The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.

The blender is not intended as a life supporting device.

Device Description

The Precision Medical, Inc. Heliox/oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of Heliox/oxygen mixtures are required.

AI/ML Overview

The provided 510(k) summary for the Precision Medical, Inc. HeliO2 Blender does not contain a study that proves the device meets specific acceptance criteria in the way described in your request.

This document is a premarket notification (510(k)) submission to the FDA. For this type of device (a medical gas blender), "proving acceptance criteria" typically involves demonstrating substantial equivalence to a predicate device, as well as meeting recognized performance standards for medical gas blenders. The submission focuses on comparison to a predicate device and outlines the device's technical specifications and intended use, rather than presenting a performance study with detailed acceptance criteria and results against those criteria.

Here's an breakdown of the information available and what is not present, based on your request:

1. Table of acceptance criteria and the reported device performance

The document provides a table comparing the Heliox/oxygen blender to its predicate (air/oxygen blender) for various specifications. These specifications act as de facto acceptance criteria for functional performance, largely demonstrating equivalence or improvement compared to the predicate.

Feature	Acceptance Criteria (Predicate Performance)	Reported Device Performance (HeliO2 Blender)
Oxygen % Range	21 to 100%	20 to 100% (for 20/80 Heliox) and 30 to 100% (for 30/70 Heliox)
Accuracy	± 3% of full scale	± 3% of full scale
Supply Pressure	30-75 psi air + O2 must be within 10 psi	30-75 psi Heliox + O2 must be within 10 psi of each other
Max Flow (High Flow)	≥ 120 lpm @60% setting at 50psi inlet	≥ 120 lpm @60% setting at 50psi inlet pressures
Pressure Drop (High Flow)	≤ 6 psi at 50 psi inlet and 40 lpm flow	≤ 3 psi at inlet pressures from 30-90 psi and at 30lpm flow rate at 60% FiO2 (This shows an improvement compared to the predicate's 6 psi)
Alarm/Bypass Reset	When inlet gas pressure differential ≤ 6 psi	When inlet gas pressure differential is ≤ 6 psi
Alarm intensity	≥80 db at 1 foot	≥80 db at 1 foot
Operating temperature	59°F to 104°F	59°F to 104°F
Max Flow (Low Flow)	≥ 30 lpm @60% setting at 50psi inlet	≥ 30 lpm @60% setting at 50psi inlet pressures
Pressure Drop (Low Flow)	≤ 6 psi at 50 psi inlet and 10 lpm flow	≤ 2 psi at 30-90 psi inlet pressure and 10 lpm flow Rate at 60%FiO2 (This shows an improvement compared to the predicate's 6 psi)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary. For a medical device like a blender, "test set" would typically refer to the various configurations and conditions under which the device was tested (e.g., different flow rates, oxygen percentages, inlet pressures, gas mixtures). The document only states the specifications; it does not detail the testing methodology, number of test runs, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable and not provided for this type of device. "Ground truth" established by experts, especially clinical experts, is relevant for AI/diagnostic devices where human interpretation is involved. For a mechanical medical gas blender, performance is measured against engineering specifications, not expert consensus on an image or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods are used in studies where there is subjective assessment or disagreement, typically in diagnostic or imaging trials. Performance of a medical gas blender is measured objectively using calibrated instruments.

5. 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

This is not applicable and not provided. MRMC studies are used for evaluating diagnostic systems where human readers interpret medical cases, often with and without AI assistance. This device is a mechanical blender, not a diagnostic tool requiring human interpretation of cases.

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

This is not applicable and not provided. "Standalone" performance testing relates to AI algorithms. This device is a mechanical blender and does not involve algorithms in the sense of AI. Its performance is inherent to its mechanical design and operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for its performance would be objective engineering measurements from calibrated test equipment, adhering to relevant standards for medical gas blenders (e.g., flow meters, oxygen analyzers, pressure gauges). This is implied by the listed specifications but not explicitly detailed as "ground truth" in the provided text.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train AI models. This device is a mechanical product, not an AI system.

9. How the ground truth for the training set was established

This is not applicable and not provided for the same reason as point 8.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the HeliO2 Blender to a predicate oxygen blender through a comparison of their technical specifications and intended use. It does not present a "study" in the typical clinical or AI sense, but rather relies on the device meeting established engineering performance criteria consistent with or better than the predicate device. The detailed methodological aspects of a performance study (like sample size for test sets, expert involvement, adjudication, or training sets) are not included in this type of regulatory submission for a mechanical device.

