TENACORE SP02 SENSORS

K053420 · Tenacore Holdings, Inc. · DQA · Nov 15, 2006 · Cardiovascular

Device Facts

• Record ID: K053420
• Device Name: TENACORE SP02 SENSORS
• Applicant: Tenacore Holdings, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Device Story

SpO2 sensors are electro-optical accessories for pulse oximeters; non-invasive; no skin penetration or electrical contact. Device utilizes two LEDs (660/895 nm or 660/940 nm) as light sources and one photodiode as a detector to measure light absorption of functional arterial hemoglobin in the finger. Sensor housed in a soft pad with a clear window; connects via cable to a monitor. Used in clinical settings for continuous monitoring of oxygen saturation and pulse rate. Output is processed by the connected oximeter to provide real-time physiological data to clinicians, facilitating patient monitoring and clinical decision-making.

Clinical Evidence

Clinical hypoxia studies conducted in an independent research lab compared subject sensors to arterial blood samples analyzed on a laboratory co-oximeter. Results demonstrated accuracy equivalent to predicate device claims. Bench testing verified pulse rate accuracy. Biocompatibility, electrical safety, and EMC testing performed to demonstrate conformance with industry standards.

Technological Characteristics

Electro-optical sensor; two LEDs (660/895 nm or 660/940 nm); photodiode (3 mm2 or 8 mm2 active area); multi-conductor shielded cable with PVC jacket; finger clip form factor; non-sterile; reusable; connects to pulse oximeter monitor.

Indications for Use

Indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients requiring pulse oximetry.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Epic SPo2 Finger Sensor (K973970)
• Medical Cables Spo2 Finger Probes (K002223)

Submission Summary (Full Text)

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K053420

### 510(k) Summary

Submitter Information Tenacore Holdings, Inc 647 E. Young Street Santa Ana, CA 92705

NOV 15 2006

Contact Brand Caso, QA Director

Ph: 714-444-4643

Fx: 714-549-7835

Date Prepared November 1, 2005

Product Name SpO2 Sensor (accessory to pulse oximeter)

Predicate Device K973970, K002223

### Product Description

SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in soft pad with a clear window. The sensor cable is terminated in a connector that couples with the corresponding monitor.

Intended Use

SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

| | Tenacore Model | Epic SPo2 Finger<br>Sensor | Medical Cables<br>Spo2 Finger Probes |
|--------------------------------------|-------------------------------|----------------------------|--------------------------------------|
| Intended use | Continuous SPO2<br>monitoring | Same | Same |
| Patient population<br>(weight range) | | | |
| Anatomical sites | Finger | Finger | Finger |
| Patient use/reuse | Reuse | Same | Same |
| Sterility | Non-sterile | Same | Same |
| Description of<br>patient attachment | Finger clip | Same | Same |

#### Comparison to Predicate Device

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| Connector design | Various; modular or<br>molded | Same | Same |
|---------------------------|------------------------------------------|------|------|
| Cable structure | Multi-conductor,<br>shielded, PVC jacket | Same | Same |
| Cable length | 3-12 ft | Same | Same |
| LED wavelength | 660/895 nm<br>660/940 nm | Same | Same |
| Photodiode active<br>area | 3 mm2, 8mm2 | Same | Same |
| Accuracy (Arms) | Acceptability within ±3% | Same | Same |

## Performance Data & Conclusions

Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Subject sensors were compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims. Bench testing was performed to verify pulse rate accuracy.

Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brand Caso Quality Assurance Director Tenacore Holdings, Incorporated 647 E. Young Street Santa Ana, California 92705

NOV 15 2006

Re: K053420

Trade/Device Name: SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 8, 2006 Received: November 8, 2006

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 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. 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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Snyite Y. Michauoms.

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: SpO2 Sensors

Indications for Use:

Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

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)

Wholly Held for Ann Graham

hesiology. General Hospital.

Number: K05 3420