(117 days)
No
The description details standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as a pulse oximeter for continuous monitoring and spotchecking of physiological parameters (SpO2 and pulse rate), not for delivering a therapeutic intervention.
Yes
Explanation: The device measures parameters (SpO2 and pulse rate) to provide information about a patient's physiological state, which can be used to inform a diagnosis or monitor a condition. While it doesn't diagnose a specific disease itself, it provides data that aids in the diagnostic process.
No
The device description explicitly states it is a "handheld device" and details hardware components like a sensor, light-electronic transducer, hardware processing unit, color TFT display, batteries, and an infrared port. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- PM-60 Function: The PM-60 Pulse Oximeter measures functional pulse oxygen saturation (SpO2) and pulse rate (PR) by placing a sensor on the patient's body (typically a finger, toe, or earlobe). This is a non-invasive measurement performed on the patient, not on a specimen taken from the patient.
The device description clearly states it measures parameters directly from the patient using a sensor and light absorption, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The PM-60 handheld Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.
Product codes
DQA
Device Description
The PM-60 Pulse Oximeter is a handheld device that measures parameters of functional pulse oxygen saturation (SpO2) and pulse rate (PR). It suits for adult, pediatric and neonatal patients.
The SpO2 measurement of PM-60 is based on the absorption of pulse blood oxygen to red and infrared light by means of sensor and SpO2 measuring unit. The light-electronic transducer in sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The pleth curve and numeral value of SpO2 will be obtained.
PM-60 can be used in spot-check mode and continuous monitoring mode, which is selectable. It can be powered by alkaline batteries or Li-ion battery, and the latter is rechargeable with a charger stand. Through a color TFT display, users can view the data and operate the device. The audible and visual alarms are also adjustable.
During SpO2 measuring, operators can export the data in real-time through the infrared port, and export trend data through the multi-functional connector. After exporting, operators can review and printing the data with the PC data management system (PMS) software.
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
adult, pediatric and neonatal patients
Intended User / Care Setting
hospitals, out-of-hospital transport and home care
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 was conducted to validate and verify that the PM-60 Pulse Oximeter met all design specifications, including EMC, electrical, mechanical durability, safety, temperature/humidity, and etc. Results of these tests demonstrate compliance to the requirements of all applied standards.
PM-60 Pulse Oximeter has been demonstrated that it is substantially equivalent to the predicate devices. Testing results demonstrate that there are no new questions of safety and effectiveness when compared to the legally marketed devices.
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
JAN - 8 2008
0026
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:
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: .
Sep. 5, 2007
Name of the device:
- . Trade/Proprietary Name: PM-60 Pulse Oximeter
- Common Name: Pulse Oximeter
- Classification
21 CFR 870.2700 Oximeter Class II 21 CFR 870.2710 Oximeter, Ear Class II
Legally Marketed Predicate Devices:
K070791 PM-8000 Express Patient Monitor, Shenzhen Mindray Bio-Medical MINDRAY®PROPRIETARY Page 1 of 3 PM-60 Pulse Oximeter
1
Electronics Co.. Ltd
K051352 OxiMax NPB-40 Pulse Oximeter, Nellcor Puritan Bennett.
Description:
The PM-60 Pulse Oximeter is a handheld device that measures parameters of functional pulse oxygen saturation (SpO2) and pulse rate (PR). It suits for adult, pediatric and neonatal patients.
The SpO2 measurement of PM-60 is based on the absorption of pulse blood oxygen to red and infrared light by means of sensor and SpO2 measuring unit. The light-electronic transducer in sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The pleth curve and numeral value of SpO2 will be obtained.
PM-60 can be used in spot-check mode and continuous monitoring mode, which is selectable. It can be powered by alkaline batteries or Li-ion battery, and the latter is rechargeable with a charger stand. Through a color TFT display, users can view the data and operate the device. The audible and visual alarms are also adjustable.
During SpO2 measuring, operators can export the data in real-time through the infrared port, and export trend data through the multi-functional connector. After exporting, operators can review and printing the data with the PC data management system (PMS) software.
Statement of intended Use:
The PM-60 handheld Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.
Testing:
Laboratory testing was conducted to validate and verify that the PM-60 Pulse Oximeter met all design specifications, including EMC, electrical, mechanical durability, safety, temperature/humidity, and etc. Results of these tests demonstrate compliance to the requirements of all applied standards.
Conclusion:
PM-60 Pulse Oximeter has been demonstrated that it is substantially equivalent to the predicate devices. Testing results demonstrate that there are no new questions of safety and effectiveness when compared to the legally marketed devices.
MINDRAY®PROPRIETARY
Page 2 of 2 PM-60 Pulse Oximeter
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the emblem.
JAN - 8 2008
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: K072581
Trade/Device Name: PM-60 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code; DQA Dated: November 29, 2007 Received: December 27, 2007
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.
3
Page 2 - Ms. Goldstein-Falk
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,
Salute y. Michaud ms
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
Exhibit #E
Page 1 of 1
510(k) Number (if known):
Device Name: PM-60 Pulse Oximeter
Indications For Use:
The PM-60 handheld Pulse Oximeter is intended for continuous monitoring, spotchecking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.
Prescription Use X (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) | |
|---|---|
| and Thiland |
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
0024
510(k) Number: (K072581