QHRV 1 - HEALTH ASSESSMENT SYSTEM

K080884 · Medtechs, LLC · DPS · Apr 11, 2008 · Cardiovascular

Device Facts

• Record ID: K080884
• Device Name: QHRV 1 - HEALTH ASSESSMENT SYSTEM
• Applicant: Medtechs, LLC
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The QHRV -1 System is intended for use in heart variability measurements in response to paced respiration and controlled exercises.

Device Story

QHRV-1 Health Assessment System measures heart rate variability (HRV) in response to paced respiration and controlled exercises. Device inputs include physiological signals related to heart rate; system processes these inputs to perform HRV analysis. Output provides data for patient health assessment. Intended for use by healthcare professionals to support health assessment procedures; not for clinical diagnosis. Benefits include objective quantification of HRV during standardized physiological challenges.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Electrocardiograph (21 CFR 870.2340). System performs HRV analysis based on RR interval measurements. Connectivity and specific hardware materials not detailed in provided documentation.

Indications for Use

Indicated for heart rate variability (HRV) measurements in response to paced respiration and standardized, controlled exercises. Not intended for clinical diagnosis; intended to substantiate patient health assessment procedures.

Regulatory Classification

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.

Predicate Devices

• Hokanson ANS 2000 RR Interval Measurement (K973426)
• Q Med Inc., Monitor One NDX HRV Analysis Function (K972991)
• Ansore Health Management System - Boston Medical (K010955)

Submission Summary (Full Text)

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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: [phone]

| Contact Person: | Meghan Ath |
|-----------------|--------------------|
| Phone Number: | 919 619 7657 |
| Fax Number: | 215 474 0127 |
| | [e-mail] |

#### 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.

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Public Health Service

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use

510K Number (if known)

K080884

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummon

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kox0884