The Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series therapy devices (BiPAP AVAPS and BiPAP S/T) to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry Module may be used in a hospital or home care environment.

The Respironics BiPAP C Series Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C Series Ventilatory System may be used in the hospital or home.

Device Description

The BiPAP AVAPS C Series device with Oximetry provides access to patient therapy information through the two-way transfer of data between patient devices and clinicians through the appropriate software including therapy efficacy and device setting as requested by the attending physician.

The Respironics Oximetry Module is designed for use with Respironics BiPAP AVAPS C Series and Respironics BiPAP S/T C Series flow generators to help the clinician monitor the end user's sleep and ensure that optimal treatment is provided.

When connected to the flow generator, the Oximetry module records treatment and pulse oximetry data during therapy. The data is stored on a secure digital card. After treatment, the secure digital card containing the data can be removed from the device and sent to the clinician for review.

Both Respironics BiPAP C-Series with Oximetry Module devices are microprocessor controlled blower based positive pressure systems with integrated heated humidifier, like the predicate cleared in K092818. The Respironics BiPAP C-Series System with Oximetry Module also delivers two positive pressure levels (IPAP/EPAP), like the predicate cleared in K092818. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. In addition, the BiPAP C-Series System includes CPAP mode in which a fixed pressure is delivered. Four bi-level operating modes, S, S/T, T & PC, are also offered which determine how the changes between IPAP and EPAP pressure are made. All therapy modes are unchanged from the previously cleared K092818.

A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters. The therapy device will provide the following indications as to the status of the Oximetry module.

The BiPAP C-Series with Oximetry System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable. (Unchanged from K092818) These alarms are specific to the ventilator and are not related to oximetry measurements.

Like its predicates, the BiPAP C-Series with Oximetry System is intended for use with a patient circuit that is used to connect the device.to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 19mm tubing, an exhalation device, and a patient interface device.

Device Modifications:

Modifications to the BiPAP AVAPS and BiPAP S/T C Series Ventilatory devices consist of the following:

Revised labeling (Refer to the request for Additional Information Packet 1, Attachment A) .
Updated BiPAP C Series software to enable the flow generator and Link module to . communicate and to provide additional display messages of the flow generator LCD to provide feedback to the use on correct connection of the Link Module
Inclusion of the Oximetry Module System (used as an accessory to the previously cleared . BiPAP C Series Devices, K092818) is a device designed for use with BiPAP C Series Devices to aid the clinician/provider in monitoring oximetry data during therapy. The data is displayed real time and stored on a memory card (SD Card). The SD Card containing the data can be removed from the Oximetry Module System device and sent to a clinician/provider for review.

The Oximetry Module System consists of the:

Nonin® Xpod® Oximeter Cable t
Nonin® Oximeter Sensor .
Philips Respironics Link Module ●
Carrying Case t
SD Card and Mailer .

· Link Module is a communication device that attaches to the BiPAP C Series device and collects oximetry data. The module transfers information to and from the Nonin oximeter sensor and the device via a data card and card reader.

· SD Card is a portable memory card that carries information from one data transfer device to another. In this system, the data card is a Secure Digital (SD) card that carries therapy information between the Link module on the BiPAP C Series device and the Encore and Direct View Series software.

· Nonin Oximetry cable and sensors provide a non-invasive measurement of the oxygen saturation levels of hemoglobin.

The BiPAP C Series device with Oximetry Module System provides access to patient therapy information through the two-way transfer of data between patient devices, the Link Module and both Encore and DirectView Patient Management Software (patient data management software).

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) summary for a medical device (Philips Respironics BiPAP C Series with Oximetry Module System) and primarily focuses on establishing substantial equivalence to predicate devices.

It states that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." and "The Respironics BiPAP C-Series with Oximetry System met the required performance criteria and functioned as intended." However, it does not provide the specific acceptance criteria themselves, nor the detailed results of the studies proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated. The document refers to "required acceptance criteria" and "applicable standards" but does not list them.
Reported Device Performance: The document generally states that the device "met the required performance criteria and functioned as intended." Specific performance metrics (e.g., accuracy for SpO2 or pulse rate, or detailed ventilatory performance statistics) are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified in the provided text. The document refers to "Design verification tests" but no sample sizes or data provenance are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic decision-making). This device is a ventilatory support system with an oximetry module, and its performance evaluation would likely involve engineering tests against known standards or reference devices, not expert consensus on medical images/diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Similar to point 3, this is generally for studies requiring human interpretation and consensus building.

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

Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It's a continuous ventilator with an oximetry module.

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

The device itself is a standalone medical device that performs its intended functions (ventilatory support, oximetry measurement). The "Design verification tests" would have evaluated its standalone performance against specifications. However, the details of these tests are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the oximetry module, the ground truth for SpO2 and pulse rate measurements would likely be established by comparison to co-oximetry (blood gas analysis) or a precisely controlled testing setup with known oxygen saturation levels and pulse rates.
For the ventilatory functions, ground truth would involve testing against known pressure, flow, and volume measurements from calibrated test lung systems or simulators.
These specific ground truth methods are not detailed in the provided text, only implied by adherence to standards.

8. The sample size for the training set

Not applicable. This device is hardware and embedded software, not a machine learning model that requires a training set in the conventional sense. Its "training" would be the engineering design and development process.

9. How the ground truth for the training set was established

Not applicable, as there's no "training set" in the context of AI/ML.

