(149 days)
The HealthGuard-15 is a non-invasive screening device intended for use in corporate wellness facilities and in health/fitness clubs. It is not for use in medical facilities such as hospitals or doctor's offices. This device measures systolic and diastolic blood pressure, heart rate, percent body fat and weight. It is operated by the client supplied PC computer. The device is intended for users eighteen years and older.
The HealthGuard-15 is a portable health kiosk that provides a means for measuring and tracking an individual's systolic and diastolic blood pressure, heart rate, percent body fat and weight. The HG-15 integrates two FDA market cleared devices ---- the Omron HEM-7200-Z [BP742] (K121932) for measurement of blood pressure and heart rate, and the FUTREX-6100/XL (K963271) for the estimation of the percent body fat --into a health kiosk with similar performance as the Health Check Kiosk (K063008). The HG-15 kiosk can typically be installed in corporate offices, lunch rooms or other community places so that employees can be measured as part of a corporate wellness program to track changes over time. It is not for use in hospitals or in other health care facilities. The HG-15 is delivered without the necessary PC computer. The client supplies the computer and Futrex supplies not only the HealthGuard-15 "kiosk" but also supplies the software that will be driven by the client's computer. In addition to making the measurements, the HealthGuard-15 also provides the recognized norms for systolic and diastolic blood pressure and weight. It provides a direct comparison of the user's measurements to these established norms, thereby providing education and motivation to the user. The computer/s monitor also warns the user not to start any exercise or diet program without first discussing it with their healthcare professional.
This document is a 510(k) Summary for the HealthGuard-15 device, which is a non-invasive screening device measuring blood pressure, heart rate, percent body fat, and weight. The information below is extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets but are based on achieving "substantially equivalent" performance to the predicate devices. The reported device performance is compared to these predicate devices.
| Measurement / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood Pressure | Substantially equivalent to Omron HEM-7200-Z (K121932) | Identical measurement range (0-299 mmHg), pulse rate (40-180 bpm), accuracy (+/-3 mmHg or 2% of reading), pulse rate accuracy (+/-5%), inflation/deflation method, and operating/storage conditions. Minor modifications (plastic exterior removed, start button replaced by computer command, cuff fabric) were shown not to affect accuracy or precision. |
| Percent Body Fat | Substantially equivalent to FUTREX-6100/XL (K963271) | Identical product code, patient population, environment of use, prescriptive use, patient connection, technology (Near-IR), prime wavelength, measurement time, limitations, data provided to user, measurement range (2-45%), accuracy (equal to hydrostatic weighing), precision (0.3%), and operating/storage conditions. Minor modifications (measurement site on triceps instead of biceps, on left arm instead of dominant arm, start button replaced by computer command) were shown not to affect accuracy or precision. |
| Weight | Substantially equivalent to Health Check Kiosk (K063008) | The HealthGuard-15 includes weight measurement, similar to the predicate kiosk. Specific performance metrics for weight are not detailed but are implied to be equivalent. |
| Heart Rate | Substantially equivalent to Omron HEM-7200-Z (K121932) | Identical pulse rate range and accuracy as the predicate blood pressure device. |
| Overall Multi-measurement Kiosk | Substantially equivalent to Health Check Kiosk (K063008) | Similar indications for use, intended population, hardware design (PC controlled, stop button), software design (automatic, oscillometric method, interactive screens), materials, cleaning materials, and components. |
| Safety and EMC | Satisfy EMC and safety requirements for medical electrical equipment | Met IEC 60601-1-2 (EMC) and IEC 60601-2, IEC 60601-1, and ANSI/AAMI SP10 (Safety). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" with a defined sample size for directly evaluating the HealthGuard-15's performance against ground truth in a clinical setting. Instead, the study relies on bench performance tests to demonstrate that modifications to integrated predicate devices (Omron Hem-7200-Z and FUTREX-6100/XL) did not affect their established accuracy or precision.
- Sample Size: Not explicitly stated for specific measurements or a general test set. The evaluation focuses on bench testing of the integrated components rather than a new clinical study with a patient cohort.
