COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301

• K Number: K092785
• Device Name: COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
• Manufacturer: VASOMEDICAL, INC.
• Date Cleared: 2010-04-02 ( 204 days)
• Product Code: DSH
• Regulation Number: 870.2800

Intended Use

Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder is a Non-Invasive oscillometric device intended to acquire Ambulatory 3 Channel ECG signals and non- invasive Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. The Recorders are intended for adults and children Who are over the age of six years. Vasomedical-Biox Ambulatory ECG CB Series Analysis System Software allows transfer of ECG and Blood Pressure data from the Recorder to a Windows based PC-based computer program via a removable and large capacity storage card (SD) for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

Device Description

Vasomedical's Ambulatory ECG and Blood Pressure Recorder is intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods up to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. 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 CB series AECG/BP Analysis system is a PC based diagnostic application running on a Microsoft Windows operating system. It is designed in conjunction with the CB series Holter Recorder and analyzes prerecorded patient's ECG and/or ABP data that has been stored by CB series Recorder, or other compatible Holter Recorders. The system provides multi-channel full disclosure for arrhythmia and ST events and synchronous three channel ECG and ABP pulses, and creates summary tables, statistics, trends, and final report regarding a variety of cardiac data indices. The cardiac data provided by the system is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap.

Predicate Devices

K003004, K083820

Reference Devices

K003004, K083820

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ambulatory ECG and blood pressure recorder and analysis system. It focuses on data acquisition, storage, transfer, and basic analysis (summary tables, statistics, trends). There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or the "Mentions AI, DNN, or ML" section. The analysis software is described as a "PC based diagnostic application" that assists trained medical personnel, but it explicitly states it "does not perform diagnostics" and "makes no diagnosis."

Therapeutic

No
The device is described as a measurement, recording, and display system for ECG and blood pressure signals, and explicitly states it "makes no diagnosis" and "does not perform diagnostics." Its purpose is to acquire and analyze data for diagnostic evaluation by physicians, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

The "CB series AECG/BP Analysis system" is described as a "PC based diagnostic application" that "analyzes prerecorded patient's ECG and/or ABP data" and provides data "used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns." Although the recorder itself does not perform diagnostics, the overall system, which includes the analysis software, is explicitly for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states that the system includes both a "Recorder" which is a portable, microprocessor-based hardware device worn by the patient, and "Analysis System Software" which runs on a PC. Therefore, it is not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body).
• This device is a non-invasive device that acquires physiological signals (ECG and Blood Pressure) directly from the patient's body in vivo (within the body).

The text clearly describes the device as:

• Non-Invasive oscillometric device
• Intended to acquire Ambulatory 3 Channel ECG signals and non- invasive Blood Pressure signals from the upper body surfaces.
• Worn by a patient

These characteristics are consistent with in vivo diagnostic devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder, #2301, is a Non-Invasive device intended to acquire Ambulatory 3 Channel ECG signals and non- invasive Oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG Signals. The Recorders are intended for adults and children who are over the age of six years.

Vasomedical-Biox Ambulatory ECG CB Series Analysis System Software allows transfer of ECG and Blood Pressure data from the Recorder to a Windows based PC program via a removable and large capacity storage card (SD) for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data.

The system is only for measurement, recording and display. It makes no diagnosis.

Product codes

DSH, DXN

Device Description

Vasomedical's Ambulatory ECG and Blood Pressure Recorder is intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods up to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. 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 CB series AECG/BP Analysis system is a PC based diagnostic application running on a Microsoft Windows operating system. It is designed in conjunction with the CB series Holter Recorder and analyzes prerecorded patient's ECG and/or ABP data that has been stored by CB series Recorder, or other compatible Holter Recorders. The system provides multi-channel full disclosure for arrhythmia and ST events and synchronous three channel ECG and ABP pulses, and creates summary tables, statistics, trends, and final report regarding a variety of cardiac data indices. The cardiac data provided by the system is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper body surfaces

Indicated Patient Age Range

adults and children over the age of six years old.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K003004, K083820

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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22 March, 2010

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510(k) Summary

Vasomedical, Incorporated

Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder 2301 and Ambulatory ECG and Blood Pressure Recorder Analysis Software

