(90 days)
Not Found
No
The description focuses on the optical and electrical components of the sensor and its connection to a separate pulse oximeter, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is a diagnostic tool used for monitoring purposes (arterial oxygen saturation and pulse rate), not for treating or preventing disease.
Yes
The device continuously monitors and provides measurements of arterial oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly details physical components (sensor, cable, plug, LEDs, photodiode) and their interaction with tissue and a separate pulse oximeter, indicating it is a hardware device.
No, 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. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that the pulse oximeter sensor is used for "continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring." It works by using optical means to measure light absorption across tissue on a living patient.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The measurement is taken directly on the patient's body.
Therefore, based on the provided information, the reprocessed pulse oximeter sensor is a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
Product codes
NLF
Device Description
SterilMed's reprocessed Masimo LNCS® Pulse Oximeter Sensors consist of a sensor, integrated sensor cable, and the sensor plug which connects to the Pulse Oximeter. The reprocessed Masimo LNOP® Pulse Oximeter Sensors consist of a sensor (two LED's and a photodiode), connector extension and connector, but do not feature an integrated cable. Both configurations have a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate.
Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and any other related equipment are not included in the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical means
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Representative samples of reprocessed pulse oximeter sensors were tested to demonstrate appropriate functional characteristics by utilizing the necessary bench testing and an in vivo clinical validation. Process validation testing was performed to validate the sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041815, K051212, K060143, K031330
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
STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION AUGUST 3, 2009 FOR REPROCESSED PULSE OXIMETER SENSORS
SUMMARY AND CERTIFICATION II.
- 510(k) Summary A.
| Submitter: | SterilMed, Inc. NOV - 3 2009 |
|---|---|
| Contact Person: | Garrett Ahlborg |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 763-488-3483 | |
| Fax: 763-488-2051 | |
| Date Prepared: | August 3, 2009 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Name: | Oximeter, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.2700 |
| Product Code: | NLF |
| Predicate
Devices: | The SterilMed reprocessed pulse oximeter sensors are substantially equivalent to the Masimo
LNCS® pulse oximeter sensors (K041815, K051212, & K060143) and the Masimo LNOP®
pulse oximeter sensors (K031330). |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed's reprocessed Masimo LNCS® Pulse Oximeter Sensors consist of a sensor,
integrated sensor cable, and the sensor plug which connects to the Pulse Oximeter. The
reprocessed Masimo LNOP® Pulse Oximeter Sensors consist of a sensor (two LED's and a
photodiode), connector extension and connector, but do not feature an integrated cable. Both
configurations have a sensor that uses an optical means to determine the light absorption of
functional arterial hemoglobin. The sensor contains three optical components: two light
emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light
receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one
another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides
continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional
hemoglobin and pulse rate.
Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and any
other related equipment are not included in the scope of this submission. |
| Intended Use: | The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive
arterial oxygen saturation (SpO2) and pulse rate monitoring. |
| Functional and
Safety Testing: | Representative samples of reprocessed pulse oximeter sensors were tested to demonstrate
appropriate functional characteristics by utilizing the necessary bench testing and an in vivo
clinical validation. Process validation testing was performed to validate the sterilization
procedures as well as device packaging. In addition, the manufacturing process includes visual
and validated functional testing of all products produced. |
| Conclusion: | The reprocessed pulse oximeter sensors are substantially equivalent to the Masimo pulse
oximeter sensors.
This conclusion is based upon the devices' similarities in functional design (principles of
operation), materials, indications for use and methods of construction. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half. Inside the circle is a stylized depiction of an eagle, which is a common symbol of the United States. The eagle is shown in profile, with its wings spread and its head turned to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. Garrett Ahlborg Regulaotry Affairs Specialist SterilMed, Incorporated 11400 73rd Avenue North, Suite 100 Minneapolis, Minnesota 55369
NOV - 3 2009
Re: K092368
Trade/Device Name: Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: August 3, 2009 Received: August 5, 2009
Dear Mr. Ahlborg:
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.
2
Page 2 - Mr. Ahlborg
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Nh fac
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Pulse Oximeter Sensors
Indications for Use:
The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
Prescription Use X (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) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k-092368
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CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.