- Data Provenance: The study does not mention country of origin or whether it was retrospective or prospective, as it primarily involves bench testing of components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The study primarily uses bench performance tests and comparison to established predicate device specifications, not a ground truth established by medical experts for a new clinical test set. The predicate devices themselves would have undergone such validation during their original clearance.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "screening device" that provides direct measurements (blood pressure, heart rate, body fat, weight) and does not involve human readers interpreting output that would then be compared to AI-assisted human reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is essentially a standalone system for taking measurements. There is no explicit mention of an "algorithm only" study in the context of comparative performance against a human or a gold standard separate from the integrated predicate devices. The device's performance is demonstrated by its components (Omron BP742 for BP/HR and FUTREX-6100/XL for body fat) which are themselves standalone measurement instruments integrated into the kiosk.
7. The Type of Ground Truth Used
The "ground truth" for the HealthGuard-15's performance is established by:
- Predicate Device Specifications: The primary method is to demonstrate that the HealthGuard-15 (or its modified internal components) maintains the accuracy and precision reported for the original, legally marketed predicate devices (Omron HEM-7200-Z for blood pressure/heart rate, FUTREX-6100/XL for percent body fat).
- Established Methods: For percent body fat, the accuracy is stated as "Equal to official method of hydrostatic weighing," which serves as a commonly accepted gold standard for body composition.
- Bench Performance Tests: These tests confirmed that minor physical and software modifications to the integrated predicate devices did not diminish their original accuracy or precision.
8. The Sample Size for the Training Set
The document does not describe a separate "training set" for the HealthGuard-15. The device integrates pre-existing, FDA-cleared technologies (Omron HEM-7200-Z and FUTREX-6100/XL). These predicate devices would have had their own validation studies and, if they included machine learning components, their own training sets, but details for these are not provided for the HealthGuard-15's submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no described training set for the HealthGuard-15 itself in this summary. Any training data for the internal components would have been part of their original development and clearance, and is not detailed here.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is formed by three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 27, 2015
Futrex, Inc. Ms. Carole Rosenthal, President 130 Western Maryland Parkway Hagerstown. MD 21740
Re: K143108
Trade/Device Name: HealthGuard-15 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN, MNW Dated: February 11, 2015 Received: February 18, 2015
Dear Ms. Rosenthal:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
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Page 2 - Ms. Carole Rosenthal
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,
theory, years,
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
K143108 510(k) Number (if known):
Device Name: HealthGuard-15
Indications For Use:
The HealthGuard-15 is a non-invasive screening device intended for use in corporate wellness facilities and in health/fitness clubs. It is not for use in medical facilities such as hospitals or doctor's offices. This device measures systolic and diastolic blood pressure, heart rate, percent body fat and weight. It is operated by the client supplied PC computer. The device is intended for users eighteen years and older.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Page 1 of 1
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510(k) Summarv
(Per 21 CFR 807.92)
I. Applicant
Futrex, Inc. 130 Western Maryland Parkway Hagerstown, Maryland 21740 USA
Contact: Carole Rosenthal, President Tel: 240-242-3980 Fax: 240-242-4038 E-mail: info@futrex.com or: carolerosenthal(@aol.com
II. Date Preparation
This 510(k) Summary was prepared on October 27, 2014
III. Medical Device
Trade Name: HealthGuard-15 Common Name: Non-invasive Blood Pressure and Body Composition Measurement System Classification Number: 21 CFR 870.1130 Classification: Class II Panel: Circulatory System Device Panel Product Code: DXN (for Blood Pressure) MNW (for Body Composition Analysis)
IV. Predicate Devices
- (1) Health Check Kiosk -- (K063008)
- (2) Omron HEM-7200-Z (BP742) -- (K121932)
- (3) FUTREX-6100/XL -- (K963271)
V. Intended Use of the Device
The HealthGuard-15 ("HG-15") is a non-invasive screening device intended for use in corporate wellness facilities and in health/fitness clubs.
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It is not for use in medical facilities such as hospitals or doctors' offices. This device measures systolic and diastolic blood pressure, heart rate, percent body fat and weight. It is operated by the client supplied PC computer. The device is intended for users eighteen years and older.
