(109 days)
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment. The LifeChoice uses molecular sieve pressure swing adsorption technology.
The provided text describes a 510(k) submission for the International Biophysics Corporation (IBC) LifeChoice Oxygen Concentrator. This is a medical device submission, and as such, the "acceptance criteria" and "device performance" are typically defined by demonstrating substantial equivalence to a predicate device, rather than explicit numerical performance metrics like those for an AI algorithm.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (portable oxygen concentrator), "acceptance criteria" are generally based on meeting the performance characteristics of an already legally marketed predicate device. The text does not provide a specific table of numerical acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative comparison.
| Acceptance Criterion (Implied) | Reported Device Performance (IBC LifeChoice) |
|---|---|
| Substantial Equivalence to Predicate Device | "Equivalent in performance, function and principles of operation to the predicate device." "Does not create any new questions of safety and effectiveness." "Substantially equivalent to the identified predicate device, the AirSep LifeStyle Oxygen Concentrator." "No significant differences between the IBC LifeChoice and the identified predicate device." |
| Technology Use | Utilizes "well established technologies" like molecular sieve pressure swing adsorption and demand flow delivery systems. |
| Intended Use | Provides supplemental, high concentration oxygen (approx. 90%) on a demand flow basis at 1.0 to 3.0 LPM equivalent. Portable for home, institution, or travel. Not life-sustaining. |
2. Sample Size Used for the Test Set and Data Provenance
The text does not provide information about a "test set" in the context of an algorithmic evaluation. This is a medical device submission for a physical oxygen concentrator, not an AI algorithm. The evaluation relies on "Benchtop performance testing" and comparison to a predicate device. Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data are not applicable in the way they would be for an AI study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no "test set" or "ground truth" to be established by experts in the context of an AI algorithm evaluation. The device's "truth" is its physical performance and adherence to established engineering principles, benchmarked against a predicate.
4. Adjudication Method
This information is not applicable for the same reasons as above. There's no expert adjudication of image or data interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is relevant for evaluating the impact of an AI system on human reader performance (e.g., radiologists interpreting images). The IBC LifeChoice Oxygen Concentrator is a physical device, not an AI algorithm, so an MRMC study was not conducted.
6. Standalone Performance Study
Yes, in a sense. The text mentions "Benchtop performance testing" for the IBC LifeChoice. This would be considered the standalone performance evaluation for the physical device itself (i.e., how it performs in terms of oxygen concentration, flow rate, power consumption, etc., without human interaction during its operation). However, the specific results of this testing are not detailed in the provided summary, only that it demonstrated substantial equivalence.
7. Type of Ground Truth Used
The "ground truth" for this medical device's performance is ultimately derived from:
- Its engineering specifications and physical measurements (e.g., actual oxygen concentration produced, flow rates, battery life).
- The performance characteristics of the predicate device (AirSep LifeStyle Oxygen Concentrator), which serves as the established benchmark for safety and effectiveness.
- Adherence to recognized standards and regulations for oxygen concentrators.
8. Sample Size for the Training Set
This information is not applicable. The IBC LifeChoice is a physical device using established technology (molecular sieve pressure swing adsorption). It does not involve machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI algorithm.
{0}------------------------------------------------
Section 5. 510 (K) Summary
Non Confidential Summary of Safety and Effectiveness
Submitter Information:
International Biophysics Corporation (IBC) 2101 East St. Elmo Rd, Suite 275 Austin, TX 78744
Contact:
David Shockley President 512-326-3244 off. 512-326-3299 fax
JAK | ZUD:
f
Date Prepared: September 19, 2007
Proprietary Name: LifeChoice Oxygen Concentrator
Model: OXY1000
Classification Name: Portable oxygen generator (concentrator)
Product Code: CAW
Device Classification: Class II
Panel: Anesthesiology
Regulation Number: 21 CFR 868.5440
Predicate Device: AirSep Corporation, LifeStyle Oxygen Concentrator, 510(K): K020324
Device Description:
The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment.
{1}------------------------------------------------
The LifeChoice uses molecular sieve pressure swing adsorption technology. This technology is well established and proven to concentrate room air into high concentration oxygen. The LifeChoice is equivalent in performance, function and principles of operation to the predicate device listed in this submission.
Indications for Use:
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable,
Technological Characteristics and Predicate Device Comparison:
The IBC LifeChoice Oxygen Concentrator utilizes well established technologies. Molecular sieve pressure swing adsorption technology has been used for many years to produce high concentration oxygen. Demand flow delivery systems have been in use on portable oxygen devices for many years also. The capability to power the device with AC, DC and/or rechargeable batteries has also been in use for many years.
The technologies used in the IBC LifeChoice Oxygen Concentrator do not create anv new questions of safety and effectiveness. These technologies are also being used in the identified predicate device. Benchtop performance testing and comparison of performance characteristics and technologies have demonstrated that the IBC LifeChoice is substantially equivalent to the identified predicate device, the AirSep LifeStyle Oxygen Concentrator. There are no significant differences between the IBC LifeChoice and the identified predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2008
Mr. David Shockley President International Biophysics Corporation 2101 East St. Elmo Road, Suite 275 Austin, Texas 78744
Re: K072688
Trade/Device Name: International Biophysics Corporation LifeChoice Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: January 3, 2008 Received: January 3, 2008
Dear Mr. Shockley:
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.
{3}------------------------------------------------
Page 2 - Mr. Shockley
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 vour 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) 276-0115. 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,
Sutte Y. Michaud M.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
{4}------------------------------------------------
Indications for Use
K072688:
Device Name: International Biophysics Corporation LifeChoice Oxygen Concentrator
Indications For Use:
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K 072688
Sinite m'chan O
mus
Page 1 of
§ 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).