AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM

• K Number: K011779
• Device Name: AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
• Manufacturer: AVID CARE CORP.
• Date Cleared: 2001-07-13 ( 36 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Special
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: K031840 , K040966 , K051470 , K113446

Intended Use

The intended use for both the cleared and the modified Home Health Monitor System is for home use, patient operated:

• 1. non-invasive blood pressure measurement.
• 2. non-invasive blood oxygen saturation measurement using pulse oximetry,
• 3. in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood, and
• 4. patient weight using a stand-on electronic scale;

and subsequent transmission of these measurements to a computer monitoring station in a clinical setting.

Device Description

Home Health Monitor System

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the AvidCare Series 100 Telemanagement System (also referred to as Home Health Monitor System). It determines substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to such a study.

The document primarily focuses on the regulatory aspects of device clearance, stating its intended use and classification.

Therefore, I cannot provide the requested information based on the given text.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

AvidCare Corporation c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K011779

Trade Name: AvidCare Series 100 Telemanagement System Regulation Number: 21 CFR 870.1130 Regulatory Class: II (two) Product Code: 74 DXN Dated: June 7, 2001 Received: June 7, 2001

Dear Mr. Kahan:

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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the

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Page 2 – Mr. Jonathan S. Kahan

Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

A.H.A. Carl. L.

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Submission, Modification K011779, Home Health Monitor System AvidCare Corporation, Milwaukee, WI 53202

510(k) Number K011779

DEVICE NAME: Home Health Monitor System

INDICATIONS FOR USE:

The intended use for both the cleared and the modified Home Health Monitor System is for home use, patient operated:

• 1. non-invasive blood pressure measurement.
• 2. non-invasive blood oxygen saturation measurement using pulse oximetry,
• 3. in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood, and
• 4. patient weight using a stand-on electronic scale;

and subsequent transmission of these measurements to a computer monitoring station in a clinical setting.

PRESCRIPTION DEVICE.

Federal Law (US) restricts this device to sale by or on the order of a physician.

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

Concurrence of CRDH, Office of Device Evaluation (ODE)

A.H.A. Liable f.-TED

Division of Cardiovascular & Respiratory Devices
510(k) Number k 011779

Prescription Use

OR

Over-The -Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).