(148 days)
The O2PAK™ Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK™ is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
The O2PAK™ is designed to be compact, lightweight, portable, durable and easy to carry for emergency use. O2PAK™ Model P26029 is the only O2PAK™ model currently available. Its principle of operation is the same as standard chemical oxygen generators. Oxygen is administered to the patient through a nasal cannula or an equivalent device.
Here's a breakdown of the acceptance criteria and study information for the O2PAK™ Portable Oxygen Generator, Model P26029, based on the provided document.
Acceptance Criteria and Device Performance
| Feature | Acceptance Criteria (Predicate Device K052396) | Reported Device Performance (O2PAK™ Model P26029) |
|---|---|---|
| Intended uses | Emergency oxygen | Emergency oxygen under supervision of trained personnel. Fits in C-Toms Medical Ruck Sack, or equivalent |
| Environments of use | Not specified | Locations where emergency oxygen may be needed. |
| Patient populations | Not specified | Adult individuals requiring oxygen in an emergency setting. |
| Solid state chemical oxygen generation | Yes | Yes |
| Portable | Yes | Yes |
| Flow rate | Approximately 6.5 liters per minute | 4 to 8 liters per minute |
| Flow Delivery Accuracy | 6 liters per minute for 15 minutes | Minimum 4 liters per minute for minimum of 22 minutes |
| Total Oxygen Capacity | Approximately 90 liters | Minimum of 90 liters |
| Medically pure [USP] oxygen | USP 99% | USP 99% Oxygen |
| Oxygen Outlet Temperature | Unknown | Maximum 6°C above ambient (at patient) |
| Oxygen Outlet Pressure | Unknown | 30 psig maximum during initial surge, 3 psig maximum during operation |
| Single use, disposable | Not specified | Yes |
| Self-contained | Not specified | Yes (Cannula NOT included) |
| Generator storage life | Not specified | 48 months |
| Weight | Not specified | < 3 lbs. |
| Physical dimensions | Not specified | Length: 9.8 inches, Diameter: 4.0 inches |
| Storage | Not specified | Optimal :+50°F to +95°F (+10°C to +35°C), Full: -40°F to 158°F (-40°C to +70°C) |
| Operating temperature range | Not specified | Optimal: +35°F to +95°F (+2°C to 35°C), Full: -4°F to 155°F (-20°C to 68°C) |
| Humidity | Not specified | Up to 95% Non-Condensing |
| Surface temperature during operation | Not specified | < 86°C |
| Relief Device | Not specified | Yes ~ 30 psig activation |
| Flow indicator | Not specified | Yes |
| Expended generator indicator | Not specified | No |
| Patient interface | Not specified | Salter Labs P/N 1600 Nasal Cannula or equivalent |
| Accessories | Not specified | Salter Labs P/N 1600 Nasal Cannula or equivalent |
| Contraindications | Not specified | None |
| Major components | Not specified | Chemical oxygen generator with housing (generator bag) |
Study Information
The document describes performance testing of the O2PAK™ Portable Oxygen Generator against various engineering and environmental standards. It does not describe a clinical study involving human patients or ground truth established by experts for diagnostic or treatment purposes.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the Shock test (MIL-STD-810G METHOD 516.6), 2 test articles were used, each subjected to 13 drops (total 26 drops). For other tests (Vibration, O2 Outlet Temperature, O2 Purity, O2 Flow, Outlet Pressure, High Temperature, Low Temperature, Humidity), the document states "Test; measured on all test articles" or "Test," implying testing was conducted on an unspecified number of test articles, but it does not provide an exact sample count beyond the shock test.
- Data Provenance: The document implies these were prospective engineering and environmental tests conducted by or for Pacific Precision Products. The country of origin of the data is not explicitly stated but is implicitly within the context of a US-based regulatory submission (510(k)).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is an oxygen generator, and its performance is evaluated against engineering specifications and industry standards rather than a "ground truth" derived from expert clinical opinion, as would be the case for a diagnostic medical device. The "ground truth" here is the established pass/fail criteria of the specified standards (e.g., ASTM F1464-93, MIL-STD-810G, IEC 60068-2-6, RTCA / DO-160G).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are typically used in studies where human readers interpret data (e.g., medical images) and their assessments need to be reconciled to establish a consensus ground truth. This is not relevant for the described engineering performance tests.
