(44 days)
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.
The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (Model 90217A) 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 Model 90217A allows the use of an automated or manual inflation system, and utilizes the oscillometric NIBP measurement method. The pressure sensor signal is amplified, digitized by an analog to digital converter (ADC), and supplied to a microprocessor which has control of the pump and vent valve. Measurements are made during the stepwise deflation of the cuff. The Model 90217A NIBP and HR algorithms are identical to that of the predicate. Additionally, the NIBP patient cuffs used with the Model 90217A are the same as those used with the predicate. A block diagram of the Model 90217A is presented in Figure 2.
The Model 90217A is powered by three (3) "AA" alkaline or rechargeable NiCad batteries; there is no capability to connect the Model 90217A to AC mains power. A lithium battery is used to provide backup power for the Model 90217A memory. Both battery types need to be periodically replaced.
The Model 90217A is carried in a pouch that is strapped and/or belted to the side of the patient. NIPB and HR measurements are taken using a blood pressure cuff attached to the patients arm. This information is recorded in the monitor, and can be transferred over a modem link, or by direct connection, between the Model 90217A and one of the ABP analysis systems.
The provided text describes the Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor and its 510(k) premarket notification. However, it does not contain the specific details required to fully address all components of your request, particularly regarding acceptance criteria, the study design (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies.
The document indicates that "Performance Testing" was conducted in accordance with applicable standards and that the device "complies with its predetermined specification." This implies that acceptance criteria were met, but the specific criteria and the detailed performance results are not provided in the summary.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Information Missing: The document states that performance testing was done and that the device "complies with its predetermined specification." However, it does not provide a table specifying the acceptance criteria (e.g., accuracy, precision targets) or the detailed reported device performance against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
Information Missing: The document states that "Performance Testing" was conducted, but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Information Missing: This device is a blood pressure monitor, and the ground truth for blood pressure measurements is typically established by another, often invasive or highly calibrated, measurement method, not usually by "experts" in the sense of image interpretation. The document does not specify how ground truth was established for performance testing, nor does it mention any experts involved in defining ground truth.
4. Adjudication Method for the Test Set
Information Missing: As there is no mention of "experts" or a consensus process for ground truth establishment for a blood pressure monitor, an adjudication method is not applicable and is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human interpretation is a primary component. The device is an automated blood pressure monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes (Implied): The device is an "Ambulatory Blood Pressure (ABP) Monitor" that "takes non-invasive blood pressure (NIBP) and heart rate (HR) measurements" and records them. It utilizes "oscillometric NIBP measurement method" and its "NIBP and HR algorithms are identical to that of the predicate." This description strongly suggests that the device operates in a standalone manner, with the algorithm performing the measurements without human intervention during the measurement process. The "Performance Testing" mentioned would assess this standalone performance.
7. Type of Ground Truth Used
Information Missing (Specifics): While not explicitly stated, for a non-invasive blood pressure measurement device, the implied ground truth for performance testing would typically be simultaneous measurements from a highly accurate reference standard, such as an intra-arterial blood pressure monitor or another highly validated non-invasive reference device. The document does not explicitly state the specific type of ground truth used.
8. Sample Size for the Training Set
Information Missing: The document states that the "NIBP and HR algorithms are identical to that of the predicate." This suggests that the algorithms themselves might not have undergone new "training" for this specific device, but rather are adopted from the predicate. If any new training was done, the sample size for the training set is not mentioned.
9. How the Ground Truth for the Training Set Was Established
Information Missing: Given the statement that the algorithms are identical to the predicate, detailed information on how ground truth was established for the original training of those algorithms (if applicable) is not provided. If new training was performed for this device, then the method for establishing ground truth for the training set is not mentioned.
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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.1 Harforde Court, John Tate RoadHertford, SG13 7NW United Kingdom | ||
| Submitter Contact: | Mr. Roger MoldonQuality ManagerSpacelabs Healthcare Ltd.1 Harforde Court, John Tate RoadHertford, SG13 7NW United Kingdom+011 (44) 1992-507730roger.moldon@spacelabs.com | ||
| Official Contact: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 | ||
| Manufacturing Site: | Spacelabs Healthcare Ltd.1 Harforde Court, John Tate RoadHertford, 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 | ||
| ClassificationRegulation: | 21 CFR §870.1300 | ||
| Product Code: | DXN | ||
| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Spacelabs Model 90217AAmbulatory BloodPressure (ABP) Monitor | K855127 | Spacelabs AmbulatoryBlood Pressure MonitorSpacelabs #90202 |
Page I of 3
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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)Monitor (Model 90217A) is a small, lightweight unit designed to takenon-invasive blood pressure (NIBP) and heart rate (HR) measurementsfor a 24 hour, 48 hour, or longer period. These measurements arerecorded in the monitor and may be transferred to Spacelabs ABPanalysis systems. |
|---|---|
| The Model 90217A allows the use of an automated or manual inflationsystem, and utilizes the oscillometric NIBP measurement method. Thepressure sensor signal is amplified, digitized by an analog to digitalconverter (ADC), and supplied to a microprocessor which has controlof the pump and vent valve. Measurements are made during thestepwise deflation of the cuff. The Model 90217A NIBP and HRalgorithms are identical to that of the predicate. Additionally, the NIBPpatient cuffs used with the Model 90217A are the same as those usedwith the predicate. A block diagram of the Model 90217A is presentedin Figure 2. | |
| The Model 90217A is powered by three (3) "AA" alkaline orrechargeable NiCad batteries; there is no capability to connect theModel 90217A to AC mains power. A lithium battery is used to providebackup power for the Model 90217A memory. Both battery types needto be periodically replaced. | |
| The Model 90217A is carried in a pouch that is strapped and/or beltedto the side of the patient. NIPB and HR measurements are taken using ablood pressure cuff attached to the patients arm. This information isrecorded in the monitor, and can be transferred over a modem link, orby direct connection, between the Model 90217A and one of the ABPanalysis systems. | |
| Intended Use: | The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP)Monitor is a small, lightweight unit designed to take blood pressure andheart rate measurements for a 24 hour, 48 hour, or longer period. Thesemeasurements are recorded in the monitor and may be transferred toSpacelabs ABP analysis systems. |
| TechnologyComparison: | The Model 90217A employs the same technological characteristics asthe predicate devices take non-invasive blood pressure (NIBP) andheart 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.Test results indicated that the Model 90217A complies with its predetermined specification and with the applicable Standards. |
| ElectromagneticCompatibilityTesting | The Model 90217A was tested for EMC in accordance with applicable Standards.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.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.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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes above a wavy line.
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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 (800) 638-2041 or (301) 796-7100 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
§ 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).