(78 days)
The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Scout Vessel Guard:
Acceptance Criteria and Device Performance for Synthes Scout Vessel Guard
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Performance Requirement | Reported Device Performance | Study Type |
|---|---|---|---|
| Mechanical Properties | Suture Retention | Met performance requirements | Non-Clinical |
| Tensile Testing | Met performance requirements | Non-Clinical | |
| Material Characteristics | Pore Size Analysis | Met performance requirements | Non-Clinical |
| Material Stability Testing | Met performance requirements | Non-Clinical | |
| Biocompatibility | Biocompatibility (in accordance with ISO 10993) | Met performance requirements | Non-Clinical |
| Usability | Usability Testing (cadaver lab) | Met performance requirements | Cadaver Lab |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes used for each test. The studies mentioned are non-clinical (benchtop/materials testing) and a cadaver lab for usability. Therefore, the data provenance is from laboratory tests and cadaveric studies, not human patient data, and thus, country of origin is not applicable in the typical sense. The studies appear to be prospective in their execution, as they were conducted to verify the device's performance.
3. Number of Experts and Qualifications for Ground Truth:
This information is not provided in the document. For the non-clinical and cadaveric studies, "ground truth" would likely be established by engineering standards and anatomical observations rather than expert consensus on patient data.
4. Adjudication Method for the Test Set:
This information is not provided in the document. As the studies were non-clinical and cadaveric, an adjudication method in the traditional sense for human patient data (e.g., 2+1 radiologist review) would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical data was not needed for this device." This indicates that studies involving human readers and clinical cases were not part of the submission to demonstrate effectiveness or comparing human performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Based on the provided information, the device is a physical medical device (a vessel guard made of hydrogel). Therefore, the concept of an "algorithm only" or "standalone" performance for AI does not apply. The device itself is the primary component, and its performance is evaluated through material and mechanical testing, and usability in a cadaveric setting.
7. Type of Ground Truth Used:
The ground truth used for this device's acceptance was based on:
- Engineering specifications and standards: For suture retention, tensile strength, pore size, and material stability.
- Biocompatibility standards (ISO 10993): For biological safety.
- Anatomical and surgical observations: For usability in a cadaver lab, ensuring the device could be placed and contoured as intended.
8. Sample Size for the Training Set:
This information is not applicable. The Synthes Scout Vessel Guard is a physical medical device, not an AI or software device that undergoes training with a dataset.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as the device is not an AI or software device that requires a training set.
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FEB 1 8 2011
510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 | |
| 510(k)Contact: | Heather GuerinRegulatory Affairs SpecialistTelephone: 610-719-5432Email: guerin.heather@synthes.com | Facsimile: 610-719-5102 |
| Date Prepared: | February 3, 2011 | |
| Trade Name: | Synthes Scout Vessel Guard | |
| Classification: | 870.3470 | |
| Class IICardiovascular Devices PanelProduct Code OMR | ||
| PredicateDevices: | Gore Preclude® Vessel Guard, K061727SpineMedica Paradis Vaso Shield™, K090022, K093551Replication Medical EnGuard™ Vessel Guard, K082782 | |
| DeviceDescription: | The Scout Vessel Guard is a permanent, non-absorbable membrane made ofhydrogel. It is packaged wet in phosphate buffered saline (PBS). This deviceis designed to be placed between the anterior spine and proximate vesselsduring anterior lumbar surgery, and is flexible, allowing it to contour to theanatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue. | |
| Intended Use/Indications forUse: | The Scout Vessel Guard is indicated as a cover for vessels during anteriorvertebral surgery. | |
| Comparison ofthe device topredicatedevice(s): | The design features, material, and indications for use of the subject ScoutVessel Guard are substantially equivalent to the predicate devices identified. | |
| PerformanceData(Non-Clinicaland/orClinical): | Synthes conducted the following verification and validation activities: sutureretention, tensile testing, pore size analysis, freeze testing, material stabilitytesting, usability (cadaver lab) testing, and biocompatibility in accordancewith ISO 10993. The Synthes Scout Vessel Guard met the performancerequirements, providing reasonable assurance of device performance for itsintended use and supporting substantial equivalence. Clinical data was notneeded for this device. |
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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.
:
. . . . . . . .
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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/.
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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
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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
§ 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).