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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:
- No. An MRMC comparative effectiveness study is not mentioned as this device is not an AI-powered diagnostic tool. The document focuses on the physical and functional performance of the oxygen generator itself.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a piece of medical equipment, not an algorithm. The testing described is for the physical device's performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests described consists of the specified pass/fail criteria within the referenced industry standards (e.g., MIL-STD-810G, IEC 60068-2-6, ASTM F1464-93, RTCA / DO-160G). These standards define acceptable ranges for physical properties, temperature, flow rates, purity, etc.
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The sample size for the training set:
- Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not Applicable. No training set for ground truth was established for this type of device and testing.
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K 120566
JUL 2 4 2012
Prepared on June 25, 2012
510(K) SUMMARY
SPONSOR Mr. Gerald White Quality Assurance Manager Pacific Precision Products 9671 Irvine Center Drive Irvine, CA 92618 U.S.A. Phone: 949.727.3844 Facsimile: 949.727.3848 E-mail: gwhite@ppp.aero Contact Person: Gerald White
NAME OF DEVICE
Trade name: O2PAK™ Portable Oxygen Generator, Model P26029
Common name: Portable oxygen generator
Classification name : 21CFR 868.5440 Portable Oxygen Generator, Product Code CA W
PREDICATE DEVICES
OxySure® Portable Oxygen Generator, Model 615, manufactured by OxySure Systems, The OxySure® FDA 510(k) control number is K052396. Emergency use
INTENDED USE AND INDICATION FOR USE
The O2PAK Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use.
The O2PAK is currently offered to be used under the direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
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PRODUCT DESCRIPTION
The O2PAK™ is designed to be compact, lightweight, portable, durable and easy to carry for emergency use. O2PAK™ Model P26029 is the only O2PAK™ model currently available. Its principle of operation is the same as standard chemical oxygen generators. Oxygen is administered to the patient through a nasal cannula or an equivalent device. 1
| PRODUCT PERFORMANCE TABLE | |
|---|---|
| Feature | Pacific Precision Products O₂PAKTM Portable OxygenGenerator, Model P26029 |
| Intended uses | The O₂PAKTM is intended to provide oxygen for emergency use, under thesupervision of trained personnel.Fits in C-Toms Medical Ruck Sack, or equivalent |
| Environments of use | Locations where emergency oxygen may be needed. |
| Patient populations | Adult individuals requiring oxygen in an emergency setting. |
| Solid state chemical oxygengeneration | Yes |
| Portable | Yes |
| Flow rate | 4 to 8 liters per minute |
| Flow Accuracy | Minimum 4 liters per minute |
| Delivery Time | Minimum of 22 minutes |
| Total Oxygen Capacity | Minimum of 90 liters |
| Medically pure [USP] oxygen | USP 99% Oxygen |
| Oxygen Outlet Temperature | Maximum 6°C above ambient (at patient) |
| Oxygen Outlet Pressure | 30 psig maximum during initial surge3 psig maximum during operation |
| Single use, disposable | Yes |
| Self-contained | Yes (Cannula NOT included ) |
| Generator storage life | 48 months |
| Weight | < 3 lbs. |
| Physical dimensions | Length: 9.8 inchesDiameter: 4.0 inches |
| Storage | Optimal :+50°F to +95°F (+10°C to +35°C)Full: -40°F to 158°F (-40°C to +70°C) |
| Operating temperature range | Optimal: +35°F to +95°F (+2°C to 35°C)Full: -4°F to 155°F (-20°C to 68°C) |
| Humidity: | Up to 95% Non-Condensing |
| Surface temperature during operation | < 86°C |
| Relief Device | Yes ~ 30 psig activation |
| Flow indicator | Yes |
| Expended generator indicator | No |
| Patient interface | Salter Labs P/N 1600 Nasal Cannula or equivalent |
| Accessories | Salter Labs P/N 1600 Nasal Cannula or equivalent |
