The Inovo AccuPulse Single Lumen Pneumatic 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.

Device Description

The Inovo, Inc. AccuPulse 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 AccuPulse 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 requlators.

The AccuPulse Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The AccuPulse then delivers oxygen to the patient by sensing the beginning of inhalation using a diaphragm, which opens a sliding valve for a specific period of time controlled by pneumatic timing. The unit is designed to deliver 12 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM.

The AccuPulse also has a continuous mode that delivers selectable continuous flow in the event of device failure.

Patient inspiration is detected by a pressure-sensitive diaphragm set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a bolus of oxygen 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.

AI/ML Overview

This 510(k) summary describes a medical device, the Inovo, Inc. AccuPulse Conserving Regulator, which is an oxygen conserving device. The information provided is for regulatory clearance and does not detail a study in the context of typical clinical trials with specific acceptance criteria outcomes. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided text in relation to your questions:

Device Acceptance Criteria and Performance (as determined by non-clinical testing for substantial equivalence)

The document does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds that need to be met for clinical effectiveness. Instead, the "acceptance" is based on demonstrating that the device performs similarly to predicate devices and does not raise new questions of safety or effectiveness. The performance testing conducted is described as "Non-Clinical Test Performed for Determination of Substantial Equivalence."

The "reported device performance" is summarized by stating that "non-clinical testing supplied demonstrates that there are no differences in their performance characteristics."

Acceptance Criteria Category	Reported Device Performance (as demonstrated by non-clinical testing)
Promoted Ignition (ASTM G175)	Tested; Implied to be acceptable as "no differences in performance" are noted.
Hydrostatic Test	Tested; Implied to be acceptable as "no differences in performance" are noted.
Proof Pressure Test	Tested; Implied to be acceptable as "no differences in performance" are noted.
Conservation Test	Tested; Implied to be acceptable as "no differences in performance" are noted. The device is designed to "extend the use time of oxygen cylinders."
Flow Regulation Test	Tested; Implied to be acceptable as "no differences in performance" are noted. ("designed to deliver 12 cc/lpm of oxygen... at flows from 1 LPM to 6 LPM.")
Environmental Testing	Tested; Implied to be acceptable as "no differences in performance" are noted.
Patient Inspiration Detection	Functions within range: 0.10 to 0.35 cm H2O. Capable of delivering bolus up to 40 BPM.
General Operation / Safety & Effectiveness	"no differences in their performance characteristics, thereby not raising any new questions of safety and effectiveness" compared to predicate devices.

Study Details Based on the Provided Text:

This submission is for a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical (human) studies to establish new safety or effectiveness claims with specific acceptance criteria and ground truth.

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. This was a non-clinical performance testing (bench testing), not a clinical trial with a "test set" of patient data. The tests were performed on the device itself.
Data Provenance: Not applicable, as there is no patient data or clinical data described. The tests were performed in a lab setting by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no "ground truth" derived from expert consensus for a test set of patient data. The performance tests are objective measurements of the device's physical and functional characteristics.

3. Adjudication method for the test set:

Not applicable. No clinical test set or adjudication process for clinical outcomes is described.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a pneumatic oxygen conserving regulator, not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an algorithm or AI device. The device operates independently once set by a healthcare provider for a patient's prescribed flow. The "standalone" performance was demonstrated through the non-clinical bench tests.

6. The type of ground truth used:

For the non-clinical performance and safety tests, the "ground truth" implicitly refers to engineering specifications, recognized industry standards (e.g., ASTM G175), and the performance characteristics of predicate devices. The device's performance was measured against these objective criteria rather than against expert consensus or pathology in a clinical setting.

7. The sample size for the training set:

Not applicable. This device is a mechanical/pneumatic device. There is no "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

Not applicable. See point 7.

Summary

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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.

