GEO

K121705 · Resmed, Ltd. · BZD · Oct 23, 2012 · Anesthesiology

Device Facts

• Record ID: K121705
• Device Name: GEO
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 23, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs (30 kg). The Geo mask system delivers airflow noninvasively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

Device Story

Geo is a non-continuous ventilator (IPPB) system; delivers noninvasive airflow to patients from an integrated CPAP device. Used in home environments and during travel for OSA treatment. Device operates by providing pressurized air to the patient via a mask system. Healthcare providers use the device to manage OSA; patient self-administers therapy. Design modifications from the predicate device include updates to pressure stability and performance characteristics. Output is therapeutic airflow; clinical benefit is the treatment of obstructive sleep apnea.

Clinical Evidence

Bench testing only. Verification activities included pressure stability, jitter, swings, ISO 17510-1 pressure performance, and functional dead space tests compared against the predicate device using common protocols.

Technological Characteristics

Non-continuous ventilator (IPPB); CPAP-based airflow delivery. Complies with ISO 17510-1 for pressure performance. Features include pressure stability, jitter, and swing control. Intended for home/travel use.

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in adult patients weighing >66 lbs (30 kg).

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

• Tasman (K112393)

Submission Summary (Full Text)

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| | ResMed | Geo Special 510(k) Submission | June 2012 |
|----------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | | Special 510(k) SUMMARY<br>[As required by 21 CFR 807.92(c)] | K121705 |
| | | Date Prepared 6th June, 2012 | OCT 2 3 2012 |
| | Submitter Name | Mr. Kim Kuan Lee | |
| | Official Contact | Mr. Jim Cassi | |
| | | Vice President - Quality Assurance Americas | |
| | | 9001 Spectrum Center Boulevard | |
| | | San Diego CA 92123 USA | |
| | | Tel: [phone] | |
| | Device Trade Name | Geo | |
| | Device Common Name | Non continuous Ventilator (IPPB) | |
| | Classification | 21 CFR 868.5905 (Class II) | |
| | Product Code | 73 BZD | |
| | Predicate Device | Tasman (K112393) | |
| | Reason for submission | Device modification | |
| | Intended Use | The Geo is indicated for the treatment of obstructive sleep<br>apnea (OSA) in adult patients weighing more than 66 lbs<br>(30 kg). The Geo mask system delivers airflow<br>noninvasively to a user from the integrated CPAP device.<br>The Geo system is intended for single-patient re-use in<br>the home environment and while traveling. | |
| | Substantial Equivalence | The modified device has the following similarities to the<br>previously cleared Tasman device. | |
| | | • Same intended use | |
| | | • Similar operating principle | |
| | | • Similar technologies | |
| | | • Similar manufacturing process | |
| | | Design and Verification activities were performed on the<br>modified device a result of the risk analysis and design<br>requirements. All tests confirmed the product met the | |
| | | predetermined acceptance criteria. This included | |
| | | pressure stability, jitter, swings, ISO 17510-1 pressure | |
| | | performance and functional dead space tests against the<br>previously cleared device using common protocols for | |
| 6th June, 2012 | | Page 25 | |

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Resmed, Limited
C/O Resmed Corporation
Mr. Jim Cassi
Vice President, Quality Assurance Americas
9001 Spectrum Center Boulevard
San Diego, California 92123

OCT 23 2012

Re: K121705

Trade/Device Name: Geo Regulation Number: 21 CFR 868.5905 Regulation Name: Non Continuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 21, 2012 Received: September 24, 2012

## Dear Mr. Cassi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Cassi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Svon Rumor

Anthony D. Watson, B.S., M.S., M.B.A. Directo

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

121705 510(k) Number (if known):

Geo

Device Name:

Indication for Use

The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs The Oco is marked for the troutinent of sostractively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

L. Schultze

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

510(k) Number:

Over-The-Counter Use AND/OR Prescription Use X (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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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