TENACORE OXYGEN BLENDER, MODEL TB-2000

K081335 · Tenacore Holdings, Inc. · BZR · Nov 14, 2008 · Anesthesiology

Device Facts

• Record ID: K081335
• Device Name: TENACORE OXYGEN BLENDER, MODEL TB-2000
• Applicant: Tenacore Holdings, Inc.
• Product Code: BZR · Anesthesiology
• Decision Date: Nov 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Tenacore Oxygen Blender is a wall-mounted mechanical device for mixing medical-grade air and therapeutic oxygen. It features inlets for both gases and allows manual adjustment of the oxygen concentration from 21-100%. The device is non-invasive and does not attach directly to the patient; it functions as a stand-alone unit or as part of a larger respiratory support system. It is operated by healthcare professionals in clinical settings. The device provides a controlled gas mixture to support patient respiratory needs. It contains no electrical components and relies on mechanical design for operation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing conducted per EN ISO 15001:2004, 60601-1, 9703-3:1998, 601-1:1988, and IEC 79-4:1975. Accuracy verified at +/- 3%.

Technological Characteristics

Mechanical gas mixer; aluminum construction; wall-mounted block form factor; non-sterile; non-electrical; manual adjustment of oxygen/air ratio (21-100%); +/- 3% accuracy.

Indications for Use

Indicated for non-invasive mixing and delivery of therapeutic oxygen and medical grade air, either as a stand-alone unit or integrated into a respiratory support apparatus. Patient population not specified; prescription use only.

Regulatory Classification

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.

Predicate Devices

• Bird Air/Oxygen Microblender (K925982)

Submission Summary (Full Text)

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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/Oxygen<br>Microblender |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended use | The Tenacore Oxygen Blender, is intended for non-<br>invasive mixing and delivery of a ratio of therapeutic<br>oxygen and medical grade air as a stand-alone unit or<br>as 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 of<br>patient 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 as<br>predicate | 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 [phone]. 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 [phone] or [phone] 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)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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