(103 days)
The Inovo Independence Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.
The Inovo, Inc. Independence Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The Independence senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen regulators. The Independence Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The Independence then delivers oxygen to the patient by sensing the beginning of inhalation using a pressure switch, which opens a solenoid valve for a specific period of time controlled by a microprocessor. The unit is designed to deliver 16 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM. The unit is powered by a single "AA" battery. The Independence also has a continuous flow back-up mode that delivers selectable continuous flow in the event of battery or device failure. The device has a two-color LED to indicate battery status. By depressing a "Battery test" switch, the device will show a Green light to indicate the battery is good. When the battery is below 0.9 vDC, the LED will be Red, indicating the battery must be changed. Under any circumstance, the "Continuous" mode can supply oxygen therapy in the event of battery failure. Patient inspiration is detected by a pressure switch set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a in the fango on at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.
I am sorry, but the provided text does not contain detailed acceptance criteria and a study that proves the device meets those criteria in the format requested.
The document is a 510(k) summary for the Inovo, Inc. Independence Conserving Regulator, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance criteria.
Here's what the document does provide in relation to your request:
- 1. A table of acceptance criteria and the reported device performance: This is not present in a tabular format detailing specific criteria (e.g., accuracy, reliability) and the numerical performance against them. The document lists "Performance Testing Included" such as Promoted Ignition ASTM G175, Hydrostatic Test, Proof Pressure Test, Conservation Test, Flow Regulation Test, Environmental Testing, and Electromagnetic Compatibility, but it does not specify the acceptance criteria for each or the reported results.
- 2. Sample sized used for the test set and the data provenance: This information is not provided. The document mentions "bench testing contained in our submission and non-clinical testing supplied" but does not detail sample sizes or data provenance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable and not mentioned, as there was no clinical study.
- 4. Adjudication method for the test set: Not applicable and not mentioned, as there was no clinical study.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, it explicitly states "Discussion of Clinical Test Performed: Not Applicable."
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone medical device, but there isn't a "standalone algorithm performance" in the context of an AI-driven device, as this is a mechanical/electronic oxygen regulator. The performance tests ("bench testing," "non-clinical testing") would represent standalone device performance.
- 7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established engineering standards and specifications (e.g., ASTM G175 for promoted ignition, industry standards for hydrostatic and proof pressure tests, and internal specifications for conservation and flow regulation).
- 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable for the same reason as above.
The document's primary goal is to establish substantial equivalence to predicate devices through non-clinical performance testing and comparison of technological characteristics, rather than a detailed report of clinical study results against specific, quantified acceptance criteria.
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SEP 2 1 2005
510(K) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: K051540
Submitter's Identification: 1.
- Inovo, Inc. 2975 S. Horseshoe Drive Naples, Fl. 34104
Date Summary Prepared: June 9, 2005
Contact Person: Mr. Kevin W. Confoy General Manager
Name of the Device: 2.
Inovo, Inc. Independence Conserving Regulator
Class and Product Code 2a.
Class II , Product Code NFB , Anesthesiology Panel
3. Predicate Device Information:
Device Description: 4.
The Inovo, Inc. Independence Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The Independence senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen regulators.
The Independence Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The Independence then delivers oxygen to the patient by sensing the beginning of inhalation using a pressure switch, which opens a solenoid valve for a specific period of time controlled by a microprocessor. The unit is designed to deliver 16 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM. The unit is powered by a single "AA" battery. The Independence
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also has a continuous flow back-up mode that delivers selectable continuous flow in the event of battery or device failure.
The device has a two-color LED to indicate battery status. By depressing a "Battery test" switch, the device will show a Green light to indicate the battery is good. When the battery is below 0.9 vDC, the LED will be Red, indicating the battery must be changed. Under any circumstance, the "Continuous" mode can supply oxygen therapy in the event of battery failure.
Patient inspiration is detected by a pressure switch set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a in the fango on at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.
Intended Use: 5.
The Independence Conserving Regulator is used to deliver a prescribed flow of medical grade oxygen to the patient while conserving gas from a highpressure cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.
Comparison to Predicate Devices: 6.
The Inovo, Inc. Independence Conserving Regulator is substantially equivalent to the Inovo Economizer (K031983), DeVilbiss PD 1000 (K020329) and the Chad Oxymatic (K003455). These predicate devices were cleared with the same indications for use as our device. The DeVilbiss and Chad devices are electronic conserving devices. The Inovo Economizer is a pneumatic device.
Similarities include features of the device, input operating pressures, outlet pressure, selectable outlet flows, oxygen conservation, inlet configuration, outlet connection, gauge, and trigger point. A major feature is a compact aluminum body with all brass in high pressure zones.
Similarities include features of the device attached as Exhibit #2.
There are two technological characteristic differences between the Independence and the predicate devices.
- a. Timing
The Independence Conserving Regulator has a fixed valve open time of 500ms, which is programmed into the microprocessor. To achieve various "pulse" volumes, the device uses various flow rates. Predicate electronic devices use a fixed flow rate of approximately 10-12 LPM and vary the valve open time between 100ms and 600ms to achieve various "pulse" volumes.
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There is no effect on safety and effectiveness.
- b. Delivery valve
The Independence Conserving Regulator uses battery power to operate a small "rile independents" ochool migran pressure to operate the pneumatic phot Solchold Varve and rogaratoic dryjces rely on battery power to operate a solenoid that controls a delivery valve. The dual-valve methodology extends battery life by nearly 40 times. The dual-valve technology used in the Independence is ine by noany 10 time to conserving devices, including the Inovo Economizer (K031983)
There is no effect on safety and effectiveness.
Discussion of Non-Clinical Test Performed for Determination of Substantial 7. Equivalence are as follows:
Performance Testing Included:
- Promoted Ignition ASTM G175 .
- Hydrostatic Test .
- Proof Pressure Test .
- Conservation Test .
- Flow Requiation Test .
- Environmental Testing .
- Electromagnetic Compatibility .
Discussion of Clinical Test Performed 8.
Not Applicable
8. Conclusions:
The subject device, the Inovo, Inc. Independence Conserving Regulator has the same intended use as the predicate devices, the Inovo Economizer (K031983), Samo Incondou as a comment (K003455). Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their performance characteristics, thereby not raising that there and his and effectiveness. Thus, the Inovo, Inc. Independence Conserving Regulator is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The caduceus is surrounded by a circle of text that reads "U.S. Department of Health and Human Services."
Public Health Service
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin W. Confoy General Manager Inovo, Incorporated 2975 S. Horseshoe Drive Naples, Florida 34104
Re: K051540
Trade/Device Name: Inovo, Inc. Independence Conserving Regulator Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilation (IPPB) Regulatory Class: II Product Code: NFB Dated: August 24, 2005 Received: August 25, 2005
Dear Mr. Confoy:
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. Confoy
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,
Ches
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
KOS 1540 510(k) Number (if known):
Device Name: Inovo, Inc. Independence Conserving Regulator
Indication For Use:
The Inovo Independence Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.
Prescription Use × (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cunn Sullivan
510(k) Number
(Division Sign-Of Division of Anesthesiology, General Hospital, Infection Control, Dental D
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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).