(186 days)
The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.
The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and therapeutic oxygen. The percentage of oxygen to air can be adjusted from 21-100%.
The Tenacore Oxygen Blender is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: +/- 3% | Accuracy: +/- 3% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is a performance test for a medical device's physical specifications (accuracy) and not an evaluation based on expert interpretation of data like medical images.
4. Adjudication Method for the Test Set
This information is not applicable for the type of performance testing described. Adjudication typically refers to resolving discrepancies between multiple expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focuses on the device's technical performance, not on human-in-the-loop improvements with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Performance Data & Conclusions" section indicates that "Performance testing was conducted as required by standards," which refers to the device itself meeting specified technical standards like accuracy.
7. Type of Ground Truth Used
The ground truth used was based on established engineering and medical device standards for oxygen blenders. Specifically, the device was tested against standards such as EN ISO 15001:2004, 60601-1, 9703-3:1998, 601-1:1988, and IEC 79-4:1975 to verify its accuracy and other performance parameters.
8. Sample Size for the Training Set
This information is not applicable. The device is a mechanical oxygen blender, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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Section 5 - 510(k) Summary or 510(k) Statement
510(k) Summary
NOV 1 4 2008
Submitter Information Tenacore Holdings, Inc 647 E. Young Street Santa Ana, CA 92705
Contact Brand Caso, QA Director
Ph: 714-444-4643
Fx: 714-549-7835
Date Prepared May 1, 2008
Product Name Tenacore Oxygen Blender
Predicate Device K925982
Product Description
The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and therapeutic oxygen. The percentage of oxygen to air can be adjusted from 21-100%.
Intended Use
The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.
Comparison to Predicate Device
| Tenacore Model | Bird Air/OxygenMicroblender | |
|---|---|---|
| Intended use | The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeuticoxygen and medical grade air as a stand-alone unit oras a component of a respiratory support apparatus. | Similar |
| Primary Material | Aluminum | same |
| Design Shape | Block | same |
| Patient use/reuse | Reuse | same |
| Sterility | Non-sterile | same |
| Description ofpatient attachment | Unit does not directly attached to patient | same |
| Connector design | Various | same |
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| Internal Components | Same design, form, function and material aspredicate | same |
|---|---|---|
| Dimensions | same | same |
| Accuracy | $+/- 3%$ | same |
Performance Data & Conclusions
Performance testing was conducted as required by standards: EN ISO 15001:2004; 60601-1; 9703-3:1998; 601-1:1988 and IEC 79-4:1975
Electrical safety testing was not performed, as there are no electrical components.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its wing, positioned to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brand Caso Director Tenacore Holdings, Incorporated 647 East Young Street Santa Ana, California 92705
NOV 1 4 2008
Re: K081335
Trade/Device Name: Tenacore Oxygen Blender Regulation Number: 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Codc: BZR Dated: October 29, 2008 Received: November 4, 2008
Dear Mr. Caso:
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 vour 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. Caso
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 Center for Devices and Radiological Heafth'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.
Clare
Chiu S. Lin, Ph. D Division 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: Tenacore Oxygen Blender
Indications for Use:
The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. Mich fa mzc
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: )<o צו 3 3 צ
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).