(65 days)
Vasomedical-Biox Model 2302 Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder is a Non-Invasive device intended to acquire Ambulatory 12 Channel ECG signals and non- invasive oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals.
Vasomedical-Biox Model 1804 Ambulatory BP Recorder is a non- invasive device intended to acquire ambulatory non-invasive oscillometric Blood Pressure signals from the upper body surfaces.
The Recorders are intended for adults and children who are over the age of six years.
The Models 2302 and 1804 work with the CB Series ECG and ABP Analysis Software which has been previously cleared under (k)092785
“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 Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 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 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 12 Channel ECG signals. The Recorders are intended for adults and children over the age of six years old.
The Model 2302 Recorder is a modified version of Model 2301 which FDA granted clearance on April 2, 2010 (K092785), with 3-Channel ECG replaced by 12-Channel ECG.
Vasomedical-Biox Ambulatory Blood Pressure Recorder Model 1804 is intended to be used as a non-invasive ABP Monitor for the purpose of recording blood pressure measurements also for a period of 24 hours. The Recorders are intended for adults and children over the age of six years old.
The Model 1804 Ambulatory Blood Pressure Recorder is a modified version of Model 2301. Model 2301 records both ECG and BP signals and Model 1804 is a Blood Pressure only Recorder.
The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.
The provided text is a 510(k) summary for the Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 and Ambulatory Blood Pressure Monitor (ABPM) Model 1804.
Based on the information provided, this submission primarily focuses on technical modifications (specifically increasing ECG channels from 3 to 12) and establishing substantial equivalence to a previously cleared predicate device (Vasomedical - Biox, 3 Channel Ambulatory ECG and Blood Pressure Recorder 2301, K092785).
The document does NOT contain a study or acceptance criteria in the typical sense of a clinical performance evaluation against specific metrics like sensitivity, specificity, or accuracy for diagnostic capability. This is because the device, as stated, "makes no diagnosis" and its intended use is for "measurement, recording and display" of ECG and blood pressure signals.
Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies, which are not detailed in this 510(k) summary for this device. The summary emphasizes technological equivalence rather than new clinical performance data.
However, I can extract the relevant information that is present and indicate where information is not available based on the provided text.
Acceptance Criteria and Device Performance Study
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) for diagnostic capabilities, nor does it report specific clinical performance results against such criteria. The focus is on demonstrating that the modified devices (Model 2302 and 1804) are substantially equivalent to the predicate device (Model 2301) in their technological and functional characteristics, and that "The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications."
The "performance" documented here is primarily related to the device's technical specifications and intended function as a recorder, rather than a diagnostic tool.
| Acceptance Criteria (Implied from Substantial Equiv.) | Reported Device Performance (from specifications) |
|---|---|
| Function as a 12-Channel Ambulatory ECG recorder | 12-Lead ECG acquisition |
| Function as a Non-invasive Ambulatory Blood Pressure Monitor | Oscillometric BP measurement |
| Acquisition of ECG and BP signals from upper body surfaces | Device intended for upper body measurements |
| Intended for adults and children over six years old | Recorders intended for adults and children over six years old |
| Measurement, recording, and display only | System is only for measurement, recording and display. It makes no diagnosis. |
| Compliance with predicate device's measurement and recording function for BP signals | Model 1804 (BP only) functions exactly the same as Model 2301/2302 for measurement and recording of Blood Pressure signals. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not describe a specific "test set" for performance evaluation in a clinical study. Substantial equivalence is asserted based on technological and functional characteristics, not new clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. No ground truth establishment by experts is described as part of this submission, as it focuses on technological equivalence rather than clinical diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary. No adjudication method is described.
5. 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
This information is not applicable / not provided. The device is an ECG and Blood Pressure recorder, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable / not provided. The device is a hardware recorder. While it works with "CB Series ECG and ABP Analysis Software," the submission explicitly states the system "makes no diagnosis" and the software was previously cleared (K092785). The current submission does not describe a standalone algorithm performance study for diagnostic purposes beyond the recording functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. As no clinical performance study against a diagnostic ground truth is described, no ground truth type is mentioned. The ground truth for technical specifications would be engineering measurements and standards.
8. The sample size for the training set
This information is not applicable / not provided. The device is a recorder, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
This information is not applicable / not provided. (See #8)
{0}------------------------------------------------
K111096
Page 1 of 4
510(k) Summary
JUN 2 4 2011
Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder Model 2302 and Ambulatory Blood Pressure Monitor (ABPM) Model 1804
| 1. | Date Prepared: | April 18, 2011 |
|---|---|---|
| 2. | Submitter's Name:and Address | Vasomedical, Inc.180 Linden Ave.Westbury, NY 11590 |
| 3. | Contact Person: | Richard GordonManager, Regulatory and Quality AffairsVasomedical, Inc.Telephone: (516) 997-4600Facsimile: (516) 997-2299E-mail: rgordon@vasomedical.com |
| 4. | Device Names: | a) Combined 12 Channel Ambulatory ECG and Blood PressureRecorder, Model 2302b) Ambulatory Blood Pressure Monitor (ABPM), Model 1804 |
| Proprietary Names: | a) Vasomedical-Biox Combined 12 Channel Ambulatory ECG andBlood Pressure Recorder Model 2302b) Vasomedical-Biox Ambulatory Blood Pressure Recorder (ABPM)Model 1804 | |
| Common Name: | a) Combined 12 Channel Ambulatory ECG and Blood PressureRecorder Model 2302b) Ambulatory Blood Pressure Monitor (ABPM) System Model 1804 | |
| Classification Name: | 870.2800 Medical Magnetic Tape Recorder870.1130 Noninvasive Blood Pressure Measurement System | |
| 5. | Predicate Device: | Vasomedical - Biox, 3 Channel Ambulatory ECG and Blood PressureRecorder 2301 was granted FDA 510(k) clearance on April 2, 2010(K092785). |
| 6. | Device Description: | Vasomedical-Biox Combined 12 Channel Ambulatory ECG and BloodPressure Recorder Model 2302 is intended to be used as a combinedHolter Ambulatory Electrocardiograph device and a non-invasiveAmbulatory Blood Pressure Monitor for the purpose of screening ECGrhythms and blood pressure measurements for periods to 24 hours. |
{1}------------------------------------------------
Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. Cardiac rhythm is acquired by 12 Channel ECG signals. The Recorders are intended for adults and children over the age of six years old.
