The Ambulatory ECG Recorder described in this 510(k) Premarket Notification is a non-invasive device intended to acquire, record and store ambulatory three (3) channel ECG signals from the upper body surface of adults and children over the age of six years old for a minimum of 24 hours. It works in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. The software does not perform diagnostics. These data are used by physicians for diagnostic evaluations.

Device Description

Vasomedical's Ambulatory ECG Recorder Model 1305 is intended to be used as a Holter ambulatory electrocardiograph monitor for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 3 channel ECG signals. The recorders are intended for adults and children over the age of six years old. The recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap. Vasomedical's Ambulatory ECG CB Series Analysis System Software allows transfer of data from the recorder to a Windows based PC via a removable storage card for the purpose of creating printouts and reports. These data are used by physicians for diagnostic evaluations.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasomedical Ambulatory ECG Recorder and Analysis Software:

Acceptance Criteria and Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, in the way one might expect for a de novo device or a more rigorous performance study, is not explicitly provided.

However, the document does list the technical specifications and features of the device, which implicitly serve as performance characteristics that are intended to meet the standards of the predicate device.

Implicit "Acceptance Criteria" (Technical Specifications) and Reported Device Characteristics:

Feature/Characteristic	Implicit "Acceptance Criteria" (as per predicate equivalence)	Vasomedical Biox 1305 / CB Series Software Performance
Recorder (1305 Biox Holter)	Substantially equivalent to Huntleight Healthcare Cardiology Products Division Recorders (Medilog AR4 and AR12)
Leads	3	3
Electrodes	5 or 7	5 or 7
Lead wire type	Lead-7C/5C	Lead-7C/5C
Display	LED	LED
Batteries	1 "AA" alkaline	1 "AA" alkaline
Dimensions	3.3" x 2.3" x 0.8"	3.3" x 2.3" x 0.8"
Storage Medium	SD Card	SD Card
Memory	1 GB or more	1 GB or more
Sample Rate	256 Hz/channel; 10,000 Hz/channel for pacemaker; 1,000 Hz/channel with SAECG option	256 Hz/channel; 10,000 Hz/channel for pacemaker; 1,000 Hz/channel with SAECG option
Resolution	10 bit, 12 bit for SAECG option	10 bit, 12 bit for SAECG option
Analysis Software (CB Series Software)	Substantially equivalent to Huntleight Healthcare Cardiology Products Division (Medilog Darwin)
QRS Classification	Ventricular, Supra-Ventricular, Normal, Artifact	Ventricular, Supra-Ventricular, Normal, Artifact
Comprehensive Event Reports	VE, VE pair, VE bigeminy, V-run, R on T, SVE, SVE pair, SVE-run, pause, long RR, tachycardia, bradycardia, and atrial fibrillation	VE, VE pair, VE bigeminy, V-run, R on T, SVE, SVE-run, pause, long RR, tachycardia, bradycardia, and atrial fibrillation
ST-segment reports	Deviation, Slope, Duration, Heart rate	Deviation, Slope, Duration, Heart rate
Analysis capability	Arrhythmia, ST-segment, HRV, pacemaker, atrial fibrillation, SAECG, HRT	Arrhythmia, ST-segment, HRV, pacemaker, atrial fibrillation, SAECG, HRT
Viewing modes	Standard ECG, ECG thumbnail, Page scanning	Standard ECG, ECG thumbnail, Page scanning
Data reporting	Trend charts, statistical tables, category specific histograms	Trend charts, statistical tables, category specific histograms
Intended Use	Acquire, record, and store 3-channel ECG signals for 24+ hours from adults/adolescents (6+ years old) for playback, review, analysis, editing, and printing.	Acquire, record, and store 3-channel ECG signals for 24+ hours from adults/adolescents (6+ years old) for playback, review, analysis, editing, and printing.

The study presented here is a substantial equivalence determination rather than a performance study with defined acceptance criteria and statistical analysis of device performance. The evidence for meeting criteria is primarily asserted through the direct comparison of technological and functional characteristics to known predicate devices that are already cleared.

Study Information:

Based on the provided K083820 510(k) summary, the following information is either not explicitly stated or not applicable because the submission method relies on substantial equivalence rather than independent performance evaluation against predefined criteria.

Sample size used for the test set and the data provenance: Not explicitly stated. The submission relies on demonstrating similarity to predicate devices. It doesn't describe a new test set with specific data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. There is no information about an independent ground truth establishment process for the device's performance data.
Adjudication method for the test set: Not applicable, as there's no described independent test set or adjudication process for this 510(k) submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI-driven device or a MRMC study. The software functions as an analysis system for human review, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" performance. The device is explicitly designed to work "in concert with the CB Series Analysis Software to playback, review, analyze, edit and print ECG data. These data are used by physicians for diagnostic evaluations." The software itself "does not perform diagnostics," indicating it's a tool for human interpretation rather than a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated or outlined within this 510(k) summary. The submission focuses on substantial equivalence based on technical specifications and intended use matching predicate devices.
The sample size for the training set: Not applicable. This submission doesn't describe a machine-learning algorithm that would require a "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set described.

Summary of this 510(k) Submission Approach:

The provided document is a 510(k) summary for a Class II medical device (Medical Magnetic Tape Recorder and Computer, Diagnostic, Programmable). The primary method for demonstrating safety and effectiveness relied on proving substantial equivalence to existing predicate devices (Huntleight Healthcare Cardiology Products Division Recorder Models MedilogAR4 and MedilogAR12; and Medilog Darwin software).