VI. Description of the Device
The HealthGuard-15 is a portable health kiosk that provides a means for measuring and tracking an individual's systolic and diastolic blood pressure, heart rate, percent body fat and weight. The HG-15 integrates two FDA market cleared devices ---- the Omron HEM-7200-Z [BP742] (K121932) for measurement of blood pressure and heart rate, and the FUTREX-6100/XL (K963271) for the estimation of the percent body fat --into a health kiosk with similar performance as the Health Check Kiosk (K063008).
The HG-15 kiosk can typically be installed in corporate offices, lunch rooms or other community places so that employees can be measured as part of a corporate wellness program to track changes over time. It is not for use in hospitals or in other health care facilities.
The HG-15 is delivered without the necessary PC computer. The client supplies the computer and Futrex supplies not only the HealthGuard-15 "kiosk" but also supplies the software that will be driven by the client's computer.
In addition to making the measurements, the HealthGuard-15 also provides the recognized norms for systolic and diastolic blood pressure and weight. It provides a direct comparison of the user's measurements to these established norms, thereby providing education and motivation to the user. The computer/s monitor also warns the user not to start any exercise or diet program without first discussing it with their healthcare professional.
VII. Technical Considerations
The HealthGuard-15 measures systolic and diastolic blood pressure using the standard oscillometric measurement method. The device includes a unique patented cuff mechanism suitable upper arm measurements of arm circumferences 9" to 13". When the arm is inserted in the cuff, the cuff automatically wraps around the arm similar to the way it is done in a doctor's office. The cuff is then inflated before it is gradually deflated through a series of controlled deflation steps in accordance with specification. The blood pressure measurement is controlled by the client's
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computer using the Futrex supplied software. The only exception to this software control is the hardware "ABORT" red pushbutton that has override authority.
VIII. Substantial Equivalence
The HealthGuard-15 is substantially equivalent to these predicate devices:
- As a multi-measurement kiosk: The Health Check Kiosk . (K063008)
- For blood pressure measurements: The Omron HEM-7200-Z . (BP742) (K121932)
- . For body fat measurements: the FUTREX-6100/XL (K963271)
Tables comparing various aspects of the HealthGuard-15 to its predicate devices start on the next page:
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| Predicate Device | HealthGuard Device | ||
|---|---|---|---|
| Xperex, Inc. Health CheckKiosk (K063008) | Model-15 | Comment | |
| Indications for Use | The Health Check is intendedto be used by the generalpublic so that a user canmeasure health parameterssuch as weight, body fat ,blood pressure and pulse ratein public places and/orcorporate environments. It isnot for diagnostic use. | The HealthGuard-15 is anon-invasive screeningdevice intended for use incorporate wellnessfacilities and inhealth/fitness clubs. It isnot for use in medicalfacilities such as hospitalsor doctors' offices. Thisdevice measures systolicand diastolic bloodpressure, heart rate,percent body fat andweight. It is operated bythe client supplied PCcomputer. The device isintended for userseighteen years and older. | Similar |
| Intended Population | General Public | Health/Fitness Clubs | Similar |
| Hardware Design | Xperex Health Check Kioskuses a built-in computer tocontrol blood pressure, pulserate and percent body fatmeasurements. A STOPpushbutton cancels the bloodpressure measurement. | HealthGuard uses the PCcomputer to control thedevice. A STOP pushbutton cancels the bloodpressure measurement. | Similar |
| Software Design | Xperex Health Check Kioskuses software as an automatedsystem for measuring bloodpressure and pulse rate. It iscompletely automatic, andmeasures blood pressure bythe oscillometric method. Theuser is guided by a series ofinteractive screens and voiceinstructions. | The HealthGuard-15software controls allmeasurements that thedevice makes. It iscompletely automatic andmeasures blood pressureusing the oscillometricmethod. The user isguided by a series ofinteractive screens. | Similar |
| Materials | Latex free polyester thread forcuff. (The rest of theirmaterials are unknown.) | Metal housing, ABSplastic, Nylon materialused in cuff cover, andlatex free thread in cuffcover. | Similar |
