HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER by HIGHLAND INSTRUMENTS

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 Description

The Highland Instrument CES and TUS Instrument Holder is intended to position and hold in position the ultrasound probe of a Transcranial Ultrasound device while at the same time assisting in maintaining the position of electrodes used with a Cranial Electrotherapy Stimulator (CES) device and keeping the electrode lead wires free from entanglement and otherwise free from being disturbed by the patient. The Highland Instrument Holder allows for a physician to utilize a commercially available CES device while simultaneously observing/measuring cerebral regional blood flow in discreet areas of the brain. It further allows the physician to utilize a commercially available CES device while imaging the brain with transcranial ultrasound imaging probes that do not contain the Doppler option.

AI/ML Overview

The provided 510(k) summary for the Highland Instruments CES and TUS Instrument Holder does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be presented for a diagnostic or AI-driven device.

This document describes a medical device that is an "instrument holder," which is a physical device used to position and hold other medical instruments (ultrasound probes and CES electrodes). Its substantial equivalence is based on its functional design and its ability to hold instruments, rather than on performance metrics related to diagnostic accuracy, sensitivity, or specificity.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or not present in this type of 510(k) submission for a physical positioning device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Functional Performance:
Ability to position and hold a variety of transducers and lead wires.	"Testing to demonstrate the ability of the device to position and hold a variety of transducers and lead wires in position was performed." (Exact metrics/results not provided).
Device meets design specifications.	"Descriptive information, laboratory bench testing... were provided to demonstrate the device meets its design specifications, performs as intended..."
Device performs as intended.	"Descriptive information, laboratory bench testing... were provided to demonstrate the device meets its design specifications, performs as intended..."
Biocompatibility:
Safe for intended use; no new materials from consumer products.	"Biocompatibility assessment were provided to demonstrate... is safe for its intended use. Specifically, the device introduces no new materials from consumer products currently on the market."
Substantial Equivalence to Predicate Devices:
Similar design, intended use, and principles of operation to predicate devices (TCD 100M/Marc 600 Spencer Probe Fixation System and Civco Assist Positioning Arm System).	"The design, intended use, and principles of operation of the Highland Instrument Holder device are substantially equivalent to those of the predicate devices cited above."

Explanation: For this type of device, "acceptance criteria" are implied by its intended function and safety. The reported performance refers to "functional testing" and a "biocompatibility assessment," but detailed quantitative results or specific pass/fail criteria are not included in this summary.

Regarding the specific questions about studies proving the device meets acceptance criteria (which are more relevant to diagnostic/AI devices):

2. Sample size used for the test set and the data provenance: Not applicable. The "testing" mentioned is laboratory bench testing for mechanical function and biocompatibility, not a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for an instrument holder.
4. Adjudication method for the test set: Not applicable.
5. 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 applicable. This is not an AI device or a diagnostic device that requires reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical stability and ability to hold instruments as designed, verified through engineering tests.
8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Functional Testing and Biocompatibility Assessment):

The submission states that "Descriptive information, laboratory bench testing and a biocompatibility assessment were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use."

Type of Study: Laboratory bench testing and biocompatibility assessment.
Objective: To demonstrate the device's ability to position and hold transducers/lead wires and its safety through material assessment.
Methodology (briefly described): Testing was performed to demonstrate the ability of the device to position and hold a variety of transducers and lead wires. A biocompatibility assessment affirmed that the device introduces no new materials from consumer products.
Results (general statement): The testing demonstrated the device's ability to perform its intended function and its safety. Specific quantitative results are not provided in this summary document.
Conclusion: The device was deemed substantially equivalent to predicate devices based on its design, intended use, principles of operation, and the results of the functional and biocompatibility testing.

Summary

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

Submitter:	Highland Instruments395 Broadway Apartment R4dCambridge MAPhone: 617-504-6031Fax: 617-945-7453
Contact Person:	Leo BastaNorthStar Biomedical Associates755 Westminster St., Unit 120Providence, RI, 02903Phone: 617.834.9866lbasta@northstarbiomedical.com
Date Prepared:	May 25, 2011
Trade Name:	Highland Instruments CES and TUS Instrument Holder
Regulation Name:	Ultrasonic pulsed doppler imaging system and accessoriesand 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 -K002533, found substantially equivalent on August 30,2000.
	Civco Assist Positioning Arm System with UltrasoundTransducer Holder - Class I 510(k) Exempt.
Device Description:	The Highland Instrument CES and TUS Instrument Holderis intended to position and hold in position the ultrasoundprobe of a Transcranial Ultrasound device while at thesame time assisting in maintaining the position ofelectrodes used with a Cranial Electrotherapy Stimulator(CES) device and keeping the electrode lead wires free
	from entanglement and otherwise free from being disturbedby the patient. The Highland Instrument Holder allows fora physician to utilize a commercially available CES devicewhile simultaneously observing/measuring cerebralregional blood flow in discreet areas of the brain. It furtherallows the physician to utilize a commercially availableCES device while imaging the brain with transcranialultrasound imaging probes that do not contain the Doppleroption.
Intended Use:	The Highland Instruments CES and TUS InstrumentHolder is intended for use in assisting holding and securingcommercially available CES electrodes and diagnosticTranscranial Ultrasound System Probes in the desiredposition on the patient's head.
Functional Testing:	Descriptive information, laboratory bench testing and abiocompatibility assessment were provided to demonstratethe device meets is design specifications, performs asintended, and is safe for its intended use. Specifically, thedevice introduces no new materials from consumerproducts currently on the market. In addition, testing todemonstrate the ability of the device to position and hold avariety of transducers and lead wires in position wasperformed.
Summary of SubstantialEquivalence:	The design, intended use, and principles of operation of theHighland Instrument Holder device are substantiallyequivalent to those of the predicate devices citedabove. Substantial equivalence is based upon descriptivecharacteristics of the various cited predicate devices andupon the testing conducted to demonstrate that the subjectdevice performs as intended and is substantially equivalentto 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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:

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

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

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.