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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Summary of Device Performance Study

The provided documentation for the Respironics VitalSense XHR (K061870) describes a submission for a modified device based on a predicate device (VitalSense K033534). The core of the study is a demonstration of substantial equivalence to this predicate device by showing that modifications (primarily to software for heart rate display) have no impact on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria for specific physiological parameters (e.g., accuracy ranges for temperature or heart rate) alongside reported device performance. Instead, it states:

Acceptance Criteria	Reported Device Performance
All tests verified to meet required acceptance criteria as a result of risk analysis and product requirements.	"Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent." "Respironics has determined that the modifications have no impact on the safety and effectiveness of the device."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document refers to "performance tests, risk analysis, and verification and validation testing" but does not give a sample size for human subjects or data points used in these tests.
Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. 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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described. This device is a physiological data recorder, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The documentation implies that "performance tests, risk analysis, and verification and validation testing" were done on the device itself. Given that it's a physiological recorder, its performance fundamentally relates to its ability to accurately sense and record data in a standalone manner. However, specific details of these "performance tests" are not provided. The focus is on the substantial equivalence of the modified software within the existing hardware.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. The document implies that the device's measurements (body core temperature, skin temperature, heart rate) are considered the "truth" for the purpose of demonstrating substantial equivalence to the predicate device. It's likely that established measurement standards or comparison to other validated devices would serve as the ground truth during performance testing, though this is not detailed.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physiological recorder, not an AI/ML device that requires a training set in the typical sense. The software modification described (allowing heart rate display) would not involve a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as no training set for AI/ML is described.

In summary:

The submission for the VitalSense XHR focuses on demonstrating substantial equivalence to an existing predicate device after a software modification. The provided text outlines a regulatory submission process rather than a detailed scientific study with quantitative performance metrics, test set descriptions, or expert involvement in establishing ground truth for a diagnostic algorithm. The "acceptance criteria" are broad statements about meeting regulatory requirements and ensuring the modifications have no impact on safety and effectiveness, rather than specific numerical targets for physiological measurement accuracy.

Summary

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TAB 3

Ka61870

AUG 3 1 2006

510(K) SUMMARY OF SAFETY & EFFECTIVENESS

Official Contact	Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	724-387-4120724-387-4206 (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:

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.

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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.

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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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Regulation Number and Section

§ 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).