ABP FOR WINDOWS by ROZINN ELECTRONICS, INC.

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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "ABP for Windows" software, which is designed to be used with the Mobile-O-Graph Blood Pressure Monitor (K964235). The submission focuses on demonstrating substantial equivalence to the predicate device's software.

Based on the provided text, the ABP for Windows software does not perform any diagnosis or provide any interpretation of data. It is purely for displaying, storing, and printing data recorded by the Mobile-O-Graph, which is then reviewed by a trained professional. Therefore, the concept of "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, AUC) and a "study that proves the device meets the acceptance criteria" in the traditional sense of AI/CADe devices for interpretation is not applicable here.

The "study" described is a comparison of technological characteristics to demonstrate substantial equivalence, rather than a clinical performance study.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As the device is software for data management (displaying and printing) and not for diagnostic interpretation, the acceptance criteria are related to its functional compatibility with the predicate device's software and its ability to process and display the blood pressure data accurately.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence: Ability to program the Mobile-O-Graph.	The software will allow the user to program the Mobile-O-Graph using the software by inputting patient identification, protocols and setting recorder clock.
Data Download & Storage: Ability to download and store recorded data.	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 store and playback systolic, diastolic, and heart rates recorded.
Data Display & Review: Ability to display data in tabular/graphical form.	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. The physician will be able to review, edit and print the data collected.
Printing & Export: Ability to print and export data.	The software will allow the data to be printed and e-mailed in PDF or HTML format if desired.
Operating System Compatibility: Compatible with specified OS.	Compatible with Windows 98 or greater (predicate was Windows 3.1). Other hardware specs (CPU, RAM, Hard disk, Display) were also compared and met or exceeded.
Safety and Effectiveness: Conformance to GxP.	"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."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study involving a "test set" of patient data for diagnostic performance evaluation. The "tests" mentioned are for software safety and efficacy, likely functional testing and compatibility, not based on patient data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There is no diagnostic "ground truth" establishment described, as the software does not perform diagnosis or interpretation.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is not relevant for this software's intended use, which is data management, not diagnostic assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a conceptual sense related to software functionality. The comparison of technological characteristics against the predicate software evaluates the "algorithm only" in terms of its ability to manage and display data, rather than interpret it. The software's performance is standalone in that it processes and presents data without human intervention in the data processing step, but human review is required for interpretation.

7. The type of ground truth used

Not applicable for diagnostic performance evaluation. For functional equivalence, the "ground truth" would be the demonstrated functionality of the predicate device's software and the specified technical requirements for the new software.

8. The sample size for the training set

Not applicable. This software does not use machine learning or AI models that require a "training set" of data.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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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: 718-366-4574 E-mail: mark@rozinn.com 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:

150

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Intended use of Device:

K021517
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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 870.1110 Blood pressure computer.

(a)
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.(b)
Classification. Class II (performance standards).