Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

K161318 · Tedan Surgical Innovations, LLC · GZT · Mar 20, 2017 · Neurology

Device Facts

• Record ID: K161318
• Device Name: Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
• Applicant: Tedan Surgical Innovations, LLC
• Product Code: GZT · Neurology
• Decision Date: Mar 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Phantom Fukushima and Mastability Neurological Holding Systems are mechanical surgical retractors used in neurological cranial procedures. Devices provide access and visualization of surgical field by retracting soft tissue. Operated by neurosurgeons in operating room settings. Systems consist of holding arms and retractor blades to maintain surgical site exposure. Benefit includes stable, hands-free retraction during complex cranial surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical self-retaining retractor system. Components include holding arms and retractor blades. Non-powered, manual operation. Materials and sterilization methods consistent with standard surgical instrumentation for neurosurgical use.

Indications for Use

Indicated for use in patients undergoing neurological cranial procedures requiring soft tissue retraction for surgical access and visualization.

Regulatory Classification

Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

K161318

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)

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