RESSCAN

K050775 · Resmed, Ltd. · BZD · May 10, 2005 · Anesthesiology

Device Facts

• Record ID: K050775
• Device Name: RESSCAN
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: May 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.

Device Story

ResScan is a software application used by clinicians to interface with ResMed flow generators. It functions by downloading therapy data from the device via a proprietary communication protocol; storing patient treatment information; and generating reports for clinical review. The software also allows clinicians to remotely configure and transfer therapy parameters to the flow generator. Used in clinical settings, it enables healthcare providers to monitor patient compliance and adjust treatment settings based on downloaded data, facilitating effective management of respiratory therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Verification activities confirmed the software met all design and functional requirements.

Technological Characteristics

Software-based system for data management and parameter configuration. Utilizes ResMed proprietary communication protocol for connectivity with flow generators. Complies with FDA guidance for software contained in medical devices (May 1998).

Indications for Use

Indicated for use by clinicians to manage therapy data and settings for patients using ResMed flow generators equipped with proprietary communication protocols.

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

• ResScan™ (K034033)
• S8 Pioneer CPAP System (K041209)

Submission Summary (Full Text)

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**MAY 10 2005**

RESMED

K050775

| Date Prepared | 23 March 2005 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 868.5895 |
| Product Code | 73 BZD |
| Common/Usual Name | CPAP System / Non continuous Ventilator (with accessory) |
| Proprietary Name | ResScan™ |
| Predicate Device(s) | ResScan™ (K034033)<br>S8 Pioneer CPAP System (K041209) |
| Reason for submission | Expanded indication; change in design |
| Indications for Use | The ResScan™ software is intended to be used by clinicians<br>ResMed flow generators that have software incorporating |

## 510(k) Summary -- ResScan™

vith ResMed's proprietary communication protocol. ResScan™ ાંક used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.

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#### Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device.

- ﺮ Similar intended use
- Same operating principle , ﻟ
- Same technologies r
- Same manufacturing process ﺮ

Design and Verification activities were performed on the new version of ResScan as a result of the risk Design and vehilodion activities we All tests confirmed the product met the acceptance criteria. andiysis and product requirement wevice is substantially equivalent to the predicate device. Resided has not alternation not the now deffectiveness when used for patient compliance management as resocurriod hot aller a the salery that have software incorporating proprietary communication an adjance with Normount in I gollies with the applicable standards and requirements referenced in the FDA guidance documents:

- FDA Reviewer Guidance for Premarket Notifications, November 1993. r
- FDA reviewer's and industry, Guidance for the content of premarket submissions for software ﺮ contained in medical devices, May 1998.

#### Intended Use

The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.

#### Device Description

The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.

ResScan allows the clinician to,

- download and view data from a ResMed Flow Generator r
- store patient details and downloaded treatment data ﺮ
- create reports on patient details and downloaded treatment data , L
- transfer treatment parameters to a ResMed Flow Generator ﺮ

Sumathy Ramesh Manager. Regulatory Affairs ResMed.

March 23, 2005

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.

MAY 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited C/O Mr. David D' Cruz Vice President US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K050775

Trade/Device Name: ResScan™ Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 24, 2005 Received: March 28, 2005

Dear Mr. D' Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because as ne he device is substantially equivalent (for the relications 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 Interstate conmiseed procession in accordance with the provisions with the provisions of Amendinents, or to act 1,000 and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 00d, Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

ﻴﺮ ﺍﻟﻤﺮﺍﺟﻊ

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (oos as olditional controls. Existing major regulations affecting (FMA), it may be subject to back address.
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the estas nouncements 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 mean that i DA mas made a actes and regulations administered by other Federal agencies.

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Page 2 - Mr. D' Cruz

You must comply with all the Act's requirements, including, but not limited to: registration r ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and home (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as between as 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) rins letter will and if you be began finding of substantial equivalence of your device to a premarket nothroation. - In 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), 11 you donto 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 maj overni 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 yours,

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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# RESMED

### Indication for Use

510(k) Number (if known):

Device Name:

ResScan™

#### Indications for Use:

The ResScan™ software is intended to be used by clinicians with ResMed flow generators that The Resocal " soltware is linendouts broprietary communication protocol. ResScan™ is used have soltware incorporating Noundal o propristary of therapy information and print reports.
to download and view therapy data, as well as store therapy information and print ResScan™ also provides functionality for setting flow generator parameters.

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)

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| Division Sign-Off | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(K) Number: | K050775 |

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