• 1. Date Prepared: 22 March, 2010 2. Submitter's Name: Vasomedical, Inc. 180 Linden Ave. and Address Westbury, NY 11590 Richard Gordon 3. Contact Person: Director, Regulatory and Quality Affairs Vasomedical, Incorporated Telephone: [phone] Facsimile: [phone] E-mail: [e-mail] Combined Ambulatory ECG and Blood Pressure Recorder 4. Device Name: Proprietary Names: Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder 2301 and Analysis Software Common Name: Combined Ambulatory ECG and Blood Pressure Recorder 2301 Classification Name: 870.2800 Medical Magnetic Tape Recorder 870.1130 Non invasive Blood Pressure Measurement System 5. Predicate Device: The AECG/BP Recorder listed above is substantially equivalent to the SunTech Medical Instruments Inc., Automatic Blood Pressure Measurement System, Oscar 2 and the Vasomedical-Biox 1305, 3 Channel ECG Holter Monitor and CB Series Analysis Software.
     Vasomedical's Ambulatory ECG and Blood Pressure Recorder is 6. Device Description: intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods up to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. Cardiac rhythm is acquired by 3 channel ECG signals. The Recorders are intended for adults and children over the age of six years old.

25, 2000 (K003004), and April 1, 2009 (K083820).

FDA granted 510(k) clearances for these predicate devices on October

APR - 2 2010

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The CB series AECG/BP Analysis system is a PC based diagnostic application running on a Microsoft Windows operating system. It is designed in conjunction with the CB series Holter Recorder and analyzes prerecorded patient's ECG and/or ABP data that has been stored by CB series Recorder, or other compatible Holter Recorders. The system provides multi-channel full disclosure for arrhythmia and ST events and synchronous three channel ECG and ABP pulses, and creates summary tables, statistics, trends, and final report regarding a variety of cardiac data indices. The cardiac data provided by the system is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

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

Lead	3	Dimensions	4.88x2.68x1.22"
Electrode	5 or 7	Weight	6.35 oz. w/o batteries
Lead wire type	Lead-7C/5C	Storage	SD Memory Card
Display	LCD	Memory	512 MB or4 more
Batteries	4 "AA" alkaline	Sample Rate	256 Hz/Channel
2048Hz Pacemaker Detection
BP Cuff	Medium	Resolution	10 Bits
Carrying Case/
Strap	Supplied	Infrared
Adaptor	Supplied
Card Reader	Supplied

Model 2301 specifications are listed in Table 1 below:

Table 1: Model CB2301 Specifications

7. Intended Use:

Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder, #2301, is a Non-Invasive device intended to acquire Ambulatory 3 Channel ECG signals and non- invasive Oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG Signals. The Recorders are intended for adults and children who are over the age of six years.

Vasomedical-Biox Ambulatory ECG CB Series Analysis System Software allows transfer of ECG and Blood Pressure data from the Recorder to a Windows based PC program via a removable and

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large capacity storage card (SD) for the purpose of creating reports

and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data.

The system is only for measurement, recording and display. It makes no diagnosis.

Refer to Attachment I, Vasomedical-Biox Model 2301 AECGBP Operator's Manual, Sections 2.2, Indications for Use, 2.2.1 Intended Use and 2.2.2 for Contraindications.

• Technological and functional characteristics of the 8. Comparison of device listed in this 510(k) Premarket Notification is Technological essentially the same as those of the predicate devices. The device Characteristics: listed in this 510(k) Premarket Notification is 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 & Human Services. The logo features a stylized eagle with its head facing left and its wings forming three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR - 2 2010

Vasomedical, Inc. c/o Mr. Richard Gordon Manager, Regulatory and Quality Affairs 180 Linden Ave Westbury, NY 11590

Re: K092785

Vasomedical-Biox 2301 Combined Ambulatory ECG and Blood Pressure Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: DSH and DXN Dated: March 22, 2010 Received: March 24, 2010

Dear Mr. Gordon:

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 - Mr. Richard Gordon

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

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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Indications for Use

510(k) Number:	K092785
Device Name:	Vasomedical-Biox Combined Ambulatory ECG and Blood
Pressure Recorder 2301 and Analysis Software
Indications for Use:	Vasomedical-Biox Combined Ambulatory ECG and Blood
Pressure Recorder is a Non-Invasive oscillometric device
intended to acquire Ambulatory 3 Channel ECG signals and
non- invasive Blood Pressure signals from the upper body
surfaces. Cardiac rhythm is acquired via 3 Channel ECG
signals. The Recorders are intended for adults and children
Who are over the age of six years.

Vasomedical-Biox Ambulatory ECG CB Series Analysis
System Software allows transfer of ECG and Blood Pressure
data from the Recorder to a Windows based PC-based
computer program via a removable and large capacity
storage card (SD) for the purpose of creating reports and
printouts. The Software does not perform diagnostics.
Physicians carry out diagnostic evaluations of this data.
The system is only for measurement, recording and display.
It makes no diagnosis. | |
| Prescription Use: YES
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use: NO
(21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED) | | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_

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