(62 days)
Not Found
No
The summary describes a device for recording and displaying ECG signals. It explicitly states the system is "only for measurement, recording and display" and "makes no diagnosis." There is no mention of AI, ML, or any analytical capabilities beyond basic signal acquisition and display.
No
The device is described as for "measurement, recording and display" of ECG signals, and explicitly states, "It makes no diagnosis." This indicates it is a diagnostic tool, not a therapeutic one.
No
The text explicitly states: "The system is only for measurement, recording and display. It makes no diagnosis."
No
The device description explicitly states that the devices are "portable, microprocessor based devices that are worn by a patient," indicating they are hardware devices, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device is a "Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces." It measures and records electrical activity of the heart from the body's surface.
- No sample analysis: There is no mention of analyzing samples taken from the body. The device directly interacts with the patient's skin to acquire signals.
- Focus on electrical signals: The device's purpose is to capture and record electrical signals related to cardiac rhythm, not to analyze biological samples for diagnostic markers.
Therefore, the Vasomedical-Biox Holter Recorders are considered medical devices for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces. Cardiac Rhythm is acquired via ECG signals.
Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303, is also a Non-Invasive device intended to acquire ambulatory 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is also acquired via ECG signals.
The Holter Recorders are intended for adults and children who are over the age of six years.
The Models 1304 and 1303 work with the CB Series ECG Analysis Software which has been previously cleared under (K083820)
"The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications". The system is only for measurement, recording and display. It makes no diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
DSH
Device Description
Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder and Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorders are intended to be used as a Holter Ambulatory Electrocardiograph device for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 12 Channel or 3 Channel ECG signals.
The Recorders are intended for adults and children over the age of six years old.
The Models 1304 and 1303 are modified versions of Model 1305 which FDA granted clearance on April 1, 2009 (K083820). Model 1304 increases the number of channels and ECG signals to 12 from 3 as in the Predicate device Model 1305.
Model 1303 is a miniaturized version of Model 1305
The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied 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 who are over the age of six years.
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
14
JUN 2 8 2011
510(k) Summary
Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder. Model 1304 Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303
- April 25, 2011 1. Date Prepared:
-
- Submitter's Name: Vasomedical, Inc. and Address 180 Linden Ave. Westbury, NY 11590
-
- Contact Person: Richard Gordon Manager, Regulatory and Quality Affairs Vasomedical, Inc. Telephone: (516) 997-4600 Facsimile: (516) 997-2299 E-mail: rgordon@vasomedical.com
-
- Device Names: a) 12 - Channel Ambulatory ECG Holter Recorder, Model 1304 b) 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303
- Proprietary Names: a) Vasomedical-Biox 12 Channel Ambulatory ECG Holter Recorder. Model 1304
- b) Vasomedical-Biox 3 Channel Miniature Ambulatory ECG Holter Recorder, Model 1303
- Common Name: a) 12 - Channel Ambulatory ECG Holter Recorder, Model 1304 b) 3 - Channel Miniature Ambulatory, ECG Holter Recorder, Model 1303
Classification Name: 870.2800 Magnetic Tape Recorder, Medical
-
- Predicate Device: Vasomedical - Biox, 3 - Channel Ambulatory ECG Holter Recorder, Model 1305 was granted FDA 510(k) clearance on April 1, 2009 (K083820).
-
- Device Description: Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder and Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorders are intended to be used as a Holter Ambulatory Electrocardiograph device for the purpose of screening ECG rhythms for periods up to 72 hours. Cardiac rhythm is acquired by 12 Channel or 3 Channel ECG signals.
1
The Recorders are intended for adults and children over the age of six years old.
The Models 1304 and 1303 are modified versions of Model 1305 which FDA granted clearance on April 1, 2009 (K083820). Model 1304 increases the number of channels and ECG signals to 12 from 3 as in the Predicate device Model 1305.
Model 1303 is a miniaturized version of Model 1305
The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.
