(52 days)
No
The summary describes a device for data display, relay, and parameter setting, with no mention of AI or ML technologies.
No.
The device acts as a data display, relay, and parameter setting tool for flow generators, rather than directly treating a condition itself. Its function is to facilitate the use of other therapeutic devices (ResMed flow generators).
Yes
The "Intended Use" states that the device "displays data, relays data to a polysomnograph and acts as a manometer," which are functions consistent with diagnostic devices, as they provide information for assessing a patient's condition. While it also sets parameters, the primary handling of data for display and relay to a polysomnograph indicates a role in diagnosis.
No
The description indicates the device interacts with "ResMed flow generators" and "CPAP or birevel Flow Generator," which are hardware devices. While the ResControl II itself might be primarily software, its function is intrinsically tied to controlling and receiving data from hardware, making it a system that includes hardware components.
Based on the provided information, the ResControl II is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The ResControl II's intended use and device description clearly state it interacts with ResMed flow generators (CPAP/bi-level machines) and polysomnographs. It displays and relays data from these devices, acts as a manometer, and sets flow generator parameters. It does not process or analyze biological samples.
- The description focuses on data transfer, display, and device control. These are not typical functions of an IVD.
The ResControl II appears to be a device used in a clinical setting (hospital or sleep lab) to interface with and control other medical devices used for sleep therapy and monitoring.
N/A
Intended Use / Indications for Use
The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The performance and functional characteristics of the ResControll II system includes all the user friendly features of the predicate device. UCU. ResControl II is designed to transfer data from a CPAP or birevel Flow Generator to a polysomnograph display system such as Sommitigica (K971813). ResControl II also provides parameter setting of Flow Generators within the hospital or sleep lab facilities.
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 / hospital or sleep lab facilities
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 Vertification activities were performed on the ResControl II as a result of the risk and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device. ResControl II has not altered the safety and effectiveness when used in treatment studies for Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sieep Apnea (OSA) in adult patients.
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.
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.
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
Ko40944
510(k) Summary - ResControl™ II
| Date Prepared | 30th March, 2004 |
|---|---|
| Official Contact | Dr Lionel King |
| V.P., Regulatory Affairs | |
| ResMed Ltd | |
| 97 Waterloo Road | |
| North Ryde, NSW 2113 | |
| Australia | |
| Tel: +61 (2) 9886 5000 | |
| Fax: +61 (2) 9878 5517 | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD |
| Common/Usual Name | CPAP System / Non continuous Ventilator (with accessory) |
| Proprietary Name | ResControl™ II |
| Predicate Device(s) | ResMed UCU (K961783) |
| Reason for submission | New Device |
| Indications for Use | The ResControl II is intended to be used by clinicians with |
| ResMed flow generators that have software incorporating | |
| ResMed's proprietary communication protocol. ResControl II | |
| displays data, relays data to a polysomnograph and acts as a | |
| manometer. ResControl II also provides functionality for setting | |
| flow generator parameters. |
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
Same intended use
Similar operating principle
Similar technologies
Same manufacturing process
Design and Vertification activities were performed on the ResControl II as a result of the risk and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device. ResControl II has not altered the safety and effectiveness when used in treatment studies for Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sieep Apnea (OSA) in adult patients. The new device complies with the applicable standards and requirements referenced in the FDA quidance documents:
- FDA Reviewer Guidance for Premarket Notifications, November 1993 关
- મુ FDA Draft Reviewer Guidance for Ventilators (July 1995)
- ﺮ FDA reviewer's and industry. Guidance for the content of premarket submissions for software contained in madical devices. May 1998.
Intended Use
The ResControl II is intended to be used by clinicians with ResMed flow generators that have software ncorporating ResMed's proprietary communication protocol. ResControl II displays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.
Device Description
The performance and functional characteristics of the ResControll II system includes all the user friendly features of the predicate device. UCU. ResControl II is designed to transfer data from a CPAP or birevel Flow Generator to a polysomnograph display system such as Sommitigica (K971813). ResControl 11 also provides parameter setting of Flow Generators within the hospital or sleep lab facilities.
LL88
Dr Lionel King V P Regulatory Affairs ResMed.
30" March, 2004
2
Image /page/2/Picture/1 description: The image is a seal or logo, likely representing a government or organizational entity. It features a circular design with text wrapping around the top half, reading 'HUMAN SERVICES - USA'. Inside the circle is a stylized emblem resembling a bird or abstract shape, composed of three curved lines. The bottom half of the circle also contains text, but it is less clear.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Resmed Limited c/o David D'Cruz Resmed Corporation 14040 Danielson St. Poway, CA 92064-6857
Re: K040944
Trade/Device Name: ResControl II Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 4, 2004 Received: April 12, 2004
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.
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.
3
Page 2 – David D'Cruz
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 (301) 594-4646. Also, please note the regulation entitled, "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/dsma/dsmamain.html.
Sincerely yours,
Carl
Chiu Lin, Ph.D.
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):
Device Name:
ResControl II
Indications for Use:
The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to Incolporating Roomos of Prophoury Commeter. ResControl II also provides functionality for setting flow generator parameters.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X 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)
Cum Sulom
Page 1 of 1
esiology, General Hospital
510(k) Number