(112 days)
The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital care facilities, the home, workplace, and alternate care settings.
The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt).
The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion.
The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
The Equivital™ Vital Signs Physiological Monitor comprises two components:
i) A chest belt containing skin electrodes and an expansion sensor
ii) A battery powered electronics module which connects directly to the chest belt and which acts to record, digitise and transmit the physiological information wirelessly to a receiving display device.
The device offers continuous monitoring of two views of the user's heart electrical activity (ECG) and respiratory breathing frequency inferred from thoracic cavity movement and uses this data to derive a Heart Rate and a Breathing Effort Rate.
The sensor also provides the following information:
- ECG and Respiration physiological waveforms. .
- an indication of the user's activity level (none, low or high) derived from a movement . detection sensor.
- . Body orientation.
- Chest skin surface temperature. .
- alternate secondary measurement of heart rate based on the detection of the user's R . wave using a separate hardware processing function.
- indications and alerts if physiology exceeds predefined boundaries. .
The device offers two variants for the wireless interface: a low power radio interface designed for military applications and a general purpose interface using Bluetooth™ technology.
The device offers two battery power options for the user, rechargeable or primary disposable cells.
The wireless data provided by the sensor may be viewed using a standalone PC based viewing application, or integrated into third party monitoring applications.
The provided text describes the Equivital™ Vital Signs Physiological Monitor and its 510(k) summary. However, it does not contain specific acceptance criteria, detailed study designs, or performance results in the format requested. The document lists the standards against which the device was evaluated but does not present the actual results or how those results met specific criteria.
Therefore, I cannot populate the table or provide detailed answers to many of the questions based solely on the provided text. I will indicate what information is available and what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Heart Rate Performance | Not specified in document | Not specified in document |
| Breathing Rate Performance | Not specified in document | Not specified in document |
| Temperature Performance | Not specified in document | Not specified in document |
| General Physical Properties Performance | Not specified in document | Not specified in document |
| Chest Expansion Respiration Performance | Not specified in document | Not specified in document |
| Activity/Motion Detection Performance | Not specified in document | Not specified in document |
| Bluetooth Telemetry Performance | Not specified in document | Not specified in document |
| Low Power 40.68MHz PAN Performance | Not specified in document | Not specified in document |
| Electrical Safety (EN60601-1) | Compliance with standard | "successfully demonstrated" |
| EMC (IEC60601-1-2) | Compliance with standard | "successfully demonstrated" |
| Biocompatibility (ISO 10993-1) | Compliance with standard | "successfully demonstrated" |
| Cardiac Monitor Standards (ANSI/AAMI EC13) | Compliance with applicable sections (not defibrillation/pacemaker immunity) | "successfully demonstrated" |
| Intermittent Temp. Spec. (ASTM E 112-00) | Compliance with standard | "successfully demonstrated" |
| General Functional Test | Not specified in document | "undertaken" |
| Environmental Performance Test | Not specified in document | "undertaken" |
| Software Lifecycle (EN60601-1-4) | Compliance with standard | "meets the requirements" |
Study that Proves the Device Meets the Acceptance Criteria:
The document states that "Performance measurement and review to the applicable sections of the following standards has been undertaken and successfully demonstrated as recommended by available guidance from the agency." This implies a series of verification and validation tests were conducted to ensure compliance with the listed standards (EN60601-1, IEC60601-1-2, ISO 10993-1, ANSI/AAMI EC13, ASTM E 112-00, and EN60601-1-4 for software). Additionally, "Additional voluntary testing has been undertaken to the following: General functional test, Environmental Performance Test."
However, none of the specific study results or methodologies for these tests are described in the provided text. The document acts as a summary for a 510(k) submission, confirming that such testing occurred and was successful, rather than detailing the studies themselves.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any test set.
- Data Provenance: Not specified. The manufacturer is based in the United Kingdom, but the origin of any test data is not mentioned within the summary.
- Retrospective or Prospective: Not specified.
