(530 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies.
No
Justification: The device's intended use and description explicitly state it is for "assessment and diagnosis of vascular status and disorders" and is a "diagnostic ultrasonic Doppler," indicating it is used to identify medical conditions rather than treat them.
Yes
The "Intended Use / Indications for Use" section states the device produces images "for assessment and diagnosis of vascular status and disorders." Additionally, the "Device Description" explicitly states, "The Explorer CVS device is a diagnostic ultrasonic Doppler."
No
The device description explicitly states it is a "diagnostic ultrasonic Doppler" and utilizes "multiple frequencies of transducers," which are hardware components.
Based on the provided information, the Explorer CVS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Explorer CVS device uses ultrasound to image within the human body.
- The intended use is for imaging and analysis of vasculature in vivo. This is a diagnostic imaging device, not a device that performs tests on biological samples.
- The device description clearly states it's a "diagnostic ultrasonic Doppler". This is a type of medical imaging equipment.
The information provided describes a device used for non-invasive imaging and assessment of blood vessels within the body, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Explorer CVS device is intended to be used to produce images of peripheral vasculature and intracranial to be analysed by medical personnel trained by vascular status and assessment and diagnosis of disorders.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Neonatal Cephalic, PWD
Peripheral Vascular, PWD, CWD
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Adult Cephalic, B
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intravascular, PWD, CWD
Peripheral Vascular, PWD, CWD
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intravascular, CWD
Peripheral Vascular, PWD, CWD
Product codes
90 IYN
Device Description
The Explorer CVS device is a diagnostic ultrasonic Doppler.
The Explorer CVS Doppler device utilizes multiple frequencies of transducers to provide high resolution images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging, fluid flow analysis, Doppler
Anatomical Site
peripheral vasculature, intracranial, Neonatal Cephalic, Adult Cephalic, Intravascular
Indicated Patient Age Range
Adult, Neonatal
Intended User / Care Setting
medical personnel trained by vascular status
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974588, K962796, K914862, K894163, K872292
Reference Device(s)
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
§ 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.
0
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 (301) 594-4591. Additionally, for contact the office or compand advertising of your device, please contact the questions on the promote (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.
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 | ||||
| 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 | X | X | ||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| 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 | ||||
| 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 | X | |||||||||
| 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:
*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