(137 days)
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.
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.
The provided text describes a Special 510(k) submission for the ResMed Geo device, which is a non-continuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA). The submission is for a device modification, and it states that the modified device has similarities to the previously cleared Tasman device in terms of intended use, operating principle, technologies, and manufacturing process.
The document indicates that design and verification activities were performed on the modified device, and these tests confirmed the product met predetermined acceptance criteria.
Here's an breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria | "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 previously cleared device using common protocols for." |
Note: The document states that the tests met the acceptance criteria, but it does not explicitly list the specific numerical/quantitative acceptance criteria themselves (e.g., "pressure stability must be within +/- X units"). It only lists the parameters that were evaluated.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Design and Verification activities" and "All tests," but does not provide details on the number of units or patients included in these tests.
- Data Provenance: Not explicitly stated. The document indicates the submitter is ResMed, with an official contact in San Diego, CA, USA. However, it does not specify the country of origin for the data generated from the testing. The study appears to be prospective in nature, as it describes "Design and Verification activities were performed on the modified device."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed (pressure stability, jitter, swings, ISO 17510-1 pressure performance, functional dead space) are primarily engineering and performance-based, rather than relying on human expert assessment for "ground truth" in clinical interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The nature of the tests described (device performance metrics) does not typically involve an adjudication method in the way clinical diagnostic studies do.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC study is not mentioned and is not relevant to the type of device performance testing described. This is a ventilation device, and the focus of the submission is on engineering performance compared to a predicate device, not on diagnostic accuracy with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable/provided. The Geo device is a physical medical device (a ventilator), not an AI algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here. The "standalone" performance in this context would refer to the device's inherent performance characteristics, which are implicitly what the "pressure stability, jitter, swings, ISO 17510-1 pressure performance and functional dead space tests" measured.
7. Type of Ground Truth Used
The "ground truth" for the tests performed was based on engineering specifications and established performance standards (specifically ISO 17510-1 for pressure performance) and comparison against the "previously cleared device using common protocols."
8. Sample Size for the Training Set
This is not applicable as the Geo device is a hardware product, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the Geo device is a hardware product, not an AI algorithm that requires a "training set."
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| ResMed | Geo Special 510(k) Submission | June 2012 | |
|---|---|---|---|
| Special 510(k) SUMMARY[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: (858) 836 6081 | |||
| 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 sleepapnea (OSA) in adult patients weighing more than 66 lbs(30 kg). The Geo mask system delivers airflownoninvasively to a user from the integrated CPAP device.The Geo system is intended for single-patient re-use inthe home environment and while traveling. | ||
| Substantial Equivalence | The modified device has the following similarities to thepreviously cleared Tasman device. | ||
| • Same intended use | |||
| • Similar operating principle | |||
| • Similar technologies | |||
| • Similar manufacturing process | |||
| Design and Verification activities were performed on themodified device a result of the risk analysis and designrequirements. 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 thepreviously 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 (800) 638-2041 or (301) 796-7100 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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§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).