(179 days)
The NPILOX is intended to convert liguid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.
The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liquid oxygen to gaseous form, which provides therapeutic oxygen to patients. This equipment meets the Aero-medical mission requirements for gaseous oxygen to be delivered to patients in the three methods listed below.
- 1240 DISS Flow control valves and humidifier bottles
- Laerdal Silicone Adult Resuscitators with 2500 ml reservoirs
- Impact 754 Eagle Ventilators
The NPTLOX has six outlet ports that are capable of delivering oxygen to a maximum of six ambulatory or litter patients according to one or more of these approved methods.
The system will be filled by current liquid oxygen storage/filling systems used in the United States Military. The design of the NPTLOX is a modification to the existing predicate device, the Portable Therapeutic Liquid Oxygen (PTLOX) 510(k) K880183. The major modifications are an improvement in maximum oxygen delivery rate, increased number of patient outlets and increased oxygen capacity.
The NPTLOX provides gaseous oxygen to patients through 6 outlet ports at an outlet pressure of 50 ± 5 psig. The 6 outlet ports have a maximum combined system outlet flow of 66 LPM. This continuous flow rate is based on a design standard of 11 LPM per outlet fitting. The system is capable of flowing at least 60 LPM to meet the ventilator peak flow requirement. The NPLTOX has an accessory kit that includes three of each of the following: medical hoses, 0-15 LPM flow control valves, and humidifier bottles. The LOX capacity of the system is 20 liters. Oxygen delivery pressure is displayed via a pressure gauge. The LOX quantity can be periodically displayed via a LOX quantity indicator that is powered by two 9 volt batteries. There is no other electronics or software in the NPTLOX.
The provided text describes a medical device, the Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX), and its clearance through a 510(k) submission. While it mentions "Testing: Extensive capability, performance, and environmental testing has been accomplished on the NPTLOX with no issues arising regarding its safety and efficiency," and that "The combined testing and analysis of resplits provides assurance that the device meets its specifications and is safe/and effective for its intended use," it does not explicitly detail specific acceptance criteria, the study design, or the performance outcomes in a quantitative manner that would allow for a direct fill of the requested table and detailed breakdown.
Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided document. However, I can extract the information that is present and highlight what is missing.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) | The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liquid oxygen to gaseous form. |
| Deliver oxygen at 50 psig nominal | The NPTLOX provides gaseous oxygen to patients through 6 outlet ports at an outlet pressure of 50 ± 5 psig. |
| Meet Aero-medical mission requirements for gaseous oxygen delivery via three methods (DISS Flow control valves, Laerdal Silicone Adult Resuscitators, Impact 754 Eagle Ventilators) | This equipment meets the Aero-medical mission requirements for gaseous oxygen to be delivered to patients in the three methods listed: 1240 DISS Flow control valves and humidifier bottles, Laerdal Silicone Adult Resuscitators with 2500 ml reservoirs, Impact 754 Eagle Ventilators. |
| Deliver oxygen to a maximum of six ambulatory or litter patients | The NPTLOX has six outlet ports that are capable of delivering oxygen to a maximum of six ambulatory or litter patients. |
| Maximum combined system outlet flow of 66 LPM (continuous flow) | The 6 outlet ports have a maximum combined system outlet flow of 66 LPM. This continuous flow rate is based on a design standard of 11 LPM per outlet fitting. |
| Capable of flowing at least 60 LPM to meet ventilator peak flow requirement | The system is capable of flowing at least 60 LPM to meet the ventilator peak flow requirement. |
| Improved normal evaporation rate compared to predicate device to lessen liquid oxygen loss during standby | The system has been optimized in the NPTLOX to improve the normal evaporation rate, allowing for less liquid oxygen loss during standby. (No quantitative data on improvement percentage or specific evaporation rate is provided, only a statement of improvement). |
| Meets specifications and is safe/effective for intended use | "Extensive capability, performance, and environmental testing has been accomplished on the NPTLOX with no issues arising regarding its safety and efficiency. The combined testing and analysis of resplits provides assurance that the device meets its specifications and is safe/and effective for its intended use." (This is a summary statement, not specific performance data against defined criteria.) |
| Intended for military settings only | Indicated for use in military settings only. (This is an indication for use rather than a performance criterion, but crucial for regulatory clearance). |
Missing Information from the document:
- Specific quantitative acceptance criteria for "capability, performance, and environmental testing."
- Detailed performance results from these tests (e.g., actual evaporation rate, detailed LPM consistency across all ports under various conditions, specific safety margins).
- Any statistical analysis or detailed study reports.
Based on the provided text, the following information is NOT available or explicitly stated:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "Extensive capability, performance, and environmental testing" but does not define the number of devices or test conditions used.
