SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE

K141113 · Spacelabs Healthcare, Ltd. · DXN · Sep 26, 2014 · Cardiovascular

Device Facts

• Record ID: K141113
• Device Name: SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 26, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

Device Story

Small, lightweight ambulatory blood pressure (ABP) monitor; records non-invasive blood pressure (NIBP) and heart rate (HR) over 24-48+ hour periods. Device uses oscillometric measurement method; cuff-based; automatic or manual operation. No physiological alarms; includes audible low battery indicator. Used in clinical or home environments; operated by patients or healthcare providers. Data recorded on device; transferred to Spacelabs ABP analysis systems for review by clinicians. Output assists in hypertension management and cardiovascular assessment; provides longitudinal blood pressure data for diagnostic decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366, IEC 80601-2-30, and ISO 81060-2. Results confirm compliance with specifications and substantial equivalence to predicate.

Technological Characteristics

Oscillometric NIBP measurement; 0-300 mmHg pressure range; accuracy ± 3 mmHg or 2%. Connectivity via data transfer to Spacelabs analysis systems. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/62366 (usability), IEC 60601-1-11 (home healthcare), IEC 80601-2-30 (sphygmomanometers), ISO 81060-2 (clinical investigation).

Indications for Use

Indicated for patients requiring 24-hour or longer ambulatory blood pressure and heart rate monitoring.

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

• Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (K103732)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2014

Spacelabs Healthcare c/o Mr. Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466

Re: K141113

Trade/Device Name: Ontrak (90227) Ambulatory Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: System, Measurement, Blood-pressure, Non-Invasive Regulatory Class: Class II Product Code: DXN Dated: August 26, 2014 Received: August 28, 2014

Dear Mr. Kroenke:

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. 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 - Mr. Thomas Kroenke

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Melissa A. Torres -S

Bram D. Zuckerman, M.D. For 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) K141113

#### Device Name

Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure (ABP) Monitor

#### Indications for Use (Describe)

The Spacelabs Model OnTrak (9027) Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Number: | K141113 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | 26 September 2014 |
| Submitter: | Spacelabs Healthcare Ltd.<br>1 Harforde Court<br>John Tate Road<br>Hertford<br>SG13 7NW<br>United Kingdom |
| Submitter Contact: | Spacelabs Healthcare<br>35301 SE Center St<br>Snoqualmie, WA 98065 |
| | Mr. Al Van Houdt<br>Spacelabs Healthcare<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Application<br>Correspondent: | Thomas Kroenke<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare<br>35301 SE Center St<br>Snoqualmie, WA 98065<br>and/or |
| | Spacelabs Healthcare Medical Equipment (SUZHOU) Co., Ltd.<br>Building 30, West Wing<br>ChuangTou Industrial Square<br>Yang Xian Road, SIP<br>Suzhou, Jiangsu, China 215122 |
| Trade Name: | Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure<br>Monitor |
| Classification Name: | System, Measurement, Blood-pressure, Non-Invasive |
| Classification<br>Regulation: | 21 CFR §870.1130 |
| Product Code: | DXN |

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| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------|
| | Spacelabs Model<br>OnTrak (90227)<br>Ambulatory Blood<br>Pressure Monitor | K103732 | Spacelabs Model 90217A<br>Ambulatory Blood<br>Pressure (ABP) Monitor |
| Device Description: | The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure<br>(ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unit<br>designed to take non-invasive blood pressure (NIBP) and heart rate<br>(HR) measurements for a 24 hour, 48 hour, or longer period. These<br>The Spacelabs OnTrak does not have any physiological alarms, but<br>does have an audible low battery indicator. The Spacelabs OnTrak<br>utilizes the same NIBP cuffs as the predicate device. | | |
| Intended Use: | The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure<br>(ABP) Monitor is a small, lightweight unit designed to take blood<br>pressure and heart rate measurements for a 24 hour, 48 hour, or longer<br>period. These measurements are recorded in the monitor and may be<br>transferred to Spacelabs ABP analysis systems. | | |
| Technology | The Spacelabs OnTrak employs the same technological characteristics | | |

Comparison:

as the predicate device.

| Characteristic | Predicate Device | Proposed Device |
|-------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------|
| Measurement Method | Oscillometric | Same |
| Measurement Mode | Automatic or Manual | Same |
| Measurement Time | Typically 35 to 50 seconds | Same |
| Systolic Pressure<br>Range | 60 to 260 mmHg | Same |
| Diastolic Pressure<br>Range | 30 to 200 mmHg | Same |
| Manometer Accuracy | 0 - 260 mmHg:<br>± 2 mmHg ± 1 digit<br><br>260 - 300 mmHg: ± 3 mmHg ± 1 digit | 0 - 300 mmHg: ± 3 mmHg or<br>2 %, whichever is<br>greater |
| Maximum Cuff<br>Pressure in normal<br>operation | 270 mmHg | Same |

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### Summary of Performance Testing:

| Software | The Spacelabs OnTrak software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following standards and guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; IEC 62304: 2006, Medical device software – Software life cycle processes. Test results indicate that the Spacelabs OnTrak software complies with its predetermined specifications and the applicable standards and guidance documents. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | The Spacelabs OnTrak was tested for performance in accordance with the following standards: IEC 60601-1: 2005, Medical electrical equipment – Part 1. General requirements for basic safety and essential performance. UL 60601-1: 2006, Medical electrical equipment, Part 1: Particular requirements for safety. Test results indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards. |
| Electromagnetic<br>Compatibility | The Spacelabs OnTrak was tested for performance in accordance with internal requirements and the following standards: IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards. |

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Performance Testing The Spacelabs OnTrak was tested for performance in accordance with – Bench internal requirements and the following standards: IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6: . General requirements for basic safety and essential performance – Collateral standard: Usability. . IEC 60601-1-11: 2010, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. IEC 62366: 2007, Medical devices – Application of usability . engineering to medical devices. . IEC 80601-2-30: 2009, Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers. . ISO 81060-2: 2009, Non-invasive sphygmomanometers – Part 2: Clinical investigation of automated measurement type. Test results indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards. Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the Spacelabs OnTrak. The results of these activities demonstrate that the Spacelabs OnTrak is as safe, as effective, and performs as well as or better than the predicate device. Therefore, the Spacelabs OnTrak is considered substantially equivalent

to the predicate device.