MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
Device Facts
| Record ID | K072516 |
|---|---|
| Device Name | MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR |
| Applicant | Midmark Diagnostics Group |
| Product Code | MWI · Cardiovascular |
| Decision Date | Oct 18, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only. The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.
Device Story
IQmark Vital Signs Monitor is a multi-parameter patient monitor for clinical settings (hospitals, clinics). Inputs: NIBP (oscillometric cuff), SpO2 (Masimo SET oximetry via red/infrared light absorption), and temperature (thermistor probes). Device processes signals to calculate systolic/diastolic BP, MAP, pulse rate, SpO2, and body temperature (predictive or continuous modes). Outputs: real-time values, pulse waveform quality bar graph, and audible pulse indicators on front panel display. Clinicians use device to monitor patient status; alarm limits for HR, BP, and SpO2 assist in clinical decision-making. Benefits include noninvasive, continuous monitoring of vital signs to support patient assessment.
Clinical Evidence
Bench testing only. Device performance verified against safety and performance standards including EN 60601-1-2, IEC 60601-1-4, EN 60601-1-8, EN 9919, IEC 60601-1, ANSI/AAMI SP10, and ASTM E1112. System-level verification and validation confirmed operational specifications for NIBP, SpO2, and temperature modules. Risk analysis and biocompatibility testing performed.
Technological Characteristics
Electronic vital signs monitor. NIBP: oscillometric method. SpO2: Masimo SET technology. Temperature: thermistor-based (predictive/continuous modes). Power: 100-240 VAC or sealed lead acid battery. Connectivity: standalone monitor. Biocompatible patient-contact materials. Software: embedded firmware for signal processing and predictive temperature algorithms. Sterilization: N/A (reusable/disposable sensors/probes).
Indications for Use
Indicated for monitoring adult, pediatric, and neonatal patients for noninvasive blood pressure, pulse rate, SpO2, and body temperature. Temperature monitoring: oral/rectal/axillary for adults/pediatrics; axillary only for neonates (up to 1 month). Contraindications: Oral/rectal temperature for neonates; prolonged use of SpO2 sensors; adhesive tape allergy for disposable SpO2 sensors.
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Predicate Devices
- CAS Medical 740 Series Vital Signs Monitor (K033048)
- Welch Allyn Vital Signs Monitor (K053027)
- IVAC Model 2080 Electronic Thermometer (K860436)
Submission Summary (Full Text)
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### SECTION 9: 510(K) SUMMARY
1. Summary Preparation Date: June 12, 2007
2. 510(k) Applicant Information:
Name: Midmark Diagnostics Group Address: 3300 Fujita Street
Torrance, CA 90505 USA
FDA Establishment registration Number: 2081230 Contact Name: Tony Capparelli, Director of Product Development Phone Number: 310-257-7217 Fax Number: 310-530-1421
3. Device Names and Designations
Proprietary Name: IQmark® Vital Signs Monitor Module Configuration:
| NIBP* | Temp | SpO₂ |
|-------|------|------|
| X | X | X |
* Noninvasive Blood Pressure
Overall Device Common/Usual Name: Vital Signs Monitor Overall Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection)
| Component | Prod-<br>uct<br>Code | Regulation<br>Number | Class | Regulation<br>Medical<br>Specialty | Review<br>Panel |
|-------------------|----------------------|----------------------|-------|------------------------------------|-----------------|
| Overall<br>Device | MWI | 870.2300 | 2 | Cardiovascular | Cardiovascular |
| NIBP | DXN | 870.1130 | 2 | Cardiovascular | Cardiovascular |
| Oximeter | DQA | 870.2700 | 2 | Cardiovascular | Anesthesiology |
| Thermometer | FLL | 880.2910 | 2 | Gen. Hospital | Gen. Hospital |
### Product Codes, Regulations, Class, and Panels;
4. Substantial Equivalency: The Midmark Diagnostics IQmark® Vital Signs Monitor is substantially equivalent to these predicate devices:
- CAS Medical 740 Series Vital Signs Monitor (K033048) .
- Welch Allyn Vital Signs Monitor (K053027) t
- and IVAC Model 2080 Electronic Thermometer (K860436) .
Like the CAS Medical 740 Series Vital Signs Monitor, the IQmark® Vital Signs Monitor is for monitoring of noninvasive blood pressure, oxygen saturation, pulse rate and temperature of adult, pediatio, and neonatal populations under care of health care professionals in general medical locations, hospitals, and alternative care environments.
