ABP FOR WINDOWS

K021517 · Rozinn Electronics, Inc. · DSK · Jul 24, 2002 · Cardiovascular

Device Facts

• Record ID: K021517
• Device Name: ABP FOR WINDOWS
• Applicant: Rozinn Electronics, Inc.
• Product Code: DSK · Cardiovascular
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1110
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ABP for Windows software is designed to allow the user to program the Mobile-O-Graph via the computer and to download the data recorded on the Mobile-O-Graph after a 24 or 48 hour period. The software will store and playback systolic, and heart rates recorded to be reviewed by a trained physician or other health care providers.

Device Story

ABP for Windows is a software application used to interface with the I.E.M. Mobile-O-Graph blood pressure monitor. The software allows clinicians to program patient identification and recording protocols into the monitor and download recorded blood pressure data (systolic, diastolic, heart rate) to a PC. It does not perform automated diagnosis or clinical interpretation; it provides tabular and graphical displays of recorded data, including patient events and recording errors. The software enables physicians to review, edit, and print reports in PDF or HTML formats. Used in clinical settings, it facilitates the management of ambulatory blood pressure monitoring data to assist in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only to confirm software safety and efficacy.

Technological Characteristics

Software application for Windows 98 or greater; requires minimum 550 MHz Pentium CPU, 64 MB RAM, 2 MB video memory, SVGA display, and serial port connectivity. Operates as a data management interface for the Mobile-O-Graph blood pressure monitor. Complies with FDA cGMP.

Indications for Use

Indicated for use by trained physicians or healthcare providers to program, download, review, and print systolic, diastolic, and heart rate data recorded by the Mobile-O-Graph blood pressure monitor over 24 or 48-hour periods.

Regulatory Classification

Identification

A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

Predicate Devices

• Mobile-O-Graph Blood Pressure Monitor, Model ABP Control (K964235)

Submission Summary (Full Text)

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K021517
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Image /page/0/Picture/1 description: The image shows the date July 24, 2002, followed by the brand name "ROZINN" in a bold, stylized font. Below the brand name is the tagline "The genius of simplicity." To the right of the brand name is a circular seal indicating "ISO 9001" certification, with the letters "SGS" at the bottom.

510 (k) Summary

Submitter:

Mark Rosoff, President Rozinn Electronics, Inc. 71-22 Myrtle Avenue 718-386-5526 Telephone: Fax: [phone] E-mail: [e-mail] Contact: Mark Rosoff Date of Summary: 05-10-02

Name of Device: ABP for Windows

Common Name: RZ250 Ambulatory Blood Pressure Software Classification Name: Blood Pressure Computer (as per 21 CFR 870.1110)

Substantial Equivalence claimed to legally marketed device: Mobile-O-Graph Blood Pressure Monitor , Model ABP Control- K964235

Description of Device:

The ABP for Windows Software is a software designed to be used in conjunction with I.E.M's Mobile-O-Graph Blood Pressure Monitor, Model ABP Control (K964235). The software will allow the user to program the Mobile-O-Graph using the software by inputting patient identification, protocols and setting recorder clock. The software will have the ability to download the data recorded from the Mobile-O-Graph to the computer to be reviewed by a trained professional. The software will allow the data to be printed and e-mailed in PDF or HTML format if desired. The ABP for Windows does not perform any diagnosis or provide any interpretation of data, it can only display and print the downloaded data such as systolic, diastolic, heart rates and mean arterial blood pressure in tabular or graphical form which was recorded by the Mobile-O-Graph. The physician will be able to review, edit and print the data collected. The ABP for Windows will provide information such as when patient events occurred , errors during recording and when day and night were marked on the Mobile-O-Graph. The software ABP for windows will be shown to be substantially equivalent to the software which is provided by I.E.M.'s Mobile-O-Graph Blood Pressure Monitor, Model ABP Control.

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Intended use of Device:

K021517
page 2 of 2

The ABP for Windows software is designed to allow the user to program the Mobile-O-Graph via the computer and to download the data recorded on the Mobile-O-Graph after a 24 or 48 hour period. The software will store and playback systolic, and heart rates recorded to be reviewed by a trained physician or other health care providers.

Comparison of Technology characteristics compared to predicate device:

Specifications

Predicate Device Mobile-O-Graph Blood Pressure Monitor ABP Control

IBM PC XT compatible

New Device ABP for Windows

- Type CPU RAM Hard disk Display Hard Disc Drive Operating System Port Printer
40 MHz or greater 8 Mbytes minimum 2 Mbytes minimum VGA 1.4 Mbytes Windows 3.1 One free serial port Printer as any Windows compatible

IBM PC XT compatible 550 MHz Pentium or greater 64 Mbytes minimum 2 Mbytes minimum SVGA 1.4 Mbytes Windows 98 or greater One free serial port Printer as any Windows compatible

## Conclusion:

The ABP for Windows and the Mobile-O-Graph Blood Pressure Monitor. ABP Control Software are both used in clinical applications to allow trained physicians or other health care providers to program, download, review and print data from the Mobile-O-Graph Blood Pressure monitor. Both are computerized programs which display a pre-digitized patient image file run under a computer operating system. Both use the computer operating system to access the displayed image. The ABP for Windows conforms to Good Manufacturing Procedures outlined by the FDA cGMP. This software is safe and effective for the application for which it is intended and has been tested to confirm the safety and efficacy of the software. The APB for Windows is found to be substantially equivalent to the Mobile-O-Graph Blood Pressure Monitor. ABP Control Software.

Image /page/1/Picture/13 description: The image shows the word "ROZINN" in bold, black letters. The letters are slightly slanted to the right. There are horizontal lines above and below the word, adding a graphic element to the design.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2002

Rozinn Electronics, Inc. c/o Mr. Mark Rosoff President 71-22 Myrtle Avenue Glendale, NY 11385-7254

Re: K021517 Trade Name: ABP for Windows Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II (two) Product Code: DSK Dated: May 10, 2002 Received: May 10, 2002

Dear Mr. Rosoff:

This letter corrects our substantially equivalent letter of July 24, 2002, regarding the trade name.

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 Concrols) 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 Rosoff

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 and additionally 21 CFR Part 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

e.lmgsn

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

Revised 7-30-2002

510(K) Number (if known): K021517

Device Name: ABP for Windows

## Indications for Use:

The APB for Windows is a software package to be used by a trained physician or health care provider to load, download, review and print data from the Mobile-O-Graph blood pressure monitor. The software will store and playback systolic, diastolic pressures as well as patients heart rates to be reviewed by a trained physician.

Division of Cardiovascular & Respiratory Devices
510(k) Number K02/517