| Contraindications | None |
| Major components | Chemical oxygen generator with housing (generator bag) |
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| The O2PAK™ has been qualified to the following environment : |
|---|
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| TEST QUALIFICATION TABLE | |||
|---|---|---|---|
| DESCRIPTION | STANDARD | COMMENTS | RESULT |
| Shock | MIL-STD-810GMETHOD 516.6 | Test per procedure IV- Transit Drop26x drops on 2x test articles; 13x each | Pass |
| Vibration (sinusoidal) | IEC 60068-2-6 | Frequency Range: 10 to 500 HzAcceleration Amplitude: 1 g (9.8 m/s²)Type and Duration of Endurance: 10sweep cycles in each axis | Pass |
| Vibration (Random) | IEC 60068-2-64(IEC 60068-2-34superseded) | Acceleration Spectral Density: 0.02 g²/HzDegree of Reproducibility: lowDuration of Conditioning: 9 minutes | Pass |
| O2 Outlet Temperature | ASTM F1464-93 | Test; measured on all test articles. | Pass |
| O2 Purity | ASTM F1464-93Section 50.4 | Test | Pass |
| O2 Flow | ASTM F1464-93Section 50 | Test | Pass |
| Outlet Pressure | ASTM F1464-93Section 50.7 & 50.8 | Test | Pass |
| High Temperature | MIL-STD-810GMETHOD 501.5 | Test, recommended and limit hightemperature for actuation and performance. | Pass |
| Low Temperature | MIL-STD-810GMETHOD 502.5 | Test, recommended and limit lowtemperature for actuation and performance. | Pass |
| Humidity | RTCA / DO-160GSECTION 6CATEGORY A | Test | Pass |
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STATEMENT OF SUBSTANTIAL EQUIVALENCE
Pacific Precision Products (PPP) is claiming substantial equivalence to the OxySure® Portable Oxygen Generator, Model 615 device manufactured by OxySure Systems, Inc. The 510(k) number is K052396 and is currently legally marketed in the United States. The OxySure® portable oxygen generator is intended to produce oxygen for emergency use.
| Feature | Predicate DeviceOxySure™ Portable OxygenGenerator, Model 615 (K052396) | Proposed DevicePacific Precision Products O2PAK™ PortableOxygen Generator Model P26029 |
|---|---|---|
| Flow rate | Approximately 6.5 liters per minute | Approximately 4 to 8 liters per minute |
| Flow Delivery Accuracy | 6 liters per minute for 15 minutes | 4 liters per minute for minimum of 22 minutes |
| Total Oxygen Capacity | Approximately 90 liters | Minimum of 90 liters |
| Oxygen Percent in Outlet Gas | USP 99% | USP 99% |
| Delivery Pressure At Gas Outlet | Unknown | Maximum 3 psig (after surge) |
| Gas temperature at Gas Outlet | Unknown | Maximum 6° C above ambient |
CONCLUSION
The intended use of the O2PAK™ Portable Oxygen Generator, Model P26029 is similar to the legally marketed predicate device mentioned above; both the proposed device and the predicate device are intended to produce oxygen. Note, The O2PAK is currently offered to be used under the direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle-like emblem. The emblem is composed of three curved lines that form the shape of a bird in flight, symbolizing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2 4 2012 JUL
Mr. Gerald White Quality Assurance Manager Pacific Precision Products 9671 Irvine Center Drive Irvine, California 92618
Re: K120566
Trade/Device Name: 02PAK Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: July 3, 2012 Received: July 3, 2012
Dear Mr. White:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.
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Page 2 - Mr. White
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony V. Matson
Anthony D. Watson, B.S., M.S., M.B.A. 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: K120566 Device Name: O2PAK
Indications for Use: The O2PAK™ Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK™ is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
Prescription Use XXX _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subparts D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
L. Schultze
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
L. Schirth
(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).