(78 days)
Not Found
No
The device description and performance studies focus on the material properties and physical function of a hydrogel membrane, with no mention of AI or ML technologies.
No.
The device acts as a temporary barrier during surgery and is not described as treating, preventing, or diagnosing a disease or condition. Its function is mechanical and protective, not therapeutic in nature.
No
The device description clearly states its purpose as a "cover for vessels during anterior vertebral surgery" and "designed to be placed between the anterior spine and proximate vessels." This indicates a protective or interventional function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is a "permanent, non-absorbable membrane made of hydrogel" and describes physical properties and testing (suture retention, tensile testing, pore size analysis, etc.), indicating it is a physical medical device, not software.
Based on the provided information, the Scout Vessel Guard is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to serve as a physical cover for vessels during anterior vertebral surgery. This is a surgical implant/device used in vivo (within the body) during a procedure.
- Device Description: The description details a physical membrane made of hydrogel, designed to be placed between anatomical structures. This is consistent with a surgical implant.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Scout Vessel Guard is clearly used in vivo as a physical barrier during surgery.
N/A
Intended Use / Indications for Use
The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
Product codes
OMR
Device Description
The Scout Vessel Guard is a permanent, non-absorbable membrane made of hydrogel. It is packaged wet in phosphate buffered saline (PBS). This device is designed to be placed between the anterior spine and proximate vessels during anterior lumbar surgery, and is flexible, allowing it to contour to the anatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine; proximate vessels; anterior lumbar surgery
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)
Synthes conducted the following verification and validation activities: suture retention, tensile testing, pore size analysis, freeze testing, material stability testing, usability (cadaver lab) testing, and biocompatibility in accordance with ISO 10993. The Synthes Scout Vessel Guard met the performance requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence. Clinical data was not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061727, K090022, K093551, K082782
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
FEB 1 8 2011
510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Name of Firm: | Synthes Spine | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| 510(k) | ||
| Contact: | Heather Guerin | |
| Regulatory Affairs Specialist | ||
| Telephone: 610-719-5432 | ||
| Email: guerin.heather@synthes.com | Facsimile: 610-719-5102 | |
| Date Prepared: | February 3, 2011 | |
| Trade Name: | Synthes Scout Vessel Guard | |
| Classification: | 870.3470 | |
| Class II | ||
| Cardiovascular Devices Panel | ||
| Product Code OMR | ||
| Predicate | ||
| Devices: | Gore Preclude® Vessel Guard, K061727 | |
| SpineMedica Paradis Vaso Shield™, K090022, K093551 | ||
| Replication Medical EnGuard™ Vessel Guard, K082782 | ||
| Device | ||
| Description: | The Scout Vessel Guard is a permanent, non-absorbable membrane made of | |
| hydrogel. It is packaged wet in phosphate buffered saline (PBS). This device | ||
| is designed to be placed between the anterior spine and proximate vessels | ||
| during anterior lumbar surgery, and is flexible, allowing it to contour to the | ||
| anatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue. | ||
| Intended Use/ | ||
| Indications for | ||
| Use: | The Scout Vessel Guard is indicated as a cover for vessels during anterior | |
| vertebral surgery. | ||
| Comparison of | ||
| the device to | ||
| predicate | ||
| device(s): | The design features, material, and indications for use of the subject Scout | |
| Vessel Guard are substantially equivalent to the predicate devices identified. | ||
| Performance | ||
| Data | ||
| (Non-Clinical | ||
| and/or | ||
| Clinical): | Synthes conducted the following verification and validation activities: suture | |
| retention, tensile testing, pore size analysis, freeze testing, material stability | ||
| testing, usability (cadaver lab) testing, and biocompatibility in accordance | ||
| with ISO 10993. The Synthes Scout Vessel Guard met the performance | ||
| requirements, providing reasonable assurance of device performance for its | ||
| intended use and supporting substantial equivalence. Clinical data was not | ||
| needed for this device. |
1
Image /page/1/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center is a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-Ci609 Silver Spring. MI> 20995-0002
Synthes Spine c/o Heather Guerin, Ph.D., P.E. Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, PA 19380
FEB 1 8 2011
Re: K103558
Synthes Scout Vessel Guard Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: OMR Dated: December 1, 2010 Received: December 2, 2010
Dear Dr. Guerin:
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 10 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.
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 Warnings section of the device's labeling:
The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established.
:
. . . . . . . .
2
Page 2 - Heather Guerin, Ph.D., P.E.,
Furthermore, the indication for use as a cover during anterior vertebral surgery must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold orint.
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 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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance ai (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (301) 796-6926. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
3
Page 3 - Fleather Guerin, Ph.D., P.E.
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 manber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chrioty Loueman
Christy Foreman Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 4 - Heather Guerin, Ph.D., P.E.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K103558
Device Name:_Synthes Scout Vessel Guard
Indications For Use: The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
una R. V. V
(Division Sign-Off) (Division of Cardiovascular Devices
Page 1 of )
510(k) Number_K103558