Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states that the functionality of the system remains identical to the predicate device, and there is no mention of AI or ML in the description or performance studies.

Therapeutic

No
The device is indicated for non-invasive "evaluation" and "diagnosis" of vascular flow irregularities, and "measures" blood flow velocity. It is a diagnostic device, not a therapeutic one.

Diagnostic

Yes
The device is indicated for "non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities" and "measures the blood flow velocity in the main cerebral arteries non-invasively for circulation diagnosis and HITS (High Intensity Transient Signals) detection". The terms "evaluation" and "diagnosis" explicitly state a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Digi-One System is a "small, lightweight, portable digital Transcranial Doppler (TCD) system" and mentions hardware modifications and testing (bench testing, electrical and mechanical safety, electromagnetic compatibility), indicating it includes physical hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Digi-One System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The Digi-One System is described as a non-invasive system that measures blood flow velocity directly within the body using ultrasound. It does not analyze samples like blood, urine, or tissue.
The intended use and device description clearly indicate a direct interaction with the patient's body. It uses ultrasound energy to evaluate vascular flow velocity irregularities in vivo.

Therefore, the Digi-One System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Digi-One System is indicated for non-invasive evaluation of intracranial vascular flow velocity irregularities in adult and in children. It is not intended for fetal use. It is not intended for neonatal use.

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

IYN, ITX

Device Description

The Digi-One System is a small, lightweight, portable digital Transcranial Doppler (TCD) system with an advanced M-mode display which can be connected to any external Windows based PC.

It measures the blood flow velocity in the main cerebral arteries non-invasively for circulation diagnosis and HITS (High Intensity Transient Signals) detection using the same Rimed TCD software application as the predicate device.

The Digi-One System is a modification of the Digi-Lite System. The hardware was modified using current electronic components, and the software was modified to allow installation on a dedicated PC (such as a laptop device). Otherwise, the functionality of the system remains identical to that of the Digi-Lite system in all aspects, including acoustic power outputs, clinical parameter measurement accuracy, examination modes, available transducers, software menus and commands (with some minor user interface modifications). As the specifications remain identical, the safety and efficacy of the device are not affected when used as labeled. Therefore, the Digi-One system remains substantially equivalent to the predicate, un-modified Digi-Lite System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound energy

Anatomical Site

intracranial vascular, extracranial vascular

Indicated Patient Age Range

adult and children. It is not intended for fetal use. It is not intended for neonatal use.

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 Software and Performance tests were performed on the Digi-One System:

Software Validation according to FDA Guidelines (tested modified software)
Bench testing to validate output energies and parameter calculation accuracies
Electrical and Mechanical Safety Standard (IEC 60601-1)
Electromagnetic Compatibility Standard (IEC60601-1-2)

The safety and effectiveness questions that were raised by these changes were equivalence of acoustic power outputs, equivalence of measurement accuracy, and safe use under low-power modes. Performance testing of the modified device included measurements of output power and measurement accuracy. The testing results demonstrated that the modified device is substantially equivalent to the predicate, unmodified device. The software functions and testing modes did not change, except for some User Interface improvements; the system defaults for low-power modes were reviewed for equivalence to the predicate device, and were demonstrated to remain identical. Software testing was performed on the modified software.

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.

K062578

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right. The profiles are connected by a flowing line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2015

Rimed Ltd. % Ms. Ahava Stein Regulatory Consultant 20 Hata'as St. (POB 124) Kfar Saba 44425 ISRAEL

Re: K143476

Trade/Device Name: Digi-One System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX Dated: May 22, 2015 Received: May 28, 2015

Dear Ms. Stein:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A. Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143476

Device Name Digi-One System

Indications for Use (Describe)

The Digi-One System is indicated for non-invasive evaluation of intracranial vascular flow velocity irregularities in adult and in children. It is not intended for fetal use. It is not intended for neonatal use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

3

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

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 | 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) | | | | | | | | | | |

Mode of Oneratio

4

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	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify)
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)

5

Indications for Use Form Fill out one 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:

						Mode of Operation
Clinical
Application	A	B	C	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(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)

6

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 | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| 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 Oneration

7

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	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
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

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SUMMARY OF SAFETY AND EFFECTIVENESS

K143476 (Premarket Notification [510(k)] Number)

1. Submitter Information

Manufacturer Name and Address	Rimed Ltd.
	25 Hacharoshet St.,
	PO Box 2402
	Industrial Park Raanana 4365613,
	Israel
Official Correspondent	Ahava Stein
	A. Stein - Regulatory Affairs Consulting Ltd.
	20 Hata'as St. (Beit Hapaamon, Suite 102)
	Kfar Saba 44425,
	Israel

Date Prepared: May 18, 2015
Device Name Digi-One System

Proprietary Name: Digi-One System

Common Name: Transcranial Doppler (TCD) Device

FDA Classification 21 CFR 892.1550; Ultrasonic Pulsed Doppler Imaging System Name:

FDA Classification: Class II, Product Code IYN; ITX

4. Predicate Devices

The Digi-One System is substantially equivalent to the following devices:

Manufacturer	Device	510(k)	Date Cleared
Rimed Ltd.	Digi-Lite System	K062578	August 23, 2006

ട. Device Description

The Digi-One System is a small, lightweight, portable digital Transcranial Doppler (TCD) system with an advanced M-mode display which can be connected to any external Windows based PC.

