(102 days)
No
The device is a mechanical holder for existing medical devices and does not perform any data processing or analysis.
No
The device is described as an "Instrument Holder" that assists in holding and securing electrodes and probes. It does not perform any therapeutic action itself, but rather facilitates the use of other therapeutic or diagnostic devices.
No
This device is an instrument holder intended to assist in positioning and holding electrodes and ultrasound probes; it does not perform any diagnostic function itself.
No
The device description clearly indicates it is a physical "Instrument Holder" designed to position and hold physical electrodes and ultrasound probes. It is a hardware device.
Based on the provided information, the Highland Instruments CES and TUS Instrument Holder is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Highland Instruments CES and TUS Instrument Holder is a physical device designed to hold and position other medical devices (CES electrodes and ultrasound probes) on the patient's head. It does not perform any diagnostic testing on biological samples.
- Intended Use: The intended use is to assist in holding and securing other devices, not to diagnose or test for any condition itself.
- Device Description: The description focuses on the mechanical function of positioning and holding, not on analyzing biological samples or generating diagnostic information from them.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with IVD devices.
The device is an accessory or positioning aid for other medical devices, specifically a Cranial Electrotherapy Stimulator (CES) and a Transcranial Ultrasound System.
N/A
Intended Use / 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.
Product codes
ITX, BWN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transcranial Ultrasound
Anatomical Site
patient's head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Descriptive information, laboratory bench testing and a biocompatibility assessment were provided to demonstrate the device meets is design specifications, performs as intended, and is safe for its intended use. Specifically, the device introduces no new materials from consumer products currently on the market. In addition, testing to demonstrate the ability of the device to position and hold a variety of transducers and lead wires in position was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TCD 100M/Marc 600 Spencer Probe Fixation System -K002533
Reference Device(s)
Civco Assist Positioning Arm System with Ultrasound Transducer Holder
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary – K110752 Highland Instruments CES and TUS Instrument Holder
| Submitter: | Highland Instruments
395 Broadway Apartment R4d
Cambridge MA
Phone: 617-504-6031
Fax: 617-945-7453 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta
NorthStar Biomedical Associates
755 Westminster St., Unit 120
Providence, RI, 02903
Phone: 617.834.9866
lbasta@northstarbiomedical.com |
| Date Prepared: | May 25, 2011 |
| Trade Name: | Highland Instruments CES and TUS Instrument Holder |
| Regulation Name: | Ultrasonic pulsed doppler imaging system and accessories
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 -
K002533, found substantially equivalent on August 30,
2000. |
| | Civco Assist Positioning Arm System with Ultrasound
Transducer Holder - Class I 510(k) Exempt. |
| 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. |
| 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. |
| Functional Testing: | Descriptive information, laboratory bench testing and a
biocompatibility assessment were provided to demonstrate
the device meets is design specifications, performs as
intended, and is safe for its intended use. Specifically, the
device introduces no new materials from consumer
products currently on the market. In addition, testing to
demonstrate the ability of the device to position and hold a
variety of transducers and lead wires in position was
performed. |
| Summary of Substantial
Equivalence: | 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. Substantial equivalence is based upon descriptive
characteristics of the various cited predicate devices and
upon the testing conducted to demonstrate that the subject
device performs as intended and is substantially equivalent
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
3
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
4
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) |
(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