(100 days)
Not Found
No
The summary explicitly states that the software "does not perform diagnostics" and there are no mentions of AI, DNN, ML, or descriptions of training/test sets typically associated with AI/ML development. The device is described as a standard Holter monitor for recording and reviewing ECG data.
No.
The device is clearly stated as intended for diagnostic evaluations by physicians to acquire, record, and store ECG signals, not for therapeutic intervention.
No
The device acquires, records, and stores ECG signals for diagnostic evaluations by physicians, but the provided text explicitly states, "The software does not perform diagnostics."
No
The device description explicitly states it is a "portable, microprocessor based device" that is "worn by a patient," indicating it includes hardware components in addition to the software.
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) to provide information for diagnosis.
- This device is an Ambulatory ECG Recorder. It acquires and records electrical signals directly from the patient's body surface (upper body). It does not analyze biological specimens.
- The text explicitly states the device is "non-invasive". IVD procedures often involve obtaining a specimen, which can be invasive.
- The device works with software to process the ECG data, but the software "does not perform diagnostics". The data is used by physicians for diagnostic evaluations, but the device itself is not performing the diagnostic test on a specimen.
Therefore, the function and method of operation of this device clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DSH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper body surface
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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. Purpura | |
| Director, Regulatory and Quality Affairs | |||
| Vasomedical, Incorporated | |||
| Telephone: (516) 997-4600 | |||
| Facsimile: (516) 997-2299 | |||
| E-mail: mpurpura@vasomedical.com | |||
| 4. | Recorder | ||
| Device Name: | |||
| Proprietary Name: | |||
| Common Name: | |||
| Classification Name: | Medical Magnetic Tape Recorder | ||
| Vasomedical Biox 1305, 3 Channel ECG Holter Monitor | |||
| 1305 Biox Holter | |||
| 870.2800 Medical Magnetic Tape Recorder | |||
| Analysis Software | |||
| Device Name: | |||
| Proprietary Name: | |||
| Common Name: | |||
| Classification Name: | Computer, Diagnostic, Programmable | ||
| Vasomedical Biox ECG Analysis System Software | |||
| CB Series Software | |||
| 870.1425 Computer, Diagnostic, Programmable | |||
| 5. | Predicate Device: | The AECG Recorder listed above is substantially equivalent to the | |
| Huntleight Healthcare Cardiology Products Division Recorder | |||
| Models MedilogAR4 and MedilogAR12. The AECG Analysis | |||
| Software listed above is substantially equivalent to the Huntleight | |||
| Healthcare Cardiology Products Division, Medilog Darwin. FDA | |||
| granted 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 is | |
| intended to be used as a Holter ambulatory electrocardiograph | |||
| monitor 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 |
1
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, artial |
| fibrillation, SAECG, HRT | |
| Viewing modes | Standard ECG, ECG thumbnail, Page scanning |
| Data reporting | Trend charts, statistical tables, category specific |
| histograms |
Table 2: Features of CB Series Software.
2
:
. .- "
ਸੰ
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 to
acquire, record and store ambulatory three (3) channel ECG
signals from the upper body surface of adult and adolescent
patients 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. |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. Comparison of
Technological
Characteristics: | Technological and functional characteristics of the
device listed in this 510(k) Premarket Notification are
essentially the same as those of the predicate devices. The device
listed in this 510(k) Premarket Notification are therefore |
substantially equivalent to the predicate devices.
3
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.
4
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
5
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:
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.
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) |
14