(42 days)
Not Found
No
The summary describes a microprocessor-controlled oxygen delivery system with a regulator and conserver. It mentions standard electrical and software compliance testing but does not include any terms or descriptions related to AI or ML.
Yes
The device is intended to provide supplemental oxygen to patients, which is a therapeutic intervention.
No
The device is described as a "portable oxygen delivery system" and an "oxygen conserver," intended to provide supplemental oxygen, not to diagnose medical conditions.
No
The device description explicitly states it is a "microprocessor-controlled device, which is a combination of a low-pressure regulator and an oxygen conserver," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients, which is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a regulator and oxygen conserver, designed to deliver oxygen. This aligns with a respiratory therapy device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver a therapeutic gas.
N/A
Intended Use / Indications for Use
The Chad Therapeutics, Inc. Lotus is intended for prescription use only to be used as a source of supplemental oxygen for patients who require supplemental oxygen in their home and for ambulatory use.
The Chad Therapeutics Lotus (modified Chad Therapeutics OXYMATIC Model 411) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as a portable oxygen delivery system for delivery of oxygen that is equivalent to 1 to 6 liters per minute, in their home and for ambulatory use.
Product codes (comma separated list FDA assigned to the subject device)
NFB
Device Description
The Chad Therapeutics Lotus is microprocessor-controlled device, which is a combination of a low-pressure regulator and an oxygen conserver designed for use with a compressed oxygen cylinder, providing oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.
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
Not Found
Intended User / Care Setting
prescription use only, in their home and for ambulatory use.
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)
All risk assessment, design verification and validation activities were conducted in accordance with all applicable requirements to demonstrate that the Chad Therapeutics Lotus would perform as intended.
- The regulator in the device passed the ASTM PS 127-00 Promoted Ignition Safety Test.
- The Electromagnetic Compatibility, Electrostatic Discharge, Immunity, Magnetic Fields Immunity, Magnetic Fields Emissions, Quasi-Static Electric Fields, Radiated and Conducted Field Emissions, etc. were conducted in accordance with the FDA Reviewer Guidance for Premarket Submissions, Anesthesiology and Respiratory Devices Branch, Division of Cardiovascular, Respiratory and Neurological Devices Document and applicable EN 60601 Medical Electrical Equipment specifications.
- The software complies with the applicable standards per the FDA Reviewers Guide for the content of premarket submissions for software contained in medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for CHAD Therapeutics. The logo consists of the word "CHAD" in large, bold letters, with the word "THERAPEUTICS" underneath in a smaller font. Below that, the text "The Ambulatory O2 Specialists!" is displayed.
21622 Plummer Streft CHATSWORTH, CA 91311 TOLL FREE: 800.423.8870 PHONE: 818.882.0883 Main Fax: 818.882.1809
SEP 2 0 2004
SPECIAL 510(k)
510(k) SUMMARY
Chad Therapeutics, Inc.
Chad Therapeutics Lotus (Modified Chad Therapeutics OXYMATIC Model 411)
| Date Prepared: | August 6, 2004 |
|---|---|
| Submitter Information: | Chad Therapeutics, Inc. |
| 21622 Plummer Street | |
| Chatsworth, CA 91311 | |
| Official Contact: | |
| Phone: | |
| FAX: | |
| E-mail: | Kevin McCulloh |
| Vice President of Engineering | |
| (818) 882-0883 extension 335 | |
| (818) 882-1809 | |
| kmcculloh@chadtherapeutics.com | |
| Proprietary Names: | Chad Therapeutics Lotus Model OM-700 |
| Chad Therapeutics Lotus Model OM-700S | |
| Common Name: | Oxygen conserver |
| Classification Name: | Non-continuous ventilator |
| Classification Reference: | Class II, 21 CFR 868.5905 |
| Product Code: | NFB |
Predicate Device Equivalence:
Substantial equivalence is claimed to the Chad Therapeutics Unmodified OXYMATIC 411, cleared for commercial distribution per K003455.
1
Device Description:
The Chad Therapeutics Lotus is microprocessor-controlled device, which is a The Chad Therapeutics Eotus is mioroprocoses, Society, Society, designed for use with combination of a low-pressure regulator and an onygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.
Intended Use:
The Chad Therapeutics, Inc. Lotus is intended for prescription use only to be used as The Chad Therapedies, Inc. Eotal is the fact to the require supplemental oxygen in their home and for ambulatory use.
Comparison of Technological Characteristics:
The Chad Therapeutics Lotus Model OM-700 and Model OM-700S has the same The Chau Therapedico Ectablicate devices. The hardware has been modified technological onaracterial aof regulator portion. The software and electronics have to reduce the size and wolght on regains a rechargeable battery pack circuit and been model OM-700S the addition of a failure to pulse alarm. In addition the labeling has for Model Owl's book the addition the software and the patient inhalation detection sensor portion of the device are identical to the predicate device.
Summary of Testing:
All risk assessment, design verification and validation activities were conducted in All HSK assessmont, doolgh vehice requirements to demonstrate that the Chad Therapeutics Lotus would perform as intended.
- The regulator in the device passed the ASTM PS 127-00 Promoted Ignition Safety > Test.
- The Electromagnetic Compatibility, Electrostatic Discharge, Immunity, Magnetic > Fields Immunity, Magnetic Fields Emissions, Quasi-Static Electric Fields, Radiated and Conducted Field Emissions, etc. were conducted in accordance with the and Sondass in the FDA Reviewer Guidance for Premarket Submissions, Anesthesiology and Respiratory Devices Branch, Division of Cardiovascular, Respiratory and Neurological Devices Document and applicable EN 60601 Medical Electrical Equipment specifications.
- The software complies with the applicable standards per the FDA Reviewers and > I he sontain o content of premarket submissions for software contained in medical devices.
Substantial Equivalence:
Based on the above, we concluded that the Chad Therapeutics modified OXYMATIC Bused on the above, we sthe els OM-700 & OM-700S) are substantially equivalent to unmodified OXYMATIC 411 devices and are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
SEP 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin McCulloh Vice President of Engineering Chad Therapeutics, Incorporated 21622 Plummer Street Chatsworth, California 91311
Re: K042142
Trade/Device Name: Chad Therapeutics Lotus Models OM-700 and OM-700S Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: September 7, 2004 Received: September 13, 2004
Dear Mr. McCulloh:
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 (1 Nr.), it hay obe as a be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your con, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. McCulloh
Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advised and to a determination that your device complies with other requirements modification any Federal statutes and regulations administered by other Federal agencies. or the Free of all the Act's requirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and libring (2) Cr read in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form in are quadiation 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), 11 you dontact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.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
510(k) Number (if known):
Device Name: Chad Therapeutics Lotus Models OM-700 and OM-700S (modified Chad Therapeutics OXYMATIC Model 411)
Indications For Use:
The Chad Therapeutics Lotus (modified Chad Therapeutics OXYMATIC Model 411) The Chad Therapoutios Ectab (manner as the unmodified device, i.e., for is intended for use in the same manner as a portable oxygen delivery system for prescription use only, to be assula as parter a percures of minute, in their home and for ambulatory use.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auy Sagrom
(Division Sign-Qff) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
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