(52 days)
Not Found
No
The document describes a pneumatic-controlled oxygen delivery device and does not mention any AI or ML components or capabilities.
Yes.
The device is intended to be part of a portable oxygen delivery system for patients requiring supplemental oxygen, which directly addresses a physiological need.
No
The device is an oxygen delivery system, not a diagnostic tool. Its purpose is to provide supplemental oxygen to patients, not to identify or monitor medical conditions.
No
The device description explicitly states it is a "pneumatic-controlled device" and a "combination of the Onad Therapoulator and an oxygen conserver," indicating it is a hardware device with mechanical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering supplemental oxygen to patients requiring it in their home and for ambulatory use. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a pneumatic-controlled device that functions as an oxygen conserver, delivering boluses of oxygen. This aligns with a respiratory therapy device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver oxygen directly to the patient, which is a treatment.
N/A
Intended Use / Indications for Use
The Chad Therapeutics, Inc. Bonsai is intended for prescription use only to be used as The Offau Thorapouriles) delivery system for patients that require supplemental oxygen in their home and for ambulatory use.
The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.
Product codes (comma separated list FDA assigned to the subject device)
NFB
Device Description
The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 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
Not Found
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 All hisk assessment, dosign product requirements to demonstrate that the Chad Therapeutics Bonsai would perform as intended.
- The regulator in the device passed the ASTM G 175-03 Standard Test Method for > The regulation in the acositivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications safety test.
- The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests.
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
K070740
MAY - 7 2007
SPECIAL 510(k)
510(k) SUMMARY
Chad Therapeutics, Inc.
Chad Therapeutics Bonsai Model 800 (Modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511)
| Date Prepared: | March 14, 2007 |
|---|---|
| Submitter Information: | Chad Therapeutics, Inc. |
| 21622 Plummer Street | |
| Chatsworth, CA 91311 | |
| Official Contact: | |
| Phone: | |
| FAX: | |
| E-mail: | Kevin McCulloh |
| Executive Vice President | |
| Vice President of Engineering | |
| (818) 882-0883 extension 335 | |
| (818) 882-1809 | |
| kmcculloh@chadtherapeutics.com | |
| Proprietary Names: | Chad Therapeutics Bonsai Model 800 |
| 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 OXYPNEUMATIC CYPRESS 511, cleared for commercial distribution per K020475.
1
Device Description:
The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 liters per minute, depending on the flow rate setting.
Intended Use:
The Chad Therapeutics, Inc. Bonsai is intended for prescription use only to be used as The Offau Thorapouriles) delivery system for patients that require supplemental oxygen in their home and for ambulatory use.
Comparison of Technological Characteristics:
The Chad Therapeutics Bonsai Model 800 has the same technological characteristics as The onau Therapour.co The hardware has been modified to reduce the size and weight the preditate ab noob. The hardware has been modified to include an additional flow of regulator portion. The have been modified to be similar to the Chad Therapeutics Setting and the believe here he labeling has been modified. Major portions of the patient inhalation detection sensor diaphragm and oxygen delivery portion of the device are identical to the primary predicate device.
Summary of Testing:
All risk assessment, design verification and validation activities were conducted in All hisk assessment, dosign product requirements to demonstrate that the Chad Therapeutics Bonsai would perform as intended.
- The regulator in the device passed the ASTM G 175-03 Standard Test Method for > The regulation in the acositivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications safety test.
- ✓ The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests.
Substantial Equivalence:
Based on the above, we concluded that the Chad Therapeutics modified Dasod on the are, no, no, no, it =, the Bonsai Model 800) are substantially OX iT NEOMATIC OTH REDS MOSEMAT (CYPRESS 511 devices and are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
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
MAY - 7 2007
Re: K070740
Trade/Device Name: Chad Therapeutics Bonsai Model 800 (Modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: April 21, 2007 Received: April 24, 2007
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 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. McCulloh
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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 Bonsai Model 800 (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511).
Indications For Use:
The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen 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)
Challho
Sign-Off)
ision of Anesthesiology, General Hospital,
Section Control, Dental Devices
510(k) Number: K070740
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