(148 days)
Not Found
No
The description focuses on the chemical and mechanical principles of oxygen generation and delivery, with no mention of AI or ML.
No.
The O2PAK™ is intended to provide oxygen for emergency use and is described as an oxygen generator; it is not described as diagnosing, treating, or preventing a disease or condition.
No
Explanation: The device is an oxygen generator intended to provide oxygen for emergency use, not to diagnose medical conditions. Its purpose is therapeutic (oxygen delivery), not diagnostic.
No
The device description clearly indicates a physical, portable oxygen generator with a principle of operation based on chemical processes, not software. The performance studies also focus on physical environmental and gas output characteristics.
Based on the provided information, the O2PAK™ Portable Oxygen Generator, Model P26029 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health by testing samples like blood, urine, or tissue.
- The O2PAK™ is a device that provides oxygen directly to a patient. It is a therapeutic device used to support breathing, not to analyze biological samples.
The description clearly states its purpose is to "provide oxygen for emergency use" and that "Oxygen is administered to the patient through a nasal cannula or an equivalent device." This aligns with the function of a medical device used for direct patient care, not for in vitro testing.
N/A
Intended Use / 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.
Product codes
CAW
Device 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.
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
Adult individuals requiring oxygen in an emergency setting.
Intended User / Care Setting
Trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The O2PAK™ has been qualified to the following environment:
- Shock: MIL-STD-810G METHOD 516.6, Test per procedure IV- Transit Drop, 26x drops on 2x test articles; 13x each - Pass
- Vibration (sinusoidal): IEC 60068-2-6, Frequency Range: 10 to 500 Hz, Acceleration Amplitude: 1 g (9.8 m/s²), Type and Duration of Endurance: 10 sweep cycles in each axis - Pass
- Vibration (Random): IEC 60068-2-64 (IEC 60068-2-34 superseded), Acceleration Spectral Density: 0.02 g²/Hz, Degree of Reproducibility: low, Duration of Conditioning: 9 minutes - Pass
- O2 Outlet Temperature: ASTM F1464-93, Test; measured on all test articles. - Pass
- O2 Purity: ASTM F1464-93 Section 50.4, Test - Pass
- O2 Flow: ASTM F1464-93 Section 50, Test - Pass
- Outlet Pressure: ASTM F1464-93 Section 50.7 & 50.8, Test - Pass
- High Temperature: MIL-STD-810G METHOD 501.5, Test, recommended and limit high temperature for actuation and performance. - Pass
- Low Temperature: MIL-STD-810G METHOD 502.5, Test, recommended and limit low temperature for actuation and performance. - Pass
- Humidity: RTCA / DO-160G SECTION 6 CATEGORY A, Test - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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 surge, 3 psig maximum during operation
- Generator storage life: 48 months
- Weight:
§ 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).
0
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.
1
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 Oxygen |
| Generator, Model P26029 | |
| Intended uses | The O₂PAKTM is intended to provide oxygen for emergency use, under the |
| supervision 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 oxygen | |
| generation | 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 surge |
| 3 psig maximum during operation | |
| Single use, disposable | Yes |
| Self-contained | Yes (Cannula NOT included ) |
| Generator storage life | 48 months |
| Weight | 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.
5
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
6
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: