(109 days)
No
The summary describes a software application for monitoring and adjusting flow generator settings, with no mention of AI or ML technologies. The focus is on real-time data display and remote control within a clinical setting.
No.
The device is a software application that allows clinicians to control and monitor flow generators, but it does not directly provide a therapeutic effect to a patient.
No
The device primarily displays real-time data and allows for setting changes on flow generators, not to diagnose a patient's medical condition. It facilitates monitoring and adjustment, which aids in treatment and management rather than diagnosis.
Yes
The device is explicitly described as a "PC-based software application" and its function is to interact with existing hardware (flow generators and PSG systems) through communication protocols and data transfer, without including any new hardware components itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the software as being used by clinicians with flow generators to display real-time data, provide setting changes, and transfer data to a polysomnograph system. This is related to monitoring and controlling a medical device used for respiratory therapy, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its function as a PC-based software for monitoring and adjusting flow generator settings and transferring data to a PSG system. Again, this is not the function of an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
The device is a software application that interacts with and controls a medical device (flow generator) and integrates with a polysomnograph system. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TxControl™ is a software application intended to be used by clinicians with ResMed flow generators that incorporate ResMed’s proprietary communication protocol. TxControl provides real-time data display directly from the flow generator or via ResControl II™.
TxControl can also provide flow generator setting changes, remotely within a clinical environment.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
ResMed’s TxControl™ is a PC-based software application that enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control raom within the sleep lab clinical setting.
TxControl is also designed to transfer data from a CPAP or bilevel flow generator to a polysomnograph (PSG) display system such as Somnologica (K971813) when used in conjunction with a ResControl II device The performance and functional characteristics of the TxControl includes similar user friendly features of the predicate device, ResControl II (K040944).
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 Found
Intended User / Care Setting
clinicians, clinical environment, sleep lab clinical setting
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)
Design and Verification activities were performed on the TxControl as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ResControl II (K040944)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Somnologica (K971813)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary - TxControl
Date Prepared
10" September 2007
K072615
page 1 of 2
| Official Contact | Dr Lionel King
V.P., Quality Assurance & Regulatory Affairs
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista, NSW 2153
Australia
Tel: +61 (2) 8884 1000
Fax: +61 (2) 8884 2021 | JAN - 4 2008 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | 73 BZD | |
| Common/Usual Name | Noncontinuous ventilator (IPPB). | |
| Proprietary Name | TxControl | |
| Predicate Device(s) | ResControl II (K040944) | |
1
Intended Use
The TxControl™ is a software application intended to be used by clinicians with ResMed flow generators that incorporate ResMed's proprietary communication protocol. TxControl provides real-time data display directly from the flow generator or via ResControl IITM.
TxControl can also provide flow generator setting changes, remotely within a clinical environment.
Device Description
ResMed's TxControl™ is a PC-based software application that enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control raom within the sleep lab clinical setting.
TxControl is also designed to transfer data from a CPAP or bilevel flow generator to a polysomnograph (PSG) display system such as Somnologica (K971813) when used in conjunction with a ResControl II device The performance and functional characteristics of the TxControl includes similar user friendly features of the predicate device, ResControl II (K040944).
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- ﺮ Similar intended use
- ﺎ ﺧ Similar operating principle
- r Similar technologies
- Simplified manufacturing process r
Design and Verification activities were performed on the TxControl as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMd has determined that the new device is Substantially Equivalent to the predicate device. The transfer of ResControl II hardware features to the TxControl software application has not alter of the transic of the council of the primarily in the management of patients with Obstructive Sleep Apnea (OSA). The new device corplies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995) ﺮ ﻣ
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices r (May 11, 2005)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999) ﺮ
- FDA Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) ﺮ Software (January 14, 2005)
10th September, 2007
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
JAN - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed, Limited C/O Mr. David D'Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K072615
Trade/Device Name: TxControlTM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 18, 2007 Received: December 26, 2007
Dear Mr. D'Cruz:
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.
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 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.
3
Page 2 -- Mr. D'Cruz
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); 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.
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) 276-0115. Also, please note the regulation cntitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sinatie H. Michaud Oms
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
TxControl™ Device Name:
Indication for Use
The TxControl™ is a software application intended to be used by clinicians with ResMed flow generators that incorporate ResMed's proprietary communication protocol. TxControl provides real-time data display directly from the flow generator or via ResControl II™.
TxControl can also provide flow generator setting changes, remotely within a clinical environment.
Prescription Use × AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(Part 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)
Page 1 of 1
(Division Sign-Off) achiz B.S.
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072615
fka
10th September, 2007
Page 13