(33 days)
The BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for one patient while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or a life-supporting device.
The BMOS is a portable thermally insulated container that provides, when filled with liquid oxygen (LOX), an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. BMOS is operated by trained emergency response to administer patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM).
This document (K071581) is a 510(k) premarket notification for a medical device called the "Backpack Medical Oxygen System (BMOS)". It aims to demonstrate substantial equivalence to a predicate device, not to prove specific clinical performance criteria for diagnosis or treatment. Therefore, many of the requested categories for AI/clinical studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench/Engineering Specifications) | Reported Device Performance (Summary from Submission) | Notes |
|---|---|---|
| Maintain vacuum insulated cryogenic container for LOX storage | Device includes a vacuum insulated cryogenic container designed to store liquid oxygen. | Implied to meet this, as it's a core component. |
| Deliver gaseous oxygen at nominal 50-psi pressure. | Delivers gaseous oxygen at a nominal 50-psi pressure near ambient temperature. | Explicitly stated as met. |
| Operate without external power. | Operates without external power. | Explicitly stated. |
| No emission of ionizing, non-ionizing, sonic, or light radiation. | Neither design emits ionizing, non-ionizing, sonic, or light radiation. | Explicitly stated. |
| No sterilization required. | Unit does not require sterilization. | Explicitly stated. |
| Ability to provide uninterrupted supply of supplemental oxygen. | Provides an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. | Implied to meet through "capability, performance, and environmental testing". |
| Administer variable amounts of gaseous oxygen in LPM. | Administers patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM). | Implied to meet through "capability, performance, and environmental testing". |
| Suitable for emergency response personnel in military and commercial fields. | Intended to be used by emergency response personnel in military and commercial fields. | Addressed by intended use and testing. |
| Safe and effective for intended use. | Extensive capability, performance, and environmental testing have been accomplished on the BMOS with no issues arising regarding its safety and efficacy. | Comprehensive statement of meeting safety and efficacy. |
| Meets specifications. | The combined testing and analysis of results provides assurance that the device meets its specifications. | Comprehensive statement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Extensive capability, performance, and environmental testing have been accomplished," but does not provide details on the number of units tested, duration, or specific test configurations.
- Data Provenance: Not specified, but implied to be internal testing conducted by Essex Cryogenics of MO., Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is a hardware system, and the "ground truth" for its performance is derived from engineering and functional testing against specifications, not from expert interpretation of data like in an AI diagnostic device. The "ground truth" here is whether the device physically performs according to its design and regulatory requirements.
4. Adjudication Method for the Test Set
- Not applicable. See explanation for #3. Adjudication typically refers to resolving disagreements between human readers, which is not relevant for physical device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI-assisted diagnostic or therapeutic device that requires human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Partially applicable, but not for an "algorithm". The "Testing" section describes standalone performance of the device itself against its specifications, but there is no "algorithm" in the context of AI. The device functions purely mechanically/physically.
7. Type of Ground Truth Used
- Engineering and Functional Specifications / Predicate Device Performance. The ground truth for the BMOS's performance is its ability to meet documented engineering specifications (e.g., pressure, flow, capacity) and to demonstrate substantial equivalence to the legally marketed predicate device (NPTLOX) in terms of its operational characteristics and safety/efficacy profile.
8. Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See explanation for #8.
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Summary for Backpack Medical Oxygen System (BMOS)
| Company/Owner Name: | Essex Cryogenics of MO., Inc. |
|---|---|
| Company Address: | 8007 Chivvis Drive, 63123 St., Louis, MO. |
| Fax: | 314-832-8208 |
| Phone: | 314-832-8077 (306) |
| Registration Number: | 1937980 |
| Point of Contact: | Elizabeth Hunnicutt, Quality Engineer / Regulatory Affairs |
| Date of Summary: | June 1, 2007 |
| Trade Name: | Backpack Medical Oxygen System (BMOS) |
| Common Name: | portable oxygen device |
| Device Classification Regulation Number and Regulatory Status: | Anesthesiology - Therapeutic DevicesPortable Liquid Oxygen UnitCFR 21 § 868.5655Class II |
| Legally Marketed Device which Substantial Equivalence is claimed: | Next Generation Portable Therapeutic Liquid Oxygen Converter (NPTLOX)2004 - 510(k) K033000 |
| JUL 11 2007 |
Description: The BMOS is a portable thermally insulated container that provides, when filled with liquid oxygen (LOX), an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. BMOS is operated by trained emergency response to administer patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM).
Indications for use: The BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for one patient while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or a life-supporting device.
Substantial Equivalence Comparison with the NPTLOX: Both devices include a vacuum insulated cryogenic container designed to store liquid oxygen. Both deliver gaseous oxygen at a nominal 50-psi pressure near ambient temperature. Neither design operates on external power. Neither design emits ionizing, non-ionizing, sonic, or light radiation. Neither unit requires sterilization. The major modifications are a decrease in liquid oxygen capacity, a lowered flow (LPM) capability and a reduced capability to support multiple patients, which resulted in a decreased overall size and weight.
Testing: Extensive capability, performance, and environmental testing have been accomplished on the BMOS with no issues arising regarding its safety and efficacy. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
Upon completion of Qualification testing, we have determined that the BMOS meets the FDA criteria for substantial equivalence to the predicate defice.
Elizabeth Hummicut
Elizabeth Hunnicutt. Ouality Engineer/Regulatory Affairs
JUNE 01, 2007
Date
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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers.
Public Health Service
JUL 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Essex Cryogenics of Missouri, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K071581
Trade/Device Name: Backpack Medical Oxygen System Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: June 26, 2007 Received: June 27, 2007
Dear Mr. Job
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.
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 - Mr. Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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): _
Backpack Medical Oxygen System Device Name: ___
Indications for Use: The BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of performer in mintary after patient/s while being transported from a crisis situation to a Supportunental oxygon for pullentee interested to be a life sustaining or a life-supporting device.
Prescription Use _ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page of
§ 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).