OCT 1 8 2007
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The following tables compare the physical and performance characteristics of the proposed device to the I no following table 1 compares the IQmark® VSM to the CAS Medical 740 Series Vital Signs production (1033048). Table 2 compares the IQmark VSM temperature module to the IVAC Model 2080 Electronic Thermometer (K860436) and Welch Allyn VSM 300 (K053027).
| Characteristic | CAS Medical 740 Series Vital Signs Monitor (K033048) | IQmark® Vital Signs Monitor |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Available module configurations | NIBP/Oximeter/Temperature | NIBP/Oximeter/Temperature |
| Overall operational modes | Adult, neonatal, power-on self-test, auto off, off and history | Adult, neonatal, power-on self test, automatic power down, and power down |
| NIBP modes | Manual, automatic, and stat | Manual, automatic, and stat |
| NIBP module operating principle | Oscillometric method employing a stepwise pressure deflation technique | Oscillometric method employing a stepwise pressure deflation technique |
| NIBP reading ranges | adult - systolic: 30-255<br>diastolic: 15-220<br>MAP: 20-235<br>neo - systolic: 30-135<br>diastolic: 15-110<br>MAP: 20-125 | adult - systolic: 30-255<br>diastolic: 15-220<br>MAP: 20-235<br>neo - systolic: 30-135<br>diastolic: 15-110<br>MAP: 20-125 |
| NIBP accuracy | +/- 5 mmHg, standard deviation no greater than 8 mmHg | +/- 5 mmHg, standard deviation no greater than 8 mmHg |
| NIBP cuff types | reusable and disposable | reusable and disposable |
| NIBP cuff sizes | adult, infant, and neonatal | adult, infant, and neonatal |
| SpO2 modes | Continuous monitoring and off | Continuous monitoring and off |
| SpO2 reading range (%) | 0 - 100 | 0 - 100 |
| SpO2 accuracy | adult: 70-100%: ± 2 counts<br>neonate: 70-100%: ± 3 counts | adult: 70-100%: ± 2 counts<br>neonate: 70-100%: ± 3 counts |
| SpO2 sensor types | Reusable and disposable | Reusable and disposable |
| SpO2 sensor sizes | adult, infant, and neonatal | Adult, infant, and neonatal |
| Alarm conditions | high and low alarms: pulse rate, systolic & diastolic BP, MAP, & SpO2 | high and low alarms: pulse rate, systolic & diastolic BP, MAP, & SpO2 |
| Power supply type | 100-240 VAC (50-60 Hz) or charged NiMH battery | 100-240 VAC (50-60 Hz) or charged sealed lead acid battery |
Table 1: Physical and Performance Characteristics of IQmark® Vital Signs Monitor To CAS Medical 740 Series Vital Signs Monitor
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| Characteristic | IVAC Model 2080<br>Electronic Thermome-<br>ter<br>(K860436) | Welch Allyn Vital Signs<br>Monitor<br>(K053027) | IQmark® Vital Signs<br>Monitor |
|--------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Thermometer type | Electronic, thermistor | Electronic, thermistor | Electronic, thermistor |
| Temperature reading<br>range<br>Continuous mode: | 26.7 - 42.2 °C<br>(80 - 108.0 °F) | 28.9 - 42.2 °C<br>(84.0 - 108.0 °F) | 28.9 - 42.2 °C<br>(84.0 - 108.0 °F) |
| Predictive mode: | 31.6 - 42.2°C<br>(88.9 - 108.0°F) | Not specified | 35.0 - 41.1 °C<br>(95.0 - 106.0 °F) |
| Accuracy<br>Continuous mode: | $±$ 0.1 °C ( $±$ 0.2 °F)<br>meet or exceeds ASTM<br>E1112-00 requirements | $±$ 0.1 °C ( $±$ 0.2 °F)<br>meet or exceeds ASTM<br>E1112-00 requirements | $±$ 0.1 °C ( $±$ 0.2 °F)<br>meet or exceeds ASTM<br>E1112-00 requirements |
| Predictive mode: | $+$ 0.6 °C ( $+$ 1.0 °F) | Not specified | $±$ 0.6 °C ( $+$ 1.0 °F) |
Table 2: Physical and Performance Characteristics of IQmark® Vital Signs Monitor To IVAC Model 2080 Electronic Thermometer and Welch Allyn VSM 300
The physical and performance characteristics of the IQmark® Vital Signs Monitor are very similar to those of the predicate device with a few non-significant differences in technological characteristics. The results of extensive software and hardware verification and validation testing, safety, and performance testing demonstrate that the different technological characteristics used in the IQmark® Vital Signs Monitor pose no new issues of safety and effectiveness and therefore is substantially equivalent to the predicate devices.
#### 5. Performance Testing Summary:
The IQmark VSM has been tested for safety and efficacy and found to be in conformance with the following safety standards and performance standards applicable to blood pressure, SpO2, and temperature modules:
EN 60601-1-2 IEC 60601-1-4 EN 60601-1-8 EN 9919 IEC 60601-1 ANSI/AAMI SP10 ASTM E1112
Additionally, the operational and performance specifications for each measurement module and for the IQmark Vital Signs Monitor as a system has been successfully verified and validated. Results demonstrate that the IQmark® Vital Sigus Monitor poses no new issues of safety and effectiveness and therefore is substantially equivalent to the predicate devices.
