HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER

K110752 · Highland Instruments · ITX · Jun 28, 2011 · Radiology

Device Facts

• Record ID: K110752
• Device Name: HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
• Applicant: Highland Instruments
• Product Code: ITX · Radiology
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The Highland Instruments CES and TUS Instrument Holder is intended for use in assisting holding and securing commercially available CES electrodes and diagnostic Transcranial Ultrasound System Probes in the desired position on the patient's head.

Device Story

Mechanical instrument holder; positions and secures ultrasound probes and CES electrodes on patient's head. Prevents lead wire entanglement; keeps wires clear of patient. Used by physicians to facilitate simultaneous use of CES devices and transcranial ultrasound imaging (including non-Doppler probes) for cerebral blood flow observation/measurement. Device is a passive mechanical positioning system; no electronic or software components. Benefits include stable probe/electrode placement and simplified clinical workflow during combined diagnostic/therapeutic procedures.

Clinical Evidence

Bench testing only. Testing demonstrated the device's ability to position and hold various transducers and lead wires as intended. Biocompatibility assessment provided; no new materials introduced compared to existing consumer products.

Technological Characteristics

Mechanical positioning arm/holder. Materials are consistent with existing consumer products. No energy source, connectivity, or software. Non-sterile device.

Indications for Use

Indicated for patients requiring the positioning and securing of commercially available Cranial Electrotherapy Stimulator (CES) electrodes and diagnostic Transcranial Ultrasound System probes on the head.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• TCD 100M/Marc 600 Spencer Probe Fixation System (K002533)
• Civco Assist Positioning Arm System with Ultrasound Transducer Holder

Submission Summary (Full Text)

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## 510(k) Summary – K110752 Highland Instruments CES and TUS Instrument Holder

| Submitter: | Highland Instruments<br>395 Broadway Apartment R4d<br>Cambridge MA<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta<br>NorthStar Biomedical Associates<br>755 Westminster St., Unit 120<br>Providence, RI, 02903<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | May 25, 2011 |
| Trade Name: | Highland Instruments CES and TUS Instrument Holder |
| Regulation Name: | Ultrasonic pulsed doppler imaging system and accessories<br>and Operating room table and attachments |
| Classification Number: | 21 CFR 892.1570, 878.4950 |
| Product Code: | ITX, BWN |
| Predicate Devices: | TCD 100M/Marc 600 Spencer Probe Fixation System -<br>K002533, found substantially equivalent on August 30,<br>2000. |
| | Civco Assist Positioning Arm System with Ultrasound<br>Transducer Holder - Class I 510(k) Exempt. |
| Device Description: | The Highland Instrument CES and TUS Instrument Holder<br>is intended to position and hold in position the ultrasound<br>probe of a Transcranial Ultrasound device while at the<br>same time assisting in maintaining the position of<br>electrodes used with a Cranial Electrotherapy Stimulator<br>(CES) device and keeping the electrode lead wires free |
| | from entanglement and otherwise free from being disturbed<br>by the patient. The Highland Instrument Holder allows for<br>a physician to utilize a commercially available CES device<br>while simultaneously observing/measuring cerebral<br>regional blood flow in discreet areas of the brain. It further<br>allows the physician to utilize a commercially available<br>CES device while imaging the brain with transcranial<br>ultrasound imaging probes that do not contain the Doppler<br>option. |
| Intended Use: | The Highland Instruments CES and TUS Instrument<br>Holder is intended for use in assisting holding and securing<br>commercially available CES electrodes and diagnostic<br>Transcranial Ultrasound System Probes in the desired<br>position on the patient's head. |
| Functional Testing: | Descriptive information, laboratory bench testing and a<br>biocompatibility assessment were provided to demonstrate<br>the device meets is design specifications, performs as<br>intended, and is safe for its intended use. Specifically, the<br>device introduces no new materials from consumer<br>products currently on the market. In addition, testing to<br>demonstrate the ability of the device to position and hold a<br>variety of transducers and lead wires in position was<br>performed. |
| Summary of Substantial<br>Equivalence: | The design, intended use, and principles of operation of the<br>Highland Instrument Holder device are substantially<br>equivalent to those of the predicate devices cited<br>above. Substantial equivalence is based upon descriptive<br>characteristics of the various cited predicate devices and<br>upon the testing conducted to demonstrate that the subject<br>device performs as intended and is substantially equivalent<br>to the predicate devices. |

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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, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Highland Instruments % Mr. Leo Basta Owner NorthStar Biomedical Associates 755 Westminister St., Unit 120 PROVIDENCE RI 02903

JUN 2 8 2011

Re: K110752

Trade/Device Name: Highland Instruments CES and TUS Instrument Holder Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX and BWN Dated: May 25, 2011 Received: May 31, 2011

Dear Mr. Basta:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

K110752 510(k) Number (if known):

Device Name:

Highland Instruments CES and TUS Instrument Holder

Indications for Use:

The Highland Instruments CES and TUS Instrument Holder is intended for use in assisting holding and securing commercially available CES electrodes and diagnostic Transcranial Ultrasound System Probes in the desired position on the patient's head.

| Prescription Use: | X | AND/OR | Over-The Counter Use: | |
|----------------------------|---|--------|----------------------------|--|
| (Per 21 CFR 801 Subpart D) | | | (Per 21 CFR 801 Subpart C) | |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Potts
Division Sign Off

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Siuk K 110752

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Highland Instruments Response to AI Letter

Confidential