In summary, while the document confirms that design verification tests were conducted and met acceptance criteria, it lacks the specificity regarding the criteria, methodologies, and results that you are requesting. This is common for 510(k) summaries, which aim to establish substantial equivalence rather than provide exhaustive study details. Manufacturers typically have detailed V&V (Verification and Validation) reports that contain this information, but they are not usually included in the public 510(k) summary.

Summary

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510(k) Summary

MAR 2 4 2011

Administrative Information and Device Identification

Name and address of the manufacturerand sponsor of the 510(k) submission:	Manufacturer:Philips Respironics1001 Murry Ridge LaneMurrysville, PA 15668Fax: (724) 387-4216Sponsor:Philips Respironics1740 Golden Mile HighwayMonroeville, PA 15146Office: 724-387-7562Fax: 724-387-7490
FDA registration number of themanufacturer of the new device:	2518422
Official contact person for allcorrespondence:	Elaine LarkinRegulatory Affairs EngineerPhilips Respironics1740 Golden Mile HighwayMonroeville, PA 15146Office: 724-387-5350Fax: 724-387-7490Email: elaine.larkin@philips.com
Classification Reference	21 CFR 868.5895a) Identification . A continuous ventilator(respirator) is a device intended to mechanicallycontrol or assist patient breathing by delivering apredetermined percentage of oxygen in thebreathing gas. Adult, pediatric, and neonatalventilators are included in this generic type ofdevice.(b) Classification . Class II (performance standards).MNS – ventilator, continuous, non-life supporting
Panel Code:	MNS – ventilator, continuous, non-life supporting
Classification Panel:	Anesthesiology
Common/Usual Name	Ventilatory Support System

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Proprietary name of new device:	Philips Respironics BiPAP C Series (BiPAPAVAPS – BiPAP S/T) with Oximetry ModuleSystem
Predicate Device Name(s) and 510(k)numbers:	1. Respironics BiPAP AVAPS VentilatorySupport System (cleared under K092818 –date of concurrence: January 22, 2010).
	2. DeVilbiss DV5M SmartLink System(cleared under K082209 – date ofconcurrence: October 28, 2008).
	3. Resmed S7 Elite and AutoSet Spirit CPAPSystems with ResLink (cleared underK024191 – date of concurrence: July 7,2003).
Reason for submission:	Device modifications and additional accessories

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Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

O Same intended use.
D Same operating principle.
O Same technology.
O Same manufacturing process.

Design verification tests were performed on the Respironics BiPAP AVAPS C Series System 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 d scribed 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. (See Section 8.0 Substantial Equivalence Discussion of the original submittal, K102465)

Intended Use

Device Description

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Device Modifications:

Modifications to the BiPAP AVAPS and BiPAP S/T C Series Ventilatory devices consist of the following:

Revised labeling (Refer to the request for Additional Information Packet 1, Attachment A) .
Updated BiPAP C Series software to enable the flow generator and Link module to . communicate and to provide additional display messages of the flow generator LCD to provide feedback to the use on correct connection of the Link Module
Inclusion of the Oximetry Module System (used as an accessory to the previously cleared . BiPAP C Series Devices, K092818) is a device designed for use with BiPAP C Series Devices to aid the clinician/provider in monitoring oximetry data during therapy. The data is

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displayed real time and stored on a memory card (SD Card). The SD Card containing the data can be removed from the Oximetry Module System device and sent to a clinician/provider for review.

The Oximetry Module System consists of the:

Nonin® Xpod® Oximeter Cable t
Nonin® Oximeter Sensor .
Philips Respironics Link Module ●
Carrying Case t
SD Card and Mailer .

· Nonin Oximetry cable and sensors provide a non-invasive measurement of the oxygen saturation levels of hemoglobin.

Non-Clinical Testing:

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The Respironics BiPAP C-Series with Oximetry System was designed and tested according to guidance outlined in:

FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993);
FDA's Draft Reviewer Guidance for Ventilators July 1995; and
FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch;

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Division of Cardiovascular, Respiratory, and Neurological Devices" the Respironics BiPAP C-Series with Oximetry System was tested in accordance with the applicable voluntary standards. The BiPAP C-Series with Oximetry System met the required performance criteria and functioned as intended.

See Section 16.7 Traceability Analysis provided with the original submittal (K102465), Response # 2, Verification and Validation Testing Documentation, included with this request for additional information packet, Section 9.3 Electromagnetic Compatibility and Electrical Safety provided with the original submittal (K102465), and Attachment A - BiPAP C-Series with Oximetry System Product Requirements Document provided with the original submittal (K102465).

Statement of Safety and Effectiveness:

Analysis of comparison of design, function and features of the BiPAP C-Series with Oximetry System to the Respironics BiPAP AVAPS device (K092818), the DeVilbiss DV5M SmartLink System (K082209) and ResMed S7Elite and AutoSet Spirit CPAP Systems with ResLink (K024191): together with the results of testing demonstrates the device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended.

Conclusion:

The Respironics BiPAP C-Series with Oximetry System is substantially equivalent to the predicate devices listed in this Summary and the device, as changed, does not raise any new issues of safety and effectiveness.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Elaine Larkin Regulatory Affairs Engineer Respironics, Incorporated . 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

MAR 2 4 201

Re: K102465

Trade/Device Name: BiPAP AVAPS with Oximetry Module Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: March 18, 2011 Received: March 21, 2011

Dear Ms. Larkin:

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.

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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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.

Sincerely vours.

hr for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 6.0 Indications for Use

Indications for Use

510(k) Number (if known): _

Device Name: BiPAP AVAPS with Oximetry Module

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K102465
Page 1 of 1

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).