(355 days)
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 (PR). The PRO₂ is intended to monitor arterial saturation on the back or forehead locations in pediatric and adult populations. The PRO₂ is for use in hospitals, hospital-type facilities and intra-hospital transport environment.
The Pro2® Pulse Reflectance Oximeter System consists of a reusable sensor that emits red and infrared light, a disposable sensor holder to attach the Sensor and detect red and infrared light, 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 Pro2 Sensor geometry includes light sources that emit light in three different wavelengths, and detection areas defined by two photodetector rings arranged concentrically with a photodetector in the center. The rings constitute an annular shape, which allow a multi-path acquisition of signals from a larger tissue area. The Monitor calculates the oxygen saturation based 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 Pro2 Sensor Holder provides optical isolation for external light and is attached to the patient with adhesive that is incorporated as part of the Sensor Holder.
The provided text describes the PRO2 Pulse Reflectance Oximeter System. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance:
The provided document states: "The Pro2® Pulse Reflectance Oximeter System performance was tested with clinical data and the results met the acceptable criteria." However, it does not specify what those "acceptable criteria" were nor does it provide a numerical breakdown of the reported device performance against those criteria. It only makes a general statement of compliance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | "met the acceptable criteria" (general statement) |
2. Sample size used for the test set and the data provenance:
The document mentions "clinical data" was used for testing but does not provide the sample size of the test set nor its provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text.
4. Adjudication method for the test set:
This information is not provided in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is a Pulse Reflectance Oximeter System, which is a medical device for measuring oxygen saturation and pulse rate. It is not an AI-assisted diagnostic imaging system, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is inherently a standalone measurement device. It continuously monitors and displays physiological parameters (SpO2 and pulse rate) without requiring human interpretation for its primary function. The "clinical data" testing would have evaluated the device's accuracy in autonomously deriving these measurements, thus representing standalone performance. However, specific details of this testing are not provided beyond the general statement of meeting acceptable criteria.
7. The type of ground truth used:
The document explicitly states the device measures "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." For oximetry devices, the gold standard for ground truth for oxygen saturation is typically arterial blood gas (ABG) analysis. While not explicitly stated, it is a standard practice in oximeter validation to compare the device's readings against ABG measurements.
8. The sample size for the training set:
Pulse oximeters are typically developed through engineering and calibration processes, not machine learning training sets in the modern sense. Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this device.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" in the AI/ML context is not applicable. The device's algorithms for calculating SpO2 and pulse rate would be based on established physiological principles of light absorption by oxygenated and deoxygenated hemoglobin, and these would be validated through engineering and clinical testing against reference methods (like ABG) rather than "training" on a dataset with established ground truth in the AI sense.
{0}------------------------------------------------
K 032831
AUG 3 1 2004
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.
Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Contact Person
Ira Duesler Director, Regulatory Affairs/Quality Assurance ConMed Corporation 525 French Road Utica, NY 13502
Phone: 315-624-3072 Fax: 315-624-3089 e-mail: ira_duesler@mail.conmed.com
Date Prepared:
September 10, 2003
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
| K012706 | IM2001 Pulse Oximeter | Imagyn Medical Technologies |
|---|---|---|
| K012891 | OxiMAX Pulse OximetrySystem with N-595 PulseOximeter | Nellcor Puritan Bennett, Inc. |
{1}------------------------------------------------
Description of Device
The Pro2® Pulse Reflectance Oximeter System consists of a reusable sensor that emits The Pro2 "Fulse Hellectance Oximotor System Serbie sensor holder to attach the Sensor and delect red and infrarrounight, a lia monitor incorporating control, processing, and displav units.
The Pro2® Monitor contains an internal battery to power the unit when AC power is not The FTD2 Twonitor contains an internal battly to percentage of oxygen saturation in the blood, pulse rate, signal quality, and alarms.
The Pro2 Sensor geometry includes light sources that emit light in three different The 1102 "School goomstly areas defined by two photodetector rings arranged wavelengths, and detection arous as in the center. The rings constitute an annular shape, which allow a multi-path acquisition of signals from a larger tissue area. The which allow a multi path acquient 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 Pro2 Sensor Holder provides optical isolation for external light and is pediatho aco: The Proz - Shesive that is incorporated as part of the Sensor Holder.
Indications For Use
The Proo® Pulse Reflectance Oximeter System is indicated for the continuous, noninvasive monitoring Pro Pulse Reflectance Oximeter System of functional oxygen invasive moniton of arterial hemoglobin (SpO2) and pulse rate. The Pro2® is intended to monitor Suttifulion on the back and forehead locations in pediatric and adult populations. The Pro2 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:
Imagyn IM2001 Pulse Reflectance Oximeter (K012706)
Nellcor OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter (K012891)
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Imagyn Medical Technologies, Incorporated C/O Ms. Ira Duesler Director, Regulatory Affairs/Quality Assurance ConMed Corporation 525 French Road Utica, New York 13502 レス…
Re: K032831
Trade/Device Name: PRO2 Plus Reflectance Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 27, 2004 Received: July 29, 2004
Dear Ms. Duesler:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares in ned the device is substantially equivalent (for the itelefocu above and nave acteriminoure) to legally marketed predicate devices marketed in includions for use bated in are a 28, 1976, the enactment date of the Medical Device incrolic confinered prior to they are reclassified in accordance with the provisions of Amendinens, or to act 100 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 approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 Nr.), it may of such 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 - Ms. Duesler
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled of a bases and its with other requirements
mean that FDA has made a determination that your device complies with one project mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal spaciences in of the Act or ally rederal statutes and regations, but not limited to: registration You must comply with an the Hot b rog 21 CFR Part 801); good manufacturing practice. and ifsuing (21 CFR int 007), lacelity systems (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 18, Cit requirements as set form in the quality of sections (Sections 531-542 of the Act); ﮩﯿﮟ 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mained of your device of your device to a premarket notification. The PDF Imalis 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), if you desire specific advice for Jour do at (301) 594-4646. Also, please note the regulation prease contact the Office or Octification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain outer general international and Consumer Assistance at its toll-free . Drember (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Quarr
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
Enclosure
{4}------------------------------------------------
Indications for Use
| 510(k) Number: | K032831 |
|---|---|
| Device Name: | PRO₂ Pulse Reflectance Oximeter System |
| 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 (PR). The PRO₂ is intended to monitor arterial saturation on the back or forehead locations in pediatric and adult populations. The PRO₂ is for use in hospitals, hospital-type facilities and intra-hospital transport environment. |
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lame Gyulcom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 285
510(k) Number:
Page 1 of 1
§ 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).