MARCH HEALTHCARE HEALTH MONITORING KIT

K060194 · March Healthcare Corporation · DXN · Feb 13, 2006 · Cardiovascular

Device Facts

• Record ID: K060194
• Device Name: MARCH HEALTHCARE HEALTH MONITORING KIT
• Applicant: March Healthcare Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

The Health Monitoring Kit (HMK) is a non-invasive, spot-measuring device intended to measure heart rate and systolic and diastolic blood pressure using the oscillometric method: functional oxygen saturation levels: pulse rate; and heart and lung sounds of both pediatric patients aged three years and older and adult patients under the care of a physician in either clinical or home enviroments.

Device Story

Portable HMK device performs spot-checks of vital signs; inputs include oscillometric blood pressure (cuff), SpO2 (photodetector/red-IR light), and heart/lung sounds (electronic stethoscope). Device transforms inputs into physiological data; displays results on built-in LCD. Operates as standalone unit or connects to host via Bluetooth/USB for remote telehealth. In telehealth, stethoscope audio and vital data transmit to remote computer for clinician review. Used by clinicians or patients in clinical/home environments. Facilitates remote monitoring and clinical decision-making by providing objective vital sign data to off-site healthcare professionals.

Clinical Evidence

Bench testing only. Comparative performance testing conducted between HMK and Welch Allyn 52000 VSM (NIBP and SpO2) and Cardionics E-Scope (frequency response). Results demonstrated equivalent performance. Risk analysis performed per ISO 14971. Device met all applicable electrical, mechanical, EMC, and environmental safety standards.

Technological Characteristics

Portable handheld unit; ABS injection-molded case. NIBP: oscillometric step-wise deflation. SpO2: red/IR photodetector. Stethoscope: microphone-based electronic signal conversion. Connectivity: Bluetooth wireless, USB wired. Power: Sealed Lead Acid (SLA) battery or IEC 60601-1 AC adapter. Patient-contact materials: 6-nylon/PVC cuffs, steel stethoscope chest piece, biocompatible oximeter sensors (ISO 10993).

Indications for Use

Indicated for non-invasive spot-checking of blood pressure, heart rate, functional oxygen saturation, pulse rate, and heart/lung sounds in pediatric patients (age 3+) and adults under physician care in clinical or home settings.

Regulatory Classification

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.

Predicate Devices

• CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 (52000) (K951193)
• E-Scope Electronic Stethoscope Model 7187-120 (K961301)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for March Healthcare. The logo consists of a geometric shape on the left, followed by the word "MARCH" in large, bold letters. Below "MARCH" is the word "HEALTHCARE" in smaller letters. Underneath the logo is the text "A March Networks Company".

FEB 1 3 2006

# 510(k) Summary of Safety and Effectiveness

### Submitter:

March Healthcare Corporation 555 Legget Drive. Tower B Ottawa, Ontario. K2K 2X3 Canada

## Contact:

Timon LeDain, VP, Engineering Toll Free: [phone] Local: [phone] Fax: [phone] Email: [e-mail]

Date: November 4. 2005

Trade Name: March Healthcare HMK

Common Name: Health Monitoring Kit

Classification Name: Non-Invasive Blood Pressure Measurement System

#### Product Code: DXN

Legally Marketed Devices: The March Healthcare HMK is substantially equivalent to the legally marketed devices listed in the chart below.

| LEGALLY<br>MARKETED DEVICE | MANUFACTURE<br>NAME | REGULATORY<br>CLASS AND<br>PRODUCT CODE | 510(K)<br>REGISTRATION<br>NUMBER |
|----------------------------------------------------------------|---------------------|-----------------------------------------|----------------------------------|
| CLINICAL VITAL<br>SIGNS MONITOR.<br>MODEL #52STP-E1<br>(52000) | Welch Allyn Inc | Class II/DXN | K951193 |
| E-Scope Electronic<br>Stethoscope Model<br>7187-120 | Cardionics | Class II/DQD | K961301 |

March Healtheare Corporation · Tower B · 555 Legget Drive · Ottawa. ON · Canada · K2K 2X3 613-591-6496 · 1-866-700-0050 · www.marchhealtheare.com

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The new March Healthcare HMK is substantially equivalent to the legally marketed devices listed based on the following rationale:

- Same indications for use: for non-invasive monitoring of blood pressure, heart > rate, functional oxygen saturation, and pulse rate of adult and pediatric patients in various health environments.
- Similar key design technical characteristics- The HMK, like the Welch Allyn > monitor, contains comparable modular-based blood pressure monitor and SpO2 components. These OEM modules are currently in use in devices that have already been FDA approved for market. The HMK incorporates Nonin's Ipod or Xpod pulse oximetry technology and CAS Medical's NE NIBP module. In addition, the HMK incorporates Cardionics` networked electronic stethoscope technology into its design.
- Same/similar components for measuring the vital signs of patient. >
- Similar size (hand held), weight, power source. and performance. >

#### Description:

The March Healthcare Health Monitoring Kit (HMK) is a portable medical device equipped with a built-in blood pressure monitor. pulse oximeter, and electronic stethoscope intended for spot-checking the basic vital signs of pediatric patients aged three and older and adult patients under the care of a physician in both clinical and home environments. The HMK can be used as a stand-alone unit or it can be connected to a host using a standard Bluetooth® wireless interface or wired universal serial bus (USB) interface to support remote control of the HMK and audio and data transmission in telehealth applications.

