(112 days)
No
The description focuses on data management, analysis, reporting, and remote device adjustment, with no mention of AI, ML, or related concepts. The performance studies section only mentions software verification/validation and cybersecurity.
No.
The software manages respiration data and adjusts settings of compatible CPAP/BPAP devices, but it does not directly treat or diagnose a patient's condition.
No
The software is for managing and adjusting settings of CPAP/BPAP devices and analyzing respiration data, not for making a diagnosis itself. It assists in patient management and follow-up, which is a post-diagnosis activity.
Yes
The device description explicitly states "The Respiration Data Management Software is a softwareonly device". The summary focuses on software verification, validation, and cybersecurity, with no mention of hardware components or their testing.
Based on the provided information, 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 Respiration Data Management Software manages and analyzes respiration data from compatible CPAP and BPAP devices. It does not perform tests on biological samples. Its primary functions are data viewing, reporting, remote device setting adjustments, and data storage.
- Intended Use: The intended use is for healthcare professionals to manage patients by viewing and reporting treatment data and adjusting device settings. This is related to managing a patient's respiratory therapy, not diagnosing a condition through laboratory testing.
Therefore, the device falls outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
BZD, MNS
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.
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 for patient use. For healthcare professionals use only.
Intended User / Care Setting
It is intended for healthcare professionals in healthcare facilities use only.
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)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
K242935 Device Name
Respiration Data Management Software
Indications for Use (Describe)
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.
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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4
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.16 | |
| Lize Road, Fengtai District, 100073 Beijing, | |
| PEOPLE'S REPUBLIC OF CHINA | |
| Submission Correspondent | Amy Wang |
| BMC Medical Co., Ltd. | |
| Phone 86-18701556244 | |
| Fax 86-22-82939881 | |
| Email wangliping@bmc-medical.com | |
| Establishment Registration # | 3008566132 |
| BMC Medical Co., Ltd. | |
| Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize | |
| Road, Fengtai District, 100073 Beijing, PEOPLE'S | |
| REPUBLIC 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:
6
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Respiration Data | |||
| Management | |||
| Software (K242935) | ResScan | ||
| (K140054) | Comparison | ||
| Classification | |||
| Device | |||
| Classification | Class II Device | Class II Device | Equivalent |
| Classification | |||
| Panel | Anesthesiology | Anesthesiology | Equivalent |
| Regulation | |||
| Number& | |||
| Product | |||
| Code | 21 CFR 868.5905, BZD | ||
| Non continuous ventilator | |||
| 21 CFR 868.5895, MNS | |||
| Continuous Ventilator | 21 CFR 868.5905, BZD | ||
| Non continuous ventilator | |||
| 21 CFR 868.5895, MNS | |||
| Continuous Ventilator | |||
| 21 CFR 868.5895, MNT | |||
| Continuous Ventilator | |||
| 21 CFR 868.5895, CBK | |||
| Ventilator, continuous, | |||
| facility use | The regulation number & | ||
| product code depends on the | |||
| compatible devices. Both the | |||
| subject device and predicate | |||
| device are compatible with | |||
| BZD and MNS devices. The | |||
| predicate device includes more | |||
| compatible product codes. This | |||
| difference does not raise new | |||
| risks to the subject device. | |||
| Regulation | |||
| Name | Noncontinuous ventilator | Noncontinuous ventilator | Equivalent |
| Intended Use and Indications for Use | |||
| Intended Use of | |||
| the Device | 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. | ResScan is intended to | ||
| augment the standard | |||
| follow-up care of patients | |||
| by providing transfer of | |||
| machine and therapeutic | |||
| information. This includes | |||
| the ability to remotely | |||
| change settings in non-life | |||
| support devices only. | |||
| It is intended to be used | |||
| by Clinicians in | |||
| conjunction with ResMed | |||
| compatible therapy | |||
| devices, using ResMed's | |||
| proprietary | |||
| communications protocol. | Equivalent | ||
| Environment of | |||
| Use | Professional healthcare | ||
| facilities | Professional healthcare | ||
| facilities | Equivalent | ||
| Patient | |||
| Population | Not for patient use. For | ||
| healthcare professionals | |||
| use only. | Not for patient use. For | ||
| healthcare professionals | |||
| use only. | Equivalent | ||
| Performance | |||
| Application | |||
| Type | PC-based software | ||
| program | PC-based software | ||
| program | Equivalent | ||
| Operating | |||
| System | Microsoft Windows | Microsoft Windows | Equivalent |
| Functionality | Display of therapy data | ||
| Generate reports | |||
| Settings management | |||
| Patient management | |||
| Upload Data | Display of therapy data | ||
| Generate reports | |||
| Settings management | |||
| Patient management | Most functions of the | ||
| subject device are | |||
| equivalent to the predicate | |||
| device. The subject device | |||
| includes a data upload | |||
| function than the predicate | |||
| device. Users can upload | |||
| the data to the cloud | |||
| platform (K160127). | |||
| Software V&V testing and | |||
| cybersecurity testing | |||
| demonstrates safety and | |||
| effectiveness of this | |||
| function. | |||
| Compatible flow | |||
| generators | BMC compatible | ||
| therapy devices (BZD, | |||
| MNS) | ResMed compatible | ||
| therapy devices (BZD, | |||
| MNS, MNT and CBK) | Both the subject device | ||
| and predicate device are | |||
| compatible with the | |||
| devices with BZD and | |||
| MNS product codes. The | |||
| predicate device includes | |||
| more compatible product | |||
| codes. This difference | |||
| does not raise new risks | |||
| to the subject device. | |||
| Communication | |||
| medium | Serial connection | ||
| Removable medium | |||
| Wireless medium | |||
| (TCP/HTTPS) | Serial connection | ||
| Removable medium | The subject device can | ||
| wirelessly upload data to | |||
| the cloud platform | |||
| (K160127), as well as | |||
| download the software | |||
| upgrade package from the | |||
| cloud platform. Software | |||
| V&V testing and | |||
| cybersecurity testing | |||
| demonstrates safety and | |||
| effectiveness of these | |||
| functions. | |||
| Patient | |||
| information | Mask Leak | ||
| AHI | |||
| Pressure | |||
| Minute Ventilation | |||
| Respiratory rate | Mask Leak | ||
| AHI | |||
| Pressure | |||
| Minute Ventilation | |||
| Respiratory rate | Equivalent | ||
| Range for | |||
| patient | |||
| parameters | Depends on the | ||
| compatible CPAP devices | Depends on the compatible | ||
| CPAP devices | Equivalent | ||
| Changeable | |||
| settings | Initial Pressure | ||
| Set Pressure | |||
| Ramp time | |||
| Humidifier level | Start Pressure | ||
| Set Pressure | |||
| Ramp time | |||
| Setting time | Equivalent. Remote | ||
| setting change | |||
| functionality only applies | |||
| to non-life support | |||
| devices. Changeable | |||
| settings of the subject | |||
| device and the predicate | |||
| device are similar. | |||
| Difference does not raise | |||
| new risks. | |||
| Changeable | |||
| setting range | Depends on the | ||
| compatible CPAP devices | Depends on the compatible | ||
| CPAP devices | Equivalent |
7
510(K) Summary
8
510(K) Summary
9
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.