RESCAN

K034033 · Resmed, Ltd. · BZD · May 5, 2004 · Anesthesiology

Device Facts

• Record ID: K034033
• Device Name: RESCAN
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

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. The ResScan software cannot be used to set or change ventilator parameters, or to modify the operation/ function of the ventilator.

Device Story

ResScan is a software application for clinicians to manage patient compliance with ResMed CPAP or Bilevel ventilators. It connects to ventilators via proprietary communication protocols to download therapy data; inputs include usage time, respiratory rate, tidal volume, leak, minute ventilation, apnea/hypopnea indices, SpO2, and pulse rate. The software processes this data by calculating basic statistics (e.g., medians) and generates patient reports for clinical review. It does not control or modify ventilator settings. Used in clinical settings, it assists providers in monitoring therapy effectiveness and patient adherence, facilitating clinical decision-making regarding treatment adjustments.

Clinical Evidence

Bench testing only. Software validated in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (1998) and General Principles of Software Validation (2002). No clinical data presented.

Technological Characteristics

Software-based data management tool. Operates on IBM-compatible PCs running Windows 98SE, 2000 SP2, NT4 SP6, or XP. Connects to ResMed ventilators via proprietary communication protocol. Features include data retrieval, statistical computation (e.g., median), report generation, and storage. Standalone application distributed on CD-ROM.

Indications for Use

Indicated for use by clinicians to download, view, store, and report therapy data from ResMed flow generators in patients requiring respiratory support.

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

• AutoScan™ software (K024191)

Submission Summary (Full Text)

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K034033

# MAY - 5 2004

### 510(k) SUMMARY—ResScan

| Submitter Name: | ResMed Corp. |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857<br>USA |
| Contact Person: | David D'Cruz, VP Regulatory & Clinical Affairs US |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | April 30, 2004 |
| Device Trade Name: | ResScan™ |
| Device Common Name/<br>Classification Name: | Data download and display software |
| Predicate Devices: | AutoScan™ software (K024191) |
| Device Description: | The ResScan software with its capabilities of data collection<br>and display of patient information provides an adjunct for<br>patient compliance management. ResScan allows the clinician<br>to download and view data from a ResMed CPAP or Bilevel<br>device. The data displayed will depend on the ventilator used.<br>Parameters displayed may include one or more of the<br>following: |
| | usage (hrs: min);<br>respiratory rate (breaths/min);<br>tidal volume (L/min); |

- . leak (L/min);
- . minute ventilation (L/min);
- apnea and hypopnea index including apnea index . (AI), hypopnea index (HI) and AHI (events/hr);
- . oxygen saturation SpO2 (%);
- pulse rate (bpm); .

The software allows the creation of reports on patient details, and downloaded treatment data. ResScan displays data as retrieved. Data processing in ResScan is limited to computing the statistics (e.g., median) on retrieved data.

The software operates under Windows 98SE, Windows 2000 SP2, Windows NT4 SP6, Windows XP, and is available on CD-ROM.

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#### 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.

The ResScan software cannot be used to set or change ventilator parameters, or to modify the operation/ function of the ventilator.

#### Device Technological Characteristics and Comparison to Predicate Device(s):

The ResScan software is based on the previously cleared predicate device ResMed's AutoScan software.

The ResScan software is used to download therapy data previously generated or logged by a ResMed ventilator on an IBM compatible computer and to allow the clinician to download, view. and store data, and print reports. The software operates under various Windows operating systems. These features are consistent with and comparable to the predicate device.

#### Performance Data:

The ResScan software was tested in accordance with the recommendations of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 29, 1998) and the General Principles of Software Validation (January 11, 2002).

The ResScan software passed all tests.

#### Conclusion:

The ResScan software complies with the requirements for functionality, safety and effectiveness, and it is substantially equivalent to the predicate device AutoScan.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird with three wing-like shapes above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Resmed Limited c/o David D'Cruz Resmed Corporation 14040 Danielson St. Poway, CA 92064-6857

Re: K034033

Trade/Device Name: ResScan Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 6, 2004 Received: April 9, 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

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Page 2 – David D'Cruz

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 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 vours.

Chis Ls

Lin Liu, 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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Image /page/4/Picture/0 description: The image shows the word "RESMED" in bold, black letters. The letters are capitalized and slightly slanted to the right. To the left of the word is a black square with a white line extending from the bottom right corner of the square to the beginning of the word.

ResMed Ltd ACN 003 765 142 97 Waterloo Road North Ryde NSW 2113 Australia Tel: [phone] Fax: [phone]

## INDICATIONS FOR USE

510(k) Number (if known):

K034033

Device Name:

. . . .

ResScan

Indications for 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.

Prescription Use Rx only (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

| (Division Sign-Off) |
|-----------------------------------------------|
| Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices |

| 510(k) Number: | K034033 |
|----------------|---------|
|----------------|---------|