In both stand-alone and remote telehealth applications. the user can spot-check the following vital signs with the blood pressure monitor and pulse oximeter: heart rate and svstolic and diastolic blood pressure. and functional blood oxygen saturation and pulse rate. In remote telehealth applications when the HMK is interfaced with a host, the electronic stethoscope transmits heart and lung sounds via the host to a health care professional at a remote computer. The data from the HMK can be viewed in one of two wavs: on the built-in HMK liquid crystal display (LCD) or from a remote computer connected to a host.

March Healtheare Corporation · Tower B · 555 Legget Drive · Ottawa. ON · Canada · K2K 2N3 613-591-6496 · 1-866-700-0050 · www.marchhealtheare.com

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The HMK blood pressure monitor uses the non-invasive, oscillometric, step-wise deflation method to measure heart rate and systolic and diastolic blood pressure. The noninvasive pulse oximeter measures functional blood oxygen saturation and pulse rate using a photodetector and a red and infrared light source to measure the absorption of red and infrared (IR) light passed through the tissuc and arterial hemoglobin. The electronic stethoscope uses a microphone within the chestpiece. bchind a diaphragm. The microphone converts the sound in the chestpiece to an clectronic signal for amplification and transmission to a health care professional at a remote computer via the host.

The HMK does not store physiological data in memory. When using the HMK as a standalone unit. the user must manually record the results displayed on the LCD. However. when the HMK is interfaced with a host, the host may store the audio and physiological data in a database for remote access by authorized clinicians.

The HMK is powered with either a Sealed Lead Acid (SLA) battery or a Medical Grade IEC 60601-1 compliant AC adapter. The AC adapter is also used to charge the SLA battery.

The HMK has only two external inputs: AC adapter input and universal serial bus (USB) input. The user connects the AC adapter to the DC power plug socket when the battery needs charging. In addition, the user can connect the HMK to the host using the Type B USB input as a wired alternative to the wireless Bluetooth interface.

The HMK is for sale by or on the order of a physician.

#### Intended for Use:

The March Healthcare Health Monitoring Kit (HMK) is a non-invasive, spot-measuring device intended to measure heart rate and systolic and diastolic blood pressure using the oscillometric method: functional oxygen saturation levels: pulse rate; and heart and lung sounds of both pediatric patients aged three vears and older and adult patients under the care of a physician in either clinical or home enviroments.

#### Technological Comparison to the Legally Marketed Devices:

Technologically, the March Healthcare HMK is substantially equivalent to the legally marketed devices listed above. The risks, safety and effectiveness, and benefits of the March Healthcare HMK are also comparable. The Table of Comparison in Section 4 will provide additional information illustrating that the new March Healthcare HMK is substantially equivalent to the Welch Allvn 52000 and the Cardionics E-Scope Stethoscone.

Viarch Healtheare Corporation · Tower B · 555 Legget Drive · Ottawa. ON · Canada · K2K 2X3 613-591-6496 = 1-866-700-0050 = www.marchhealtheare.com

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To highlight:

- The Non-Invasive Blood Pressure measurement specifications and performance . are equivalent to the Welch Allyn 52000 Vital Signs Monitor (K951193). The HMK and the Welch Allyn 52000 Vital Signs Monitor use a CAS Medical OEM NIBP module that is similar in design.
- The HMK SpO2 measurement and performance specifications are equivalent to . the Welch Allyn 52000 Vital Signs Monitor (K951193) because both units use Nonin OEM pulse oximetry technology.
- The heart and lung sound specifications and performance are derived from the . Cardionics stethoscope (K961301). The networked clectronic stethoscope is an added feature on the HMK that is not available on the Welch Allyn 52000. However, the stethoscope has been approved for market by the FDA to be incorporated into systems like the HMK: consequently, the inclusion of the FDAapproved stethoscope technology raises no new issues of safety and effectiveness and does not affect a substantial equivalence determination.

#### Materials and Biocompatibility:

The blood pressure monitor, pulse oximeter and electronic stethoscope modules are encased in an UL-approved acrylonitrile-butadiene-styrcne (ABS) injection molded carrying case.

