The Digi-Lite TCD device is intended for use in the non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

Device Description

The Rimed Transcranial Doppler Systems are based on a PC platform system running under Microsoft Windows XP embedded. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disk, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15" TFT color SVGA that provides 1024 x 768 points graphic resolution. In addition to the main PC card, the system hardware contains one Doppler Card that transmits the ultrasound power, translates the received signals to Doppler shift frequencies, and provides the required signal processing functionality. This card contains analog and digital circuits, a FPGA chip for timing and basic hardware digital signal processing, and a DSP chip for performing general control and digital signal processing algorithms. The complete system contains one Doppler card, two 2 MHz probes, a 1 MHz probe, a 4 MHz probe, and an 8 MHz probe. In addition, a Remote Control unit, printer and Foot Switch can be used.

AI/ML Overview

The provided document focuses on the 510(k) premarket notification for the Digi-Lite TCD device and largely attests to its substantial equivalence to a predicate device. It does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the "Performance Testing" section (Page 2, Section 7) describes general categories of testing performed to ensure the device meets its specifications and is safe and effective. The conclusion states that "Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications." However, no specific quantitative or qualitative acceptance criteria are provided, nor are the detailed results of these tests.

Therefore, many of the requested details about a study proving the device meets acceptance criteria cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Based on the provided text, a table of specific, quantifiable acceptance criteria and reported device performance values cannot be constructed. The document states:

"Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications." (Page 2, Section 7)

However, the "specifications" themselves, or the acceptance criteria for the mentioned tests (Acoustic output testing, Clinical measurement accuracy, Doppler sensitivity testing, Estimate of temperature rise), are not detailed. Therefore, specific metrics like sensitivity, specificity, or accuracy are not present.

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

This information is not provided in the document. The performance testing described is largely "bench testing" (Page 2, Section 7.C), implying laboratory-based evaluations rather than extensive clinical studies with human subjects.

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)

This information is not provided. Given the nature of the described "performance testing - bench," it's unlikely that expert-established ground truth on clinical data was a primary component.

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

This information is not provided.

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

This device (Digi-Lite TCD Device) is a TransCranial Doppler (TCD) system used for non-invasive evaluation of vascular flow. It acts as a diagnostic tool rather than an AI-assisted interpretation system for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and not mentioned in this document.

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

The device itself is a standalone diagnostic instrument. The performance testing described (Page 2, Section 7) is for the device's inherent performance. While not explicitly termed "standalone algorithm performance" (as it's hardware/software combined), the bench testing assesses the device's technical specifications.

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

For "Acoustic output testing," "Clinical measurement accuracy," "Doppler sensitivity testing," and "Estimate of temperature rise," the ground truth would likely refer to established physics principles, calibrated measurement devices, and known standards for ultrasonic performance rather than clinical ground truth like pathology or outcomes data. The document does not specify these "ground truths."

8. The sample size for the training set

This is not applicable and not provided. The document describes a medical device rather than an AI/ML system requiring a training set in the typical sense.

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

This is not applicable and not provided.

Summary

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Page 1 of 3

SEP 1 8 2006

SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

K 062578

(Premarket Noti fication [510(k)] Number)

Applicant

Rimed Ltd. 7 Hayezira St. P.O.Box 2402 Industrial Park Raanana 43000 ISRAEL Tel: +972-9-7484425 Fax: +972-4-7484417

Corresponding Official:

Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534

Device Name: Device trade/proprietary name: Digi-Lite TCD Device Common Name: Classification Name:

Digi-Lite TCD Device TransCranial Doppler (TCD) Device Ultrasonic Pulsed Doppler Imaging System (product code IYN, class II, classification section 892.1550). The device' transducers fall under classification section 892.1570; Diagnostic Ultrasonic Transducer, and product code ITX.

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3. Predicate Devices

The Digi-Lite TCD device is substantially equivalent to the following device:

Device	Manufacturer	510(k) No.
Intra-View device	Rimed Ltd.	K974588

4. Intended Use

5. Description of the Device

In addition to the main PC card, the system hardware contains one Doppler Card that transmits the ultrasound power, translates the received signals to Doppler shift frequencies, and provides the required signal processing functionality. This card contains analog and digital circuits, a FPGA chip for timing and basic hardware digital signal processing, and a DSP chip for performing general control and digital signal processing algorithms.