Models 1304 and 1303 specifications are listed in Table 1 below:
| Model 1504 | Model 1505 | |
|---|---|---|
| Lead | 12 | 3 |
| Electrode | 10 | 5 |
| Lead wire type | 10F/10G | 7E/5E |
| Display | LED | LCD |
| Batteries | 1 x "AA" Alkaline | 1 x "AAA" Alkaline |
| Carrying Case/ | ||
| Strap | Supplied | Supplied |
| Card Reader | Supplied | Supplied |
| Dimensions | 3.3 x 2.3 x 0.88" | 2.6 x 2.1 x 0.7" |
| Weight | 2.45 oz | 1.76 oz |
| Storage | SD Memory Card | SD Memory Card |
| Memory | ||
| Capacity | 1 GB or more | 1 GB or more |
| Sample Rate | 256 Hz/Channel | |
| 10,000 Hz | ||
| Pacemaker | ||
| Detection | 256 Hz/Channel | |
| 1,000Hz for SAECG | ||
| option | ||
| Resolution | 10 Bit | 10 Bit; 12 Bit for |
| SAECG option | ||
| Infrared | ||
| Adaptor | Supplied | Supplied |
Model 1304
Model 1303
Table 1: Model 1304 and 1303 Specifications
2
7. Intended Use:
Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, Model 1304, is a Non-Invasive device intended to acquire ambulatory 12 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals.
Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, Model 1303, is also a Non-Invasive device but intended to acquire ambulatory 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is also acquired via ECG signals.
The Holter Recorders are intended for adults and children who are over the age of six years.
The Models 1304 and 1303 work with the CB Series ECG Analysis Software which has been previously cleared under (k)083820
The system is only for measurement, recording and display. It makes no diagnosis.
Refer to Attachment I and II, Vasomedical-Biox Model 1305/1304 AECG Instruction Manual for Users and Model 1303 AECG Instruction Manual for Users, Sections 2.2, Indications for Use, 2.2.1 Intended Use and 2.2.2 for Contraindications.
8. Comparison of Technological Characteristics:
Technological and functional characteristics of the devices listed in this Special 510(k) Notification for Modification are essentially the same as those of the Predicate device. The devices listed in this 510(k) Premarket Notification is therefore substantially equivalent to the predicate device.
"The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications".
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" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vasomedical, Inc. c/o Mr. Richard E. Gordon Manager, Regulatory and Quality Affairs 180 Linden Avenue Westbury, NY 11590
JUN 2 8 2011
Re: K11180
Trade/Device Name: Vasomedical-Biox 12-Channel Ambulatory ECG Holter Recorder (Model 1304) and Vasomedical-Biox 3-Channel Miniature Ambulatory ECG Holter Recorder (Model 1303) Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: DSH Dated: June 2, 2011
Received: June 3, 2011
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 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 - Mr. Richard E. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
C. Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
April 25, 2011 '
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Indications for Use
| 510(k) Number: | k | |
|---|---|---|
| Device Names: | a) Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, | |
| Model 1304 | ||
| b) Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter | ||
| Recorder, Model 1303 | ||
| Indications for Use: | Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder, | |
| Model 1304, is a Non-Invasive device intended to acquire ambulatory | ||
| 12 - Channel ECG signals from the upper body surfaces. Cardiac Rhythm is | ||
| acquired via ECG signals. | ||
| Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder, | ||
| Model 1303, is also a Non-Invasive device intended to acquire ambulatory | ||
| 3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm is | ||
| also acquired via ECG signals. | ||
| The Holter Recorders are intended for adults and children who are over the | ||
| age of six years. | ||
| The Models 1304 and 1303 work with the CB Series ECG Analysis Software | ||
| which has been previously cleared under (K083820) | ||
| "The Intended Use of the modified devices as described in its labeling, | ||
| has not changed as a result of the modifications". | ||
| 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) | ||
| (Division Sign-Off) | ||
| Division of Cardiovascular Devices |
510(k) Number_K 111,80
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