Summary

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K090781

510(k) Summary

Precision Medical, Inc. Blender

Submitter Information

Submitter	Precision Medical, Inc.300 Held DriveNorthampton, Pa.18067	AUG 1 3 2009
Contact	James ParkerQuality Assurance Manager
Tel:Fax:Email	(610)-262-6090 Extensions 228(610)-262-6080jparker@precisionmedical.com
Preparation Date:	March 20, 2009
Device Name

Proprietary Name:	HeliO2 Blender
Common Name:	Helium- Oxygen Blender
Classification Name:	Blender, HeliO2 Unit (BZR) as per CFR 868.5330
Two models:
Low flow Blender	PM 5470/5480 flow, range 2 to 30 liters per minute
High flow blender	PM 5580/5570 flow, range 15 to 120 liters per minute

Predicate Device Equivalence

510K # K053232

Precision Medical, Inc. is claiming substantial to Precision Medical, Inc. oxygen blender same as oxygen blender except air fitting has been replaced with helium male fitting and scale on dial has been altered to add the Helium to the concentration.

Four models will be marketed

1. Low flow HeliO2 uses 70/30 helium to oxygen mixture
1. Low Flow HeliO2 uses 80/20 helium to oxygen mixture
1. Hi Flow HeliO2 uses 70/30 helium to oxygen mixture
1. Hi Flow HeliO2 uses 80/20 helium to oxygen mixture.

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Device Description

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Intended Use

The Precision Medical, Inc. Heliox Blender Oxygen System is intendcd to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.

The blender is not intended as a life supporting device.

Manufacturer	Precision Medical, Inc.Heliox/oxygen blender	Precision Medical, Inc.air/oxygen blender
Dimensions	H 3 ½ " W 2 ¼ " 5 ¼ "	H 3 ½ " W 2 ¼ " 5 ¼ "
Weight	2 ¾ lbs	2 ¾ lbs
Oxygen % Range	20 to 100% and 30 to 100%	21 to 100%
Accuracy	± 3% of full scale	± 3% of full scale
Supply Pressure	30-75 psi Heliox + O2 mustbe within 10 psi of eachother	30-75 psi air + O2 must bewithin 10 psi of each other
Max Flow (High Flow)	≥ 120 lpm @60% setting at50psi inlet pressures	≥ 120 lpm @60% setting at50psi inlet pressures
Pressure Drop (high flow)	≤ 3 psi at inlet pressuresfrom 30-90 psi and at30lpmflow rate at 60%FiO2	≤ 6 psi at 50 psi inletpressure and 40 lpm flow
Alarm/Bypass Reset	When inlet gas pressuredifferential is ≤ 6 psi	When inlet gas pressuredifferential is ≤ 6 psi
Alarm intensity	≥80 db at 1 foot	80 db at 1 foot
Operating temperature	59°F to 104°F	59°F to 104°F

Table of Comparisons to Predicate Device

The low flow model has the same characteristics as listed above, with the Max flow and the pressure drop being the only differences.

Manufacturer	Precision Medical, Inc.Heliox/oxygen blender	Precision Medical, Inc.air/oxygen blender
Max Flow ( Low Flow)	$\ge$ 30 lpm @60% setting at50psi inlet pressures	$\ge$ 30 lpm @60% setting at50psi inlet pressures
Pressure Drop (low flow)	$\le$ 2 psi at 30-90 psi inletpressure and 10 lpm flowRate at 60%FiO2	$\le$ 6 psi at 50 psi inletpressure and 10 lpm flow

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067

AUG 1 3 2009

Re: K090781

Trade/Device Name: Helium-Oxygen Blender Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: August 10, 2009 Received: August 11, 2009

Dear Mr. Parker:

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 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. Parker

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Arthur Dimock

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510 (k) number K090781

Device Name: Precision Medical, Inc. Helium-Oxygen Blender

Indications for use:

The blender is not intended as a life supporting device.

Prescription Use X (Per 21 CFR 801.109) Or

Over the counter use (Optional Format 1-2-9)

(Please do not write below this line- continue on another page if needed) Concurrence of CDRH, office of device Evaluation (ODE)

L. Schutter

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090781

Regulation Number and Section

§ 868.5330 Breathing gas mixer.

(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).