APNEALINK

K070263 · Resmed Germany, Inc. · MNR · Jun 15, 2007 · Anesthesiology

Device Facts

• Record ID: K070263
• Device Name: APNEALINK
• Applicant: Resmed Germany, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Jun 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.

Device Story

ApneaLink is a battery-powered, two-channel respiratory pressure sensor and oximetry system. It records nasal pressure, pulse rate, and oxygen saturation (SpO2) during sleep. The patient wears the device at home, securing it with a chest belt, nasal cannula, and finger-mounted oximetry sensor (via XPOD). After recording, the device is returned to a physician. The physician uses ApneaLink software on a PC to analyze the data, which includes automated detection of apneas, hypopneas, flow limitation, snoring, and probability of Cheyne-Stokes respiration. The resulting report assists the physician in recognizing sleep-related respiratory disorders and determining the need for further clinical diagnosis or therapy. Reports can be shared electronically with sleep laboratories or hospitals.

Clinical Evidence

Bench testing only. Verification activities were performed based on risk analysis and product requirements to confirm the device met predetermined acceptance criteria. No clinical trial data was provided.

Technological Characteristics

Two-channel battery-powered respiratory pressure sensor and oximetry system. Includes nasal cannula and XPOD pulse oximetry module. Software-based analysis of respiratory flow and SpO2. Complies with IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60068-2-1, ISO 10993-1, and EN ISO 14971.

Indications for Use

Indicated for patients requiring sleep screening to determine the need for further clinical diagnosis of sleep-related respiratory disorders, including apnea, hypopnea, flow limitation, snoring, and Cheyne-Stokes respiration.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• ApneaLink (K061405)

Submission Summary (Full Text)

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

KOTO 263

ApneaLink Traditional 510(k) Premarket Notification

# RESMED

### 510(k) Summary - ApneaLink

Date Prepared

16" January 2007

JUN 1 5 2007

| Official Contact | David D'Cruz<br>V.P., Clinical & Regulatory Affairs<br>ResMed Corp.<br>14040 Danielson St,<br>Poway CA 92064-6857<br>USA<br>Tel: [phone]<br>Fax: [phone] |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.2375 |
| Product Code | MNR - Ventilatory Effort Recorder |
| Common/Usual Name | Ventilatory Effort Recorder |
| Proprietary Name | ApneaLink |
| Predicate Devices | ApneaLink (K061405) |
| Reason for submission | Expanded Indications |

:

{1}------------------------------------------------

## RESMED

#### Substantial Equivalence

The new device has the following similarities to the previously cleared devices:

- ্ Intended use Similar
- ﺳﺮ Operating principle Same
- ﯩﺰ Technologies Same
- :A Manufacturing process Same

Design and Verification activities were performed on the ApneaLink as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the ApneaLink is Substantially Equivalent to the predicate device. The ApneaLink complies with the applicable standards and requirements referenced in the following:

- ﺮ FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices (May 11, 2005)
- ﻨﺰ FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
- ﯩﺰ FDA General Principles of Software Validation (January 11, 2002)
- ﻧﺰ IEC 60601-1-1 (Medical Electrical Equipment Part 1: General requirements for safety)
- 送 IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility - Requirements and tests)
- IEC 60601-1-4 (Medical Electrical Equipment Part 1-4: General requirements for safety Collateral تر Standard: Programmable electrical medical systems)
- 人 IEC 60068-2-1/ and the following (Environmental testing)
- ﺰ ISO 10993-1 (Biological evaluation of medical devices - Part 1 Evaluation and testing)
- ﻨﺰ EN ISO 14971: 2001 (Medical Devices - Application of risk management to medical devices)

#### Intended Use

ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.

#### Device Description

The performance and functional characteristics of the ApneaLink includes all the user-friendly features of the predicate device. The ApneaLink is a further development of the previous submitted device ApneaLink (K061405). This submission addresses the expanded indications for use of the Apneal.ink by analyzing the flow signal for periods of Cheyne-Stokes respiration breathing patterns.

The ApneaLink recorder is a two-channel battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory flow, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink recorder must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula and pulse oximetry module. The disposable plastic nasal cannula is connected to the ApneaLink recorder and fixed at the patient's nose. The oximetry sensor is connected to the XPOD and fixed at the patient's finger. The XPOD is connected to the ApneaLink recorder, After recording, the Apneal.ink recorder is returned to the physician. With the Apneal.ink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data. For further clinical diagnosis the physician has the possibility to send the recording and the report via email to the sleep laboratory/hospital.

16" January, 2007

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, rendered in black, with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 1 5 2007

Re: K070263

Trade/Device Name: ApneaLink Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 11, 2007 Received: June 13, 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.

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.

{3}------------------------------------------------

Page 2 -- Mr. D'Cruz

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 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/industry/support/index.html.

Sincerely yours.

Suyite Y. Michael Dmd.

Chíu 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):

Device Name:

ApneaLink

Indication for Use

ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.

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) Page 1 of 1 16th January, 2007 24000 Page 23 ാന Sign-Off) Sion of Anesthesiology, General Hospital, Interion Control, Dental Devices 10(k) Number: