(30 days)
Not Found
No
The description focuses on the physical principles (Pressure Swing Adsorption) and mechanical components of the oxygen concentrator. There is no mention of AI, ML, or any data-driven algorithms for controlling or optimizing the device's performance.
Yes.
The device provides supplemental therapeutic oxygen to a patient and is used in a military field hospital setting by medical personnel. Its intended use directly supports patient treatment, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as providing supplemental therapeutic oxygen. It generates and delivers oxygen, but does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly outlines a hardware system based on Pressure Swing Adsorption, including a gaseous oxygen generator, molecular sieve, storage, delivery ports, and accessory kit. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Provides supplemental therapeutic oxygen to a patient in a military field hospital setting." This describes a device used on a patient for therapeutic purposes, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a system that generates and delivers oxygen to a patient. It focuses on flow rates, pressure, and oxygen purity, all related to providing respiratory support. There is no mention of analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document explicitly states "Not Found" for key characteristics typically associated with IVDs, such as:
- Mentions image processing
- Mentions AI, DNN, or ML (often used in analyzing diagnostic data)
- Input Imaging Modality
- Anatomical Site (relevant for where a diagnostic test might be applied or what it's analyzing)
- Description of training/test sets for performance studies (common for validating diagnostic algorithms or tests)
- Key Metrics like Sensitivity, Specificity, PPV, NPV (standard metrics for evaluating diagnostic test performance)
In summary, the Portable Therapeutic Oxygen Concentration System (PTOCS) is a therapeutic device designed to provide oxygen directly to a patient, not a device used for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.
Product codes
CAW
Device Description
The Portable Therapeutic Oxygen Concentration System (PTOCS) has been designed to accommodate Military Personnel with a source of supplemental oxygen in a setting where liguid oxygen may be unavailable. Aeromedical Evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. The gaseous oxygen generator will also be required to provide oxygen at the prescribed flow rates and pressures required to operate the oxygen driven equipment included in the AFMS deployable medical assemblages. Requirements are based on the deployable oxygen system, operational requirements document that has been issued by the United States Air Force.
This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of three ports (1/2 to 15 lpm settings) with a maximum litre per minute flow of 45 total at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit consisting of 20 feet of medical grade oxygen hose and flow regulators for each outlet.
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 bench testing conducted by Essex Cryogenics of MO., Inc. as provided is conclusive in establishing substantial equivalence of the PTOCS to the predicate devices on which SE is claimed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Essex Cryogenics of Missouri, Inc.
A SUBSIDIARY OF ESSEX INDUSTRIES, INC. 8007 CHIVVIS DRIVE · ST. LOUIS, MO 63123-2395 (314) 832-8077 · FAX (314) 832-8208 www.essexind.com
Image /page/0/Picture/4 description: The image is a logo for Essex Industries celebrating 50 exciting years. The logo is in black and white and features a diamond shape with the number 50 in large, stylized font at the top. Below the number 50, the words "EXCITING YEARS" are written in a smaller font. At the bottom of the diamond, the words "ESSEX INDUSTRIES" are written in a simple, sans-serif font.
510(k) Summary for PTOCS
July 29, 2002
| Applicant: | Essex Cryogenics of MO., Inc.
8007 Chivvis Drive,
Saint Louis, MO 63123 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Fax: | 314-832-8208 |
| Phone: | 314-832-8077 (306) |
| Contact: | Elizabeth Hunnicutt, Quality Engineer / Regulatory Affairs
314-832-8077 ext. 306
email: ehunnicutt@essexind.com |
| Trade Name: | Portable Therapeutic Oxygen Concentration System (PTOCS) |
| Common Name: | Oxygen Concentrator |
| Establishment Registration Number: | 1937980 |
| Manufactured at: | Same as Applicant |
| Classification Name: | Oxygen Concentrator
Product code CAW, CFR 21 § 868.5440
Class II |
| Reason for 510(k): | Initial Release of PTOCS |
| | Legally Marketed Device, which Substantial Equivalence is claimed: |
SEP 1 1 2002
Patient Ventilation Oxygen Concentrating System K013223 Invacare 6 Oxygen Concentrator K904087
Description: The Portable Therapeutic Oxygen Concentration System (PTOCS) has been designed to accommodate Military Personnel with a source of supplemental oxygen in a setting where liguid oxygen may be unavailable. Aeromedical Evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. The gaseous oxygen generator will also be required to provide oxygen at the prescribed flow rates and pressures required to operate the oxygen driven equipment included in the AFMS deployable medical assemblages. Requirements are based on the deployable oxygen system, operational requirements document that has been issued by the United States Air Force.
This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of three ports (1/2 to 15 lpm settings) with a maximum litre per minute flow of 45 total at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit consisting of 20 feet of medical grade oxygen hose and flow regulators for each outlet.
Indications For Use: Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.
Conclusion: Non-clinical bench testing conducted by Essex Cryogenics of MO., Inc. as provided is conclusive in establishing substantial equivalence of the PTOCS to the predicate devices on which SE is claimed.
1
Prepared and Submitted by:
Elizabeth Hunnicutt Quality Engine/Regulatory Affairs
Date July 29,2002
By signing my name, I certify that I am the responsible party for submitting regulatory information to the FDA on behalf of Essex
Cryogenics. Requests for additional informat
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Hunnicutt Quality Engineer / Regulatory Affairs Essex Cryogenics of MO., Incorporated 8007 Chivvis Drive Saint Louis, Missouri 63123
Re: K022684
Portable Therapeutic Oxygen Concentration System (PTOCS) Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II (two) Product Code: 73 CAW Dated: July 29, 2002 Received: August 12, 2002
Dear Ms. Hunnicutt:
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. In addition, if you wish to change or expand your current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.
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 - Ms. Hunnicutt .
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski Directdr 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): _ Ko22Lo84
Device Name:
Portable Therapeutic Oxygen Concentration System
Indications For Use:
Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ` (Per 21 CFR 801.109)
Over-the-Counter Use (Optional Format 1-2-96)
OR (Opt
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_