RESSCAN-PRO

K082983 · Resmed, Ltd. · BZD · Jan 2, 2009 · Anesthesiology

Device Facts

• Record ID: K082983
• Device Name: RESSCAN-PRO
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings. It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.

Device Story

ResScan-Pro is a software system used by clinicians to manage patient therapy via ResMed flow generators. It functions by downloading, viewing, and storing patient and machine data from the flow generator; it also allows clinicians to transfer updated treatment parameters back to the device. Used in clinical settings, it facilitates patient compliance management and remote adjustment of therapeutic settings. By enabling remote data transfer and parameter modification, the device assists clinicians in optimizing patient follow-up care and therapy effectiveness.

Clinical Evidence

No clinical data. Bench testing and design verification activities were performed to confirm the system met predetermined acceptance criteria.

Technological Characteristics

Software-based system for data management and remote parameter adjustment. Operates via proprietary communication protocols with ResMed flow generators. Complies with FDA guidance for software contained in medical devices and off-the-shelf software use.

Indications for Use

Indicated for use by clinicians to manage patient compliance and therapy settings for patients using ResMed compatible flow generators.

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 (K050775)

Submission Summary (Full Text)

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K0f2983

# 510(k) Summary - ResScan-Pro

Date Prepared

30th Sept, 2008

JAN - 2 2009

Official Contact

Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

| Classification Reference | 21 CFR 868.5905 |
|--------------------------|-----------------------------------|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | ResScan-Pro |
| Predicate Device(s) | ResScan (K050775) |

Reason for submission

New Device

30th Sept, 2008

Tel: [phone] Fax: [phone]

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#### Indication for Use

ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings.

It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.

#### Substantial Equivalence

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

- _六海 Similar intended use
- Same operating principle 15
- Similar technologies ﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ
- Same manufacturing process ్లో ప్రాథమ

Design and Verification activities were performed on the ResScan-Pro system as a result of the risk and design requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device is substantially equivalent to the predicate device. ResScan-Pro has not altered the safety and effectiveness when used for patient compliance management as an adjunct with ResMed flow generators that have software incorporating proprietary communication protocol. The new device complies with the applicable requirements referenced in the FDA guidance documents:

- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)

#### Device Description

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

ResScan-Pro allows the clinician to:

- Download, view and store patient and machine details from a ResMed Flow Generator ﺮ ﺍﻟﻤﺮﺍﺟﻊ
- Create and print reports on patient and machine details
- Transfer treatment parameters to a ResMed Flow Generator

#### Conclusion

The ResScan-Pro System is substantially equivalent to the predicate device, ResScan (K050775).

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN - 2 2009

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

Re: K082983

Trade/Device Name: ResScan-Pro Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 30, 2008 Received: October 6, 2008

### 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.

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## 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Audite H. Mchan Davis.

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: ResScan-Pro

. .

Indication for Use

ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings. It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.

:

| 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) | <img alt="Signature" src="signature.jpg"/> |
|--------------------------------------------------------|----------------------------------------------|
| Page 1 of 1 | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |
| 0(k) Number: | k082983 |
| 30th Sept, 2008 | Page 13 |