(76 days)
No
The description focuses on mechanical components (regulator, cylinder, valves) and pressure settings for oxygen delivery and refilling. There is no mention of AI or ML terms, data processing, or algorithms.
Yes.
The device is intended to provide supplemental oxygen to patients requiring additional oxygen, which is a therapeutic purpose.
No
This device is intended to provide supplemental oxygen, not to diagnose a condition or disease.
No
The device description clearly outlines two hardware components: a high-pressure regulator and a lightweight, portable high-pressure cylinder. There is no mention of software as a component of this system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients requiring additional oxygen. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a system for delivering and refilling oxygen cylinders. It does not involve testing samples from the human body (in vitro).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device clearly falls outside of that category.
N/A
Intended Use / Indications for 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.
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.
Product codes
CAN, ECX, KGA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 - Proof Pressure Test - Cycle Test - ASTM G175 (Cyl-Fil Regulator, K031983) - ISO 10297 & ISO 15996 (Cyl-Fil Valve)
Key Metrics
Not Found
Predicate Device(s)
K031983, K891771, K950777, K780359, K901831
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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)
1
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:
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.
2
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.
3
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).
4
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.
5
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
6
Indications for Use
510(k) Number: K061785
Cyl-Fil Oxygen System Device Name:
Indications for Use:
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.
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
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