The complete system contains one Doppler card, two 2 MHz probes, a 1 MHz probe, a 4 MHz probe, and an 8 MHz probe. In addition, a Remote Control unit, printer and Foot Switch can be used.

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6. Technological Characteristics Compared to Predicate Device

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Digi-Lite TCD device are substantially equivalent to the predicate device cited above.

7. Performance Testing

The following performance testing activities were performed for the Digi-Lite™ device:

A. Software Validation
B. Electromagnetic Compatibility/ Electrical Safety Testing
C. Performance Testing- Bench- according to the FDA guidance for ultrasound devices (September 1997), the following tests were performed:
- a. Acoustic output testing
- b. Clinical measurement accuracy
- c. Doppler sensitivity testing
- d. Estimate of temperature rise

Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three distinct strokes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2006

Rimed Ltd. % Ms. Ahava Stein A. Stein Regulatory Consulting 20 Hata'as St. Kfar Saba, 44425 ISRAEL

Re: K062578

Trade Name: Digi-Lite TCD Device 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: August 23, 2006 Received: August 31, 2006

Dear Ms. Stein:

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 Digi-Lite TCD Device, as described in your premarket notification:

Transducer Model Number

1 MHz PW 2 MHz PW

4 MHz PW 8MHz

Image /page/3/Picture/14 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a circular border with text, and there are three stars at the bottom of the logo.

noting 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, you 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 (240) 276-3150 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 at (301) 594-1212.

Sincerely yours,

Caulyn 4. Newland

Jor Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K 0625 10

Digi-Lite TCD device Device Name:

The Digi-Lite Trans Cranial and Vascular Doppler (TCD) is Indications for use: intended for use in the non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

Prescription Use _ (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Caulo 4 Neubad for N Braydon
(Division Sign Off)
Division of Reproductive, Abdominal,
and
Material Devices K062578
510(k, Number
i-5

{7}------------------------------------------------

K 062578

Indications for Use Form Fill out one form for each ultrasound system and each transducer. Digi-Lite System:

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

Mode of Operation
ClinicalApplication	A	B	C	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic				X	X
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic				X
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular				X	X
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial
Other (Specify)

Additional Comments:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Caula Y. Newland for N.C. Brogdon

(Division Sign (Off) (Division Significally of Reproductive, Abdom and Radiological Devices 510(k) Number

{8}------------------------------------------------

K062578

Indications for Use Form Fill out one form for each ultrasound system and each transducer. 1 MHZ PW HAND-HELD TRANSDUCER

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

						Mode of Operation
ClinicalApplication	A	B	C	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic				X
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic				X
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular				X
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial
Other (Specify)

Mode of Operation

Additional Comments:

(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)

Cauleys 4 Neulend for N.C. Brogdon

(Division Sign-Off)
ision of Reproductive, Abdominal,
Radiological Devices K06 2578
(k) Number i-7

{9}------------------------------------------------

长 062578

Indications for Use Form Fill out onc form for each ultrasound system and each transducer. 2 MHZ PW HAND-HELD TRANSDUCER

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

ClinicalApplication	A	B	C	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic				X
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic				X
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular				X
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial
Other (Specify)

Mode of Oneration

Additional Comments:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

i -8

Prescription Use (Per 21 CFR 801.109)

Carlon 4 Newland for N.C. Brogden

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K162578

{10}------------------------------------------------

长062578

Indications for Use Form

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

4 MHZ TRANSDUCER

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

ClinicalApplication	PWD	CWD
Ophthalmic	X	X
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular	X	X
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial
Other (Specify)

Mode of Operation

Additional Comments:

(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)

i -9

Carolyn Y. Newland for N.C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
510(k) Number 2062578

{11}------------------------------------------------

K 062578

Indications for Use Form Fill out one form for each ultrasound system and each transducer. 8 MHZ TRANSDUCER

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

Mode of Operation
Clinical Application	A	B	C	PWD	CWD	Color Doppler(Amplitude)Doppler	PowerVelocityImaging	ColorCombined(Specify)	Other(Specify)
Ophthalmic				X	X
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral Vascular				X	X
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial
Other (Specify)

Mode of Operation

Additional Comments:

(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)
Carolyn Y. Newland for N.C. Brogdon

escription Use (Per 21 CFR 801.109)

(Division Sign-Off)

on of Reproductive, Abdominal

ical Devices K062578 i-10

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.