The Cyl-Fil Oxygen System is intended to provide supplemental oxygen by prescription only. Cyl-Fil is a two component system. The first component consists of a high pressure regulator that delivers USP oxygen from a supply cylinder having two pressure settings. The second component is a light-weight portable, high pressure cylinder that is refilled by use of the Cyl-Fil pressure regulator.

The intended patient population is to supply, by prescription only, supplemental oxygen to patients requiring additional oxygen.

Device Description

The Responsive Respiratory Cyl-Fil Oxygen System is a two component system. The first component is a high pressure regulator that delivers USP Grade oxygen at two pressure settings. The second component is a lightweight, portable high pressure cylinder with an oxygen specific post valve (similar to CGA-870 with an additional pin/hole location unique to the Cyl-Fil system) that incorporates a residual pressure retention device to insure that the USP oxygen is always retained in the cylinder. The portable cylinder is prepared and filled with USP oxygen according to industry and FDA requirements.

A supply cylinder supplies USP oxygen to the inlet connection (standard CGA-540) of the Cyl-Fil regulator. The Cyl-Fil regulator pressure setting delivers USP oxygen to the Cyl-Fil portable cylinder at a pressure and rate that does not exceed the safety rating of the cylinder, according to the cylinder manufacturer's specifications. The second Cyl-Fil regulator pressure setting delivers USP oxygen to an auxiliary outlet connection (CGA-1240) for continuous oxygen therapy support in the home.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Cyl-Fil Oxygen System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technological characteristics. It does not typically involve detailed clinical studies with human subjects, complex statistical analysis of performance metrics like sensitivity/specificity, or multi-reader, multi-case studies, as would be expected for a device relying on AI or requiring efficacy testing.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this document. The "acceptance criteria" here are essentially that the device performs its intended function safely and effectively, and is substantially equivalent to existing predicate devices, as demonstrated by the non-clinical tests listed.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Delivery of USP Grade Oxygen at two pressure settings	The Cyl-Fil Oxygen System's high-pressure regulator delivers USP Grade oxygen at two pressure settings. One setting for filling the portable cylinder, ensuring it does not exceed the cylinder's safety rating. The second setting delivers USP oxygen to an auxiliary outlet for continuous oxygen therapy.
Safe and effective operation for ambulatory oxygen use	The system is intended for patients prescribed oxygen for ambulatory use, allowing them to fill portable cylinders at home. It is deemed substantially equivalent in safety and effectiveness to predicate devices.
System integrity for portable cylinder connection	The Cyl-Fil portable cylinder has a proprietary connection (similar to CGA-870 with additional pin/hole) unique to the system to maintain integrity. The regulator's initial outlet connects specifically to this portable cylinder.
Maintenance of residual pressure in portable cylinder	The Cyl-Fil valve is designed to maintain a residual pressure (14 PSI to 72 PSI) to eliminate the need for evacuation between refills due to contamination, ensuring positive pressure is always retained.
Compliance with relevant industry standards and safety ratings	Components are designed for 100% pure oxygen applications and tested accordingly. The device and its components (regulator, valve, cylinder) are stated to follow: CGA recommendations (Compressed Gas Association), DOT guidelines ("Compressed gas cylinders"), ISO 10297, ISO 15996, and ASTM G175. The regulator manufacturer (Inovo), valve manufacturer (Cavagna Group), and cylinder manufacturer (Luxfer Gas Cylinders) are established and certified (e.g., ISO certified) and are members of organizations instilling safety (CGA, DOT).
Durability and structural integrity of components	Non-clinical tests performed include: Hydrostatic Test, Proof Pressure Test, Cycle Test, ASTM G175 (for regulator), and ISO 10297 & ISO 15996 (for valve). This indicates testing for pressure resistance, leakage, and endurance.
Substantial equivalence to predicate oxygen regulators and valves	The Cyl-Fil regulator is stated to be substantially equivalent to other Class I Oxygen Regulators and Inovo's Oxygen Conserving Regulator (Class 2), citing similar components, material, and design. The Cyl-Fil portable cylinder valve is substantially equivalent to other Class I Oxygen cylinder valve manufacturers. The document repeatedly states "No significant difference in safety and effectiveness between Cyl-Fil and the above predicate devices." The additional features (two outlets, proprietary connection, residual pressure) are presented as allowing "the patient to utilize the supply gas more effectively" rather than posing new safety or effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human subject "test set" data (e.g., patient cases) is mentioned. The testing refers to non-clinical, component-level engineering tests.
Data Provenance: The data comes from non-clinical engineering tests performed on the device components (regulator, valve, cylinder) to ensure they meet specified standards and safety requirements. The specific testing facilities or retrospective/prospective nature of the engineering tests are not detailed beyond listing the types of tests and standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable: This type of information is pertinent to studies involving expert review of medical images or other diagnoses to establish a "ground truth" for evaluating an algorithm or human performance. This 510(k) concerns a physical medical device (oxygen system) and its non-clinical performance, not diagnostic accuracy requiring expert ground truth.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods (like 2+1, 3+1) are used in clinical studies or algorithm evaluations where multiple experts provide opinions that need to be reconciled to establish a ground truth. This is not reported for the non-clinical engineering tests performed on the Cyl-Fil Oxygen System.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: A MRMC study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance across multiple cases. It is not relevant for a physical oxygen delivery system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No: This is not an AI/algorithm-based device. Therefore, a standalone algorithm performance study is not applicable. The listed "Performance Testing" are standalone tests of the device's physical components.

