DIGI-LITE TCD DEVICE

• K Number: K062578
• Device Name: DIGI-LITE TCD DEVICE
• Manufacturer: RIMED LTD.
• Date Cleared: 2006-09-18 ( 18 days)
• Product Code: IYN
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

K974588

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details standard digital signal processing (DSP) and FPGA technology for ultrasound signal processing, with no mention of AI or ML algorithms. The performance studies focus on standard ultrasound device testing.

Therapeutic

No.
The device is intended for non-invasive evaluation and provides diagnostic information, but it does not directly treat or alleviate a medical condition.

Diagnostic

Yes
The device is described as being for "non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities," which directly indicates its use in the diagnosis of these irregularities.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a PC platform, processor, hard drive, USB, RS232, LAN, keyboard, mouse, touch screen, Doppler Card, probes, Remote Control unit, printer, and Foot Switch. The performance studies also include hardware-specific testing like Acoustic output testing and Estimate of temperature rise.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities." This involves using ultrasound to measure blood flow within the body.
• Device Description: The description details hardware components related to ultrasound transmission and reception, signal processing, and display. These are characteristic of an ultrasound device used for imaging and Doppler measurements in vivo (within the living body).
• Input Imaging Modality: The input modality is "Ultrasonic Pulsed Doppler," which is an in vivo imaging technique.
• Anatomical Site: The anatomical site is "Intracranial and extracranial vascular," which are locations within the body.

In vitro diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Digi-Lite System:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (PWD, CWD), Adult Cephalic (PWD), Vascular (PWD, CWD)

1 MHZ PW HAND-HELD TRANSDUCER
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (PWD), Adult Cephalic (PWD), Peripheral Vascular (PWD)

2 MHZ PW HAND-HELD TRANSDUCER
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (PWD), Adult Cephalic (PWD), Peripheral Vascular (PWD)

4 MHZ TRANSDUCER
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (PWD, CWD), Peripheral Vascular (PWD, CWD)

8 MHZ TRANSDUCER
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic (PWD, CWD), Peripheral Vascular (PWD, CWD)

Product codes (comma separated list FDA assigned to the subject device)

IYN, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Intracranial, extracranial vascular, Ophthalmic, Adult Cephalic, Peripheral Vascular

Indicated Patient Age Range

Adults and children

Intended User / Care Setting

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K974588

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Page 1 of 3

SEP 1 8 2006

SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

K 062578

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

1. Applicant

Rimed Ltd. 7 Hayezira St. P.O.Box 2402 Industrial Park Raanana 43000 ISRAEL Tel: [phone] Fax: [phone]

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: [phone] Fax: [phone]

2. 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.

1

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

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.

5. Description of the Device

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.

2

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.

3

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

4

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

5

If you have any questions regarding the content of this letter, please contact Andrew Kang at [phone].

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)

6

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
Clinical
Application	A	B	C	PWD	CWD	Color
Doppler	Power
(Amplitude
)
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic				X	X
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
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-Skeletal
Conventional
Muscolo-Skeletal
Superficial
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
Clinical
Application	A	B	C	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combine
d
(Specify)	Other
(Specify)
Ophthalmic				X
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal
Cephalic
Adult Cephalic				X
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular				X
Laparoscopic
Musculo-Skeletal
Conventional
Muscolo-Skeletal
Superficial
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:

| Clinical
Application | A | B | C | PWD | CWD | Color
Doppler | Power
(Amplitude
)
Doppler | Color
Velocity
Imaging | Combine
d
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|-------------------------------------|------------------------------|---------------------------|--------------------|
| Ophthalmic | | | | X | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | X | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral
Vascular | | | | X | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal
Conventional | | | | | | | | | | |
| Muscolo-Skeletal
Superficial | | | | | | | | | | |
| 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:

| Clinical
Application | A | B | C | PWD | CWD | Color
Doppler | Power
(Amplitude
)
Doppler | Color
Velocity
Imaging | Combine
d
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|-------------------------------------|------------------------------|---------------------------|--------------------|
| Ophthalmic | | | | X | X | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| 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-Skeletal
Conventional | | | | | | | | | | |
| Muscolo-Skeletal
Superficial | | | | | | | | | | |
| 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	Power
Velocity
Imaging	Color
Combined
(Specify)	Other
(Specify)
Ophthalmic				X	X
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
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-Skeletal
Conventional
Muscolo-Skeletal
Superficial
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