The IQmark® Vital Signs Monitor Risk Analysis document identifies potential failure / hazard combinations associated with the use of the VSM, and mitigations to reduce patient risks. The document con-
> Section 9 510(k)Summary_Rev 6_080607.doc Page 3 of 5
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cludes that the IQmark® Vital Signs Monitor is a safe device that poses no unacceptable risks to the patient.
## 6. Intended Use, Indications for Use, & Environment.
Intended Use and Indications: The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO-), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only.
Intended Environment: The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.
Contraindications: The IQmark® Vital Signs Monitor may not be suitable for use on patients under the following conditions:
- Oral and Rectal temperature measurements are contraindicated for neonatal use. a.
- Reusable SpO2 sensors are contraindicated for prolonged use. The sensors must be removed b. every 4 hours and, if indicated by circulatory condition and skin integrity, reapplied to a different monitoring site.
- Disposable SpO- sensors are contraindicated for patients that exhibit allergic reactions to ad-C. hesive tape. The sensors must be removed every 8 hours and, if indicated by circulatory condition and skin integrity, reapplied to a different monitoring site.
Complications: Except for temperature measurement, the IQmark® Vital Signs Monitor is a noninvasive device. The device is safe in construction and performance. This has been confirmed by the successful completion of Verification and Validation Testing, Biocompatibility Confirmation, and Risk Analysis.
Following are some possible complications:
- a. Prolonged use of the adhesive tape used to attached disposable SpO2 sensors may cause allergic reactions in some patients.
- Prolonged use of reusable or disposable SpO2 sensors may cut-off circulation in some patients. b.
- Repeated application and use of temperature probe covers to the same tissue area may cause C. mild irritation at tissue site.
- Failure to follow directions for rectal probe insertion could result in bowel perforation, esped. cially in young children.
7. General Device Description: The Midmark Diagnostics IQmark® Vital Signs Monitor consists of the following three individual measurement Modules:
- Noninvasive blood pressure (NIBP) a.
- Pulse Oximeter b.
- Temperature c.
In the Automatic or STAT Modes of operation, the NIBP Module automatically inflates an occluding cuff placed around the patient's arm or leg. It uses the oscillometric measurement technique to measure and record the patient's systolic and diastolic pressure as well as pulse rate. From these measurements the IQmark VSM also calculates the mean arterial blood pressure (MAP). Measurement results along with
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operator prompts and error messages are indicated on the front panel display. The frequency of NIBP determination can be selected by the operator at fixed times between one and ninety minutes. The Manual Mode of operation also covers a variety of clinical uses. A variety of reusable and disposable cuff types and sizes is available for adult, pediatric, and neonatal applications. The NIBP Module requires routine calibration and maintenance.
The Pulse Oximeter Module measures and records the patient's arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through tissue (SpO₂). Changes in alsorption caused by pulsations of blood in the patient's vascular bed are used to determine arterial oxygen saturation and pulse rate. Oxygen saturation and heart rate are indicated on the front panel display. A bar graph display gives the user a pulse visual indication of waveform signal quality. An audible indicator can be enabled which automatically generates a sound each time the SpO2 sensor detects a pulse. The 1Qmark VSM utilizes the Masimo Set" oximeter. A variety of reusable and disposable sensor types and sizes is available for adult, pediatric and neonatal applications. These oximeter does not require routine calibration or maintenance.
The Temperature Module measures and records a patient's temperature in either the Predictive or Continuous Mode of operation using either oral (also used for axillary) or rectal probes. In the Predictive Mode, the thermometer's software predicts body temperature in about 15 seconds for oral and axillary temperatures. The IQmark VSM Temperature Module does not support Predictive Mode measurements for the rectal temperature probe. The default mode used by the IQmark VSM for oral temperature determinations is the Predictive Mode. The Continuous Mode is usually used for longer-term monitoring or when difficult situations prevent accurate patient temperature measurement in the Predictive Mode. Temperature probe covers are required and are available for the oral/axillary and rectal probes. The Temperature Module requires routine calibration and maintenance.
When the Alarm Setting Mode is activated, high and low alarm limits can be set (within specification and safety limits) for heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and SpO2.
8. Device Materials Biocompatibility: All blood pressure cuff, SpO2 sensor, and temperature probe cover materials that come into contact with the patient's body tissue are in full compliance with all the applicable FDA biocompatibility requirements.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol of three human figures connected at the shoulders, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Midmark Diagnostics Group c/o Mr. Tony Capparelli Director of Product Development 3300 Fujita Street Torrance, CA 90505
Re: K072516
Igmark® Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 3, 2007 Received: October 4, 2007
Dear Mr. Capparelli:
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 may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Tony Capparelli
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): 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.
Blommor 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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# SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Midmark Diagnostics IQmark® Vital Signs Monitor
Indications For Use:
The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only.
The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.
Prescription Use X (Per 21 CFR 801.109 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)
Blummeno
ision Sion-Division of Cardiova 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Section 4 - Indications Form Rev4 052507.doc
