(217 days)
No
The description focuses on standard Doppler ultrasound technology and proprietary software for waveform display, with no mention of AI or ML terms or concepts.
No
The device is described as a diagnostic ultrasound system for measuring blood velocity, not for treating a condition. Its intended use is for "Measurement of penile cavernosal artery velocities" and "Diagnostic ultrasound imaging or fluid flow analysis."
Yes
Explanation: The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular (PWD)," and the device is designed to measure blood velocity in penile cavernosal arteries, which is a diagnostic application.
No
The device description explicitly states the system consists of a personal computer, a proprietary circuit board, and transducers, indicating it includes hardware components in addition to software.
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.
- Device Function: The UroMetrics Knoll/MIDUS System uses Doppler ultrasound to measure blood velocity within the body (specifically, in the penile cavernosal arteries). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," which is a description of an in vivo diagnostic procedure, not an in vitro one.
Therefore, this device falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Measurement of penile cavernosal artery velocities. Not intended for fetal use.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular (CWD)
Product codes
90 IYN, 74 DPW
Device Description
The UroMetrics Knoll/MIDUS System is an office based Doppler ultrasound system designed to measure blood velocity in the penile cavernosal arteries. The system consists of a portable or desktop IBM compatible personal computer containing a proprietary circuit board and transducers. Blood velocity is determined by detecting the Doppler shifts of an 8 MHz ultrasound signal. Proprietary software converts this data into a useable waveform display, which is shown on the computer video display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
penile cavernosal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
office based
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Attachment 1
K97/790
DEC 17 1997
Summary of Safety and Effectiveness
This summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807.92 and was prepared November 25, 1997.
| Submitter: | UroMetrics Inc.
445 Etna Street
Suite 56
St. Paul, MN. 55106
612-774-1552 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Philip A. Messina
President, COO |
| Common Name: | Bi-directional Vascular Doppler with Spectral Analysis |
| Proprietary Name: | Knoll/MIDUS |
| Classification Name: | Ultrasonic transcutaneous blood flowmeter (w/wo calibration),
21 CFR 8970.2100 |
| Classification: | Class II |
| Predicate Device: | The Knoll/MIDUS is substantially equivalent to the SPECS
USA, Inc. Stenodoc/EPC bi-directional vascular Doppler with
spectral analysis (K946349). |
| Description: | The UroMetrics Knoll/MIDUS System is an office based
Doppler ultrasound system designed to measure blood velocity in
the penile cavernosal arteries.
The system consists of a portable or desktop IBM compatible
personal computer containing a proprietary circuit board and
transducers. Blood velocity is determined by detecting the
Doppler shifts of an 8 MHz ultrasound signal. Proprietary
software converts this data into a useable waveform display,
which is shown on the computer video display. |
| Intended Use: | Measurement of penile cavernosal artery velocities. Not
intended for fetal use. |
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Phillip A. Messina President & COO UroMetrics, Inc. 445 Etna Street, Suite 56 Saint Paul, MN 55106
Re: K971790 Knoll/MIDUS™ System (with SureAngle™ probes and
Gold Guard™ cradle) Dated: December 5, 1997 Received: December 8, 1997 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 870.2100/Procode: 74 DPW
Dear Mr. Messina:
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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Knoll/MIDUS™ System, as described in your premarket notification:
Transducer Model Number
TD1 (8MHz, CW 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 Regulations, Title 21, Parts 800 to 895. A 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) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may 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.
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.
2
Page - 2 - Mr. Phillip Messina
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free 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 Perez at (301) 594-1212.
Sincerely vours.
Utind C. Bergman
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1 of ใ Ultrasound Device Indications Statement Fage_
K971790 510(k) Number (if known); _ K971790
Device Name: Knoll/MIDUS Male Intracavernosal Doppler UltraSound Transducer Model TDI
Fill out one form for each ultrasound system and each transducer.
Attachment 1
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use : human body as follows:
node of Operation
| Clinical
Application | A | B | M | 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 | | | | | | |
| Laparoscopic | | | | | | | | | | |
| musculo-skeletal | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
(PLAASE LINES-CONTINUE ON ANOTHER PAGE IF
Concurrence of OSE, Office of Service Evaluation (OSE)
Prescription Use (Per 21 CFR 801
801/109)
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological I 510(k) Number