1060751 The assigned 510(k) number is:

1. Submitter's Identification:

Inovo, Inc. 2975 S. Horseshoe Drive Naples, Fl. 34104

Date Summary Prepared: March 10, 2006

Contact Person: Mr. Michael T. Dildine Quality Assurance Manager

2. Name of the Device:

Inovo, Inc. AccuPulse Conserving Requlator

3. Class and Product Code

Class II , Product Code NFB , Anesthesiology Panel

4. Predicate Device Information:

1. Precision Medical Inc. Easy Pulse 5 (K032018)
1. Chad Oxypneumatic Cypress Model 511 (K020475)
1. Inovo Economizer (K031983)

5. Device Description:

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The AccuPulse also has a continuous mode that delivers selectable continuous flow in the event of device failure.

Intended Use: 6.

The AccuPulse Conserving Requlator 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.

7. Comparison to Predicate Devices:

The Inovo, Inc. AccuPulse Conserving Regulator is substantially equivalent to the Precision Medical Inc. Easy Pulse 5 (K032018), the Chad Oxyoneumatic Cypress Model 511 (K020475) and the Inovo Economizer (K031983). These predicate devices were cleared with the same indications for use as our device.

Similarities include features of the device, input operating pressures, outlet pressure, selectable outlet flows, oxygen conservation, inlet configuration, outlet connection (except the Economizer, K031983, which has a dual-lumen 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 is one technological characteristic difference between the AccuPulse and the predicate devices:

Timing

The AccuPulse Conserving Regulator has a sliding valve which connects the outflow of oxygen to the outlet port. Upon patient inhalation, sliding valve closes the passage between the sensing diaphragm and the outlet port and then opens a passage to allow oxygen to the patient. The valve does not allow any oxygen to contact the sensing diaphragm, thereby protecting the diaphragm. In addition, the valve does not allow the unit to pulse a second time until a defined interval has passed.

There is no effect on safety and effectiveness.

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Discussion of Non-Clinical Test Performed for Determination of Substantial 8. Equivalence are as follows:

Performance Testing Included:

Promoted Ignition ASTM G175 .
Hydrostatic Test .
Proof Pressure Test .
Conservation Test .
Flow Regulation Test .
Environmental Testing .

ல் Discussion of Clinical Test Performed

Not Applicable

10. Conclusions:

The subject device, the Inovo, Inc. AccuPulse Conserving Regulator has the same intended use as the predicate devices, the Inovo Economizer (K031983), Precision Medical (K032018) and the Chad (K020475). 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 any new questions of safety and effectiveness. Thus, the Inovo, Inc. AccuPulse 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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2006

Mr. Michael T. Dildine Quality Assurance Manager Inovo, Incorporated 2975 S. Horseshoe Drive, Suite 600 Naples, Florida 34104

Re: K060751

Trade/Device Name: Inovo, Inc. AccuPulse Single Lumen Pneumatic Conserving Regulator Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: July 12, 2006 Received: July 12, 2006

Dear Mr. Dildine:

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. Dildine

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issualics or a subscriptives with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administers byt not limited to: r of the Act of any rederal statues and reguirements, including, but not limited to: registration
You must comply with all the Act strements, and monufacturing practice You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Par and listing (21 CFR Fall 807), labeling (21 CFR Pat 820); of CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Partisers 531, 542 requirements as set form in the quality systems (Sections 53) -542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 10(k)
the success of the same of the same in a consisted in a I his letter will anow you to begin mailer.ing your and equivalence of your device to a premarket notification. The PDA initing of substantler of a consisted on the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). A If you desire specific advice for your de roo on one of the regulation of the regulation please contact inc Office or Comphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general mionnational and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

510(k) Number (if known):

Device Name: Inovo, Inc. AccuPulse Single Lumen Pneumatic Conserving Regulator

Indication For Use:

Prescription Use X (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)

W Mak fn AAb

Vision Sign-Off) I sion of Anesthesiology, General Hospital. Control, Dental Dental Devi

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Regulation Number and Section

§ 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).