This means the submission's "study" wasn't a de novo clinical trial or performance study against specific acceptance criteria, but rather an engineering and functional comparison to prove that the new device's technical specifications and features are "essentially the same as those of the predicate devices" and "therefore substantially equivalent." There is no detailed information provided on the specific performance validation data (e.g., accuracy, sensitivity, specificity) against a ground truth dataset, which would typically be included in a de novo submission or a more complex device requiring specific performance metrics beyond equivalence.

Summary

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510(k) Summary

Vasomedical, Incorporated Ambulatory ECG Recorder Ambulatory ECG Recorder Analysis Software

APR - 1 2009

1.	Date Prepared:	20 February 2009
2.	Submitter's Name:and Address	Vasomedical, Inc.180 Linden Ave.Westbury, NY 11590
3.	Contact Person:	Melissa M. PurpuraDirector, Regulatory and Quality AffairsVasomedical, IncorporatedTelephone: (516) 997-4600Facsimile: (516) 997-2299E-mail: mpurpura@vasomedical.com
4.	RecorderDevice Name:Proprietary Name:Common Name:Classification Name:	Medical Magnetic Tape RecorderVasomedical Biox 1305, 3 Channel ECG Holter Monitor1305 Biox Holter870.2800 Medical Magnetic Tape Recorder
	Analysis SoftwareDevice Name:Proprietary Name:Common Name:Classification Name:	Computer, Diagnostic, ProgrammableVasomedical Biox ECG Analysis System SoftwareCB Series Software870.1425 Computer, Diagnostic, Programmable
5.	Predicate Device:	The AECG Recorder listed above is substantially equivalent to theHuntleight Healthcare Cardiology Products Division RecorderModels MedilogAR4 and MedilogAR12. The AECG AnalysisSoftware listed above is substantially equivalent to the HuntleightHealthcare Cardiology Products Division, Medilog Darwin. FDAgranted 510(k) clearances for this predicate device on April 6,2007 under K070818 and December 22, 2005 under K053369.
6.	Device Description:	Vasomedical's Ambulatory ECG Recorder Model 1305 isintended to be used as a Holter ambulatory electrocardiographmonitor for the purpose of screening ECG rhythms for periods un
Lead	3
Electrode	5 or 7
Lead wire type	Lead-7C/5C
Display	LED
Batteries	1 "AA" alkaline
Dimensions	3.3" x 2.3" x 0.8"
Storage Medium	SD Card
Memory	1 GB or more
Sample Rate	256 Hz/channel; 10,000 Hz/channel for pacemaker; 1,000 Hz/channel with SAECG option
Resolution	10 bit, 12 bit for SAECG option

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to 72 hours. Cardiac rhythm is acquired by 3 channel ECG signals. The recorders are intended for adults and children over the age of six years old.

The recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap.

1305 Biox Holter specifications are noted in table 1

Table 1: Specification of 1305 Biox Holter.

Vasomedical's Ambulatory ECG CB Series Analysis System Software allows transfer of data from the recorder to a Windows based PC via a removable storage card for the purpose of creating printouts and reports. These data are used by physicians for diagnostic evaluations.

Vasomedical's Ambulatory ECG Analysis System Software features are noted in table 2.

QRS classification	Ventricular, Supra-Ventricular, Normal, Artifact
Comprehensive event reports	VE, VE pair, VE bigeminy, V-run, R on T, SVE,SVE pair, SVE-run, pause, long RR, tachycardia,bradycardia, and atrial fibrillation
ST-segment reports	Deviation, Slope, Duration, Heart rate
Analysis capability	Arrhythmia, ST-segment, HRV, pacemaker, artialfibrillation, SAECG, HRT
Viewing modes	Standard ECG, ECG thumbnail, Page scanning
Data reporting	Trend charts, statistical tables, category specifichistograms

Table 2: Features of CB Series Software.

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K083820
20 February 2009 p 3/3

7. Intended Use:	The Ambulatory ECG Recorder described in this 510(k)Premarket Notification is a non-invasive device intended toacquire, record and store ambulatory three (3) channel ECGsignals from the upper body surface of adult and adolescentpatients for a minimum of 24 hours. It works in concert with theCB Series Analysis Software to playback, review, analyze, editand print ECG data.
8. Comparison ofTechnologicalCharacteristics:	Technological and functional characteristics of thedevice listed in this 510(k) Premarket Notification areessentially the same as those of the predicate devices. The devicelisted in this 510(k) Premarket Notification are therefore

substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2009

Vasomedical, Inc. c/o Ms. Melissa M. Purpura Director, Regulatory and Quality Affairs 180 Linden Avenue Westbury, NY 11590

Re: K083820

Trade/Device Name: Vasomedical Biox 1305, 3 Channel ECG Holter Monitor and Ambulatory ECG Analysis System Software CB Series Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: DSH Dated: February 20, 2009 Received: February 24, 2009

Dear Ms. Purpura:

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 - Ms. Melissa M. Purpura

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

07 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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K083820, Amendment #1

Indications for Use Statement

510(k) Number:

Device Name:

Vasomedical Biox 1305, 3 Channel ECG Holter Monitor Ambulatory ECG Analysis System Software CB Series

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	B Zuckerman
(Division Sign-Off)	3/31/09
Division of Cardiovascular Devices
510(k) Number	K083820

Prescription Use X	OR	Over-The Counter Use ______
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).