TXCONTROL

K072615 · Resmed, Ltd. · BZD · Jan 4, 2008 · Anesthesiology

Device Facts

• Record ID: K072615
• Device Name: TXCONTROL
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 Story

TxControl is a PC-based software application used by clinicians in sleep labs to monitor and control ResMed flow generators. It receives real-time patient and device data via a proprietary communication protocol, either directly from the flow generator or through the ResControl II hardware interface. Clinicians use the software to view data and remotely adjust flow generator settings from a control room. It can also transfer data to polysomnography (PSG) display systems like Somnologica. The device facilitates clinical management of patients with Obstructive Sleep Apnea (OSA) by enabling centralized, remote monitoring and adjustment of therapy parameters.

Clinical Evidence

Bench testing only. Design and verification activities were performed based on risk analysis and product requirements; all tests confirmed the device met predetermined acceptance criteria.

Technological Characteristics

PC-based software application; utilizes proprietary communication protocol for data exchange with ResMed flow generators; supports remote monitoring and setting adjustments; interoperable with PSG display systems; complies with FDA guidance for software in medical devices and cybersecurity for networked medical devices.

Indications for Use

Indicated for use by clinicians to monitor and adjust settings on ResMed flow generators for patients, primarily those with Obstructive Sleep Apnea (OSA), within a clinical sleep lab environment.

Regulatory Classification

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.

Predicate Devices

• ResControl II (K040944)

Reference Devices

• Somnologica (K971813)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary - TxControl

Date Prepared

10" September 2007

K072615
page 1 of 2

| Official Contact | Dr Lionel King<br>V.P., Quality Assurance & Regulatory Affairs<br>ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista, NSW 2153<br>Australia<br>Tel: [phone]<br>Fax: [phone] | 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 [phone]. 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 [phone] or [phone] 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