(15 days)
No
The description focuses on standard ultrasound and plethysmography technologies, manual user input for pressure values, and basic calculations (ABI, TBI). There is no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No
Explanation: The device is described as a "diagnostic ultrasound device" intended for "detection of blood flow" and "diagnosis of peripheral vascular disease," which are diagnostic rather than therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "as an aid for the diagnosis of peripheral vascular disease." Additionally, the "Device Description" refers to it as a "diagnostic ultrasound device," and the predicate device is also a "Diagnostic Ultrasound Device."
No
The device description explicitly mentions hardware components such as a diagnostic ultrasound device, pressure cuff, internal power source, external power supply, and a rolling stand.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
- Device Function: The Vista AVS™ is a diagnostic ultrasound device that uses Doppler ultrasound to detect blood flow within the body (in vivo). It also uses pressure cuffs and other modalities to measure blood pressure and obtain waveforms directly from the patient.
- Intended Use: The intended use is for the detection of blood flow and as an aid for the diagnosis of peripheral vascular disease, which is done by interacting directly with the patient's body.
The device operates by applying energy to the body and receiving signals back, which is characteristic of in vivo diagnostic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular, CWD mode of operation, E= added under Appendix E.
Product codes
JAF
Device Description
The Vista AVS is a diagnostic ultrasound device used to aid the clinician in obtaining systolic pressure values at the arms, legs and feet. The device will provide a bi-directional Doppler for detecting presence or absence of blood flow, and will control the inflation and deflation of a pressure cuff under direction of the user. Two additional modalities, Pulse Cuff Recording (PCR) and Photoplethysmography (PPG), will provide additional information for the clinician. PCR will be used as a plethysmograph to obtain alternative blood flow waveforms, and the PPG will be used primarily to obtain toe pressures. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has accepted or entered the appropriate pressure values. Waveforms, pressure values, and index results can be printed directly from the device or uploaded using AVS Report report generating software and an external user supplied PC via a USB port. The unit can run from an internal power source or from an external power supply, and mounts to a rolling stand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
arms, legs, and feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, Prescription Use
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in 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
SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. Vista AVS
| Name and Address: | Summit Doppler Systems, Inc.
4620 Technology Dr. #100
Golden, CO 80403
Phone: (303) 423-7572
Fax: (303) 431-5994 | | DEC 19 2006 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------|
| Contact: | Ken Jarrell -- President | | |
| Preparation Date: | November 3, 2006 | | |
| Device Name: | Vista AVS | | |
| Common Name: | Vascular Ultrasound Monitor | | |
| Classification: | Class II per:
Non-fetal, UltraSound Monitor | FR Number
892.1540 | Product Code
JAF |
| Indications for Use: | This device is intended for detection of blood flow in veins and arteries and as
an aid for the diagnosis of peripheral vascular disease. | | |
| Description: | The Vista AVSTM is a diagnostic ultrasound device used to aid the clinician in
obtaining systolic pressure values at the arms, legs and feet. The device will
provide a bi-directional Doppler for detecting presence or absence of blood
flow, and will control the inflation and deflation of a pressure cuff under
direction of the user. Two additional modalities, Pulse Cuff Recording (PCR)
and Photoplethysmography (PPG), will provide additional information for the
clinician. PCR will be used as a plethysmograph to obtain alternative blood
flow waveforms, and the PPG will be used primarily to obtain toe pressures.
The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI)
or segmental values once the clinician has accepted or entered the appropriate
pressure values. Waveforms, pressure values, and index results can be printed
directly from the device or uploaded using AVS ReportTM report generating
software and an external user supplied PC via a USB port. The unit can run
from an internal power source or from an external power supply, and mounts to
a rolling stand. | | |
| Substantial Equivalence: | The Vista AVS is substantially equivalent to the cleared device shown below. | | |
| | IMEXLAB 9100 Diagnostic Ultrasound Device
K973562, Cleared 4/15/98 | | |
| Technologies Summary: | Doppler ultrasound technology is the same as substantially equivalent device
shown above. | | |
| Conclusion: | Based on comparisons of device features, materials, intended use and
performance, and user instructions, the Vista AVS is shown to be substantially
equivalent to the commercially available and legally marketed device indicated
above. | | |
:
A2
1
Attachment C – Indication for Use
: : :
()
| System Indications for Use................................................ | C2 |
|---|---|
| 5.0BD Probe Indications for Use........................................ | C3 |
| 8.0BD Probe Indications for Use........................................ | C4 |
: :
and the comments of the comments of
100 100 100
. . . . . . .
.
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 stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Summit Doppler Systems, Inc. c/o Ms. Laura Danielson Program Manager TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112
DEC 1 9 2006
Re: K063600 Trade Name: Vista AVS Regulation Number: 21 CFR §892.1540 Regulation Name: Nonfetal ultrasonic monitor Regulatory Class: Class II Product Code: JAF Dated: November 22, 2006 Received: December 4, 2006
Dear Ms. Danielson:
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 Vista AVS, as described in your premarket notification:
Transducer Model Number
5.0BD and 8.0BD MHz CW Peripheral Vascular Probes
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.
3
Page 2 - Ms. Laura Danielson
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 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
If you have any questions regarding the content of this letter, please contact Ewa Czerska, M.D., at (240) 276-3666.
Sincerely yours,
David A. Lyman
for N. G. Pond
Nancy C. Brogd Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Diagnostic Ultrasound Indications for Use Form
Vista AVS with 5.0BD and 8.0BD Ultrasound Probes
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 | |||||||||||
| Transurethal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | E | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Previously cleared indication is K024197, issued 1/3/03
The system consists of main unit plus an 5.0BD or 8.0BD probe Additional Comments: _________________________________________________________________________________________________________________________________________________________
Only one transducer can be used with the main unit at a time.
(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 CRF 801.109)
David A. Seppam
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _
C2
5
Diagnostic Ultrasound Indications for Use Form
5.0BD MHz CW Peripheral Vascular Probe
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 | ||||||||||
| Transurethal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
The above is for 5.0 MHz Bi-Directional Peripheral Vascular Probe Additional Comments: _
Previously submitted appendix E on K060410 cleared 4/7/06
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEQED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Prescription Use (Per 21 CRF 801.109)
C3
6
Diagnostic Ultrasound Indications for Use Form
8.0BD MHz CW Peripheral Vascular Probe
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 | ||||||||||
| Transurethal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
The above is for 8.0 MHz Bi-Directional Peripheral Vascular Probe Additional Comments: _
Previously submitted appendix E on K060410 cleared 4/7/06
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CRF 801.109)
Denis le Sequer
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number _ C4
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