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)
- Not specified. The document does not describe the use of human experts for ground truth establishment for performance testing. Performance is noted to be measured against standards, implying instrument-based or standardized reference methods rather than expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. The document does not describe a scenario requiring expert adjudication or consensus for ground truth on a test set.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a "Vital Signs Physiological Monitor" and does not involve AI assistance for human readers/clinicians, but rather directly measures physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device itself is a standalone monitor, meaning its core function is to collect, digitize, and transmit physiological information. The performance measured would inherently be the algorithm/device only for parameters like heart rate, breathing rate, and temperature. The document states "Performance measurement and review to the applicable sections of the following standards has been undertaken and successfully demonstrated," suggesting performance evaluations of the device's output against established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The implicit ground truth is likely reference measurements from established, validated medical devices or standardized calibration methods as per the requirements of the listed performance standards (e.g., ANSI/AAMI EC13 for cardiac monitors, ASTM E 112-00 for temperature). The document does not mention expert consensus, pathology, or outcomes data as ground truth.
8. The sample size for the training set
- Not applicable/Not specified. The document does not provide information about a "training set" as it describes a hardware physiological monitor, not typically a machine learning or AI-driven diagnostic device that undergoes explicit training on a dataset in the way a software algorithm might.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as no training set is mentioned for this device.
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Image /page/0/Picture/0 description: The image shows the word "hidalgo" followed by four filled circles. Below the circles, there is handwritten text that reads "K061993" and "P 1/4". The text appears to be a label or identifier associated with the image.
510(k) Summary
Submitter
NOV - S 2006
: :
Hidalgo Ltd Stable Block at the Grange 20 Market St Cambridge CB4 5QG United Kingdom
Contact: J.Pisani - Operations Director Tel: +441954233430
Manufacturer
Hidalgo Ltd Stable Block at the Grange 20 Market St Cambridge CB4 5QG United Kingdom
Hidalgo propose to register as the manufacturer of the device in accordance with 21CFR Part 807.
Name of Device
Equivital™ Vital Signs Physiological Monitor Device Trade Name:
Device Common Name: Ambulatory Patient Monitor
Device Classification and Product Code:
| 74 DRT | 870.2300 - Monitor, Cardiac (incl Cardiotachometer & rate alarm) |
|---|---|
| 74DPS | 870.2340 - Electrocardiograph |
| 73BZQ | 868.2375 - Monitor, Breathing Frequency |
| 80FLL | 880.2910 - Thermometer, Electronic, Clinical |
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Image /page/1/Picture/0 description: The image shows the word "hidalgo" followed by five filled circles. Below the circles, there is handwritten text that reads "K061993 p2/4". The text appears to be a label or identifier for the image.
Predicate Devices
| GMP Wireless Medicine | LifeSync™ | - K030795 |
|---|---|---|
| Dymedix Inc | Re-usable Respiratory Effort Belt Sensor | - K040605 |
| Nexan Inc | NX-300 | - K003520 |
| Protocol Systems | Propaq Encore 200 | - K012451 |
| Respironics | Actiheart® | - K052489 |
| Vivometrics | Life Shirt™ Real Time | -K043604 |
The device has been compared to the following predicates:
Device Description
The Equivital™ Vital Signs Physiological Monitor comprises two components:
i) A chest belt containing skin electrodes and an expansion sensor
ii) A battery powered electronics module which connects directly to the chest belt and which acts to record, digitise and transmit the physiological information wirelessly to a receiving display device.
The device offers continuous monitoring of two views of the user's heart electrical activity (ECG) and respiratory breathing frequency inferred from thoracic cavity movement and uses this data to derive a Heart Rate and a Breathing Effort Rate.
The sensor also provides the following information:
- ECG and Respiration physiological waveforms. .
- an indication of the user's activity level (none, low or high) derived from a movement . detection sensor.
- . Body orientation.
- Chest skin surface temperature. .
- alternate secondary measurement of heart rate based on the detection of the user's R . wave using a separate hardware processing function.
