E100 SERIES SPO2 SENSORS

K970098 · Epic Medical Equipment Services, Inc. · DQA · Apr 30, 1998 · Cardiovascular

Device Facts

• Record ID: K970098
• Device Name: E100 SERIES SPO2 SENSORS
• Applicant: Epic Medical Equipment Services, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Ohmeda (E112-02), Novametrix 500 (E192-03), Novametrix Superbright (E112-03), Spacelabs oximeter module (E112-04), Criticare (E112-05), BCI (E103-06), Datascope (E112-07).

Device Story

Reusable finger sensor for continuous non-invasive monitoring of arterial oxygen saturation and pulse rate. Device interfaces with specific compatible oximeter modules (Ohmeda, Novametrix, Spacelabs, Criticare, BCI, Datascope). Operates by transmitting light through tissue to detect pulsatile blood flow; sensor output processed by host oximeter to calculate SpO2 and pulse rate. Used in clinical settings by healthcare professionals to assist in patient physiological assessment. Provides real-time monitoring data to support clinical decision-making regarding patient oxygenation status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable finger sensor; optical sensing principle (photoplethysmography); compatible with specified third-party oximeter modules via proprietary connectors; non-sterile.

Indications for Use

Indicated for patients requiring continuous non-invasive monitoring of arterial oxygen saturation and pulse rate. Intended for prescription use.

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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 30 1998

Mr. Jeffrey Secunda
Epic Medical Equipment Services, Inc.
4643 Westgrove Drive
Dallas, TX 75248

Re: K970098
Epic Series E100 SpO₂ Finger Sensor
Regulatory Class: II (two)
Product Code: 74 DQA
Dated: February 1, 1998
Received: February 3, 1998

Dear Mr. Secunda:

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 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). 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 regulations 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 Regulation (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 assumptions. Failure to comply with the GMP regulation may result in 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.

{1}

Page 2 - Mr. Jeffrey Secunda

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/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{2}

K970098

DEVICE NAME:
EPIC SERIES E100 SpO₂ FINGER SENSOR

## INDICATIONS FOR USE

Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters:

| Oximeter | Epic M/N |
| --- | --- |
| Ohmeda | E112-02 |
| Novametrix 500 | E192-03 |
| Novametrix Superbright | E112-03 |
| Spacelabs oximeter module | E112-04 |
| Criticare | E112-05 |
| BCI | E103-06 |
| Datascope | E112-07 |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ or Over-the-Counter Use ☐
(per 21 CFR 801.109)


510k\ifu.doc