(108 days)
Not Found
No
The document describes a standard Transcranial Doppler ultrasound system and does not mention any AI or ML capabilities in the intended use, device description, or other sections.
No.
The device is intended for diagnostic purposes (measuring blood velocities, assessing blood flow, detecting micro embolic signals) and is explicitly stated as a "diagnostic ultrasound fluid flow analysis system" and "diagnostic ultrasound system," not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as a diagnostic ultrasound fluid flow analysis system" and its purpose includes "measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values" and to "assess arterial cerebral blood flow for the occurrence of micro embolic signals." Furthermore, the "Device Description" section clearly refers to it as a "Transcranial Doppler (TCD) diagnostic ultrasound system."
No
The device description explicitly states it is a Transcranial Doppler (TCD) diagnostic ultrasound system with a pulse wave and/or continuous wave Doppler transducer, indicating the presence of hardware components beyond just software.
Based on the provided information, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nodecrest Transcranial Doppler Ultrasound System is an ultrasound device that measures blood flow velocities within the body (specifically, in cerebral arteries). It uses sound waves to analyze fluid flow, not to analyze samples taken from the body.
- Intended Use: The intended use clearly describes the measurement of blood velocities and the assessment of blood flow in vivo (within a living organism).
Therefore, because the device operates by analyzing physiological processes directly within the patient's body rather than analyzing samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:
-
For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values
-
To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.
The Nodecrest Transcranial Doppler is intended for use during:
- a) Diagnostic exams
b) Surgical interventions
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
Product codes
IYN, ITX
Device Description
The EMS9U range is a Transcranial Doppler (TCD) diagnostic ultrasound system, with a pulse wave and / or continuous wave Doppler transducer that can be used free hand (or head frame mounted for longer term monitoring). A supplementary M-mode disala ( nay be used to help locate blood flow signals to position the sample gate for Doppler signal, and for detection of emboli signals. Each of the three models in the range is identical in terms of hardware the difference being features that the end user does not request are turned off in the software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasonic pulsed doppler imaging system
Anatomical Site
Cerebral artery, middle, anterior and posterior cerebral arteries, vertebral mid basilar arteries, ophthalmic artery, intracranial internal carotid artery, Peripheral Vascular
Indicated Patient Age Range
Adult Cephalic
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Noderrest LLC MAY - 5 2006
SUMMARY STATEMENT
| Contact Person: | David G. Pegler |
|---|---|
| Address: | Nodecrest LLC |
| 1478 Powells Tavern Place | |
| Herndon, Virginia 20170 | |
| Phone: | 703-627-6636 |
| Classification Name: | System, Imaging, Pulsed Doppler, Ultrasonic |
| Common Usual Name: | Transcranial Doppler Ultrasound System |
| Classification: | Class II |
| Product Code: | 90 IYN |
| Classification Panel: | Radiology |
Device Description
The EMS9U range is a Transcranial Doppler (TCD) diagnostic ultrasound system, with a pulse wave and / or continuous wave Doppler transducer that can be used free hand (or head frame mounted for longer term monitoring). A supplementary M-mode disala ( nay be used to help locate blood flow signals to position the sample gate for Doppler signal, and for detection of emboli signals. Each of the three models in the range is identical in terms of hardware the difference being features that the end user does not request are turned off in the software.
Intended Use
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:
-
For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values
-
To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the
1
vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.
The Nodecrest Transcranial Doppler is intended for use during:
- a) Diagnostic exams
b) Surgical interventions
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
| Parameters | Nodecrest | Rimed Ltd. |
|---|---|---|
| 510(k) Number | K974588 | |
| Transducer Frequency | 2MHz, 4MHz, 8MHz | 2MHz, 4MHz, 8MHz |
| Frequency Spectrum | FFT 256/512 dots | 64/512 dots |
| Frequency Ranges | 1 to 16 MHz | 2 to 32 MHz |
| Depth Measurement | 5 to 136 mm | 15-150 mm |
| Gain | 0 ~ 40db | Manually control 20 steps |
| Clinical Application | ||
| for: 2MHz | ||
| PWD | Ophthalmic, Adult Cephalic | |
| & Peripheral Vascular | Ophthalmic, Adult Cephalic | |
| CWD | Ophthalmic & Peripheral | |
| Vascular | Ophthalmic & Peripheral | |
| Vascular | ||
| Clinical Application | ||
| for: 4MHz | ||
| PWD | Peripheral Vascular | |
| CWD | Peripheral Vascular | Peripheral Vascular |
| Clinical Application | ||
| for: 8MHz | ||
| PWD | Peripheral Vascular | |
| CWD | Peripheral Vascular | Ophthalmic & Peripheral |
| Vascular | ||
| General Electrical | ||
| Testing | IEC 60601-1-1, | |
| IEC 60601-1-2, IEC 60601- | ||
| 1-4, UL 2601-1 | EN 60601-1-1 & | |
| EN 60601-1-2 | ||
| Biocompatibility Tests | ||
| ISO 10993 | Cytotoxicity, Sensitization | Unknown |
12.1 Product Comparison Chart
22
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| skin irritation | ||
|---|---|---|
| USP | Acute Toxicity, | |
| Intracutaneous Reactivity, | ||
| Implantation & Cytotoxicity | Unknown |
12.2 Summary of Safety and Effectiveness:
The Nodecrest Transcranial Doppler Ultrasound System and the Rimed Smart-Lite™ Transcranial Doppler have similar intended use: both offer similar transducer frequency, frequency spectrum, frequency ranges, depth measurement, gain, and offer similar clinical applications. Both systems meet IEC 60601-1 & IEC 60601-1-2 Standards for general electrical safety of medical devices and electrical emissions.
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DEPARTMENT OF HEALTH & HUMAN SERVICE
Public Health Se
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nodecrest, LLC % Mr. E. J. Smith President Smith Associates 1676 Village Green, Suite A CROFTON MD 21114
MAY 5 2006
Re: K060112
Trade Name: Nodecrest Transcranial Doppler Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic ultrasonic transducer
Regulatory Class: II
Product Code: IYN and ITX
Dated: March 1, 2006
Received: March 2, 2006
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Nodecrest Transcranial Doppler Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 2 MHz |
|---|
| 4 MHz |
| 8 MHz |
Image /page/3/Picture/20 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The letters FDA are in bold in the center of the logo.
Investing and Promoting Public Health
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
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If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely yours,
David A. Lyman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (If known):