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K Number
K242935
Device Name
Respiration Data Management Software (PAP Link PC)
Manufacturer
BMC Medical Co., Ltd.
Date Cleared
2025-01-15

(112 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
K160127,K140054
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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.

§ 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).