- Data Provenance: Not specified.
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)
- This device is mechanical (a liquid oxygen system), not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" derived from expert consensus in the typical sense (e.g., for image interpretation) does not apply. Testing would involve engineering, performance, and environmental validation against physical specifications. No expert consensus process for "ground truth" is mentioned or implied.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not a diagnostic device involving human interpretation and adjudication of results.
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. This is not an AI-assisted diagnostic or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a device like this would be its engineering specifications and validated performance against those specifications using calibrated measurement equipment and standardized test procedures (e.g., flow meters, pressure gauges, temperature sensors, etc.). The document states "device meets its specifications," implying that the specifications themselves serve as the ground truth for performance.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The text is oriented diagonally, running from the lower-left to the upper-right corner of the image. The characters are somewhat stylized and slightly distorted, giving the impression of being written quickly or with a degree of artistic flair. The text string appears to be "K033000".
MAR 2 2 2004
Summary for 50C-0083-1 NPTLOX
Essex Cryogenics of MO., Inc.
8007 Chivvis Drive, 63123 314-832-8208 Fax: 314-832-8077 (306) Phone: Elizabeth Hunnicutt Contact: 02/24/04 Date of revised summary:
Next Generation Portable Therapeutic Liquid Oxygen Trade Name: System Portable Liquid Oxygen System Common Name: Portable Liquid Oxygen Unit Classification Name: CFR 21 § 868.5655, Product Code: BYJ Class II Anesthesiology
Legally Marketed Device which substantial equivalence is claimed: Portable Therapeutic Liquid Oxygen System (PTLOX) 510(k) K880183
Description: The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liquid oxygen to gaseous form, which provides therapeutic oxygen to patients. This equipment meets the Aero-medical mission requirements for gaseous oxygen to be delivered to patients in the three methods listed below.
- 1240 DISS Flow control valves and humidifier bottles 나
- Laerdal Silicone Adult Resuscitators with 2500 ml reservoirs �
- Impact 754 Eagle Ventilators の
The NPTLOX has six outlet ports that are capable of delivering oxygen to a maximum of six ambulatory or litter patients according to one or more of these approved methods.
The system will be filled by current liquid oxygen storage/filling systems used in the United States Military. The design of the NPTLOX is a modification to the existing predicate device, the Portable Therapeutic Liquid Oxygen (PTLOX) 510(k) K880183. The major modifications are an improvement in maximum oxygen delivery rate, increased number of patient outlets and increased oxygen capacity.
The NPTLOX provides gaseous oxygen to patients through 6 outlet ports at an outlet pressure of 50 ± 5 psig. The 6 outlet ports have a maximum combined system outlet flow of 66 LPM. This continuous flow rate is based on a design standard of 11 LPM per outlet
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fitting. The system is capable of flowing at least 60 LPM to meet the ventilator peak flow requirement. The NPLTOX has an accessory kit that includes three of each of the following: medical hoses, 0-15 LPM flow control valves, and humidifier bottles. The LOX capacity of the system is 20 liters. Oxygen delivery pressure is displayed via a pressure gauge. The LOX quantity can be periodically displayed via a LOX quantity indicator that is powered by two 9 volt batteries. There is no other electronics or software in the NPTLOX.
Indications for use: The NPTLOX is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military settings only.
Comparison with the PTLOX: Both devices include a vacuum insulated cryogenics container, with the LOX capacity and the resultant dimensional increase being the significant change. The system has been optimized in the NPTLOX to improve the normal evaporation rate, allowing for less liquid oxygen loss during standby.
Testing: Extensive capability, performance, and environmental testing has been accomplished on the NPTLOX with no issues arising regarding its safety and efficiency. The combined testing and analysis of resplits provides assurance that the device meets its specifications and is safe/and effective for its intended use.
"lizabeth Hunnicutt Feb 27, 2001
Elizabeth Hunnicutt, Quality Engineer/Regulatory Affairs
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures connected at the shoulders, with flowing lines representing movement or energy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Ms. Elizabeth Hunnicutt Quality Engineer / Regulatory Affairs Essex Cryogenics of MO., Incorporated 8007 Chivvis Drive St. Louis, MO 63123-2395
Re: K033000
Trade/Device Name: Next Generation Portable Therapeutic Liquid Oxygen System Regulation Number: 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: February 27, 2004 Received: March 4, 2004
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. Elizabeth 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), please contact the Office of Compliance at (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chiu-Ling, Ph.D.
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 (if known): K033000
Device Name: Next Generation Therapeutic Liquid Oxygen System
Indications For Use:
The NPILOX is intended to convert liguid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.
Prescription Use ਮੈ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Af Wuthen
Page 1 of
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K033000
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).