(137 days)
Not Found
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that would typically indicate the presence of AI/ML technology. The description focuses on the device's function (delivering airflow for OSA) and intended use.
Yes
The device is indicated for the "treatment of obstructive sleep apnea (OSA)", which is a therapeutic purpose.
No
The provided text states that the device is "indicated for the treatment of obstructive sleep apnea (OSA)", rather than for diagnosis. It describes airflow delivery and reuse, consistent with a therapeutic device.
No
The device description explicitly mentions a "Geo mask system" and an "integrated CPAP device," which are hardware components. The summary also describes performance studies related to pressure and functional dead space, further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) by delivering airflow noninvasively. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the therapeutic nature of the device, focusing on delivering airflow for treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
single-patient re-use in the home environment and while traveling.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design and Verification activities were performed on the modified device a result of the risk analysis and design 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 previously cleared device using common protocols for
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tasman (K112393)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
| 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 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. | |||
| Substantial Equivalence | The modified device has the following similarities to the | ||
| previously cleared Tasman device. | |||
| • Same intended use | |||
| • Similar operating principle | |||
| • Similar technologies | |||
| • Similar manufacturing process | |||
| Design and Verification activities were performed on the | |||
| modified device a result of the risk analysis and design | |||
| 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 | |||
| 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.
3
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
4
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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