(59 days)
No
The description focuses on sensing, recording, and displaying physiological data, with no mention of AI/ML terms or functionalities like analysis beyond basic display and conversion.
No.
The device is described as a physiological data recorder used for understanding body function and quantifiable analysis of temperature or heart rate data, not for treating any condition.
No
The device is described as a "physiological data recorder" that "senses and records physiological data and displays the data on its LCD screen." Its intended use is for "furthering the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable," which focuses on data collection and analysis rather than diagnosis of a condition.
No
The device description explicitly states it is a "physiological data recorder that is worn on the body" and "senses and records physiological data and displays the data on its LCD screen," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the VitalSense XHR is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as measuring physiological body core temperature, skin temperature, and heart rate to understand body function or for quantifiable analysis of this data. This involves measuring parameters within the body or on the body surface, not analyzing samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The device is described as a physiological signal conditioner and data recorder worn on the body. It senses and records physiological data. This aligns with devices that measure vital signs directly from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
- Classification: The device is classified under 21 CFR 882.1845, which is for physiological signal conditioners. This classification is for devices that process physiological signals, not for devices that analyze samples in vitro.
- Predicate Devices: The predicate devices listed (VitalSense and Actiheart) are also devices that measure physiological parameters directly from the body, not IVDs.
In summary, the VitalSense XHR is a device that measures physiological parameters directly from the body, which falls under the category of medical devices used for monitoring or recording vital signs, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
"VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable."
Product codes
GWK
Device Description
"The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. VitalSense XHR is a physiological data recorder that is worn on the body. Up to ten sensor inputs may be used with a single VitalSense XHR recorder. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs."
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
"any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable."
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
"Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent. Accepted and voluntary standards are followed in the design, manufacture, and operation of this product."
"Design verification tests were performed on the Respironics VitalSense XHR as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VitalSense (K033534), Actiheart (K052489)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1845 Physiological signal conditioner.
(a)
Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.(b)
Classification. Class II (performance standards).
0
TAB 3
Ka61870
AUG 3 1 2006
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120
724-387-4206 (fax)
Email: Zita.Yurko@Respironics.com |
| Classification Reference | 21 CFR 882.1845 |
| Product Code | GWK - Physiological Signal Conditioner |
| Common/Usual Name | Physiological Signal Recorder |
| Proprietary Name | Respironics VitalSense XHR |
| Predicate Device(s) | VitalSense (K033534)
Actiheart (K052489) |
| Reason for submission | Modified design. |
Description of Device:
The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. VitalSense XHR is a physiological data recorder that is worn on the body. Up to ten sensor inputs may be used with a single VitalSense XHR recorder. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs.
Intended Use:
VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable.
1
Comparison of Technical Characteristics:
The VitalSense XHR System and the predicate devices are very similar in materials, design, function, and technological characteristics. The software in the predicate device, VitalSense (K033054), was modified to allow display of the heart rate data. No hardware modifications were required for the recorder. Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent. Accepted and voluntary standards are followed in the design, manufacture, and operation of this product.
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- ロ Similar intended use.
- D Same operating principle.
- ロ Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics VitalSense XHR as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 2006.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 2006
Ms. Zita A Yurko Respironics, Inc. Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K061870
Trade/Device Name: VitalSense XHR Regulation Number: 21 CFR 882.1845 Regulation Name: Physiological signal conditioner Regulatory Class: Class II Product Code: GWK Dated: July 31, 2006 Received: August 1, 2006
Dear Ms. Yurko:
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 for association 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 such additional controls. Existing major regulations affecting your device can may or subject to back as basil 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 r that FDA has made a determination that your device complies with other requirements of the Act that 1127 has intates and regulations administered by other Federal agencies. You must or any I odotal states and states and ing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Far 607); advertise (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by country (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Zita A Yurko
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of__1
510(k) Number (if known): K061870
Device Name: Respironics VitalSense XHR
The VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XXXXXX (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Harbacio Brielm
Division of General, Restorative. and Neurological Devices
510(k) Number K061870