(149 days)
Not Found
No
The summary describes a standard ambulatory blood pressure monitor and its software, focusing on basic safety, performance, and compliance with established standards. There is no mention of AI, ML, or any related concepts like image processing, training sets, or specific algorithms that would indicate the use of these technologies.
No.
The device is intended for measurement and recording of blood pressure and heart rate, which is a diagnostic function, not a therapeutic one.
Yes
The device is designed to "take blood pressure and heart rate measurements for a 24 hour, or longer period," and these "measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems." This collection and analysis of physiological data for health assessment classifies it as a diagnostic device.
No
The device description explicitly states it is a "small, lightweight unit designed to take blood pressure and heart rate measurements," indicating it is a physical hardware device. The performance studies also include electrical safety, electromagnetic compatibility, and bench testing, which are relevant to hardware devices, not software-only devices.
Based on the provided text, the Spacelabs Model OnTrak (9027) Ambulatory Blood Pressure (ABP) Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to take blood pressure and heart rate measurements from a living patient over a period of time. This is a direct physiological measurement, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the device's function in taking non-invasive blood pressure and heart rate measurements. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Reagents or assays.
- Detection of specific substances or markers in samples.
Therefore, the Spacelabs Model OnTrak is a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for 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, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure (ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) 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. The Spacelabs OnTrak does not have any physiological alarms, but does have an audible low battery indicator. The Spacelabs OnTrak utilizes the same NIBP cuffs as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Test results indicate that the Spacelabs OnTrak software complies with its predetermined specifications and the applicable standards and guidance documents.
Test results indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards.
Test results indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Bench Performance Testing: The Spacelabs OnTrak was tested for performance in accordance with 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.
Conclusion: Verification and validation activities were conducted to establish the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The logo is presented in black and white.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Number: | K141113 |
|---|---|
| Submission Date: | 26 September 2014 |
| Submitter: | Spacelabs Healthcare Ltd. |
| 1 Harforde Court | |
| John Tate Road | |
| Hertford | |
| SG13 7NW | |
| United Kingdom | |
| Submitter Contact: | Spacelabs Healthcare |
| 35301 SE Center St | |
| Snoqualmie, WA 98065 | |
| Mr. Al Van Houdt | |
| Spacelabs Healthcare | |
| Phone: +1 (425) 363-5970 | |
| Fax: +1 (425) 363-5762 | |
| Email: al.vanhoudt@spacelabs.com | |
| Application | |
| Correspondent: | Thomas Kroenke |
| Speed To Market, Inc. | |
| PO Box 3018 | |
| Nederland, CO 80466 USA | |
| tkroenke@speedtomarket.net | |
| 303 956 4232 | |
| Manufacturing Site: | Spacelabs Healthcare |
| 35301 SE Center St | |
| Snoqualmie, WA 98065 | |
| and/or | |
| Spacelabs Healthcare Medical Equipment (SUZHOU) Co., Ltd. | |
| Building 30, West Wing | |
| ChuangTou Industrial Square | |
| Yang Xian Road, SIP | |
| Suzhou, Jiangsu, China 215122 | |
| Trade Name: | Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure |
| Monitor | |
| Classification Name: | System, Measurement, Blood-pressure, Non-Invasive |
| Classification | |
| Regulation: | 21 CFR §870.1130 |
| Product Code: | DXN |
4
| Substantially
Equivalent Devices: | New Spacelabs Model | Predicate
510(k) Number | Predicate
Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------|
| | Spacelabs Model
OnTrak (90227)
Ambulatory Blood
Pressure Monitor | K103732 | Spacelabs Model 90217A
Ambulatory Blood
Pressure (ABP) Monitor |
| Device Description: | The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure
(ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unit
designed to take non-invasive blood pressure (NIBP) and heart rate
(HR) measurements for a 24 hour, 48 hour, or longer period. These
The Spacelabs OnTrak does not have any physiological alarms, but
does have an audible low battery indicator. The Spacelabs OnTrak
utilizes the same NIBP cuffs as the predicate device. | | |
| 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. | | |
| 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 | ||
| Range | 60 to 260 mmHg | Same |
| Diastolic Pressure | ||
| Range | 30 to 200 mmHg | Same |
| Manometer Accuracy | 0 - 260 mmHg: | |
| ± 2 mmHg ± 1 digit |
260 - 300 mmHg: ± 3 mmHg ± 1 digit | 0 - 300 mmHg: ± 3 mmHg or
2 %, whichever is
greater |
| Maximum Cuff
Pressure in normal
operation | 270 mmHg | Same |
5
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 | |
| 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. |
6
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.