(104 days)
Not Found
No
The description focuses on standard pulse oximetry technology and does not mention AI or ML.
No.
The device is described as a monitor that measures oxygen saturation and pulse rate. There is no indication that it provides any therapeutic treatment or intervention.
Yes.
Explanation: The device is described as a "Pulse Oximeter" which is used to monitor oxygen saturation and pulse rate, providing physiological signals that can be used to assess a patient's health status, thus aiding in diagnosis.
No
The device description explicitly states it is a "battery powered Pulse Oximeter" and acquires physiological signals, indicating it includes hardware components beyond just software.
Based on the provided information, the PM-50 Pulse Oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- PM-50 Function: The description clearly states the PM-50 is a "non-invasive, spot-check, oxygen saturation and pulse rate monitor." It acquires "physiological signals" directly from the patient using sensors applied to the body. This is a non-invasive, in vivo measurement.
The PM-50 measures physiological parameters directly from the living body, not by testing samples taken from the body in a laboratory setting. Therefore, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The PM-50 is a flexible, portable, battery powered Pulse Oximeter. The PM-50 Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LCD screen.
PM-50 uses a two-wavelength pulsatile system - red and infrared light – to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO₂ and pulse rate are obtained and indicated on the LCD screen.
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
neonates to adults
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)
Laboratory testing and clinical study was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications and was substantially equivalent to predicate device.
The following quality assurance measures were applied to the development of the device:
- Risk Analysis
- Environmental Testing
- Function and Performance Testing
- Clinical Study .
The conclusions drawn from clinical and laboratory testing of the PM-50 Pulse Oximeter demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the PM-50 Pulse Oximeter numbered K#052693.
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.
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
510(K) SUMMARY
SEP - 5 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: Ko61442
Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 2658 2888
Fax: +86 755 2658 2680
- Contact Person: .
- Li Dongling
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
- . Date Prepared:
May 12, 2006
Name of the device:
- Trade/Proprietary Name: PM-50 Pulse Oximeter .
- 0 Common Name: Pulse Oximeter
- e Classification
21 CFR 870.2700 Oximeter, Pulse Class II 21 CFR 870.2710 Ear Oximeter, Pulse Class II
Legally Marketed Predicate Device:
K052693 PM-50 Pulse Oximeter
MINDRAY PROPRIETARY
0026
1
Description:
The PM-50 is a flexible, portable, battery powered Pulse Oximeter. The PM-50 Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LCD screen.
PM-50 uses a two-wavelength pulsatile system - red and infrared light – to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO₂ and pulse rate are obtained and indicated on the LCD screen.
Statement of intended Use:
The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.
Comparison of Technological Characteristics:
The PM-50 Pulse Oximeter employs the same functional technology as the predicate device.
Testing:
The device modification involved the addition of SpO2 probes for the PM-50 Pulse Oximeter. The purpose of adding these added probes is a business decision. The subject new probes are selectable by customers; we will not discontinue marketing the previously cleared probes.
Laboratory testing and clinical study was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications and was substantially equivalent to predicate device.
The following quality assurance measures were applied to the development of the
2
device:
- . Risk Analysis
- . Environmental Testing
- Function and Performance Testing
- Clinical Study .
Conclusion:
The conclusions drawn from clinical and laboratory testing of the PM-50 Pulse Oximeter demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the PM-50 Pulse Oximeter numbered K#052693.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged around the perimeter of the circle.
SEP - 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shenzhen Mindray Bio-Medical Electronics Company, Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K061442
Trade/Device Name: PM-50 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 8, 2006 Received: August 9, 2006
Dear Ms. Goldstein-Falk:
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.
4
Page 2 - Ms. Goldstein-Falk
,
3.
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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) 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), please contact the Office of 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lian, Ph.D.
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
5
Exhibit #E
Page 1 of
510(k) Number (if known):
Device Name: PM-50 Pulse Oximeter
Indications For Use:
The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.
Prescription Use × (Per 21 CFR 801 Subpart D)
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)
Hice Suliom
Jon Sign-Off) ിഗ്ന Sign-Om)
Sign of Anesthesiology, General Hospital, I .. Jotion Control, Dental D o (0 (k) Number:
0024