| Cleaning Materials | Non-sterile; cleaning anddisinfecting instructions areprovided. | Non-sterile; cleaning anddisinfecting instructionsare provided. | Identical |
| ElectromagneticCompatibility | Unknown | Meets IEC 60601-1-2 | - |
| Components | Blood Pressure, Body Fat, Pulse Rate and Weight | Blood Pressure, Body Fat, Pulse Rate and Weight | Identical |
| Blood Pressure | Oscillometric method. The user is guided by a series of interactive screens and voice instructions. | Oscillometric method. The user is guided by a series of interactive screens. | Similar |
| Body Fat Technology | Near-IR | Near-IR | Identical |
| User Interaction | Interactive screens and voice instructions | Interactive screens | Similar |
| Omron Hem-7200-Z | HealthGuard-15 | Comment | |
| [BP742] | |||
| (K121932) | |||
| Indications for Use | The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult patient population.The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal with readings. | The HealthGuard-15 is anon-invasive screeningdevice intended for use incorporate wellnessfacilities and inhealth/fitness clubs. It isnot for use in medicalfacilities such as hospitalsor doctors' offices. Thisdevice measures systolicand diastolic bloodpressure, heart rate,percent body fat andweight. It is operated bythe client supplied PCcomputer. The device isintended for userseighteen years and older. | Similar |
| Patient Population | Adult | Adult | Identical |
| Environment of Use | Home | Health & fitness centers | Similar |
| Prescriptive | OTC | OTC | Identical |
| Patient Connection | Yes via cuff | Yes via cuff | Identical |
| Technology | Oscillometric | Oscillometric | Identical |
| Measurement range | Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm | Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm | Identical |
| Accuracy or pressureindicator | +/-3 mmHg or 2% of reading | +/-3 mmHg or 2% ofreading | Identical |
| Accuracy Pulse Rate | +/-5% | +/-5% | Identical |
| Inflation Method | DC rolling pump | DC rolling pump | Identical |
| Deflation Method | Dynamic linear deflation | Dynamic linear deflation | Identical |
| Display Type | Graphical | Graphical | Similar |
| Auscultatory | No | No | Identical |
| Power Source | AA battery or AC adapter | Rechargeable Battery | Similar |
| Operating Conditions | Temperature: 10° to 40° CHumidity: 15 to 90% RH | Temperature: 10° to 40°CHumidity: 15 to 90% RH | Identical |
| Storage Conditions | Temperature: -20° to 60° CHumidity 10 to 95% RH | Temperature: -20° to 60°CHumidity 10 to 95% RH | Identical |
Table 5.1 - Comparing the HealthGuard Device to the Predicate Kiosk Device
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Table 5.1 (Continued)
Measurement of Blood Pressure – The predicate blood pressure measurement device is the Omron HEM-7200-Z [BP742] (K121932) - - - hereinafter called the "Omron BP742." The HealthGuard-15's blood pressure measurement is accomplished by building the Omron BP742 into the HG-15. The only modifications made to the built-in BP742 are:
- The plastic exterior covers are removed.
- The pushbutton that starts the measurement has been replaced by a computer command signal.
- . The inflation bladder's cloth cover was replaced with a more durable Nylon cloth cover.
Comprehensive bench performance tests were performed that proved that these minor changes did not affect the accuracy or precision of the systolic and diastolic blood pressure measurements and the heart rate measurement.
Table 5.2 compares the specifications of the predicate Omron BP742 with the device as installed in the HealthGuard-15.
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Measurement of Percent Body Fat – The predicate body fat measurement device is the FUTREX-6100/XL (K963271). The HealthGuard-15's percent body fat measurement is accomplished by building the FUTREX-6100/XL into the HG-15. The only modifications made to the FUTREX-6100/XL are:
- . The measurement site is on the triceps area at a fixed distance from the elbow instead of at the center of the biceps.
- . Measurement is always on the left arm instead of always being done on the dominant arm.
- . The pushbutton that starts the measurement has been replaced by a computer command signal.
Comprehensive bench performance tests were performed that proved these changes did not affect the accuracy or precision of the percent body fat measurements.
Table 5.3 compares the specifications of the unmodified predicate FUTREX-6100/XL with the device as installed in the HealthGuard-15.