7. Type of Ground Truth Used

Engineering Standards and Specifications: The "ground truth" for the non-clinical tests is adherence to established engineering standards (ISO, ASTM, CGA, DOT) and the manufacturer's own safety and performance specifications for the components (e.g., pressure ratings, material compatibility with 100% oxygen, cycle life). The objective is to demonstrate that the device meets these pre-defined technical criteria.

8. Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of an AI algorithm for this device. If interpreted as samples used for development/testing of the physical device components, the text does not specify quantities beyond referring to "all brass constructed regulators and brass post valves" and "components are designed for use in 100% pure oxygen applications and tested accordingly." This implies standard manufacturing and quality control sample sizes for component testing.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there is no AI training set, this question is not relevant. The performance metrics for the device components are based on physical laws, material science, and established engineering standards.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Responsive Respiratory Inc. The logo features a large, stylized letter "R" in black, with a white space creating a negative space "R" within it. Below the large "R", the words "RESPONSIVE" and "RESPIRATORY INC." are printed in a smaller, sans-serif font, stacked on top of each other.

261 Wolfner Drive Fenton, Missouri 63026

K061785

636.600.4030 636.600.4035 fax www.respondo2.com

SEP - 7 2006

Section 3

510(K) Summary and Substantial Equivalence Comparison

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: K061785 Trade Name: Cyl-Fil Oxygen System

1. Submitter's Identification:

Responsive Respiratory, Inc. 261 Wolfner Drive Fenton, MO 63026

Tel: 636-600-4030 Fax: 636-600-4035

Date Summary prepared: June 21, 2006 Amendment - August 9, 2006

Contact Person: Mr. Thomas K. Bannon Ext. 2701 President Email: tkb@respondo2.com

2. Name of Device:

Cyl-Fil Oxygen System

2a. Class and Product Code:

Class 1, 21CFR 868.2700 73 CAN

3. Predicate Device Information:

Regulators & Conserving Regulators

Inovo Inc. - Oxygen Conserving Regulator #K031983 Same components, material and design as Cyl-Fill regulator.

Victor Equipment (Thermadyne) - K891771 (6-23-1989)

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MADA Medical - K950777 (4-14-1995)

Erie Medical - K780359 (4-4-1978)

Precision Medical - K901831 (8-14-1990)

Oxygen Cylinder Valve - Class 1 (unclassified) - Product Code ECX

Cavagna Group -

The International Standard ISO 10297 Transportable Gas Cylinders - Cylinder Valves - Specifications & Type Testing. 2. International Standard ISO 15996 Gas Cylinders - Residual Pressure Valves - General Requirements & Type Testing 3. As well as following CGA recommendations.

Sherwood - Follows CGA recommendations, ISO certified

Oxygen Cylinders - Class 1 (unclassified) - Product Code KGA

Luxfer Gas Cylinders - Cylinders are manufactured to DOT-3AL 2216 and TC-3ALM 153 specifications. Follows DOT quidelines for "Compressed gas cylinders". ISO certified

Catalina Cylinders - Cylinders are manufactured to DOT-3AL 2216 and TC-3ALM 153 specifications. Follows DOT guidelines for "Compressed gas cvlinders.

