(1002 days)
Not Found
No
The device description and intended use focus on a physical implantable mesh and its mechanical function. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is described as a "Containment Device" used in spinal fusion procedures to maintain the position of bony tissue. It is not intended for load-bearing and acts as a mechanical support rather than directly treating a disease or condition. The intended use focuses on maintaining anatomical position during a surgical procedure, not therapeutic intervention in the sense of healing or curing.
No
The device is described as an implantable mesh intended for use in spinal fusion procedures to maintain the position of bony tissue, not to diagnose a condition.
No
The device description clearly states it is a "flexible, synthetic composite implantable mesh" and describes physical components like polyester mesh, ePTFE, suture, and suture anchors. This indicates a physical medical device, not a software-only one.
Based on the provided information, the Anova Containment Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Anova Containment Device Function: The Anova Containment Device is an implantable surgical mesh used to maintain the position of bone grafts during spinal fusion procedures. It is a physical device implanted within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure and the device's role in supporting bone grafts, not diagnosing a condition.
Therefore, the Anova Containment Device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Product codes
EZX, KWQ
Device Description
The Anova Containment Device is a flexible, synthetic composite implantable mesh. It includes a polyester mesh component connected by a mono-filament suture to a porous expanded polytetrafluoroethylene or "ePTFE" component. This ePTFE component is placed between the polyester mesh and the overlying soft tissues. The ePTFE component is not anchored to the disc. The Anova Containment Device is attached to the spine with four suture anchors (two fastened to the vertebra above and two fastened to the vertebra below the disc). The sutures from the anchors overlay the mesh and hold it against the vertebral body and to reinforce the mesh against pressure from the graft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.
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)
Not Found
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
K063461...
ィー・・・・・・
Anova Corporation Page 6
2.0 510(K) SUMMARY FOR THE ANOVA CONTAINMENT DEVICE
Submission Date: November 15, 2006
Submitter Information:
| Company: | Anova Corporation
25 DeForest Avenue
Summit, NJ 07901 | AUG 13 200. |
|-----------------|----------------------------------------------------------------------------------|-------------|
| Contact Person: | Bret Ferree, M.D.
President and CEO
Tel: 513-817-7327
Fax: 513-871-3131 | |
Correspondent Information:
Campbell Tuskey, M.S.P.H. 2001 Pennsylvania Avenue, NW Suite 575 Washington, DC 20006 Tel: 202-822-1850 Fax: 202-822-1859
Device Information:
| Trade Name: | Anova Containment Device |
|---|---|
| Common Name: | Surgical mesh |
| Spinal intervertebral body fixation orthosis | |
| Classification: | 21 CFR §878.3300 EZX |
| 21 CFR §888.3060 KWQ | |
| Device Class: | Class II |
| Trade Name: | MYSTIQUE™ Resorbable Graft Containment Plating |
| System | |
| Manufacturer: | MacroPore Biosurgery, Inc. |
| K Number: | K041105 |
| Product Code: | K WQ |
| Trade Name: | OptiMesh™ 1500 |
| Manufacturer: | Spineology, Inc. |
| K Number: | K014200 |
| Product Code: | EZX |
| Trade Name: | Graft Containment Device |
| Manufacturer: | NuVasive, Incorporated |
| K Number: | K070148 |
| Product Code: | KWQ |
| Intended Use: | The Anova Containment Device, in conjunction with |
| traditional rigid fixation, is intended for use in spinal fusion | |
| procedures as a means to maintain the relative position of | |
| weak bony tissue such as allografts or autografts. The | |
| device is not intended for load bearing indications. | |
| Device Description: | The Anova Containment Device is a flexible, synthetic |
| composite implantable mesh. It includes a polyester mesh | |
| component connected by a mono-filament suture to a | |
| porous expanded polytetrafluoroethylene or "ePTFE" | |
| component. This ePTFE component is placed between the | |
| polyester mesh and the overlying soft tissues. The ePTFE | |
| component is not anchored to the disc. | |
| The Anova Containment Device is attached to the spine | |
| with four suture anchors (two fastened to the vertebra | |
| above and two fastened to the vertebra below the disc). | |
| The sutures from the anchors overlay the mesh and hold it | |
| against the vertebral body and to reinforce the mesh against | |
| pressure from the graft material. |
1
·
Predicate Devices:
.
2
Image /page/2/Picture/0 description: The image is a black and white photograph. The image is blurry and out of focus. There are some dark spots in the image.
510(k) Premarket Notification Anova Containment Device
Anova Corporation Page 8 100
Comparison to Predicate Devices: The Anova Containment Device has the same intended use and similar technological characteristics as the predicate devices. Differences in the design and performance from the cited predicates do not affect either the safety and/or effectiveness of the Anova Containment Device for its intended use. The safety and effectiveness evaluations based on data provided in this 510(k) demonstrate that the Anova Containment Device is substantially equivalent to the cited predicate devices. Conclusion: The results of our evaluation of the Anova Containment Device support the conclusion that it is as safe and effective as legally marketed devices for its intended use and that because it has the same intended use and similar technology, it is substantially equivalent to the cited predicate devices.
3
Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wings, representing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Anova Corporation % Becker & Associates Consulting, Inc. Ms. Campbell T. Hutton, MSPH 2001 Pennsylvania Avenue, SW Washington, District of Columbia 20006
Re: K063461
Trade/Device Name: Anova Containment Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: EZX, KWO Dated: July 8, 2009 Received: July 8, 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 18 2009
Dear Ms. Hutton:
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 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-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.
4
Page 2 - Ms. Campbell T. Hutton, MSPH
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/CDRHOffices/ucm115809.htm for 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/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Buchr
Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1.0 STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K
Device Name:
Anova Containment Device
Indications for Use:
The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K063461
Page 1 of 1