(472 days)
Not Found
Not Found
No
The summary describes a reusable finger sensor for basic physiological monitoring (oxygen saturation and pulse rate) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a sensor for monitoring oxygen saturation and pulse rate, which are diagnostic functions, not therapeutic.
No
The device is used for monitoring physiological parameters (oxygen saturation and pulse rate) and not for diagnosing a disease or condition. This is a monitoring device that provides data for assessment, but does not itself provide a diagnosis.
No
The device description explicitly states it is a "Reusable finger sensor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring." This involves measuring physiological parameters directly from the body (non-invasively) and does not involve analyzing samples taken from the body.
Therefore, this device falls under the category of a medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Ohmeda, Novametrix 500, Novametrix Superbright, Spacelabs oximeter module, Criticare, BCI, Datascope.
Product codes
74 DQA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 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 February 3, 1998 Received:
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 beqin 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Thomas J. Callahan
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)
M.P.S
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Respiratory, Divisionrological Devices
510(k) Number