4. Device Description:

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5. Intended Use:

The Cyl-Fil Oxygen System is used by patients who have been prescribed oxygen for ambulatory use. Cyl-Fil regulator allows the patient to maintain a supply of oxygen in their home that delivers the prescribed flow per the physician and also allows the patient to use the primary oxyqen cylinder to fill the Cyl-Fil portable cylinder for their ambulatory needs.

6. Comparison to Predicate Devices:

The Cyl-Fil requlator is substantially equivalent to other Class | Oxygen Regulators and Inovo's Oxygen Conserving Regulator (Class 2). These companies are Victor Equipment Co., MADA Medical, Erie Medical, Precision Medical and Inovo Inc. Our design is of an all brass construction which uses the same components, materials and design as Inovo's Conserving Regulator K031983.

The Cyl-Fil portable cylinder valve is substantially equivalent to other Class I Oxygen cvlinder valve manufacturers. These companies are Sherwood Valve Co. a division of Harsco Corp. and Cavagna Group. Both are active members in the Compressed Gas Association (CGA) which sets the standards with compressed gases.

There are three technological characteristic differences between Cvl-Fil and the other predicate devices.

6a. The Cyl-Fil regulator has two outlets preset to deliver specific pressures and may be used in conjunction. The initial outlet connects the Cyl-Fil portable cylinder which has a proprietary connection to maintain system intearity. This regulator limits the maximum pressure and rate of flow.

6b. The second outlet allows for use in the home setting.

The Cyl-Fil is substantially equivalent in safety and effectiveness to the predicate devices referred above "#3 Predicate Device Information".

6c. The Cyl-Fil valve is designed to maintain a residual pressure to eliminate the need to evacuate between refills due to contamination. The residual pressure retention maintains a positive pressure in the cylinder (14 PSI to 72PSI). The valve includes a proprietary pin index connection to fit only the Cyl-Fil requlator which maintains system integrity.

There is no significant difference in safety and effectiveness between Cyl-Fil and the above predicate devices.

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7. Discussion of Non-Clinical Tests Performed for Determining Substantial Equivalence

We have followed the tests associated with all brass constructed regulators and brass post valves. All of the components are designed for use in 100% pure oxygen applications and tested accordingly. Performance Testing Included:

Hydrostatic Test o
Proof Pressure Test ্ত
Cycle Test o
ASTM G175 (Cyl-Fil Regulator, K031983) o
o ISO 10297 & ISO 15996 (Cyl-Fil Valve)

8. Conclusions:

The subject device, the Responsive Respiratory, Inc., Cyl-Fill Oxygen System has the same intended use as the predicate regulators and valves listed. The additional features incorporated allow the patient to utilize the supply gas more effectively. Moreover, the manufacturers of the Cyl-Fil regulator (INOVO Inc.), Cyl-Fil valve (Cavagna Group) and cylinder (Luxfer gas Cylinders) for Responsive Respiratory Inc. are established in the market and have demonstrated their commitment to quality through previous FDA involvement and membership to associations that instill safety to the industry (CGA) and (DOT).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle-like symbol with stylized lines, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2006

Mr. Thomas K. Bannon President Responsive Respiratory, Incorporated 261 Wolfner Drive Fenton, Missouri 63026

Re: K061785

Trade/Device Name: Cyl-Fil Oxygen System Regulation Number: 21 CFR 868.2700 Regulation Name: Pressure Regulator Regulatory Class: I Product Code: CAN, ECX and KGA Dated: July 31, 2006 Received: August 1, 2006

Dear Mr. Bannon:

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. Bannon

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

Sincerely vours,

Cure Suleon for
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: K061785

Cyl-Fil Oxygen System Device Name:

Indications for Use:

The intended patient population is to supply, by prescription only, supplemental oxygen to patients requiring additional oxygen.

Prescription Use x (Part 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)

Auy Surom

(Division Sidn-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device:

510(k) Number

Page 1 of

Regulation Number and Section

§ 868.2700 Pressure regulator.

(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.