The Model 2302 Recorder is a modified version of Model 2301 which FDA granted clearance on April 2, 2010 (K092785), with 3-Channel ECG replaced by 12-Channel ECG.
Vasomedical-Biox Ambulatory Blood Pressure Recorder Model 1804 is intended to be used as a non-invasive ABP Monitor for the purpose of recording blood pressure measurements also for a period of 24 hours. The Recorders are intended for adults and children over the age of six years old.
The Model 1804 Ambulatory Blood Pressure Recorder is a modified version of Model 2301. Model 2301 records both ECG and BP signals and Model 1804 is a Blood Pressure only Recorder.
The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a supplied Carrying Case and Strap.
Models 2302 and 1804 specifications are listed in Table 1 below:
| Lead | 12 | NA |
|---|---|---|
| Electrode | 10 | NA |
| Lead wire type | 10 | NA |
| Display | LCD | LCD |
| Batteries | 4 x AA Alkaline | 4 x AA Alkaline |
| BP Cuff | Medium (standard)(Small and Largeare optional) | Medium (standard)(Small and Largeare optional) |
| Carrying Case/Strap | Supplied | Supplied |
| Card Reader | Supplied | Supplied |
Model 2302
Model 1804
{2}------------------------------------------------
| Model 2302 | Model 1804 | |
|---|---|---|
| Dimensions | 4.88 x 2.68 x 1.22" | 4.88 x 2.68 x 1.22" |
| Weight | 6.35 oz. | 6.34 oz. |
| Storage | SD Memory Card | SD Memory Card |
| MemoryCapacity | 1 GB or more | 1 GB or more |
| Sample Rate | Max. 10000 Hz256 Hz/Channel2048 Hz PacemakerDetection | Max. 10000 Hz256 Hz/Channel2048 Hz PacemakerDetection |
| Resolution | 12 Bits | 12 Bits |
| InfraredAdaptor | Supplied | Supplied |
Table 1: Model 2302 and 1804 Specifications
7. Intended Use:
Vasomedical-Biox Combined 12 Channel Ambulatory ECG and Blood Pressure Recorder, Model 2302, is a Non-Invasive device intended to acquire Ambulatory 12 Channel ECG signals and non- invasive oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via ECG signals.
Vasomedical-Biox Model 1804 Ambulatory BP Recorder is a noninvasive device intended to acquire ambulatory non-invasive oscillometric Blood Pressure signals from the upper body surfaces. This ABP Recorder functions exactly the same as Model 2301/2302 for measurement and recording of Blood Pressure signals.
The Recorders are intended for adults and children who are over the age of six years.
The system is only for measurement, recording and display. It makes no diagnosis.
Refer to Attachments I and II, Vasomedical-Biox Model 2301/2302 AECGBP and Model 1804 ABPM Instruction Manual for Users, Sections 2.2, Indications for Use, 2.2.1 Intended Use and 2.2.2 for
{3}------------------------------------------------
April 18, 2011
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 device 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".
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 10903 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: 4 2011
Re: K11096
Trade/Device Name: Vasomedical-Biox Combined 12-Channel Ambulatory ECG and Blood Pressure Recorder (Model 2302) with CB Series ECG and ABP Analysis Software and Vasomedical-Biox Ambulatory Blood Pressure Monitor (ABPM) (Model 1804)
Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: DSH, DXN Dated: May 25, 2011 Received: May 26, 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, Jrug, 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, l'isting 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
{5}------------------------------------------------
Page 2 - Mr. Richard E. Gordon
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. 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/ucm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
| 510(k) Number: | k | |
|---|---|---|
| Device Names: | a) Vasomedical-Biox Combined 12 Channel Ambulatory ECGAnd Blood Pressure Recorder, Model 2302 with CB SeriesECG and ABP Analysis Softwareb) Vasomedical-Biox Ambulatory Blood Pressure Monitor(ABPM), Model 1804 | |
| Indications for Use: | Vasomedical-Biox Model 2302 Combined 12 Channel AmbulatoryECG and Blood Pressure Recorder is a Non-Invasive device intendedto acquire Ambulatory 12 Channel ECG signals and non- invasiveoscillometric Blood Pressure signals from the upper body surfaces.Cardiac rhythm is acquired via ECG signals.Vasomedical-Biox Model 1804 Ambulatory BP Recorder is a non-invasive device intended to acquire ambulatory non-invasiveoscillometric Blood Pressure signals from the upper body surfaces.The Recorders are intended for adults and children who are over the ageof six years.The Models 2302 and 1804 work with the CB Series ECG and ABPAnalysis Software which has been previously cleared under (k)092785“The Intended Use of the modified devices as described in itslabeling, has not changed as a result of the modifications”.The system is only for measurement, recording and display. Itmakes 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 IFNEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K11056
§ 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).