The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Description

The Profill Q601 series oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities.

The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile.

AI/ML Overview

The provided document describes a K091716 submission for the Merits Health Products Profill Q601 Series Oxygen Filling Accessory. This device is subject to a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against detailed acceptance criteria through a clinical study in the way an AI diagnostic device would.

Therefore, many of the typical questions for AI device studies regarding acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable in this context. This submission relies on performance data from engineering tests and a comparison of technological characteristics to establish substantial equivalence.

Here's the breakdown of the information that can be extracted, and where typical AI study information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Safety Tests	Leakage Currents Test	Meets safety standards	Confirmed
	Dielectric Strength	Meets safety standards	Confirmed
	Rigidity Test	Meets safety standards	Confirmed
	Stability Test	Meets safety standards	Confirmed
	Heating Test	Meets safety standards	Confirmed
	Abnormal Operation & Fault Condition	Meets safety standards	Confirmed
	Power Cord Test	Meets safety standards	Confirmed
	Transformer Dielectric Strength	Meets safety standards	Confirmed
	Ball Pressure Test	Meets safety standards	Confirmed
Electromagnetic Compatibility (EMC) Tests	EN60601-1-2	Meets EMC standards	Finished
	EN61000-3-2	Meets EMC standards	Finished
	EN61000-3-3	Meets EMC standards	Finished
Technological Characteristics	Oxygen Source	Same as predicate	Oxygen concentrator
	AC-Powered Motors	Similar to predicate	Similar
	Oxygen Compressors	Same size & material as predicate	Same
	Filling Time	Same as predicate	Same
	Filling Pressure	Same as predicate	Same
	Safety & EMC Requirements	Same as predicate	Same

Note: For 510(k) submissions, the "acceptance criteria" for these engineering tests are implicitly that the device meets the relevant industry performance and safety standards. The document states "Verification testing has confirmed the product meets its specifications," which indicates successful completion of these tests in accordance with established benchmarks for safety and functionality.

Regarding the study that proves the device meets the acceptance criteria (and other AI-specific questions):

For this type of device (an Oxygen Filling Accessory), the "study" proving it meets acceptance criteria is a series of engineering and safety tests, not a clinical study involving patients or human readers as would be typical for an AI diagnostic device.

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

Not Applicable (N/A). This device is an oxygen filling accessory, not an AI diagnostic tool. The performance data is based on engineering and safety tests of the device itself, not on a test set of patient data or images.

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)

Not Applicable (N/A). Ground truth in the context of AI refers to expert labeling of data. For this device, "ground truth" relates to the physical and electrical safety standards that the device must meet, which are objectively measurable by testing engineers.

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

Not Applicable (N/A). This pertains to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

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

Not Applicable (N/A). This type of study is for evaluating AI's impact on human performance in diagnostic tasks and is not relevant for an oxygen filling accessory.

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

Not Applicable (N/A). This refers to the performance of an AI algorithm in isolation, which is not relevant for this device. The device's "performance" is its ability to safely and effectively pressurize oxygen and fill cylinders.

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

Objective Engineering Standards and Safety Regulations. The "ground truth" for this device's performance is adherence to established international and national safety, electrical, and EMC standards (e.g., EN60601-1-2, EN61000-3-2, EN61000-3-3) and the device's functional specifications (filling time, pressure).

8. The sample size for the training set

Not Applicable (N/A). This device does not involve machine learning or a training set.

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

Not Applicable (N/A). As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a medical device that demonstrates substantial equivalence through technical comparisons and adherence to engineering safety standards, rather than clinical efficacy studies often associated with AI diagnostic tools.

Summary

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K091716

9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

APR - 2 2010

	"510(k) SUMMARY"
9.1	Manufacturer:	Merits Health Products Co., LTD.9, Road 36,Taichung Industrial ParkTaichung, Taiwan R.O.C
9.2	Submitted By:	Steve ChaoMerits Health Products Co., LTD.9, Road 36,Taichung Industrial ParkTaichung, Taiwan R.O.C.Tel: 886-4-2359-4985 ext. 200Fax: 886-4-2359-4992E-mail: stevechao@merits.com.tw
9.3	Trade/Proprietary Name:	Merits Health Products Oxygen FillingAccessory
9.4	Common/Usual Name:	Oxygen Concentrator (Accessory)
9.5	Classification Name:	Portable Oxygen Generator21 CFR 868.544073 CAW

9.6 Comparison to Currently Marketed Devices

The modified Merits Health Products Profill Q601 Series Oxygen Filling Accessory is substantially equivalent to the currently marketed Merits Oxygen Filling Accessory (K050430).

9.7 Device Description

9 ก

ﻴﺔ

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SUMMARY OF SAFETY AND EFFECTIVENESS (Con't)

Indications for Use 9.8

The Oxygen Concentrators with the Oxygen Filling accessory are intended to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. They are not intended to sustain or support life.

g.g Technological Characteristics

The subject and the predicate devices both use the oxygen concentrator as its oxygen source, similar AC-Powered Motors to drive the oxygen compressors. Both the oxygen compressors use cylinders of the same size and material. The oxygen flows in is compressed in the cylinders and then fill into a medical cylinder through the filling connector. The filling time and filling pressure are the same. Both meet the same Safety and EMC requirements. The technological characteristics of the Profill 0601 series oxygen filling machines are the same as the predicate devices.

9.10 Performance Data

The Safety tests under conduct are summarized in the following.

a. Leakage Currents Test
b. Dielectric Strenath
c. Rigidity Test
d. Stability Test
e. Heating Test
f. Abnormal operation and fault condition
g. Power cord Test
h. Transformer dielectric strength
Ball pressure Test -

The regarding electromagnetic compatibility (EMC) tests has been finished are listed in the following.

a. EN60601-1-2
b. EN61000-3-2
c. EN61000-3-3

Verification testing has confirmed the product meets its specifications.

9.11 Conclusion

Based on the design, performance specifications, testing and intended use, the Oxygen Filling Accessories are substantially equivalent to the currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail feathers.

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

APR - 2 2010

Mr. Steve Chao Merits Health Products Company, Limited 9, Road 36, Taichung Industrial Park Taichung, Taiwan 407

Re: K091716

Trade/Device Name: The Merits Health Products Profill Q601 Series Oxygen Filling Accessory Regulation Number: 21CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: March 10, 2010 Received: March 11, 2010

Dear Mr. Chao:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Chao

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.html 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. · 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 STATEMENT

510(k) File Number:

Device Name:

The Merits Health Products Profill Q601 Series Oxygen Filling Accessory

Indications For Use:

Prescription Use ✓ (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

510(k) Number: _ Co91716

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).