SYNTHES SCOUT VESSEL GUARD

K103558 · Synthes Spine · OMR · Feb 18, 2011 · Cardiovascular

Device Facts

• Record ID: K103558
• Device Name: SYNTHES SCOUT VESSEL GUARD
• Applicant: Synthes Spine
• Product Code: OMR · Cardiovascular
• Decision Date: Feb 18, 2011
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

Device Story

Scout Vessel Guard is a permanent, non-absorbable hydrogel membrane; designed for placement between anterior spine and proximate vessels during anterior lumbar surgery. Flexible material allows contouring to patient anatomy; can be affixed to bone or soft tissue. Packaged wet in phosphate buffered saline (PBS). Used by surgeons in operating room settings to provide a physical barrier/cover for vessels. Device does not prevent post-operative adhesion formation. Benefit is protection of vessels during spinal procedures.

Clinical Evidence

No clinical data was needed for this device. Performance supported by non-clinical verification and validation activities including suture retention, tensile testing, pore size analysis, freeze testing, material stability testing, usability (cadaver lab) testing, and biocompatibility per ISO 10993.

Technological Characteristics

Permanent, non-absorbable hydrogel membrane. Packaged wet in phosphate buffered saline (PBS). Flexible form factor for anatomical contouring. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for use as a vessel cover during anterior vertebral surgery in patients undergoing such procedures.

Regulatory Classification

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.

Predicate Devices

• Gore Preclude® Vessel Guard (K061727)
• SpineMedica Paradis Vaso Shield™ (K090022, K093551)
• Replication Medical EnGuard™ Vessel Guard (K082782)

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 1 8 2011

## 510(k) Summary

| 510(k) Summary | | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 | |
| 510(k)<br>Contact: | Heather Guerin<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email: [e-mail] | Facsimile: 610-719-5102 |
| Date Prepared: | February 3, 2011 | |
| Trade Name: | Synthes Scout Vessel Guard | |
| Classification: | 870.3470 | |
| | Class II<br>Cardiovascular Devices Panel<br>Product Code OMR | |
| Predicate<br>Devices: | Gore Preclude® Vessel Guard, K061727<br>SpineMedica Paradis Vaso Shield™, K090022, K093551<br>Replication Medical EnGuard™ Vessel Guard, K082782 | |
| Device<br>Description: | The Scout Vessel Guard is a permanent, non-absorbable membrane made of<br>hydrogel. It is packaged wet in phosphate buffered saline (PBS). This device<br>is designed to be placed between the anterior spine and proximate vessels<br>during anterior lumbar surgery, and is flexible, allowing it to contour to the<br>anatomy. The Scout Vessel Guard can be affixed to bone and/or soft tissue. | |
| Intended Use/<br>Indications for<br>Use: | The Scout Vessel Guard is indicated as a cover for vessels during anterior<br>vertebral surgery. | |
| Comparison of<br>the device to<br>predicate<br>device(s): | The design features, material, and indications for use of the subject Scout<br>Vessel Guard are substantially equivalent to the predicate devices identified. | |
| Performance<br>Data<br>(Non-Clinical<br>and/or<br>Clinical): | Synthes conducted the following verification and validation activities: suture<br>retention, tensile testing, pore size analysis, freeze testing, material stability<br>testing, usability (cadaver lab) testing, and biocompatibility in accordance<br>with ISO 10993. The Synthes Scout Vessel Guard met the performance<br>requirements, providing reasonable assurance of device performance for its<br>intended use and supporting substantial equivalence. Clinical data was not<br>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 [phone]. 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 [phone]. 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 [phone] or [phone] 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