The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.

Device Description

The Precision Medical, Inc. Air and 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 air/oxygen mixtures is required.

AI/ML Overview

The provided text describes the Precision Medical, Inc. Blender, an oxygen blender, and its substantial equivalence to a predicate device (Bio-Med Blender). The document explicitly lays out performance specifications for the device and a summary of performance testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device Specification)	Reported Device Performance (Precision Medical, Inc. Blender)
Oxygen % Range	21 to 100%	21 to 100%
Accuracy	± 3% of full scale	± 3% of full scale
Supply Pressure	30-75 psi air + O2 must be within 10 psi of each other	30-75 psi air + O2 must be within 10 psi of each other
Max Flow (High Flow)	≥ 120 lpm @60% setting at 50psi inlet pressures	≥ 120 lpm @60% setting at 50psi inlet pressures
Pressure Drop (High Flow)	≤ 6 psi at 50 psi inlet pressure and 40 lpm flow	≤ 6 psi at 50 psi inlet pressure and 40 lpm flow
Max Flow (Low Flow)	≥ 30 lpm @60% setting at 50psi inlet pressures	≥ 30 lpm @60% setting at 50psi inlet pressures
Pressure Drop (Low Flow)	≤ 6 psi at 50 psi inlet pressure and 10 lpm flow	≤ 6 psi at 50 psi inlet pressure and 10 lpm flow
Alarm/Bypass Reset	When inlet gas pressure differential is ≤ 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° to 104°F	59°F to 104°F
Dimensions	H 3 ½ "x W 2 ¼" D 2 ⅞ "	H 3 ½ " W 2 ¼ " 5 ¼ "
Weight	2 ¼ lbs	2 ¼ lbs

The "Reported Device Performance" column directly reflects the specifications of the Precision Medical, Inc. Blender, which are stated to be equivalent to the predicate device. The document affirms that "The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance."

2. Sample size used for the test set and the data provenance

The document states, "The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in technical reports that would accompany such a submission but is not present in this summary.

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

This device is an oxygen blender, which is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment. Therefore, this section is not applicable. The performance is measured against established physical and mechanical parameters.

4. Adjudication method for the test set

As this is a mechanical device, performance is evaluated against defined physical and operational specifications using measurement tools, not through human interpretation or adjudication. Therefore, an adjudication method is not applicable.

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 device is an oxygen blender, not an AI-assisted diagnostic or interpretive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study is not applicable.

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

This question is related to AI/algorithm performance. The Precision Medical, Inc. Blender is a purely mechanical device. Therefore, this is not applicable.

7. The type of ground truth used

For the Precision Medical, Inc. Blender, the "ground truth" for performance evaluation is based on defined engineering specifications and measurable physical/mechanical parameters (e.g., oxygen concentration, flow rates, pressure differentials, alarm intensity, temperature range). These are objective measurements rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This device is not an AI/machine learning system that requires a "training set." Its design and performance are based on engineering principles and physical testing. Therefore, this is not applicable.

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

As there is no training set for this mechanical device, this is not applicable.

Summary

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510(k) Summary

Precision Medical, Inc. Blender

Submitter Information

Submitter	Precision Medical, Inc.300 Held DriveNorthampton, Pa.18067
Contact	James ParkerQuality Assurance Manager
Tel:Fax:	(610)-262-6090 Extensions 228(610)-262-6080
Preparation Date:	November 17, 2005
Device Name
Proprietary Name:	Precision Blender
Common Name:	Oxygen Blender
Classification Name:Two models:	Blender, Oxygen Unit (73 BYJ) as per CFR 868.5330
Low flow Blender	PM 5300 flow, range 0 to 30 liters per minute

High flow blender PM 5200 flow, range 2 to 120 liters per minute

Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to the Bio-Med Blender 510K # K925982

Device Description

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Intended Use

The Precision Medical Inc. Air and oxygen blender is designed to dispense a continuous and precise blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients. The exact FIO2 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen (FiO2) setting indicated by the control face.

Manufacturer	BIO-Med Blender	Precision Medical, Inc.
Dimensions	H 3 ½ "x W 2 ¼" D 2 ⅞ "	H 3 ½ " W 2 ¼ " 5 ¼ "
Weight	2 ¼ lbs	2 ¼ lbs
Oxygen % Range	21 to 100%	21 to 100%
Accuracy	± 3% of full scale	± 3% of full scale
Supply Pressure	30-75 psi air + O2 must be within 10 psi of each other	30-75 psi air + O2 must be within 10 psi of each other
Max Flow (High Flow)	≥ 120 lpm @60% setting at 50psi inlet pressures	≥ 120 lpm @60% setting at 50psi inlet pressures
Pressure Drop (high flow)	≤ 6 psi at 50 psi inlet pressure and 40 lpm flow	≤ 6 psi at 50 psi inlet pressure and 40 lpm flow
Alarm/Bypass Reset	When inlet gas pressure differential is ≤ 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° 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	BIO-Med Blender	Precision Medical, Inc.
Max Flow ( Low Flow)	$\geq$ 30 lpm @60% setting at 50psi inlet pressures	$\geq$ 30 lpm @60% setting at 50psi inlet pressures
Pressure Drop (low flow)	$\leq$ 6 psi at 50 psi inlet pressure and 10 lpm flow	$\leq$ 6 psi at 50 psi inlet pressure and 10 lpm flow

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Summary of Performance Testing

The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance

Conclusions

In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen blender is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.

Risk Analysis

Precision Medical, Inc. is using International Standard ISO 14971 Medical Devices Application of Risk management to medical devices Risk analysis has been completed for this device. This document will be updated and released as part of design control.

Design control

Precision Medical, Inc. is in compliance with 21 CFR 820.30 for design control. The design inputs/outputs matrix has been developed using form PMF 202. These documents will be completed before the release of the product.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN I 0 2006

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

Re: K053232

Trade/Device Name: Precision Medical, Inc Blender Regulation Number: 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: November 17, 2005 Received: November 18, 2005

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 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. 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); 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,

Sygite Y. Michael Oms.

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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510 (k) number (if known)

Device Name: Precision Medical, Inc.Blender

Indications for use:

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)

Smitte Y. Michie Omd.

Oral, Dental Devices

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).