RESCONTROL II

K040944 · Resmed, Ltd. · BZD · Jun 3, 2004 · Anesthesiology

Device Facts

• Record ID: K040944
• Device Name: RESCONTROL II
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Intended 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.

Device Story

ResControl II is a clinical interface device used in hospital or sleep lab settings by clinicians to manage ResMed flow generators. It functions as a manometer and data relay system; it transfers real-time flow generator data to external polysomnograph display systems (e.g., Sommitigica). The device enables clinicians to remotely adjust flow generator parameters via a proprietary communication protocol. By facilitating data visualization and parameter control, it assists clinicians in monitoring and optimizing therapy for patients with COPD or OSA.

Clinical Evidence

Bench testing only. Design verification and validation activities were performed to confirm the device met all product requirements and acceptance criteria. No clinical trials were conducted.

Technological Characteristics

Interface device for CPAP/bilevel flow generators; acts as a manometer and data relay. Utilizes proprietary communication protocol for connectivity with ResMed flow generators and polysomnograph display systems. Designed for use in hospital or sleep lab environments.

Indications for Use

Indicated for use by clinicians in hospital or sleep lab facilities to manage ResMed flow generators for adult patients with COPD or OSA.

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

• ResMed UCU (K961783)

Reference Devices

• Sommitigica (K971813)

Submission Summary (Full Text)

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Ko40944

# 510(k) Summary - ResControl™ II

| Date Prepared | 30th March, 2004 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Dr Lionel King<br>V.P., Regulatory Affairs<br>ResMed Ltd<br>97 Waterloo Road<br>North Ryde, NSW 2113<br>Australia<br>Tel: [phone]<br>Fax: [phone] |
| 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<br>ResMed flow generators that have software incorporating<br>ResMed's proprietary communication protocol. ResControl II<br>displays data, relays data to a polysomnograph and acts as a<br>manometer. ResControl II also provides functionality for setting<br>flow generator parameters. |

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#### 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

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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

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esiology, General Hospital

510(k) Number