EXPLORER CVS TRANSCRANIAL DOPPLER

K990517 · Diagnostic Medical Systems · IYN · Aug 1, 2000 · Radiology

Device Facts

• Record ID: K990517
• Device Name: EXPLORER CVS TRANSCRANIAL DOPPLER
• Applicant: Diagnostic Medical Systems
• Product Code: IYN · Radiology
• Decision Date: Aug 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Explorer CVS Doppler is intended to be used to produce images of peripheral vasculature and intracranial vasculature to be analysed by trained medical personnel for the assessment and diagnosis of vascular status and disorders.

Device Story

Explorer CVS is a diagnostic ultrasonic Doppler system; utilizes multiple frequency transducers (2 MHz, 4 MHz, 8 MHz) to acquire ultrasound signals from peripheral and intracranial vasculature; processes signals to provide high-resolution images and fluid flow analysis; operated by trained medical personnel in clinical settings; output used for assessment and diagnosis of vascular status and disorders; aids clinical decision-making by visualizing blood flow and vascular anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by technical specifications and acoustic output measurements.

Technological Characteristics

Diagnostic ultrasonic Doppler system; utilizes multiple frequency transducers (2 MHz, 4 MHz, 8 MHz); supports PW-Doppler and CW-Doppler modes; intended for peripheral, intracranial, and intravascular applications; complies with 21 CFR 892.1550; requires post-clearance submission of acoustic output measurements.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, specifically peripheral vascular, intracranial (adult/neonatal cephalic), and intravascular applications using pulsed-wave (PW) and continuous-wave (CW) Doppler modes.

Regulatory Classification

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.

Predicate Devices

• Transcranial Doppler Device (K974588)
• Bilateral Transcranial Doppler System (K962796)
• Neuroguard Ultrasound System (K914862)
• Cerebrovascular Diagnostic System (K894163)
• Trans-Scan Transcranial Probe (K894163)
• Phase 2 Transcranial Doppler (K872292)

Submission Summary (Full Text)

{0}------------------------------------------------

K990517

1 2000 AUG

510 (k) Summary

Manufacturer : A.

DIAGNOSTIC MEDICAL SYSTEMS DHS -Parc de la Mediterranee District de Montpellier 34470 Perols France

Submitted By:

Ferguson Medical Consultant to DMS

+33.467.50.49.00 Phone : B. Contact Information: PAX: +33.467.50.49.09

- Classification Name: System, Imaging, Pulsed Doppler, ਂ Ultrasonic
Transcranial/Vascular Doppler Common/usual Name:

Explorer CVS Transcranial and Proprietary Name: Peripheral Vascular Doppler

- Classification Number: 901 YN D.
- Rimed Limited Intra-View E. Substantial Equivalence : Transcranial Doppler Device (K974588), Bilateral Transcranial Doppler Inc. Neuroguard Medasonics, Medasonics, (K962796), Inc. System Ultrasound System; CDS (K914862), Cerebrovascular Diagnostic 2 Transcranial Probe Biosound, Phase Inc. Acuson Corp. Acuson S228 Transducer Fox (K894163), (K894163), Medasonics, Inc. Doppler Transcranial (K872292) , and Doppler Transpect Transcranial others.

The Explorer CVS device is a Device Description: r.

{1}------------------------------------------------

#### diagnostic ultrasonic Doppler.

- device 18 Explorer CV8 Doppler Intended Use : The G. produce images of be used to intended to peripheral vasculature to be and intracranial the medical personnel 17 analysed trained by vascular status and assessment and diagnosis of disorders.
- The Explorer CVS Doppler ਜ -Technological Characteristics: device utilizes multiple frequencies of transducers to provide high resolution images.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The logo is rendered in black and white.

1 2008 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diagnostic Medical Systems, Inc. c/o Frank Ferquson Official Correspondent Ferquson Medical P.O. Box 12038 LaJolla, CA 92039

Re: K990517 Explorer CVS Transcranial and Peripheral Vascular Doppler Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Dated: May 15, 2000 Received: May 30, 2000

Dear Mr. Ferguson:

We have reviewed your Section 510(k) 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 Ameraments, 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 Explorer CVS Transcranial and Peripheral Vascular Doppler, as described in your premarket notification:

Transducer Model Number

2 MHz PW-Doppler 4 MHz CW/PW-Doppler 8 MHz CW/PW-Doppler

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ನ್ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, the Food and Drug Administration (FDA) may regulatory action. publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

#### Page 2 - Frank Ferguson

This determination of substantial equivalence is granted on the condition that Inis decermination of Subbeancear oquon submit a postclearance special report. prior co shipping the rise amplete information, including acoustic output measurements based on production line devices, requested in Appendix G,
measurements based on production 1ine derices , requested in Appartuages (enclosed) of the Center 3 September 30) III, III, III, International Systems and Transducers." Seeking Marketing Crearance of Disacted or contains unacceptable values (e.g., II the Special report 15 Incompressed overs), then the 510(k) clearance may acoustic oucpar groduction units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It The special report should forceines the manufacturing 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 The FDA finding of substantial equivalence of your premarket notification. premarket notification. Inc predicate device results in a classification for device to a logally master your device to proceed to market.

If you desire specific advice for your device on our labeling requlation (21 II you desire specific advice ac- 10 for in vitro diagnostic devices), please critic of the dualemaniance at [phone]. Additionally, for contact the office or compand advertising of your device, please contact the questions on the promote [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

David C. Lippman

Schultz, M.D. Daniel G. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{4}------------------------------------------------

### EXPLORER CVS Transcranial Doppler System 2,4 and 8MHz Transducers

### Diagnostic Ultrasound Indications for Use Form

## 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:

| | 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 | | | | X | | | | | | |
| 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:

(PLEASE DO NOT WRITE BELOW THUS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

።

... ..........................................................................................................................................................................

Daniel C. Lynn

Bivision Sign=And દ-૩ Division of Reproduetive, Abdominal, ENT, and Radiological Devices

> 310(k) Number • ﺑﺎﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗ

{5}------------------------------------------------

## 2 MHz PW-Doppler Transducer (Serial Number 98-311)

Appendix F

### Diagnostic Ultrasound Indications for Use Form

## 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:

| | 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 | | | X | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

f

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTIMUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Toril A. Lynn

---

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K990517

{6}------------------------------------------------

# 4 MHz CW/PW-Doppler (Serial Number 115)

#### Diagnostic Ultrasound Indications for Use Form

### 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:

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

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

**Additional Comments:**

Prescription Use (Per 21 CFR 801.109)

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

Concurrence of CORH, Office of Device Evaluation (ODE)

Yoriel A. Sgenon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K990517

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

### Diagnostic Ultrasound Indications for Use Form

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

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

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

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

Additional Comments:

*Rrescription Use (Per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS UNE - CONTINUE ON ANOTHER PAGE IF NEEDEDI Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Regner

(Division Sign-Off) Division of Repreductive, Abdominal, ENT,

and Radiological Devices

510(k) Number