(44 days)
No
The description focuses on standard oscillometric blood pressure measurement and data storage/transfer, with no mention of AI or ML algorithms. The NIBP and HR algorithms are explicitly stated to be identical to the predicate device.
No.
The device is described as a monitor that takes and records blood pressure and heart rate measurements; it does not mention treatment or therapy.
Yes
The device is intended to take physiological measurements (blood pressure and heart rate) over an extended period which can then be transferred to analysis systems, supporting the diagnosis of conditions related to these measurements.
No
The device description clearly outlines hardware components such as a pressure sensor, analog to digital converter, microprocessor, pump, vent valve, batteries, and a physical unit carried in a pouch with a blood pressure cuff.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is designed to take non-invasive blood pressure and heart rate measurements directly from the patient's arm using a cuff. It does not analyze samples taken from the body.
The device is a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's arm
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
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Road | |||
| Hertford, SG13 7NW United Kingdom | |||
| Submitter Contact: | Mr. Roger Moldon | ||
| Quality Manager | |||
| Spacelabs Healthcare Ltd. | |||
| 1 Harforde Court, John Tate Road | |||
| Hertford, SG13 7NW United Kingdom | |||
| +011 (44) 1992-507730 | |||
| roger.moldon@spacelabs.com | |||
| Official Contact: | Thomas Kroenke | ||
| Principal Consultant | |||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | Spacelabs Healthcare Ltd. | ||
| 1 Harforde Court, John Tate Road | |||
| 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 | |||
| Regulation: | 21 CFR §870.1300 | ||
| Product Code: | DXN | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Spacelabs Model 90217A | |||
| Ambulatory Blood | |||
| Pressure (ABP) Monitor | K855127 | Spacelabs Ambulatory | |
| Blood Pressure Monitor | |||
| Spacelabs #90202 |
Page I of 3
1
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 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. |
| 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. |
| Technology
Comparison: | The Model 90217A employs the same technological characteristics as
the predicate devices take non-invasive blood pressure (NIBP) and
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.
Test results indicated that the Model 90217A complies with its predetermined specification and with the applicable Standards. |
| Electromagnetic
Compatibility
Testing | 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. |
2
510(k) Premarket Notification Spacelabs Healthcare Ltd. Spacelabs Model 90217A ABP Monitor 510(k) Summary .
Summary of Performance Testing:
3
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.
. . . . . . . . . . . . .
1
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.
4
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
5
. 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