(90 days)
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Not Found
No
The provided text describes a liquid oxygen reservoir for home use and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device is described as a reservoir for liquid oxygen, not as a device that provides therapy itself. It facilitates the use of a portable unit but is explicitly stated as "not life supporting nor life sustaining."
No
The HomeLox is described as a LOX reservoir for filling a portable unit, intended for creating and storing liquid oxygen in a patient's home. Its purpose is to allow patients to fill portable units, not to diagnose any medical condition.
No
The intended use describes a device that creates and stores liquid oxygen, which inherently requires hardware components.
Based on the provided information, the HomeLox device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create and store liquid oxygen for a patient to fill a portable unit for ambulation. This is a device used for delivering a therapeutic substance (oxygen) to a patient, not for performing tests on biological samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
- Device Description (Not Found): While a detailed description is missing, the intended use clearly points away from diagnostic testing.
- Lack of IVD-Specific Information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information
The HomeLox is a medical device, but its function is related to oxygen delivery and storage, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The HomeLox is intended to create and store liquid oxygen in a patient's home, so that a patient will be able to fill their liquid portable unit and ambulate. The device is intended only to be a LOX reservoir for filling a portable unit and provide the ability for the patient to be mobile. This device is not life supporting nor life sustaining.
Product codes
CAW
Device Description
The HomeLox is intended to create and store liquid oxygen in a patient's home, so that a patient will be able to fill their liquid portable unit and ambulate. The device is intended only to be a LOX reservoir for filling a portable unit and provide the ability for the patient to be mobile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
patient's home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Incorporated Ms. Zita A. Yurko Director, Regulatory Affairs Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
JUL 2 8 2008
Re: K081206 Trade/Device Name: HomeLox Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: April 25, 2008 Received: April 29, 2008
Dear Ms. Yurko:
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 cither 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.
1
Page 2 - Ms. Yurko
Please be advised that FDA's issuance of a substantial cquivalence 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 CHR 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
MNamuel(s)fleur, ~ for //
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
2
Indications for Use
510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
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Prescription Use ____________________________________________________________________________________________________________________________________________________________
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Off) Oivision of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: