K Number
K992215
Device Name
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED
Date Cleared
2000-03-29

(272 days)

Product Code
Regulation Number
870.2700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Continuous or spot monitoring of non-invasive arterial oxygen saturation.
Device Description
Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The device description is limited to the sensor type.

No
The device is described as a monitor for non-invasive arterial oxygen saturation, which indicates a diagnostic or monitoring function rather than a therapeutic one.

Yes
The device is used for "monitoring of non-invasive arterial oxygen saturation," which involves assessing a physiological parameter to gain information about a patient's health status, aligning with the definition of a diagnostic device.

No

The device description explicitly mentions "Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)", which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "Continuous or spot monitoring of non-invasive arterial oxygen saturation." This describes a device that measures a physiological parameter directly from the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
  • Device Description: The description mentions "Oximeter Sensor(s)," which are used for pulse oximetry, a non-invasive method of measuring oxygen saturation.
  • Lack of IVD Indicators: The information does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, etc.)
    • Detecting or measuring substances within those samples
    • Providing information for diagnosis, monitoring, or screening based on sample analysis.

Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Product codes

74 DQA

Device Description

Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Not Found

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).

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle in flight, with three horizontal lines forming the body and stylized curves representing the wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2000

Mr. Stephen H. Gorski EnviteC-Wismar GmbH c/o Kelgor, Inc. N8259 Cottage Drive Fond Du Lac, WI 54937

Re : K992215 Multicompatible EnviteC Disposable and Reusable Oximeter Sensors Regulatory Class: II (two) Product Code: 74 DQA Dated: February 18, 2000 Received: February 22, 2000

Dear Mr. Gorski:

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, Deen reclassi 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 (Premarked abore) inco entiler class II (Special
additional controls - Existing manapproval), 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 A substantially equivalent defermination assumes compliance to 895. 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 of inspections, the Food and Drug Addin's cracing (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: 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 351 through 542 of the Act
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

1

Page 2 - Mr. Stephen H. Gorski

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 (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 requlation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III

James E. Dillard ÍII Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known):

Device Name: Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)

Indications for use:

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcoll

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992215

Prescription Use_4 (Per 21 CFR801.109)

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OR

Over the Counter Use_________