(31 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional optical sensing technology and signal processing.
No
The description states the device is for monitoring physiological parameters (oxygen saturation and pulse rate), not for treating any condition.
No
A diagnostic device identifies a disease or condition. This device is for "continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are physiological parameters, not diseases. While this information can be used in diagnosis, the device itself is a monitor.
No
The device description explicitly states that the system consists of a reusable sensor, a disposable sensor holder, a connecting cable, and a monitor, all of which are hardware components.
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 PRO2® Pulse Reflectance Oximeter System is a non-invasive device that measures oxygen saturation and pulse rate by emitting and detecting light through the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous, non-invasive monitoring."
Therefore, the PRO2® Pulse Reflectance Oximeter System falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PRO2® Pulse Reflectance Oximeter System is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The PRO2 is intended to monitor arterial saturation on the back or forehead locations in the pediatric and adult populations. The PRO2 is for use in hospital, hospital-type facilities, and intra-hospital transport environment.
Product codes
74 DQA
Device Description
The Pro 9 Pulse Reflectance Oximeter System consists of a reusable sensor that emits and detect red and infrared light, a flexible disposable sensor holder to attach the sensor to the skin, a connecting cable, and a monitor incorporating control, processing, and display units.
The Pro2® Monitor contains an internal battery to power the unit when AC power is not available. The monitor displays the percentage of oxygen saturation in the blood, pulse rate, signal quality, and alarms.
The Proo Sensor geometry includes light sources that emit light in three different wavelengths, and detection areas defined by two photodetector rings arranged concentrically with the light sources in the center. The rings constitute an annular shape. which allow a multi-path acquisition of signals from a larger tissue area. The measurement of SpO2 is dependent upon specific wavelengths of light detected by its sensor.
The Pro2 device has a disposable sensor holder; Model # AHL-200 for adults and pediatric use. The Pro Sensor Holder provides optical isolation for external light and is attached to the skin via adhesive that is incorporated as part of the Sensor Holder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back and forehead locations
Indicated Patient Age Range
pediatric and adult populations
Intended User / Care Setting
hospital, hospital-type facilities, and intra-hospital transport environment
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)
Nonclinical Performance: The Pro2 Pulse Reflectance Oximeter System was tested and passed all required electrical and biocompatibility testing.
Clinical Performance: The Pro2® Pulse Reflectance Oximeter System performance was tested with clinical data and the results met the acceptable criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness
PRO2® Pulse Reflectance Oximeter System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
MAY 2 2 2006
Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Contact Person
lra Duesler Director, Requlatory Affairs ConMed Corporation 525 French Road Utica, NY 13502
Phone: 315-624-3072 Fax: 315-624-3225 e-mail: ira_duesler@mail.conmed.com
Date Prepared:
April 18, 2006
Name of Device
Pro2 Pulse Reflectance Oximeter System
Classification Names
Oximeter
Device Classification
| Regulatory Class: | Class II |
|---|---|
| Product Code: | 74 DQA |
| Classification Panel: | Cardiovascular Device Panel |
| Regulation Number: | 21 CFR 870.2700 |
Predicate Devices
ConMed Pro2 Pulse Reflectance K032831 ConMed Corporation Oximeter System
1
Description of Device
The Pro 9 Pulse Reflectance Oximeter System consists of a reusable sensor that emits and detect red and infrared light, a flexible disposable sensor holder to attach the sensor to the skin, a connecting cable, and a monitor incorporating control, processing, and display units.
The Pro2® Monitor contains an internal battery to power the unit when AC power is not available. The monitor displays the percentage of oxygen saturation in the blood, pulse rate, signal quality, and alarms.
The Proo Sensor geometry includes light sources that emit light in three different wavelengths, and detection areas defined by two photodetector rings arranged concentrically with the light sources in the center. The rings constitute an annular shape. which allow a multi-path acquisition of signals from a larger tissue area. The measurement of SpO2 is dependent upon specific wavelengths of light detected by its sensor.
The Pro2 device has a disposable sensor holder; Model # AHL-200 for adults and pediatric use. The Pro Sensor Holder provides optical isolation for external light and is attached to the skin via adhesive that is incorporated as part of the Sensor Holder.
Indications For Use
The Pro2 Pulse Reflectance Oximeter System is indicated for the continuous, non-invasive monitoring Pro> Pulse Reflectance Oximeter System of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Pro2 is intended to monitor arterial saturation on the back and forehead locations in pediatric and adult populations. The Pro is for use in hospital, hospital-type facilities, and intra hospital transport environment.
Nonclinical Performance
The Pro2 Pulse Reflectance Oximeter System was tested and passed all required electrical and biocompatibility testing.
Clinical Performance
The Pro2® Pulse Reflectance Oximeter System performance was tested with clinical data and the results met the acceptable criteria.
Conclusion
The Pro2 Pulse Reflectance Oximeter System is substantially equivalent to the following 510(k) cleared devices:
ConMed Pro2® Pulse Reflectance Oximeter System (K032831)
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2006
Mr. Ira Duesler Director, Regulatory Affairs ConMed Corporation 525 French Road Utica, New York 13502
Re: K061112
Trade/Device Name: ConMed™ PRO2® Pulse Reflectance Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 19, 2006 Received: April 25, 2006
Dear Mr. Duesler:
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.
3
Page 2 - Mr. Duesler
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the For ar) - ruth all the Act's requirements, including, but not limited to: registration 1 od intoc comply Trail and and (21 CFR Part 801); good manufacturing practice and ibuing (= = = = = 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) This letter wifi anow Jourse FDA finding of substantial equivalence of your device to a premiured notification - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific act Compliance at (240) 276-0120. 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
4
Indications For Use
| 510(k) Number (if known) _ K | |
|---|---|
| Device Name: | ConMed PRO2 Reflectance Oximeter System |
Indications for use:
The PRO2® Pulse Reflectance Oximeter System is indicated for the continuous, กดก-The PRO2 - Fulse Reliectanice Oximocor Oytenh is natural hemoglobin (SpO2) and pulse invasive monitoring of functional oxygon on the back or forehead locations in the frealitions in rate. The PRO2 is intended to monitor aronton outch one in hospital-type facilities and intra-hospital transport environment.
Prescription Use X (per 21 CFR 801.109)
and/or
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martindale
Anesthesiology, General Hospital.
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