9

It measures the blood flow velocity in the main cerebral arteries non-invasively for circulation diagnosis and HITS (High Intensity Transient Signals) detection using the same Rimed TCD software application as the predicate device.

The Digi-One System is a modification of the Digi-Lite System. The hardware was modified using current electronic components, and the software was modified to allow installation on a dedicated PC (such as a laptop device). Otherwise, the functionality of the system remains identical to that of the Digi-Lite system in all aspects, including acoustic power outputs, clinical parameter measurement accuracy, examination modes, available transducers, software menus and commands (with some minor user interface modifications). As the specifications remain identical, the safety and efficacy of the device are not affected when used as labeled. Therefore, the Digi-One system remains substantially equivalent to the predicate, un-modified Digi-Lite System.

| Technological
Characteristic | Digi-One System
Rimed Ltd. | Digi-Lite System
Rimed Ltd.
(K062578) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Class | IYN, ITX
Class II | IYN, ITX
Class II |
| Indications for
Use | The Digi-One System is
indicated for 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. | The Digi-Lite System is
indicated for 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. |
| Energy Used /
Delivered | Ultrasound energy | Ultrasound energy |
| Design:
(Modification
from predicate) | The Digi-One System consists
of a small unit which connects
to a PC and to which probes are
connected. | The Digi-Lite System consists
of a unit with a display to
which probes are connected. |
| - Mechanism of
Action | Doppler Ultrasound, with the
following modes:
Unilateral
Bilateral
Multichannel
Monitoring
Multidepth (up to 8 spectrums
at various depths)
M-Mode (64 gates) | Doppler Ultrasound, with the
following modes:
Unilateral
Bilateral
Multifrequency
Multichannel
Monitoring
Multidepth (up to 8 spectrums
at various depths)
M-Mode (64 gates) |

Predicate Comparison Table:

10

| Technological
Characteristic | Digi-One System
Rimed Ltd. | Digi-Lite System
Rimed Ltd.
(K062578) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - Accessories | Probe types:

1MHz PW, 16mm
2MHz PW, 14mm
4MHz PW/CW, 8mm
8MHz PW/CW, 5mm
Remote control
Monitoring probe holder
Color printer Footswitch | Probe types:
1MHz PW, 16mm
2MHz PW, 14mm
4MHz PW/CW, 8mm
8MHz PW/CW, 5mm
Remote control
Monitoring probe holder
Color printer Footswitch
CD ROM backup
DAT Tape |
| Performance | | |
| Sample volume | (for 1 MHz) (for 2 MHz)
15-92 mm 15-146 mm | (for 1 MHz) (for 2 MHz)
15-92 mm 15-146 mm |
| Depth | | |
| Power (%) | 0-100% at 7% steps | 0-100% at 7% steps |
| Acoustic output | 1MHz PW Ispta=34.15mW/cm2
2MHz PW Ispta=181.3mW/cm2
4MHz PW Ispta=232.2mW/cm2
4MHz CW Ispta=183mW/cm2
8MHz PW Ispta=149.8mW/cm2
8MHz CW Ispta=414mW/cm2 | 1MHz PW Ispta=34.15mW/cm2
2MHz PW Ispta=181.3mW/cm2
4MHz PW Ispta=232.2mW/cm2
4MHz CW Ispta=183mW/cm2
8MHz PW Ispta=149.8mW/cm2
8MHz CW Ispta=414mW/cm2 |

Indications for Use 6.

The Digi-One System is indicated for 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.

7. Performance Standards

There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Digi-One System.

8. Performance Testing

The following Software and Performance tests were performed on the Digi-One System:

Software Validation according to FDA Guidelines (tested modified ● software)
Bench testing to validate output energies and parameter calculation accuracies
Electrical and Mechanical Safety Standard (IEC 60601-1)
Electromagnetic Compatibility Standard (IEC60601-1-2)

9. Technological Characteristics Compared to Predicate Device

The original Digi-Lite device underwent modification to electronics and software. The safety and effectiveness questions that were raised by these changes were

11

equivalence of acoustic power outputs, equivalence of measurement accuracy, and safe use under low-power modes. Performance testing of the modified device included measurements of output power and measurement accuracy. The testing results demonstrated that the modified device is substantially equivalent to the predicate, unmodified device. The software functions and testing modes did not change, except for some User Interface improvements; the system defaults for low-power modes were reviewed for equivalence to the predicate device, and were demonstrated to remain identical. Software testing was performed on the modified software. The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the modified Digi-One System are substantially equivalent to the predicate device cited above. Based on the results of performance testing, the Digi-One device is substantially equivalent to the predicate device.