(137 days)
Not Found
No
The device description details standard pulse oximetry technology based on light absorption and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is a pulse oximeter for monitoring and spot-checking, not for providing therapy or treatment.
Yes
A diagnostic device is used to identify or monitor medical conditions. This pulse oximeter monitors SpO2 and pulse rate, which are physiological parameters used in the diagnosis or management of various conditions.
No
The device description explicitly mentions hardware components such as a sensor, batteries, LED display, and a buzzer, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The MD300K1 Pulse Oximeter works by applying a sensor to the skin (specifically, a pulsating arteriolar vascular bed) to measure oxygen saturation and pulse rate directly from the patient's body. This is an in vivo measurement, meaning it's done within the living body.
The device description clearly outlines a non-invasive method of measurement using light absorption through the skin, which is characteristic of a pulse oximeter and not an IVD.
N/A
Intended Use / Indications for Use
The MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Pulse Oximeter MD300K1 can display %SpO2, pulse rate value and vertical bar graph pulse amplitude. It suits for adult and pediatric patients. The device has physiological alarm which includes PR high/low alarm and SpO2 high/low alarm. At the same time, the device has a buzzer which is used for sensor off indication, pulse.indication, low voltage indication and PR & SpO2 alarm.
The pulse oximeter adapts 8-segment digital LED as indication. The applicant device has low battery voltage alarm function and automatically power of function. The device supplies a sensor as the accessory and uses 2 * AA batteries. -
The MD300K1 Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pulsating arteriolar vascular bed
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals 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)
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.
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
KCAV399
Premarket Notification 510(k) Submission-S10(k) Summary Report No .: Report No .: TE20090108
JUL 2.0 2009
510(k) Summary
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: Pending
1. Submitter Information
● Manufacturer Name:
Beijing Choice Electronic Technology Co., Ltd. Room 1127-1128 Building B, Bailangyuan Fuxing Road . No. A36 Beijing, CHINA 100039
● Contact Person:
Ms. Yajing Li North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88790480 x 6046 Fax:+86-10-88798860 Email: liyajing@choicemmed.com
- . Date prepared: January 8, 2009
2. Applicant Device Information
- Trade/Proprietary Name: Pulse Oximeter MD300K1
- Common Name: Pulse Oximeter .
- Classification: 21CFR 870.2700 Oximeter Class: II
3. Legally Marketed Predicate Device
Pulse Oximeter PM-60
K-number: K072581
Shenzhen Mindray Bio-medical Electronics Co., LTD
1
4. Description
The Pulse Oximeter MD300K1 can display %SpO2, pulse rate value and vertical bar graph pulse amplitude. It suits for adult and pediatric patients. The device has physiological alarm which includes PR high/low alarm and SpO2 high/low alarm. At the same time, the device has a buzzer which is used for sensor off indication, pulse.indication, low voltage indication and PR & SpO2 alarm.
The pulse oximeter adapts 8-segment digital LED as indication. The applicant device has low battery voltage alarm function and automatically power of function. The device supplies a sensor as the accessory and uses 2 * AA batteries. -
The MD300K1 Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
5. Intended use
The MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
6. Statement
.
のアイデント、アイデント、ア
This is a traditional 510(k) report for Pulse Oximeter MD300K1, which has the same intended use to PM-60 Pulse Oximeter (K072581).
The Pulse Oximeter MD300K1 is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care, which is same as the predicate device Pulse Oximeter PM-60. PM-60. PM-60.
7. Substantially Equivalence Determination
Comparison Analysis
The applicant device has same classification information, same intended use, same design principle, same specifications, same product materials and performance effectiveness as the
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2009
Ms. Yajing Li North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing CHINA 100041
Re: K090599
Trade/Device Name: MD300K1 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 25, 2009 Received: July 6, 2009
Dear Ms. Yajing Li:
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 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. Yajing Li
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runore
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and . Radiological Health
4
Premarket Notification 510(k) Chapter II Indication for Use Statement Report No.: TE20090108
Indication For Use
510(k) Number (if known): __ Pending
Device Name: MD300K1 Pulse Oximeter
Indications for Use:
The MD300K 1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
Prescription Use J V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Adlutt
ivision Sign-Off) Tivision of Anesthesiology, General Hospital ection Control, Dental Devices
Page 1 of 1
10905 10(k) Number:
II-2