(11 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No.
The intended use states that the measurements and analysis provided by the device are "not intended as clinical diagnosis but only to substantiate appropriate patient health assessment procedures," which indicates it is for assessment rather than treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "These measurements and analysis are not intended as clinical diagnosis but only to substantiate appropriate patient health assessment procedures."
Unknown
The provided summary does not explicitly state whether the device is software-only. While it describes a "Health Assessment System" and mentions "HRV Measurements," it doesn't clarify if this system is purely software or includes dedicated hardware for data acquisition. The predicate devices listed are also systems that could potentially include hardware components.
Based on the provided information, the QHRV 1 -- Health Assessment System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements and analysis are "not intended as clinical diagnosis." IVDs are specifically designed for the diagnosis of diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Nature of Measurement: The device measures Heart Rate Variability (HRV) in response to exercises. This is a physiological measurement taken directly from the patient, not an analysis of a sample (like blood, urine, or tissue) taken from the patient, which is characteristic of IVDs.
Therefore, while it's a health assessment system, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QHRV -1 System is intended for use in heart variability measurements in response to paced respiration and controlled exercises.
Product codes
DPS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
MEDTECHS LLC
APR 11 2008
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device systems Act 1990 and 21 CFR Sec. 807.92
510(k) Number: Applicant Information:
Image /page/0/Picture/5 description: The image contains a handwritten string of characters, "K080834". The characters are written in a dark ink, and there is a horizontal line below the string. The handwriting appears to be somewhat stylized.
Date Prepared:
Name:
March 2, 2008
MTecHS Division of MedTechs, LLC Address: 111, Beaver Dam Run Durham, NC 27703 Phone: 1 877 833 3493
| Contact Person: | Meghan Ath |
|---|---|
| Phone Number: | 919 619 7657 |
| Fax Number: | 215 474 0127 |
| meghan@medtechs.us |
Device system Information:
| Classification: | DPS/Class II/870.2340 |
|---|---|
| Trade Name: | QHRV 1 - Health Assessment System |
| Common Name: | HRV Analysis System |
| Classification Name: | Electrocardiograph |
Substantial Equivalence:
QHRV-1 is substantially equivalent to the following Predicate Device systems.
| Hokanson ANS 2000 RR Interval Measurement | K973426 |
|---|---|
| Q Med Inc., Monitor One NDX HRV Analysis Function | K972991 |
| Ansore Health Management System - Boston Medical | K010955 |
Intended Use:
QHRV-1 Health Assessment System has the same intended use as the legally marketed predicate device systems. The QHRV -1 System is intended for use in heart variability measurements in response to paced respiration and controlled exercises.
1
Public Health Service
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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2008
MTechsHS Division of MedTechs LLC c/o Ms. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55513
Re: K080884
QHRV 1 -- Health Assessment System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 28, 2008 Received: March 31, 2008
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
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.
2
Page 2 -- Mr. Mark Job
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 Section 510(k) 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 the 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.
Sincerely yours,
Blummenstock for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510K Number (if known)
Device system Name:
QHRV 1 - Health Assessment System
Indications for Use:
The QHRV 1 -- Health Assessment System is intended for (HRV) I leart Rate Variability Measurements in response to a series of paced respiration, standardized and controlled These measurements and analysis are not intended exercises. as clinical diagnosis but only to substantiate appropriate patient health assessment procedures.
Prescription Use __ X_ (Part 21 CFR 801 Subpart D)
10 NO MO BO A V TO K F A Y Y S M S M S M 5 M 5 S M P A S M S A S M P M P M S S S M P M P S S M P M P S S M P S S S M P S S S M P S S S M P S S S M P S S S M P S S S M P S S
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummon
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kox0884