(149 days)
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.
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.
The provided document details the 510(k) premarket notification for the Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure Monitor. This document does not contain information about an AI-powered device, nor does it conduct a study comparing human readers with and without AI assistance. Instead, it focuses on the substantial equivalence of a new medical device to a legally marketed predicate device.
However, I can extract the acceptance criteria and performance information as presented for this device, and infer what would typically be considered "acceptance criteria" based on the standards cited for medical device performance.
Acceptance Criteria and Reported Device Performance
For a blood pressure monitor, the primary acceptance criteria revolve around accuracy of blood pressure measurement. The document refers to ISO 81060-2: 2009 for "Clinical investigation of automated measurement type," which sets the standard for blood pressure monitor accuracy. While the document doesn't explicitly list the detailed clauses of ISO 81060-2 as "acceptance criteria" tables, the "Manometer Accuracy" under the technology comparison section provides a direct performance metric.
| Acceptance Criteria Category | Acceptance Criteria from ISO 81060-2 (Implied) | Reported Device Performance (as stated in comparison) |
|---|---|---|
| Manometer Accuracy | For automated non-invasive sphygmomanometers, ISO 81060-2 typically requires: | 0 - 300 mmHg: ± 3 mmHg or 2 %, whichever is greater |
| Method Difference (Clinical Validation) | ISO 81060-2 (2009) criteria for clinical validation: | "Test results indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards." (Implicitly meets ISO 81060-2) |
| Mean difference | ≤ 5 mmHg | Not explicitly stated in this document |
| Standard deviation | ≤ 8 mmHg | Not explicitly stated in this document |
| Software Performance | Compliance with predetermined specifications and recognized standards (e.g., IEC 62304) | "Complies with its predetermined specifications and the applicable standards and guidance documents." |
| Electrical Safety | Compliance with IEC 60601-1 and UL 60601-1 | "Complies with its predetermined specifications and the applicable standards." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | "Complies with its predetermined specifications and the applicable standards." |
| Usability | Compliance with IEC 60601-1-6 and IEC 62366 | "Complies with its predetermined specifications and the applicable standards." |
| Home Healthcare Environment Suitability | Compliance with IEC 60601-1-11 | "Complies with its predetermined specifications and the applicable standards." |
Study Information (Based on the provided document):
-
Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for the clinical testing (if a specific clinical test was conducted beyond meeting the standard's criteria implicitly) or for the various bench tests. It refers to "Test results" which "indicate that the Spacelabs OnTrak complies with its predetermined specifications and the applicable standards."
Data provenance is not mentioned. Given the regulatory nature of the submission (510(k)), it would typically be prospective clinical study data if a new clinical trial was undertaken, or extensive bench testing. The primary comparator is the predicate device, implying testing was done to show equivalence. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a blood pressure monitor clinical validation (as per ISO 81060-2), ground truth is typically established by trained observers using a mercury sphygmomanometer or highly accurate reference methods, often with multiple observers following a specific protocol. The qualifications would be highly trained technicians or clinicians. -
Adjudication method for the test set:
This information is not provided. In clinical validation studies of blood pressure monitors, an adjudication method (such as an averaged reading from two trained observers, or a third observer for discrepancy) is commonly used to establish the reference blood pressure. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is an Ambulatory Blood Pressure Monitor, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance testing described is for the standalone device. The Spacelabs OnTrak is an automated system designed to measure blood pressure independently. The "Summary of Performance Testing" for Software, Electrical Safety, EMC, and Bench performance refers to the device's inherent functionality without human intervention for the measurement process itself. The user interaction relates to operating the device (usability standard), not interpreting its output. -
The type of ground truth used:
For the blood pressure measurements, the ground truth for clinical validation (if detailed data were provided, which they are not) would typically be established by simultaneous measurements using a reference method, such as a mercury sphygmomanometer operated by trained personnel, per the requirements of ISO 81060-2. For other aspects like software, electrical safety, etc., the "ground truth" is adherence to the specified technical standards. -
The sample size for the training set:
This device does not utilize a "training set" in the context of machine learning, as it is not an AI/ML-powered device. Its operation is based on established oscillometric principles rather than learned algorithms from a dataset. -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of device.
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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 (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
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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.1 Harforde CourtJohn Tate RoadHertfordSG13 7NWUnited Kingdom |
| Submitter Contact: | Spacelabs Healthcare35301 SE Center StSnoqualmie, WA 98065 |
| Mr. Al Van HoudtSpacelabs HealthcarePhone: +1 (425) 363-5970Fax: +1 (425) 363-5762Email: al.vanhoudt@spacelabs.com | |
| ApplicationCorrespondent: | Thomas KroenkeSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare35301 SE Center StSnoqualmie, WA 98065and/or |
| Spacelabs Healthcare Medical Equipment (SUZHOU) Co., Ltd.Building 30, West WingChuangTou Industrial SquareYang Xian Road, SIPSuzhou, Jiangsu, China 215122 | |
| Trade Name: | Spacelabs Model OnTrak (90227) Ambulatory Blood PressureMonitor |
| Classification Name: | System, Measurement, Blood-pressure, Non-Invasive |
| ClassificationRegulation: | 21 CFR §870.1130 |
| Product Code: | DXN |
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| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | PredicateManufacturer / Model |
|---|---|---|---|
| Spacelabs ModelOnTrak (90227)Ambulatory BloodPressure Monitor | K103732 | Spacelabs Model 90217AAmbulatory BloodPressure (ABP) Monitor | |
| Device Description: | The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure(ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unitdesigned to take non-invasive blood pressure (NIBP) and heart rate(HR) measurements for a 24 hour, 48 hour, or longer period. TheseThe Spacelabs OnTrak does not have any physiological alarms, butdoes have an audible low battery indicator. The Spacelabs OnTrakutilizes 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 bloodpressure and heart rate measurements for a 24 hour, 48 hour, or longerperiod. These measurements are recorded in the monitor and may betransferred 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 PressureRange | 60 to 260 mmHg | Same |
| Diastolic PressureRange | 30 to 200 mmHg | Same |
| Manometer Accuracy | 0 - 260 mmHg:± 2 mmHg ± 1 digit260 - 300 mmHg: ± 3 mmHg ± 1 digit | 0 - 300 mmHg: ± 3 mmHg or2 %, whichever isgreater |
| Maximum CuffPressure in normaloperation | 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. |
| ElectromagneticCompatibility | 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.
§ 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).