- indications and alerts if physiology exceeds predefined boundaries. .
The device offers two variants for the wireless interface: a low power radio interface designed for military applications and a general purpose interface using Bluetooth™ technology.
The device offers two battery power options for the user, rechargeable or primary disposable cells.
The wireless data provided by the sensor may be viewed using a standalone PC based viewing application, or integrated into third party monitoring applications.
Intended Use Summary
The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital care facilities, the home, workplace, and alternate care settings.
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The device consists of a chest belt hamess and a body wom electronics module (SEM) supported by the chest belt).
The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion.
The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
hidalo
Technological Characteristics
Substantial equivalence has been measured by the technological review and comparison of performance data for the following.
| Function | Predicate 1 | Additional Predicates |
|---|---|---|
| ECG Heart Rate,Breathing RateTemperature andGeneral PhysicalProperties | Protocol Systems PropaqEncore 200K003520 | Nexan Inc NX-300K003520 |
| Chest ExpansionRespiration | DymedixRe-usable RespiratoryEffort Belt - K040605 | Nexan Inc NX-300K003520Vivometrics LifeShirtReal TimeK043604 |
| Activity/MotionDetection | RespironicsActiheart - K052489 | Vivometrics LifeShirtReal TimeK043604 |
| Bluetooth telemetryand ECG transmission | GMP Wireless Medicine -LifeSyncTM K030795 | |
| Low Power 40.68MHzPAN | RespironicsActiheart - K052489 |
The device technological characteristics compare to the following predicates:
Performance Measurement Summary
Performance measurement and review to the applicable sections of the following standards has been undertaken and successfully demonstrated as recommended by available guidrance from the agency:
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Image /page/3/Picture/0 description: The image shows the word "hidalgo" followed by four solid black circles. Below the circles, there is handwritten text that reads "K061993" and "P 4/4". The text is in black ink and appears to be a label or identifier for the image.
- EN60601-1: Medical Electrical Equipment -- Part 1 General Requirements for Safety. .
- IEC60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: . Electromagnetic Compatibility.
- ISO 10993-1: Biological Evaluation of Medical Devices: Evaluation and Testing. .
- ANSI/AAMI EC13: 2002 Cardiac Monitors, heart rate meters, and alarms. The device was . not evaluated against the criteria for defibrillation and pacemaker immunity as it is not indicated for use in either of these cases.
- ASTM E 1 12-00 Standard Specification for intermittent determination of patient . temperature.
Additional voluntary testing has been undertaken to the following:
- . General functional test.
- Environmental Performance Test. .
The device software has been developed using a structured software lifecycle which meets the requirements of EN60601-1-4 Programmable Systems, which also applies to ongoing maintenance of the software.
Substantial Equivalence Conclusion
This pre-market notification has demonstrated the substantial equivalence of the Equivital™ Vital Signs Physiological Monitor to the predicates identified, by comparison to the describition material and performance testing of the device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Hidalgo Limited c/o Mr. Justin Pisani Operations Director 20 Market Street Cambridge, CB4 5QG United Kingdom
Re: K061993
Equivital Vital Signs Physiological Monitor Regulation Number: 21 CFR 870 1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: September 29, 2006 Received: October 5, 2006
Dear Mr. Pisani:
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 max publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Justin Pisani
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that vour 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B.Bimmofor for
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 (if known): K061993
Device Name: Equivital™ Vital Signs Physiological Monitor
Indications For Use:
The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs The Equivilal™ Vital Signs Friyslological Rions and and States (16 - 65years) in hospital care facilities, the home, workplace and alternate care settings.
The device consists of a chest belt hamess and a body worn electronics module (SEM) supported by the chest belt.
The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion.
The monitor is indicated for use as a general patient monitor, to provide physiological The monitor is inalcated for ose as a general patient maniforing system, and for general research and performance measurement purposes.
Federal Law (US) restricts this device to sale by or on the order of a physician
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B/Bummerman
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K011993
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.