(57 days)
The AccuO2 System, which provides oxygen therapy on demand, based on continuous, non-invasive monitoring of oxygen saturation, is indicated for home use by adult Chronic Obstructive Pulmonary Disease (COPD) patients who are prescribed low-flow (0-3 L/min) supplemental oxygen via nasal cannula and USP portable oxygen.
The AccuO2 System is a portable, battery-operated system consisting of a proprietary demand oxygen delivery module combined with a commercially available pulse oximeter module. The system is used with a standard nasal cannula and USP portable oxygen. The proprietary software in the AccuO2 demand oxygen delivery module is designed to deliver oxygen on inhalation only and to maintain the patients at an oxygen saturation (SpO2) level of 90% while conserving oxygen.
Here's a breakdown of the acceptance criteria and study information for the MITI Corp. AccuO2 System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accurately and reliably detect each inhaled breath | Verified by functional testing |
| Actuate the valve correctly | Verified by functional testing |
| Accurate pulse oximeter readings | Verified by functional testing; functions equivalently to commercially available pulse oximeters |
| Accurate oxygen amount calculations | Verified by functional testing |
| Maintain patients at or above 90% SpO2 | Demonstrated by clinical studies |
| Not increase time patient spends in hypoxic state compared to commercially available devices | Demonstrated by clinical studies |
| Meet performance objectives and comply with applicable FDA guidelines and standards (functional, environmental, and safety testing) | Demonstrated by functional, environmental, and safety testing |
Study Details
2. Sample size for the test set and data provenance:
- Sample Size: Not explicitly stated in the provided abstract. The text only mentions "clinical testing was conducted to evaluate the ability to maintain patients at or above 90% SpO2 as designed."
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective given they are evaluating the device's performance, but this is not explicitly stated as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not specified. The document refers to the device maintaining SpO2 levels and not increasing hypoxic states, which are physiological measurements, not interpretationsrequiring expert consensus in the same way an imaging study would.
4. Adjudication method for the test set:
- Not applicable/Not specified. The assessment criteria are objective physiological measurements (SpO2 levels, detection of breaths, valve actuation, oxygen amount calculation) rather than subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic imaging device that would typically involve human readers. The AccuO2 system is a demand oxygen delivery system with an integrated pulse oximeter. The clinical studies compare its performance against existing devices, not human interpretation with/without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The functional testing and clinical studies described evaluate the device's performance directly, independent of continuous human intervention in its core functioning (e.g., detecting breaths, actuating valves, maintaining SpO2). The system's purpose is to automate oxygen delivery based on physiological inputs.
7. The type of ground truth used:
- Physiological measurements and objective device performance. The ground truth for the pulse oximeter's accuracy would likely be against a co-oximeter or arterial blood gas (ABG) analysis, though this is not explicitly detailed. For breath detection and valve actuation, the ground truth would be based on direct measurement of those events. For SpO2 maintenance, the ground truth is the patient's actual oxygen saturation as measured by the device itself (and likely validated against a reference standard during development/testing).
8. The sample size for the training set:
- Not applicable/Not specified. This device predates the widespread use of deep learning and often doesn't involve a "training set" in the modern machine learning sense, as it relies on proprietary software for control rather than a learned model from a large dataset. The software logic would be developed and verified, not "trained."
9. How the ground truth for the training set was established:
- Not applicable/Not specified, for the reasons mentioned above. The "ground truth" for the device's operational logic would have been established through engineering design, physiological principles, and functional testing to ensure the software correctly implements the intended control strategy.
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JUN 16 2005
11
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | MITI Corp. |
|---|---|
| Contact Person: | Matthew F. Schmidt, Ph.D.MITI Corp.738 Country Lakes DriveLino Lakes, MN 55014Phone: 651-592-8493Fax: 952-826-0876 |
| Date Prepared: | April 19, 2005 |
| Trade Name: | MITI Corp. AccuO2 System |
| Classification Name:and Number: | Class II, 21 CFR 868.5905 |
| Product Code: | NFB |
| Predicate Device(s): | The AccuO2™ Pulse Oximeter and Demand OxygenDelivery System is substantially equivalent to the PulseDose Series Oxygen Conserving device manufactured byDeVilbiss Health Care, Inc. and the Model 8500A PulseOximeter, manufactured by Nonin® Medical, Inc.). |
| Device Description: | The AccuO2 System is a portable, battery-operated systemconsisting of a proprietary demand oxygen delivery modulecombined with a commercially available pulse oximetermoduleᵃ. The system is used with a standard nasal cannulaand USP portable oxygen. The proprietary software in theAccuO2 demand oxygen delivery module is designed todeliver oxygen on inhalation only and to maintain thepatients at an oxygen saturation (SpO2) level of 90% whileconserving oxygen. |
| Intended Use: | The AccuO2 System, which provides oxygen therapy ondemand based on continuous, non-invasive monitoring ofoxygen saturation, is indicated for home use by adult |
4 Pulse oximeter module from Nonin Medical, and is the same as the pulse oximeter module used in the following FDA-cleared devices: Sleep Screen/ApnoeScreen Cardio manufactured by Erich Jaeger GmbH (K021138); Model 9303 Neonatal/Adult Vital Signs Monitor, manufactured by CAS Medical (K982776); and the MTS Option for the ESCORT II Monitor manufactured by Medical Data Electronics (K970763).
Premarket Notification (510(k)) for the AccuO2 System CONFIDENTIAL
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COPD patients who are prescribed low-flow (0-3 L/min) supplemental oxygen via nasal cannula and USP portable oxygen.
Functional testing included verification of the AccuO2 System's ability to accurately and reliably detect each inhaled breath, and actuate the valve correctly, as well as verification of the accuracy of the pulse oximeter readings and oxygen amount calculations when used with the system. Clinical testing was conducted to evaluate the ability to maintain patients at or above 90% SpO2 as designed.
In addition, all functional, environmental and safety testing performed on the device demonstrated that it met its performance objectives and complies with applicable FDA guidelines and standards.
Conclusion: The bench studies verified that the AccuO2 System works as designed with back-up safety features functioning correctly. Furthermore, clinical studies demonstrated the AccuO2 maintains patients at or above a pre-set oxygenation level. Clinical studies also showed the Accu02 does not increase the amount of time the patient spends in an hypoxic state when compared to commercially available devices. Finally, as part of the AccuO2 system, the pulse oximeter functions in a manner equivalent to commercially available pulse oximeters in sensing oxygen levels in patients.
Clinical data demonstrate that the AccuO2 System is substantially equivalent to previously cleared devices and raises no new questions of safety and efficacy over commercially available oxygen conserving systems.
MITI Corp.
WDC - 86138/0001 - 2102849 v1
Functional and
Safety Testing:
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The image is in black and white.
Public Health Service
JUN 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MITI Corporation C/O Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 13th Street, NW Washington, DC 20004-1109
Re: K051007
Trade/Device Name: AccuO2 System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: April 19, 2005 Received: April 21, 2005
Dear Mr. Kahan:
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. Kahan
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 Office of Compliance at (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suite Marian Ones
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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INDICATIONS FOR USE PAGE
Device Name: AccuO2 System
Indications for Use:
The AccuO2 System, which provides oxygen therapy on demand, based on continuous, non-invasive monitoring of oxygen saturation, is indicated for home use by adult Chronic Obstructive Pulmonary Disease (COPD) patients who are prescribed low-flow (0-3 L/min) supplemental oxygen via nasal cannula and USP portable oxygen.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Mitchel Vahdat
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
MITI Corp.
Premarket Notification (510(k)) for the AccuO2 System CONFIDENTIAL
§ 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).