(62 days)
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.
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 portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.
This 510(k) summary does not contain information typically found in a study or a clear set of acceptance criteria for the device performance beyond its substantial equivalence to a predicate device. The document primarily focuses on describing the device, its intended use, and comparing its technological characteristics to a previously cleared predicate device to establish substantial equivalence.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not provide a table of specific, quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity for cardiac event detection) or detailed reported device performance against such criteria. The core argument for clearance is "substantial equivalence" to a predicate device (Vasomedical-Biox, 3-Channel Ambulatory ECG Holter Recorder, Model 1305, K083820). The document states:
"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 only "performance" reported are the device specifications in Table 1, which are hardware characteristics rather than clinical performance metrics.
| Feature | Model 1304 (New Device) | Model 1303 (New Device) | Model 1305 (Predicate) |
|---|---|---|---|
| Lead | 12 | 3 | 3 |
| Electrode | 10 | 5 | 5 |
| Sample Rate | 256 Hz/Channel, 10,000 Hz Pacemaker Detection | 256 Hz/Channel, 1,000Hz for SAECG option | 256 Hz/Channel, 1,000Hz for SAECG option |
| Resolution | 10 Bit | 10 Bit; 12 Bit for SAECG option | 10 Bit; 12 Bit for SAECG option |
| Intended Use Statement | Acquire ambulatory 12-channel ECG signals. System is for measurement, recording, and display. Makes no diagnosis. | Acquire ambulatory 3-channel ECG signals. System is for measurement, recording, and display. Makes no diagnosis. | (Implied equivalent to new 3-channel device) System is for measurement, recording, and display. Makes no diagnosis. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention any specific test set, clinical study, or patient data (retrospective or prospective) used to demonstrate performance for the devices (Model 1304 and 1303). The clearance is based on technological and functional equivalence to the predicate device (Model 1305).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no specific test set or clinical study is mentioned for performance evaluation in this document, there is no information regarding experts used to establish ground truth.
4. Adjudication Method
No adjudication method is mentioned as no performance study is detailed in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. The devices (Holter recorders) are for data acquisition, recording, and display, and do not involve an AI component requiring human-in-the-loop performance evaluation in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an ECG Holter recorder, which is a physical device for signal acquisition and recording. It is not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study without a human-in-the-loop does not directly apply in the way it would for diagnostic AI software. The performance of the recording hardware is typically assessed through technical specifications and verification/validation, rather than a standalone algorithm performance study in the AI sense. The document does not detail any such performance validation study.
7. The Type of Ground Truth Used
As no specific performance study is detailed, no type of ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned. The clearance relies on substantial equivalence of the device's design and specifications, rather than a clinical performance study with established ground truth.
8. The Sample Size for the Training Set
The concept of a "training set" applies to machine learning or AI models. The devices described are hardware Holter recorders. Therefore, there is no training set applicable in this context.
9. How the Ground Truth for the Training Set was Established
Again, as these are hardware devices and not AI, there is no training set and thus no ground truth establishment for a training set.
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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
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- 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
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- Predicate Device: Vasomedical - Biox, 3 - Channel Ambulatory ECG Holter Recorder, Model 1305 was granted FDA 510(k) clearance on April 1, 2009 (K083820).
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- 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.
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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 |
| MemoryCapacity | 1 GB or more | 1 GB or more |
| Sample Rate | 256 Hz/Channel10,000 HzPacemakerDetection | 256 Hz/Channel1,000Hz for SAECGoption |
| Resolution | 10 Bit | 10 Bit; 12 Bit forSAECG option |
| InfraredAdaptor | Supplied | Supplied |
Model 1304
Model 1303
Table 1: Model 1304 and 1303 Specifications
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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".
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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" 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.
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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
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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 HolterRecorder, Model 1303 | ||
| Indications for Use: | Vasomedical-Biox 12 - Channel Ambulatory ECG Holter Recorder,Model 1304, is a Non-Invasive device intended to acquire ambulatory12 - Channel ECG signals from the upper body surfaces. Cardiac Rhythm isacquired via ECG signals. | |
| Vasomedical-Biox 3 - Channel Miniature Ambulatory ECG Holter Recorder,Model 1303, is also a Non-Invasive device intended to acquire ambulatory3 - Channel ECG signals from the upper body surfaces. Cardiac rhythm isalso acquired via ECG signals. | ||
| The Holter Recorders are intended for adults and children who are over theage of six years. | ||
| The Models 1304 and 1303 work with the CB Series ECG Analysis Softwarewhich 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 nodiagnosis. | ||
| 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 IFNEEDED) | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
| (Division Sign-Off)Division of Cardiovascular Devices |
510(k) Number_K 111,80
·
§ 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).