(52 days)
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.
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.
The provided text describes a 510(k) submission for the Chad Therapeutics Bonsai Model 800, which is a modified oxygen conserver. However, the document does not contain an acceptance criteria table or a study report detailing specific performance metrics against acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general statements about design verification and validation activities.
Therefore, many of the requested sections below cannot be populated from the provided text.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states that "The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests." However, it does not provide a table with specific acceptance criteria or the reported performance data for each criterion. It only mentions one specific safety test the regulator passed.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| (Specific performance metrics relating to flow rate accuracy, pressure regulation, oxygen delivery consistency, battery life, safety features, etc. are not provided.) | "The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests." |
| Compliance with ASTM G 175-03 for Regulator Sensitivity and Fault Tolerance | "The regulator in the device passed the ASTM G 175-03 Standard Test Method for Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications safety test." |
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 the document. The document only generally states "All risk assessment, design verification and validation activities were conducted in accordance with approved product requirements to demonstrate that the Chad Therapeutics Bonsai would perform as intended."
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 as this device is an oxygen conserver and the document describes engineering verification and validation, not studies requiring expert visual assessment or ground truth establishment in a medical imaging or diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing described.
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
This information is not applicable as this device is an oxygen conserver and does not involve human readers interpreting images or data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a mechanical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device (oxygen conserver), "ground truth" would generally refer to established engineering standards, specifications, and physical measurements. The document implies that the "ground truth" for the tests involved verifying the device's performance against predefined "product requirements" and industry standards like ASTM G 175-03.
8. The sample size for the training set
This information is not applicable as this is a mechanical medical device, not an algorithm or AI system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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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 StreetChatsworth, CA 91311 |
| Official Contact:Phone:FAX:E-mail: | Kevin McCullohExecutive Vice PresidentVice President of Engineering(818) 882-0883 extension 335(818) 882-1809kmcculloh@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.
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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.
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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.
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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
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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
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).