ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS

K083735 · Medtechs, LLC · JOM · Feb 18, 2009 · Cardiovascular

Device Facts

• Record ID: K083735
• Device Name: ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
• Applicant: Medtechs, LLC
• Product Code: JOM · Cardiovascular
• Decision Date: Feb 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

ANSHA -QHRV1 has the same intended use as the legally marketed predicate device systems. The ANSHA -QHRV1 is intended for non-invasive measurement of pulse waveform by photoelectric plethysmography and heart rate by electrocardiograph. The device is for use in outpatient departments of hospitals, healthcare clinics and physician practices.

Device Story

ANSHA-QHRV1 performs non-invasive physiological monitoring; inputs include pulse waveform data via photoelectric plethysmography and heart rate data via electrocardiograph. Device operates in clinical settings including hospitals, clinics, and physician practices; operated by healthcare professionals. System processes physiological signals to provide diagnostic data for clinical assessment. Benefits include non-invasive patient evaluation of cardiovascular parameters to assist in clinical decision-making.

Clinical Evidence

Bench testing only; no clinical data provided. Device performance verified against safety and performance standards of predicate systems.

Technological Characteristics

Photoelectric plethysmograph and electrocardiograph sensors. Non-invasive measurement principle. Class II device (21 CFR 870.2780). Product codes JOM and DPS.

Indications for Use

Indicated for non-invasive pulse waveform and heart rate measurement in patients within medical clinics, healthcare practices, and hospital outpatient departments.

Regulatory Classification

Identification

A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

Predicate Devices

• Medicore Co.Ltd. SA 3000P System (K073323)
• QHRV-1 Health Assessment System (K080884)

Submission Summary (Full Text)

{0}------------------------------------------------

# MEDIECHS ILC

## 510(k) SUMMARY

page 1/1

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: K083735

FEB 1 8 2009

Date Prepared:

November 12, 2008

Name:

MTecHS Division of MedTechs, LLC Address: 111, Beaver Dam Run Durham, NC 27703 Phone: [phone]

Contact Person: Phone Number: Fax Number:

Meghan Ath 919 619 7657 215 474 0127 [e-mail]

## Device system Information:

| Classification: | JOM/ClassII/870.2780 |
|-----------------|--------------------------|
| Trade Name: | 'ANSHA' |
| Common Name: | Pneumatic Plethysmograph |

## Substantial Equivalence:

Medicore Co.Ltd. SA 3000P System QHRV-1 Health Assessment System

K073323 K080884

Reason for submission:

Modification - additional features to existing product

Performance:

The functions are substantially equivalent to the predicate. In addition the device has undergone performance testing and meets the same safety and performance standards as the predicate.

#### Intended Use:

ANSHA -QHRV1 has the same intended use as the legally marketed predicate device systems. The ANSHA -QHRV1 is intended for non-invasive measurement of pulse waveform by photoelectric plethysmography and heart rate by electrocardiograph. The device is for use in outpatient departments of hospitals, healthcare clinics and physician practices.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular fashion around the eagle, also in black. The overall design is simple and conveys a sense of official authority.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 8 2009

MEDTECHS, LLC. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th St NW Buffalo, MN 55313

K083735 Re:

Trade/Device Name: ANSHA - QHRV1 Regulation Number: 21 CFR 870.2780 Regulation Name: Plethysmograph, photoelectric, pneumatic or hydraulic Regulatory Class: Class II Product Code: JOM, DPS Dated: January 26, 2009 Received: January 28, 2009

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 23, 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, Diug. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

AN Bram D_Zuckerman, M.D. Director ... .. .. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Medtechs LLC. The logo consists of a stylized triangle shape on the left, followed by the text "MEDTECHS" in a bold, sans-serif font. To the right of "MEDTECHS" is the text "LLC" in a smaller font size.

; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## Indications for Use

510K Number (if known)

K083735

Device system Name:

ANSHA - QHRV1

Indications for Use: ANSHA (QHRV1) is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rase by electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of (DRH, Office of Device Evaluation (ODE) -

formal

(Division Sign-Off) 2/17/09 Division of Cardiovascular Devices 510(k) Number K083735