(426 days)
The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.
The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Guard to bone. The single-use Scout Tack implant is made of a titanium alloy (TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)," January 1, 2005). It has a low profile head. The tack is inserted by light impaction through the Scout Vessel Guard into lumbar vertebral bone. The Scout Tack implant can be used as an alternative to, or a complement to, suturing the Scout Vessel Guard in place.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance |
|---|---|
| Pullout Strength (compared to suture fixation and predicate devices) | Performed equivalently to or superior to predicate devices (Synthes Arch Fixation System, Replication Medical EnGuard Vessel Guard, Covidien Autosuture Tacker System) and suture fixation. |
| Dynamic Mechanical Testing (compared to suture fixation) | Performed equivalently to or superior to suture fixation. |
| Dynamic Biomechanical Testing (compared to suture fixation) | Performed equivalently to or superior to suture fixation. |
| Usability (cadaver lab testing) | Demonstrated equivalent usability to predicate devices and suture fixation. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each test (pullout, dynamic mechanical, dynamic biomechanical, and usability). However, it implies that the tests involved sufficient samples to draw conclusions about equivalence or superiority.
The data provenance is not explicitly stated as "country of origin," but the testing was conducted by Synthes, an American company. The tests are described as "non-clinical," and the phrase "cadaver lab testing" suggests a controlled, pre-clinical environment. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices and methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the number of experts used or their specific qualifications for establishing ground truth in the non-clinical tests. For usability testing in cadaver labs, it is implied that surgeons or trained professionals evaluated the device, but their number and specific qualifications (e.g., years of experience, specialty) are not provided.
4. Adjudication Method for the Test Set:
The document does not describe a formal adjudication method. The evaluation of test results (e.g., pullout strength measurements, mechanical properties) would typically involve engineering analysis and comparison against pre-defined thresholds or predicate device performance. For usability, it's likely a qualitative assessment by the testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The tests described are non-clinical, mechanical, and biomechanical evaluations, along with cadaver lab usability, not studies involving multiple human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device (tack fixation) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests was based on direct measurements of mechanical properties (e.g., pullout strength, dynamic response) and observations of usability in a cadaver model, compared against the performance of established predicate devices and traditional fixation methods (suturing). There is no "pathology" or "outcomes data" ground truth as this is a pre-clinical evaluation.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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JUN 1 4 2012
510(k) Summary
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| 510(k) Summary | 510(k) Summary |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Heather GuerinSenior Regulatory Affairs SpecialistTelephone: 610-719-5432Facsimile: 610-719-5102Email: guerin.heather@synthes.com |
| Date Prepared: | January 3, 2012 |
| Trade Name: | Synthes Scout Tack Fixation |
| Classification: | 21 CFR § 870.3470Class IICardiovascular Devices PanelProduct Code: OMR (vessel guard or cover)21 CFR § 888.3040Class IIOrthopaedic Devices PanelProduct Code: NDM (pin, fixation, threaded, metallic) |
| PredicateDevices: | Synthes Scout Vessel Guard, K103558Synthes Arch Fixation System, K032534Replication Medical EnGuard Vessel Guard, K082782Covidien Autosuture Tacker System, K090470 |
| DeviceDescription: | The Synthes Scout Tack Fixation is a method of fixation of the Scout VesselGuard to bone. The single-use Scout Tack implant is made of a titanium alloy(TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700),"January 1, 2005). It has a low profile head. The tack is inserted by lightimpaction through the Scout Vessel Guard into lumbar vertebral bone. TheScout Tack implant can be used as an alternative to, or a complement to, suturingthe Scout Vessel Guard in place. |
| Intended Use/Indications forUse: | The Scout Vessel Guard System is indicated as a cover for vessels duringanterior vertebral surgery. |
| Comparison ofthe device topredicatedevice(s): | The Tack Fixation for the Synthes Scout Vessel Guard is substantiallyequivalent to suture fixation of the Scout Vessel Guard (as cleared inK103358) as demonstrated by pullout testing and dynamic mechanicaland biomechanical testing and by usability testing in cadaver labs. The Tack Fixation for the Synthes Scout Vessel Guard is substantiallyequivalent to Synthes Arch Fixation System (K032534) in terms ofmaterial of manufacture (TAN), biocompatibility, intended use (fixationin the spine) and as demonstrated by pullout testing. The Tack Fixation for the Synthes Scout Vessel Guard is substantiallyequivalent to Replication Medical EnGuard Vessel Guard (K082782), asthis device is marketed for fixation by means including tacks or staples.Hence the intended use of the device is the same as Scout Tack fixationof the Scout Vessel Guard. The Tack Fixation for the Synthes Scout Vessel Guard is substantiallyequivalent to the Covidien Autosuture Tacker System (K090470) in |
| 510(k) Summary | |
| material of manufacture, design (e.g. low profile, and helical geometryfor bone purchase), pullout testing, and in intended use (fixation ofprosthetic material during surgical procedures). | |
| PerformanceData(Non-Clinicaland/or Clinical): | Synthes conducted the following non-clinical tests to support a determination ofsubstantial equivalence: pullout testing, dynamic mechanical testing, dynamicbiomechanical testing, and usability (cadaver lab) testing. Clinical testing wasnot required. |
| Conclusions: | The results of the non-clinical tests listed above support a determination ofsubstantial equivalence because the Synthes Tack fixation performedequivalently to or superior to the predicate devices in these tests. |
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and the comments of the comments of
K111048 Response to Request for Additional Information CONFIDENTIAL
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
JUN 1 4 2012
Synthes Spine c/o Heather Guerin Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, PA 19380
Re: K111048
Trade/Device Name: Synthes Scout Vessel Guard System Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: OMR, NDM Dated: January 04, 2012 Received: January 05, 2012
Dear Ms. 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 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.
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 - Ms. Heather Guerin
Furthermore, the indication for use as a cover for vessels 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 print.
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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.
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Page 3 – Ms. Heather Guerin
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Christy Foreman
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration
Enclosure
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Indications for Use Statement 5
K 111048 510(k) Number: (if known)
Synthes Scout Tack Fixation Device Name:
Indications for Use:
The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.
X Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.y. Killchem
(Division Sign-Off) (Division Sign-Oh)
Division of Cardiovascular Devices
KIII048 510(k) Number
§ 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).