(42 days)
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 patients who require supplemental oxygen at flow rates equivalent to 1 to 6 liters per minute, in their home and for ambulatory use.
The Chad Therapeutics Lotus is a microprocessor-controlled device, which is a combination of a low-pressure regulator and an oxygen conserver, designed for use with a compressed oxygen source to provide a pulse of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.
This document is a 510(k) premarket notification for a medical device modification, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. A 510(k) submission, especially a "Special 510(k)," primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical trial to prove efficacy against acceptance criteria.
However, I can extract the information that is present and explain why certain information is not available in this type of document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device operates safely | Met: - The regulator in the device passed the ASTM PS 127-00 Promoted Ignition Safety Test. - 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 applicable standards per FDA Reviewers and content of premarket submissions for software contained in medical devices. |
| Functionality: Device performs as intended (delivering oxygen equivalent to 1 to 6 liters per minute) | Met (by substantial equivalence): The document states that "All risk assessment, design verification and validation activities were conducted in accordance with device requirements to demonstrate that the Chad Therapeutics Lotus would perform as intended." It also claims that the modified device "has the same technological characteristics" and "the software and the patient inhalation detection sensor portion of the device are identical to the predicate device." While specific performance metrics against an explicit numerical acceptance criterion are not provided, the conclusion of "substantial equivalence" implies that its performance is considered equivalent to the predicate device, which was already cleared for this function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in this 510(k) submission. The testing described (ASTM, EMC, software compliance) involves engineering and bench testing, not typically a "test set" in the context of human data. There's no human subject data mentioned, so concepts like country of origin, retrospective/prospective, or sample size are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The testing performed is primarily technical and regulatory compliance (e.g., engineering standards, software standards). There is no mention of "ground truth" being established by medical experts for a diagnostic or interpretative purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts are involved in interpreting data (e.g., radiology images). The tests described are bench tests and engineering compliance checks.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This is a special 510(k) for a device modification (oxygen conserver), and it does not involve AI or human interpretation of cases. The document focuses on demonstrating physical and software modifications maintain safety and effectiveness equivalent to the predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an oxygen conserver, a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on engineering standards, safety standards (e.g., ASTM PS 127-00), and regulatory compliance specifications (e.g., EN 60601 for EMC, FDA guidance for software). These standards define the acceptable performance characteristics and safety profiles for the device. There's no biological or clinical "ground truth" derived from patient data mentioned.
8. The sample size for the training set
This is not applicable. The device is a hardware product with software; it is not a machine learning model that requires a "training set" of data in the AI sense.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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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 StreetChatsworth, CA 91311 |
| Official Contact:Phone:FAX:E-mail: | Kevin McCullohVice President of Engineering(818) 882-0883 extension 335(818) 882-1809kmcculloh@chadtherapeutics.com |
| Proprietary Names: | Chad Therapeutics Lotus Model OM-700Chad 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.
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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.
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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.
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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
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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:
Page 1 of __ 1___
§ 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).