(30 days)
Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.
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.
The provided text is a 510(k) summary for the Portable Therapeutic Oxygen Concentration System (PTOCS). This document focuses on establishing substantial equivalence to predicate devices based on non-clinical bench testing, rather than detailed clinical study data with acceptance criteria for a new AI/software device.
Therefore, many of the requested categories for AI/software device studies are not applicable to this submission. The submission is for a physical medical device (an oxygen concentrator) and relies on bench testing to demonstrate performance, not a study evaluating an algorithm's diagnostic performance against a ground truth with human readers.
Here's a breakdown of the information that can be extracted from the document based on your request, with a clear indication of what is not applicable:
Acceptance Criteria and Device Performance
The document states that the PTOCS has an "oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%." This can be inferred as a key performance criterion for the device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Oxygen concentration purity level: 93% minimum | Oxygen concentration purity level: 93% minimum, with an oxygen purity level average of 95% |
| Flow rates and pressures for oxygen-driven equipment | Capable of providing oxygen at prescribed flow rates and pressures required to operate oxygen driven equipment in AFMS deployable medical assemblages. |
| Maximum flow capacity | 45 total lpm at 50 psig |
| Flow rate settings | 1/2 to 15 lpm settings (through three ports) |
Study Information (as applicable to this type of device submission)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/software study. The testing was "non-clinical bench testing," which implies testing of device units. The number of units tested is not specified.
- Data Provenance: The bench testing was "conducted by Essex Cryogenics of MO., Inc." This indicates the testing was performed internally by the manufacturer in the USA. It is prospective testing of the manufactured device.
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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. This is a physical medical device submission, not an AI/software diagnostic device. Ground truth in this context would likely refer to calibrated measurement equipment used in bench testing, not expert consensus on diagnostic images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is for a physical device, and the testing described is non-clinical bench testing, not a clinical study involving human readers or expert adjudication.
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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. This is not an AI-assisted diagnostic device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm-only device. The device itself (the oxygen concentrator) is the standalone entity. Its performance was evaluated through non-clinical bench testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance (e.g., oxygen purity, flow rates) would be established by calibrated measurement instruments in a laboratory setting during "non-clinical bench testing." The document does not provide details on the specific gold standard instruments used, but this is the typical "ground truth" for such physical device testing.
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The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/software device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. No training set for an AI/software device is mentioned.
Conclusion from the Document:
The 510(k) summary states: "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." This indicates that the performance criteria listed above (oxygen purity, flow rates, pressure) were met during the bench testing, allowing the device to be deemed substantially equivalent to existing predicate oxygen concentrators.
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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
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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 Affairs314-832-8077 ext. 306email: 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 ConcentratorProduct code CAW, CFR 21 § 868.5440Class 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.
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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.
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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:_
§ 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).