterile, three-dimensional surgical mesh container made of knitted polyester yarn and offered in a range of sizes. The device is packaged in double Tyvek/Mylar pouches and a cardboard carton, and terminally sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
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)
Where technological differences exist, performance data was provided to demonstrate that the questions raised no new concerns about safety or 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
§ 878.3300 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
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a human figure embracing the world.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela Snyder Director of Clinical and Regulatory Affairs Spineology, Inc. 1815 Northwestern Avenue Stillwater, Minnesota 55082-6500
Re: K014200 Device: OptiMesh™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: EZX Dated: July 30, 2003 Received: August 1, 2003
Dear Ms. Snyder:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
NOV 2 6 2003
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Contraindications section of your device's labeling:
Do not use this device in patients with instability (e.g. resected or collapsed vertebral bodies or fracture of the anterior column). This device does not provide structural support.
In addition, the following warning must appear in a black box immediately below your indications for use statement of the device's labeling:
The safety and effectiveness of this device used for fusion of the interbody space has not been established.
1
Page 2 - Ms. Pamela Snyder
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel Schultz, M.D Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K014200
Device Name:_OptiMesh™
FDA's Statement of the Indications For Use for device:
OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.
3
JAN-06-2004 12:36 Spineology
P.02/02
Spineology Inc. Premarket Notification: OptiMesh K014200
510(k) Summary
| Submitter Information | |
|---|---|
| Manufacturer's Name & Address | Manufacturer's Contact Person |
| Spineology Inc. | Pamela Snyder |
| 1815 Northwestern Avenue | Director of Clinical & Regulatory |
| Stillwater, MN 55082 | Phone: 651-351-1011 |
| Fax: 651-351-0712 |
| Device Names | |
|---|---|
| Proprietary Name: | OptiMesh |
| Classification Name: | 888.3060, appliance, fixation, spinal device; |
| 878.3300 surgical mesh | |
| Device Product Code: | KWQ, EZX |
Predicate Devices
The subject device is substantially equivalent to the predicate device, MacroPore OS Spinal System, K010911, and related predicate device, MERSILENE Mesh, a preamendment device.
Device Description
OptiMcsh is a sterile, three-dimensional surgical mesh container made of knitted polyester yarn and offered in a range of sizes. The device is packaged in double Tyvek/Mylar pouches and a cardboard carton, and terminally sterilized.
Intended Use
OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.
The safety and effectiveness of this device used for fusion of the interbody space has not been established.
Technological Characteristic Comparisons
The device was shown to be substantially equivalent to the intended use, materials and configuration of the predicate products. Where technological differences exist, performance data was provided to demonstrate that the questions raised no new concerns about safety or effectiveness.