Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.

Device Description

The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.

AI/ML Overview

The provided text is a 510(k) Summary for the "Respiration Data Management Software." It highlights the device's indications for use and its substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document focuses on:

Software Verification and Validation: Stating that it was conducted according to FDA guidance.
Cybersecurity: Stating that it was considered and evaluated according to FDA guidance.
Comparison to Predicate Device: Detailing similarities and differences in functionality, compatible devices, and communication mediums, and asserting that differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2025

BMC Medical Co., Ltd. Amy Wang Regulatory Affairs Specialist Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road Fengtai District Beijing, 100073 China

Re: K242935

Trade/Device Name: Respiration Data Management Software Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 13, 2024 Received: December 13, 2024

Dear Amy Wang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242935 Device Name

Respiration Data Management Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name	Respiration Data Management Software
Model	PAP Link PC
Common/Usual Name	Respiration Data Management Software
Date Prepared	September 25, 2024
Sponsor Identification	BMC Medical Co., Ltd.Room 10, 17F, Building 4, Huiya Plaza, No.16Lize Road, Fengtai District, 100073 Beijing,PEOPLE'S REPUBLIC OF CHINA
Submission Correspondent	Amy WangBMC Medical Co., Ltd.Phone 86-18701556244Fax 86-22-82939881Email wangliping@bmc-medical.com
Establishment Registration #	3008566132BMC Medical Co., Ltd.Room 10, 17F, Building 4, Huiya Plaza, No.16 LizeRoad, Fengtai District, 100073 Beijing, PEOPLE'SREPUBLIC OF CHINA
Classification	Class II Device (21 CFR 868.5905)
Classification Name	Noncontinuous ventilator
Classification Panel	Medical Device
Products Code	BZD, MNS
Medical Specialties	Anesthesiology
Predicate Device(s)	ResScan (K140054)
Reason for Submission:	New Device

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Indications for Use Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only. Device Description The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff

to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.

Substantial Equivalence:

The subject and predicate devices are substantially equivalent in the following aspects:

Same Indications for Use
Similar operating principle
Similar technological characteristics

Comparison of Technological Characteristics with the Predicate Device:

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	Subject Device	Predicate Device
	Respiration DataManagementSoftware (K242935)	ResScan(K140054)	Comparison
Classification
DeviceClassification	Class II Device	Class II Device	Equivalent
ClassificationPanel	Anesthesiology	Anesthesiology	Equivalent
RegulationNumber&ProductCode	21 CFR 868.5905, BZDNon continuous ventilator21 CFR 868.5895, MNSContinuous Ventilator	21 CFR 868.5905, BZDNon continuous ventilator21 CFR 868.5895, MNSContinuous Ventilator21 CFR 868.5895, MNTContinuous Ventilator21 CFR 868.5895, CBKVentilator, continuous,facility use	The regulation number &product code depends on thecompatible devices. Both thesubject device and predicatedevice are compatible withBZD and MNS devices. Thepredicate device includes morecompatible product codes. Thisdifference does not raise newrisks to the subject device.
RegulationName	Noncontinuous ventilator	Noncontinuous ventilator	Equivalent
Intended Use and Indications for Use
Intended Use ofthe Device	RespirationDataManagement Software isinstalled in a computerto perform patientmanagement bytreatment data viewing,treatment data reportingand remotely adjustingthe prescribedcompatible BMC CPAPand BPAP devices'settings. It is intendedfor healthcareprofessionals inhealthcare facilities useonly.	ResScan is intended toaugment the standardfollow-up care of patientsby providing transfer ofmachine and therapeuticinformation. This includesthe ability to remotelychange settings in non-lifesupport devices only.It is intended to be usedby Clinicians inconjunction with ResMedcompatible therapydevices, using ResMed'sproprietarycommunications protocol.	Equivalent
Environment ofUse	Professional healthcarefacilities	Professional healthcarefacilities	Equivalent
PatientPopulation	Not for patient use. Forhealthcare professionalsuse only.	Not for patient use. Forhealthcare professionalsuse only.	Equivalent
Performance
ApplicationType	PC-based softwareprogram	PC-based softwareprogram	Equivalent
OperatingSystem	Microsoft Windows	Microsoft Windows	Equivalent
Functionality	Display of therapy dataGenerate reportsSettings managementPatient managementUpload Data	Display of therapy dataGenerate reportsSettings managementPatient management	Most functions of thesubject device areequivalent to the predicatedevice. The subject deviceincludes a data uploadfunction than the predicatedevice. Users can uploadthe data to the cloudplatform (K160127).Software V&V testing andcybersecurity testingdemonstrates safety andeffectiveness of thisfunction.
Compatible flowgenerators	BMC compatibletherapy devices (BZD,MNS)	ResMed compatibletherapy devices (BZD,MNS, MNT and CBK)	Both the subject deviceand predicate device arecompatible with thedevices with BZD andMNS product codes. Thepredicate device includesmore compatible productcodes. This differencedoes not raise new risksto the subject device.
Communicationmedium	Serial connectionRemovable mediumWireless medium(TCP/HTTPS)	Serial connectionRemovable medium	The subject device canwirelessly upload data tothe cloud platform(K160127), as well asdownload the softwareupgrade package from thecloud platform. SoftwareV&V testing andcybersecurity testingdemonstrates safety andeffectiveness of thesefunctions.
Patientinformation	Mask LeakAHIPressureMinute VentilationRespiratory rate	Mask LeakAHIPressureMinute VentilationRespiratory rate	Equivalent
Range forpatientparameters	Depends on thecompatible CPAP devices	Depends on the compatibleCPAP devices	Equivalent
Changeablesettings	Initial PressureSet PressureRamp timeHumidifier level	Start PressureSet PressureRamp timeSetting time	Equivalent. Remotesetting changefunctionality only appliesto non-life supportdevices. Changeablesettings of the subjectdevice and the predicatedevice are similar.Difference does not raisenew risks.
Changeablesetting range	Depends on thecompatible CPAP devices	Depends on the compatibleCPAP devices	Equivalent

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510(K) Summary

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510(K) Summary

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Non-Clinical Data

The following non-clinical data were used in support of the substantial equivalence determination.

Software Verification and Validation

Software verification and validation were conducted and documentation was provided in accordance with FDA's Guidance "Content of Premarket Submissions for Device Software Functions".

Cybersecurity

Cybersecurity was considered and evaluated in accordance with FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".

Conclusion

The subject device Respiration Data Management Software has the same intended use and similar technological characteristics as the predicate device. Differences in the technological characteristics between the subject device and predicate device do not raise new/different questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).