(426 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation method of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "cover for vessels" and a "method of fixation," which does not indicate it is used for treating or diagnosing a disease or condition. Its purpose is to hold the vessel guard in place during surgery.
No
The device is described as a system for fixation of a vessel guard during anterior vertebral surgery, which is a surgical tool, not a diagnostic one.
No
The device description explicitly states it is a "single-use Scout Tack implant is made of a titanium alloy" and is inserted into bone. This is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a cover for vessels during anterior vertebral surgery." This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The description details a surgical implant (tack) and a cover (vessel guard) used to secure the cover to bone. This is consistent with a surgical instrument/implant, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.
Product codes (comma separated list FDA assigned to the subject device)
OMR, NDM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar vertebral bone
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 non-clinical tests to support a determination of substantial equivalence: pullout testing, dynamic mechanical testing, dynamic biomechanical testing, and usability (cadaver lab) testing. Clinical testing was not required. The results of the non-clinical tests listed above support a determination of substantial equivalence because the Synthes Tack fixation performed equivalently to or superior to the predicate devices in these tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Scout Vessel Guard, K103558, Synthes Arch Fixation System, K032534, Replication Medical EnGuard Vessel Guard, K082782, Covidien Autosuture Tacker System, K090470
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 1 4 2012
510(k) Summary
.
| 510(k) Summary | 510(k) Summary |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Heather Guerin |
| Senior Regulatory Affairs Specialist | |
| Telephone: 610-719-5432 | |
| Facsimile: 610-719-5102 | |
| Email: guerin.heather@synthes.com | |
| Date Prepared: | January 3, 2012 |
| Trade Name: | Synthes Scout Tack Fixation |
| Classification: | 21 CFR § 870.3470 |
| Class II | |
| Cardiovascular Devices Panel | |
| Product Code: OMR (vessel guard or cover) |
21 CFR § 888.3040
Class II
Orthopaedic Devices Panel
Product Code: NDM (pin, fixation, threaded, metallic) |
| Predicate
Devices: | Synthes Scout Vessel Guard, K103558
Synthes Arch Fixation System, K032534
Replication Medical EnGuard Vessel Guard, K082782
Covidien Autosuture Tacker System, K090470 |
| Device
Description: | 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. |
| Intended Use/
Indications for
Use: | The Scout Vessel Guard System is indicated as a cover for vessels during
anterior vertebral surgery. |
| Comparison of
the device to
predicate
device(s): | The Tack Fixation for the Synthes Scout Vessel Guard is substantially
equivalent to suture fixation of the Scout Vessel Guard (as cleared in
K103358) as demonstrated by pullout testing and dynamic mechanical
and biomechanical testing and by usability testing in cadaver labs. The Tack Fixation for the Synthes Scout Vessel Guard is substantially
equivalent to Synthes Arch Fixation System (K032534) in terms of
material of manufacture (TAN), biocompatibility, intended use (fixation
in the spine) and as demonstrated by pullout testing. The Tack Fixation for the Synthes Scout Vessel Guard is substantially
equivalent to Replication Medical EnGuard Vessel Guard (K082782), as
this device is marketed for fixation by means including tacks or staples.
Hence the intended use of the device is the same as Scout Tack fixation
of the Scout Vessel Guard. The Tack Fixation for the Synthes Scout Vessel Guard is substantially
equivalent to the Covidien Autosuture Tacker System (K090470) in |
| 510(k) Summary | |
| | material of manufacture, design (e.g. low profile, and helical geometry
for bone purchase), pullout testing, and in intended use (fixation of
prosthetic material during surgical procedures). |
| Performance
Data
(Non-Clinical
and/or Clinical): | Synthes conducted the following non-clinical tests to support a determination of
substantial equivalence: pullout testing, dynamic mechanical testing, dynamic
biomechanical testing, and usability (cadaver lab) testing. Clinical testing was
not required. |
| Conclusions: | The results of the non-clinical tests listed above support a determination of
substantial equivalence because the Synthes Tack fixation performed
equivalently 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
2
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.
3
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.
4
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
5
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