(313 days)
The Phantom™ Fukushima and Mastability Neurological Holding Systems are intended to provide access and allow visualization of the surgical field, and to retract soft tissue during neurological cranial procedures.
Not Found
This is a 510(k) clearance letter for the Phantom Fukushima Neurological Holding Systems and Phantom Mastability Neurological Holding Systems. The document states that the devices are substantially equivalent to legally marketed predicate devices and outlines the general controls provisions of the Act that apply.
However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy. It is a regulatory clearance document, not a performance study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant, as this is a surgical holding system, not an AI diagnostic device, and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
- The type of ground truth used: Not present.
- The sample size for the training set: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
- How the ground truth for the training set was established: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2017
Tedan Surgical Innovations LLC John Willis Manager of RA/OA 12615 W. Airport Blvd, Suite 200 Sugar Land. Texas 77478
Re: K161318
Trade/Device Name: Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: February 15, 2017 Received: February 16, 2017
Dear Mr. Willis:
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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
Device Name
Phantom™ Fukushima and Mastability Neurological Holding Systems
Indications for Use (Describe)
Type of Use (Select one or both, as applicable)
The Phantom™ Fukushima and Mastability Neurological Holding Systems are intended to provide access and allow visualization of the surgical field, and to retract soft tissue during neurological cranial procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).