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.

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.

AI/ML Overview

The provided document K060112 is a 510(k) premarket notification for the Nodecrest Transcranial Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving their fulfillment that would typically be found in a De Novo or PMA submission.

However, based on the provided text, we can infer the "acceptance criteria" were primarily related to demonstrating substantial equivalence to the predicate device (Rimed Smart-Lite™ Transcranial Doppler) in terms of technical specifications and safety standards.

Here's an analysis of the provided information within that context:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are implied by the features and performance of the predicate device (Rimed Smart-Lite™ Transcranial Doppler). The sponsor (Nodecrest LLC) demonstrates its device's performance by showing it has similar specifications to the predicate.

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Nodecrest)
Transducer Frequency: 2MHz, 4MHz, 8MHz	Transducer Frequency: 2MHz, 4MHz, 8MHz
Frequency Spectrum: 64-512 dots	Frequency Spectrum: FFT 256/512 dots
Frequency Ranges: 2-32 MHz	Frequency Ranges: 1-16 MHz
Depth Measurement: 15-150 mm	Depth Measurement: 5-136 mm
Gain: Manually controlled, 20 steps	Gain: 0-40db
Clinical Application (2MHz PWD): Ophthalmic, Adult Cephalic	Clinical Application (2MHz PWD): Ophthalmic, Adult Cephalic & Peripheral Vascular
Clinical Application (2MHz CWD): Ophthalmic & Peripheral Vascular	Clinical Application (2MHz CWD): Ophthalmic & Peripheral Vascular
Clinical Application (4MHz PWD): Peripheral Vascular (predicate implied from other CWD entry)	Clinical Application (4MHz PWD): Peripheral Vascular
Clinical Application (4MHz CWD): Peripheral Vascular	Clinical Application (4MHz CWD): Peripheral Vascular
Clinical Application (8MHz PWD): Peripheral Vascular (predicate implied from other CWD entry)	Clinical Application (8MHz PWD): Peripheral Vascular
Clinical Application (8MHz CWD): Ophthalmic & Peripheral Vascular	Clinical Application (8MHz CWD): Peripheral Vascular
General Electrical Testing: EN 60601-1-1 & EN 60601-1-2	General Electrical Testing: IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, UL 2601-1
Biocompatibility Tests: Unknown (for predicate)	Biocompatibility Tests (ISO 10993): Cytotoxicity, Sensitization, Skin Irritation, USP: Acute Toxicity, Intracutaneous Reactivity, Implantation & Cytotoxicity

Note on Device Performance: For a 510(k), "performance" in this context refers to technical specifications matching or being similar to the predicate, rather than clinical performance metrics like sensitivity/specificity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical test set or clinical study to prove performance against specific acceptance criteria. The submission relies on technical comparison and compliance with electrical and biocompatibility standards. Therefore, information regarding "sample size," "data provenance," "retrospective or prospective" is not applicable in the context of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical test set is described, there's no mention of experts or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication process is described.

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 a Transcranial Doppler Ultrasound System, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a diagnostic ultrasound system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There is no clinical study described that required a ground truth for performance evaluation. The "ground truth" for this submission would be the established equivalency of performance and safety specifications to the predicate device.

8. The sample size for the training set

Not applicable. As a hardware device for diagnostic ultrasound, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

Summary

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K060112

Noderrest LLC MAY - 5 2006

SUMMARY STATEMENT

Contact Person:	David G. Pegler
Address:	Nodecrest LLC1478 Powells Tavern PlaceHerndon, 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

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

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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

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 Applicationfor: 2MHz
PWD	Ophthalmic, Adult Cephalic& Peripheral Vascular	Ophthalmic, Adult Cephalic
CWD	Ophthalmic & PeripheralVascular	Ophthalmic & PeripheralVascular
Clinical Applicationfor: 4MHz
PWD	Peripheral Vascular
CWD	Peripheral Vascular	Peripheral Vascular
Clinical Applicationfor: 8MHz
PWD	Peripheral Vascular
CWD	Peripheral Vascular	Ophthalmic & PeripheralVascular
General ElectricalTesting	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

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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): < 060112

Device Name: Nodecrest Transcranial Doppler Ultrasound System

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 eve.

The Nodecrest Transcranial Doppler is intended for use during:

a) Diagnostic exams
b) Surgical interventions

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Depaon

ive. Abdominal

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148 - 124 - 12

And and and the same of the states

Diagnostic Ultrasound Indications for Use Form

Friday of the commend to the states

Fill out one form for each ultrasound system and each transqucer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the hurnan body as follows:

Clinical Application:	A	B	M	PWID	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic				X
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				X
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				X
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: EMS 9U TRANSCRANIAL Doppler SYSTEM 2MHz PROBE

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

(Division Sign-Oll)
Division of Reproductive, Abdominal, F-3 and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

011

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19, 2017

Disgnostic Uitrasound Indications for Use Form

Fill out one form for cech ultrasound system and each transduder.

Intended Use: Diagnostic ultrasound imaging or fivid flow andlysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				X	X
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: EMS9U TRANSCRANIAL DOPPLE

SYSTEM 4MHZ PROBE

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

F-3

Prescription Use (Per 21 CFR 801.109)

Daniel A. Larson

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 5 புரு) Number

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Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular									XX
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N= new Indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: EMS9U TRANSCRANIAL DOPPER SYSTEM

8MHZ PROBE

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

F-3

Daniel A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal,
and Radiological Devices A (Alol 510(k) Number _

Regulation Number and Section

§ 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.