The following components contact the patient:

- A & D Medical LifeSource Pressure Cuffs: The pressure cuff is made from cloth . material (6-nylon) and the cuff hose is made from latex-free PVC plastic.
- Nonin Pulse Oximeters: All oximeter sensors are constructed using materials that . have been previously validated by Nonin for biocompatibility per ISO 10993.
- Cardionics Stethoscope: The stethoscope chest piece is made from steel. .

These patient contacting materials have a history of biocompatibility with respect to patient contact. These materials contact the patient in the same locations for less or the same amount of time. Moreover. March Healthcare Corporation has not modified these materials in any way. A&D Medical. Nonin. and Cardionics have tested all patient contacting equipment and accessories for biocompatibility. and these manufacturers have obtained adequate biocompatibility results. For these reasons. March Healthcare Corporation believes that no further biocompatibility testing is required.

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#### Summary of Performance Testing:

The March Healthcare HMK was tested for comformance to the design specifications in accordance to the HMK Validation Test Plan, included with the submission, using accordance to the Intent units prior to release to market. The HMK passed all tests and productuates the functionality indicated in the design specifications for the unit.

A risk analysis identifying potential hazards and documenting mitigations of the hazards A Tisk and your released as part of the March Healthcare Corporation product nus been actively and risk analysis is based on ISO14971 - Risk Analysis for Medical Devices.

Comparative testing between the March Healthcare Health Monitoring Kit and the Welch Allyn 52000 Vital Signs Monitor (K951193) was performed to validate the functional Anyh 52000 Vita. Bigneh Bankthcare HMK. In particular, CAS NE NIBP and Nonin SpO2 performance tests were performed to show substantial equivalence to the Welch Allyn 52000 VSM. Comparative testing was performed between the HMK and the E-Scope Electronic Stethoscope Model 7187-120 for similar frequency response. The comparison testing was performed with each vital signs measurement device and demonstrated that the HMK and the Welch Allyn 52000 Vital Signs Monitor and the HMK and the Cardionics E-Scope perform equivalently.

The HMK has been subjected to performance testing to applicable safety. electrical. mechanical, EMC standards. and environmental standards. All specifications were met.

#### Conclusion:

The March Healthcare Health Monitoring Kit (HMK) is safe and effective. complies with the appropriate medical standards, and is substantially equivalent in performance, design and intended use to the legally marketed devices listed above.

> March Healtheare Corporation - Tower B - 555 Legget Drive - Ottawa. ON - Canada - K2K 2X3 613-591-6496 · 1-866-700-0050 · www.marchhealtheare.com

> > HMK S&F- v

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Image /page/5/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

ﻤﻨﺘﺴ

FEB 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

March Healthcare Corporation c/o Ms. Laura Danielson TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K060194

Trade Name: Health Monitoring Kit (HMK) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 24, 2006 Received: January 25, 2006

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainter is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate for use stated in the enclosure) the arrived the devices marketed in interstate for use stated in the enclosure) to regally mancede producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1770, the enablems and the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Federal PMAN devices that nave been recassified in accordance wanted approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approval application o and Cosment Act (Act) that do not require approval on the general controls provisions of the Act. The You may, therefore, market the device, see, see, see in of the of the supportuned in and general Controls provisions of the Procellers, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and literal EDA may be subject to such additional controller and the 21, Parts 800 to 898. In addition, FDA may be found in the Oods of Peacharting your device in the Federal Register.

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Page 2 -- Ms. Laura Danielson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualled of a backan............................................................................................................................ that IDA has made a decommance that your and your Federal agencies. You must of any I ectifical statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, netwarts, and manufacturing practice requirements as set CPR Part 807); labeling (21 CFR Part 801); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GFR 1880 form in the quality systems (QD) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-105 product radiation control provisions (Sections over device as described in your Section 510(k) I his letter will anow you to begin manteang your antial equivalence of your device to a legally premarket notheation: "The PDF miding of basification 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 If you desire specific advice for your ac not 2012-01-20. Also, please note the regulation entitled, comaci the Office of Compullion as (217) 21 CFR Part 807.97). You may obtain " Misoralluming by reference to premanter noutheast the Act from the Division of Small other general information on your response in its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar 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 | K060194 (To be assigned) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Health Monitoring Kit (HMK) |
| Indications for Use: | The Health Monitoring Kit (HMK) is a non-invasive, spot- measuring device used to measure blood pressure, heart rate, oxygen saturation levels, pulse rate, and heart and lung sounds. |
| Target Population: | Pediatric patients over the age of three and adult patients who are under the care of a health care professional. |
| Environment of Use: | For use in clinical environments by health care professionals and/or in home environments by patients under the care of a physician. |

Prescription Use: ✔ AND/OR (21 CFR 801 Subpart D)

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)

Blymmma
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invision of Cardiovascular Devices ושמחשות (O(K) וי 060142