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| Predicate DeviceFUTREX-6100/XL(K9632710 | HealthGuard-15 | Comment | |
|---|---|---|---|
| Indications for Use | The FUTREX-6100/XL is tobe used to estimate thepercent body fat in adulthumans between the ages of18-85. It has not beenvalidated for subjects usingdiuretics or estrogenreplacement therapy. | The HealthGuard-15 is anon-invasive screeningdevice intended for use incorporate wellness facilitiesand in health/fitness clubs.It is not for use in medicalfacilities such as hospitalsor doctors' offices. Thisdevice measures systolicand diastolic bloodpressure, heart rate, percentbody fat and weight. It isoperated by the clientsupplied PC computer. Thedevice is intended for userseighteen years and older. | Similar. |
| Product Code | MNW | MNW | Identical |
| Patient Population | Adults | Adults | Identical |
| Environment for Use | Not for diagnostic use | Not for diagnostic use | Identical |
| Prescriptive | OTC | OTC | Identical |
| Patient Connection | Yes via Cuff | Yes via Cuff | Identical |
| Technology | Near-IR | Near-IR | Identical |
| Prime Wavelength | 940 nm | 940 nm | Identical |
| Measurement Site | On biceps of dominant arm | On triceps of left arm | Similar (seeNote 2) |
| Measurement Time | 2 seconds approximately | 2 seconds approximately | Identical |
| Limitations | Measurement site must notbe covered with clothing | Measurement site must notbe covered with clothing | Identical |
| Data Provided to theUser | % body fat, BMI, BMR,% lean, % water. | % body fat, BMI, BMR,% lean, % water. | Identical |
| Measurement Range | 2 - 45% | 2 - 45% | Identical |
| Accuracy | Equal to official method ofhydrostatic weighing | Equal to official method ofhydrostatic weighing | Identical |
| Precision | 0.3% | 0.3% | Identical |
| Power Source | Batteries or an AC Adapter | 12 V Rechargeable Battery | Similar |
| Operating Conditions | Temperature: 10° to 40° CHumidity: 15 to 90% RH | Temperature: 10° to 40° CHumidity: 15 to 90% RH | Identical |
| Storage Conditions | Temperature: -20° to 60° CHumidity 10 to 95% RH | Temperature: -20° to 60° CHumidity 10 to 95% RH | Identical |
Table 5-3 – Percent Body Fat Device Measurement Comparison
NOTE 2 – Performance bench testing has been performed to demonstrate that this difference does not affect the accuracy of measurement.
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IX. Testing
The HealthGuard-15 has been subjected to bench testing to ascertain measurement precision and accuracy compared to its predicate devices. This bench performance testing demonstrated that the HealthGuard-15 measurements are substantially equivalent to the predicate devices.
Moreover, testing by an independent laboratory has shown that the HealthGuard-15 also satisfies the EMC requirements for medical electrical equipment. Similarly, the HealthGuard-15 satisfied the safety requirements for electrical medical equipment.
X. Contraindications
There are no known contraindications.
XI. Differences Between Other Legally Marketed Predicate Devices
The HG-15, as shown in the previous three tables, has only minor differences to its predicate devices. Bench testing has been performed that proved that these minor differences do not diminish the HG-15's safety or effectiveness.
XII. Indications
The indications for use are identical
- XIII. Design and Technology - The HG-15 has equivalent design and features as its predicate devices, and uses essentially the identical technology as its predicate devices.
- Performance and Specifications The HG-15 has equivalent specifications XIV. of performance as its predicate devices.
- Compliance with standards The HG-15 are in compliance with the XV. following Standards:
- -ISO 14971
- ANSI/AAMI SP10 -
- BS/EN 60601-1 ।
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XVI. Materials
The patient contact material of the HG-15 (the cuffs) has been FDA market cleared in other 510(k) submissions as described in Section 15 -Biocompatibility. Materials are detailed in Section 15 as well.
XVII. Environment of Use
The HG-15 is intended for use in business locations
XVIII. Patient Population
The HG-15 and its predicate devices are for populations 18 years and older.
XIX. Performance Testing
We have performed bench tests and found that the HG-15 met all requirements, specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:
- -Testing for compliance to IEC 60601-1
- Testing for compliance o IEC 60601-2 -
- Testing for compliance to AAMI SP10 -
- Comparative Testing to the Predicate -
XX. Conclusion
Futrex maintains that the HealthGuard-15 is substantially equivalent to the predicate devices (listed in Item IV above) in indications for use, patient population, environment for use, technology characterizes, specifications/performance and compliance with international standards.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).