(87 days)
No
The summary describes a standard ultrasonography system for blood flow measurement and guidance, with no mention of AI, ML, or related concepts in the intended use, device description, or specific sections for AI/ML information.
No
The device is used for intraoperative diagnosis and guidance, not for treating or rehabilitating a medical condition.
Yes
The device description and intended use/indications for use state that the system is used to measure and detect abnormal blood flow patterns and quantify stenosis in arteries, which are diagnostic functions.
No
The device description explicitly states it utilizes "Transit time and Doppler ultrasonography" to obtain measurements, indicating the use of hardware components (ultrasound probes/transducers) in addition to any potential software.
Based on the provided information, the Medi-Stim VeriQ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Medi-Stim VeriQ System directly measures blood flow and velocity within the body using ultrasonography during surgery. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use and device description clearly indicate direct in-vivo measurements. The system is used intraoperatively to guide surgeons and measure blood flow within arteries and veins.
Therefore, the Medi-Stim VeriQ System falls under the category of a medical device used for direct physiological measurement and guidance during surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Medi-Stim VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:
- Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation- and neuro-surgery.
- Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
- Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
- Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
- Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
Product codes
74 DPW
Device Description
The Medi-Stim VeriQ System is used intraoperatively to measure blood volume and velocity waveforms in arteries and veins. Transit time and Doppler ultrasonography is used to obtain these measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonography, Doppler ultrasonography
Anatomical Site
Arteries and veins (specifically in cardiovascular-, vascular-, transplantation- and neuro-surgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons; Intraoperative
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
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
APR 2 9 2004
510(k) – Medi-Stim VeriQ System 510(k) Summary Page 95
510(k) Summary
510(k) Summary
as required by 807.92 (c)
for Medi-Stim VeriQ System, VQ1001 -- VQ4122
Prepared January 28th, 2004
| Submitted by: | Medi-Stim AS
Sandakerveien 110
P.O. Box 35 Grefsen
N-0484 Oslo
Norway
Tel. 011 47 23 05 96 60 (switch board)
Fax 011 47 23 05 96 61 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jon H. Hoem, VP Sales & Marketing, Medi-Stim USA, Inc.
7601 Northland Drive, Mailstop A150, Brooklyn Park,
MN55428
Tel. (763) 493 6664 direct / (612) 730 7310 cell
Fax (763) 391 9922 |
| Device Trade Name: | Medi-Stim VeriQ System |
| Common Name: | Medical blood volume and velocity system with blood pressure
and auxiliary data acquisition options. |
| Classification: | Class II |
1
Predicate Devices:
Medi-Stim AS Medi-Stim Butterfly Flowmeter (K992305)
Koven Technology, Inc. Doppler Flowmeter DVM-4300T (K010452) Doppler Flowmeter ES-1000SPM Smartdop (K903026)
12125 Woodcrest Executive Drive, Suite 220 St. Louis, MO 6314 Tel: 1 (800) 521 8342 Fax: (314) 542 6020
Description of Device
The Medi-Stim VeriQ System is used intraoperatively to measure blood volume and velocity waveforms in arteries and veins. Transit time and Doppler ultrasonography is used to obtain these measurements.
Intended Use of Device
The Medi-Stim VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device include, but are not restricted to, the following:
-
- Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation- and neuro-surgery.
-
- Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
-
- Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
-
- Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
-
- Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
2
4.3. Indications for Use Statement
The Medi-Stim VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:
- Accurate transit time blood volume and Doppler velocity flow measurements 1. during cardiovascular-, vascular-, transplantation- and neuro-surgery.
- Simultaneous measurements of blood pressure, vascular resistance, interfaced 2. physiological signals and other derived parameters during these procedures.
- Detection of normal and abnormal blood volume and Doppler velocity flow ನ್ patterns during these procedures.
- Provides guidance to prepare surgical plans at the initiation of surgery and to 4. support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
- Detection and quantification of the degree of stenosis in arteries by using the 5. Doppler velocity profile.
4.3.1. 510(k) Indications for Use Forms
Please find the Indications for Use Forms following.
3
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Medi-Stim AS c/o Mr. Jon H. Hoem Vice President, Sale & Marketing Medi-Stim USA, Inc. 7601 Northland Drive, Mailstop A150 Brooklyn Park, MN 55428
Rc: K040228 Medi-Stim VeriQ System Regulation Number: 870.2190 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: 74 DPW Dated: January 28, 2004 Received: February 2, 2004
Dear Mr. Hoem:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have loviewed your 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 microate commerce prob to 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 i cactal I ood, Drug, and Colline Cornett Co. . The general controls provisions of the Act include the general bonners 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 Medi-Stim VeriQ System, as described in your premarket notification:
PQ101011, PQ101012, PQ100021, PQ100031, PQ100041, PQ100051, PQ100022, PQ100032, PQ100042, PQ100052, PA100081, PA100101, PA100121, PA100161, PA100211, PA100271, PA100082, PA100101, PA100122, PA100161, PA100162, PR100251, PR100301, PR100351, PI100181, PI100141, PI100381, PI100121,
4
Page 2 - Mr. Jon H. Hoem
PC100181, PC103161, PC103161, PC103162, PC100141, PC100142, PC100382, PC100383, PC100122, PC100123, PC100124, PE100022, PE100032, PE100042, PE100052, PD110751, PD110752, PD120751, PD120752
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.
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 (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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Kachi Enyinna at (301) 443-8262.
Sincerely yours,
Donna R. Lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Indications for Use
510(k) Number (if known): K040228
Device Name: Medi-Stim VeriQ System
Indications For Use:
The Medi-Stim VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:
- Accurate transit time blood volume and Doppler velocity flow measurements 1. during cardiovascular-, vascular-, transplantation- and neuro-surgery.
- Simultaneous measurements of blood pressure, vascular resistance, interfaced 2. physiological signals and other derived parameters during these procedures.
- Detection of normal and abnormal blood volume and Doppler velocity flow 3. patterns during these procedures.
- Provides guidance to prepare surgical plans at the initiation of surgery and to 4. support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
- Detection and quantification of the degree of stenosis in arteries by using the 5. Doppler velocity profile.
AND/OR -Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dona Piccione
Page 1 of 1
510(k) Number K040228
(Division Sign-Off) Division of Cardiovascular Devices