STAT-SHELL DISPOSABLE SPO2 SENSOR

K992092 · Epic Medical Equipment Services, Inc. · DQA · Dec 22, 1999 · Cardiovascular

Device Facts

• Record ID: K992092
• Device Name: STAT-SHELL DISPOSABLE SPO2 SENSOR
• Applicant: Epic Medical Equipment Services, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.

Device Story

Stat-Shell Disposable SpO2 Sensor is an electro-optical accessory for pulse oximeters; monitors functional arterial oxygen saturation and pulse rate. Device uses two LEDs (light sources) and one photodiode (detector) to measure light absorption of arterial hemoglobin; non-invasive; no skin penetration or heat transfer. Photodiode housed in rigid shell for digit placement; LEDs housed in foam tape wrapped around digit. Connects to oximeter via 2-foot cable with DB-9 connector; adapter cable available for Hypertronics-style connection. Used in clinical settings; operated by healthcare professionals. Output displayed on compatible oximeter; assists clinicians in patient oxygenation assessment; provides continuous monitoring benefit.

Clinical Evidence

Bench testing only. Simulated use testing verified oximeter compatibility with the modified photodiode. Testing confirmed device meets standards for biocompatibility, EMC, safety, and pulse oximetry performance.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode. Rigid shell and foam tape construction. 2-foot cable with DB-9 connector; adapter for Hypertronics interface. Non-invasive, no electrical contact or heat transfer. Complies with pulse oximeter standards, EMC, and biocompatibility requirements.

Indications for Use

Indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >30 kg.

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 100 Series SpO2 sensor (K970098)

Submission Summary (Full Text)

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Epic Medical Equipment Services

1800 10TH STREET, SUITE 300, PLANO, TEXAS 75074

DEC 22 1999

# 510(k) Summary

### Submitter Information:

Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074

Providina Solutions Throp

### Contact:

Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: [phone] Fax: [phone]

#### Date Prepared:

June 18, 1999

## Product Name:

Common Name: SpO2 Sensor (accessory to pulse oximeter) Trade Name(s): Stat-Shell Disposable SpO2 Sensor

#### Predicate Device:

This product is a modification to the Epic 100 Series SpO2 sensor marketed under 510(k) # K970098.

## Description:

The Stat-Shell SpO2 Disposable Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 photodiode is housed in a textured, rigid shell that is contoured for patient digit placement. The LED's are housed in a foam tape that is positioned over the nail bed and wrapped around the patient's digit.

The sensor cable is 2 feet in length and is terminated in a DB-9 style connector. An adapter cable extends the length and converts the connector to a Hypertronics style.

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### Intended Use:

The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.

## Comparison to Predicate Device:

The Stat-Shell SpO2 Disposable Sensor uses the same theory and principle of operation as the predicate device. The Stat-Shell SpO2 Disposable Sensor differs from the predicate device in essentially three ways:

- 1) it uses a different method of attachment to the patient (foam tape vs. clip/finger pad);
- 2) it is intended for limited, single patient reuse (predicate device is multi-patient durable reusable);
- 3) it uses a smaller photodiode (1.7mm2 vs. 8.23mm2)

The LED specifications, as well as the electrical/optical specifications of the photodiode, are identical to the predicate device.

# Performance Data & Conclusions:

Changes to the predicate device do not affect those aspects of the device related to accuracy. Changes to the photodiode's mechanical size affects the device's ability to be recognized by the compatible oximeter. Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode.

Other bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility, EMC, safety, and pulse oximeter standards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1999

Ms. Krista Oakes Epic Medical Equipment Services, Inc. 1800 10th Street, Suite 300 Plano, TX 75074

Re: K992092 Stat-Shell Disposable Spo2 Sensor, Model E502-02 Regulatory Class: II (two) Product Code: 74 DQA Dated: October 1, 1999 Received: October 4, 1999

Dear Ms. Oakes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Krista Oakes

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Jeanne A Westerhener for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX B

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# Statement of Indications For Use

K992092 510(k) # Device Name: Stat-Shell Disposable SpO2 Sensor

Indications for Use:

The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use

L. A. Weitershan

n Sign-Off) (Division Sign-Oir)
Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number