SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR

K103732 · Spacelabs Healthcare, Ltd. · DXN · Feb 4, 2011 · Cardiovascular

Device Facts

• Record ID: K103732
• Device Name: SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Spacelabs Model 90217A 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

The Spacelabs Model 90217A is a portable, battery-powered ambulatory blood pressure (ABP) monitor. It utilizes an oscillometric method to measure blood pressure and heart rate via an arm cuff. The device features an automated or manual inflation system; a pressure sensor signal is amplified and digitized by an ADC before being processed by a microprocessor that controls the pump and vent valve. Measurements are captured during stepwise cuff deflation. The unit is worn by the patient in a pouch strapped or belted to their side. Data is recorded internally and subsequently transferred to Spacelabs ABP analysis systems via direct connection or modem link for clinician review. By providing longitudinal blood pressure data, the device assists healthcare providers in diagnosing and managing hypertension or other cardiovascular conditions, enabling better therapeutic decision-making and patient monitoring outside of clinical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including performance, electrical safety, and electromagnetic compatibility (EMC) testing, alongside verification and validation of the software development process.

Technological Characteristics

Portable, battery-powered (3 AA alkaline or NiCad) monitor with lithium backup for memory. Uses oscillometric sensing principle. Dimensions: small, lightweight form factor. Connectivity: direct connection or modem link to analysis systems. Software: embedded firmware. Biocompatibility: uses same patient-contact cuffs as predicate.

Indications for Use

Indicated for patients requiring ambulatory blood pressure and heart rate monitoring over extended periods (24, 48 hours, or longer).

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 Ambulatory Blood Pressure Monitor Spacelabs #90202 (K855127)

Submission Summary (Full Text)

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ભાર K103732

## 510(k) Premarket Notification Spacelabs Healthcare Ltd. Spacelabs Model 90217A ABP Monitor 510(k) Summary

FEB - 4 2011

| Submission Date: | 29 November 2010 | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare Ltd.<br>1 Harforde Court, John Tate Road<br>Hertford, SG13 7NW United Kingdom | | |
| Submitter Contact: | Mr. Roger Moldon<br>Quality Manager<br>Spacelabs Healthcare Ltd.<br>1 Harforde Court, John Tate Road<br>Hertford, SG13 7NW United Kingdom<br>+011 (44) 1992-507730<br>[e-mail] | | |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<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 Ltd.<br>1 Harforde Court, John Tate Road<br>Hertford, SG13 7NW United Kingdom | | |
| Trade Name: | Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor | | |
| Common Name: | Non-invasive Blood-Pressure Measurement System | | |
| Classification Name: | System, Measurement, Blood-pressure, Non-invasive | | |
| Classification<br>Regulation: | 21 CFR §870.1300 | | |
| Product Code: | DXN | | |
| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Spacelabs Model 90217A<br>Ambulatory Blood<br>Pressure (ABP) Monitor | K855127 | Spacelabs Ambulatory<br>Blood Pressure Monitor<br>Spacelabs #90202 |

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## 510(k) Premarket Notification · Spacelabs Healthcare Ltd. Spacelabs Model 90217A ABP Monitor 510(k) Summary

| Device Description: | The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP)<br>Monitor (Model 90217A) is a small, lightweight unit designed to take<br>non-invasive blood pressure (NIBP) and heart rate (HR) measurements<br>for a 24 hour, 48 hour, or longer period. These measurements are<br>recorded in the monitor and may be transferred to Spacelabs ABP<br>analysis systems. |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Model 90217A allows the use of an automated or manual inflation<br>system, and utilizes the oscillometric NIBP measurement method. The<br>pressure sensor signal is amplified, digitized by an analog to digital<br>converter (ADC), and supplied to a microprocessor which has control<br>of the pump and vent valve. Measurements are made during the<br>stepwise deflation of the cuff. The Model 90217A NIBP and HR<br>algorithms are identical to that of the predicate. Additionally, the NIBP<br>patient cuffs used with the Model 90217A are the same as those used<br>with the predicate. A block diagram of the Model 90217A is presented<br>in Figure 2. |
| | The Model 90217A is powered by three (3) "AA" alkaline or<br>rechargeable NiCad batteries; there is no capability to connect the<br>Model 90217A to AC mains power. A lithium battery is used to provide<br>backup power for the Model 90217A memory. Both battery types need<br>to be periodically replaced. |
| | The Model 90217A is carried in a pouch that is strapped and/or belted<br>to the side of the patient. NIPB and HR measurements are taken using a<br>blood pressure cuff attached to the patients arm. This information is<br>recorded in the monitor, and can be transferred over a modem link, or<br>by direct connection, between the Model 90217A and one of the ABP<br>analysis systems. |
| Intended Use: | The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP)<br>Monitor is a small, lightweight unit designed to take blood pressure and<br>heart rate measurements for a 24 hour, 48 hour, or longer period. These<br>measurements are recorded in the monitor and may be transferred to<br>Spacelabs ABP analysis systems. |
| Technology<br>Comparison: | The Model 90217A employs the same technological characteristics as<br>the predicate devices take non-invasive blood pressure (NIBP) and<br>heart rate (HR) measurements. |
| Biocompatibility | The patient contact NIBP cuffs used with the Model 90217A are the same as those used with the predicate, and were cleared with the predicate. Therefore, biocompatibility testing is not necessary for the Model 90217A. |
| Electrical Safety | The Model 90217A was tested for patient safety in accordance with applicable Standards.<br>Test results indicated that the Model 90217A complies with its predetermined specification and with the applicable Standards. |
| Electromagnetic<br>Compatibility<br>Testing | The Model 90217A was tested for EMC in accordance with applicable Standards.<br>Test results indicated that the Model 90217A complies with its predetermined specification and with the applicable Standards. |
| Performance Testing | The Model 90217A was tested for performance in accordance with applicable Standards.<br>Test results indicated that the Model 90217A complies with its predetermined specification and with the applicable Standards. |
| Software Testing | Software for the Model 90217A was designed and developed according to a robust software development process, and was rigorously verified and validated.<br>Test results indicated that the Model 90217A complies with its predetermined specification. |
| Conclusion | Based upon a comparison of devices and performance testing results, Model 90217A is substantially equivalent to the predicate device. |

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## 510(k) Premarket Notification Spacelabs Healthcare Ltd. Spacelabs Model 90217A ABP Monitor 510(k) Summary .

## Summary of Performance Testing:

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

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

用用器 -- 4 2011

Re: K103732

Trade/Device Name: Model 90217A Ambulatory Blood Pressure (ABP) Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood-Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 30, 2010 Received: December 22, 2010

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.

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.

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Page 2 – Spacelabs Healthcare Ltd. c/o Mr. Thomas Kroenke

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 liasting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing on modical forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 100-1050.

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/ucm1180017; by fast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Als., please note the regulation entitled, "Misbranding by reference to premarket notification" (21 GE) Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (11 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours.

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

103732 K 5 10(k) Number (if known): Device Name: Monitor

Indications for Use:

Spacelabs Model 90217A Ambulatory Blood Pressure (ABP)

The Spacelabs Model 90217A 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.

Prescription Use X (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)

W.M.

iovascular Devices

510(k) Numbe