(90 days)
The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
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.
This document, K092368, is a 510(k) premarket notification for reprocessed pulse oximeter sensors by SterilMed, Inc. It aims to demonstrate substantial equivalence to predicate devices (Masimo LNCS® and LNOP® pulse oximeter sensors).
Given the nature of this submission (reprocessed medical devices) and the available information, the "device" in the context of your request refers to the reprocessed pulse oximeter sensors. The study described is primarily focused on demonstrating that the reprocessed sensors perform equivalently to new, predicate sensors.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance metrics for specific clinical parameters (e.g., SpO2 accuracy, pulse rate accuracy). Instead, it describes a more general approach to ensuring functional equivalence.
The document states: "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."
And further: "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."
While not a direct table of specific numerical acceptance criteria, the implicit acceptance criterion is that the reprocessed sensors demonstrate functional characteristics equivalent to the predicate devices. The study and testing performed aimed to confirm this.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Appropriate functional characteristics equivalent to predicate devices | Demonstrated through in vivo clinical validation and bench testing to ensure functional equivalence in terms of optical means for oxygen saturation and pulse rate determination. The manufacturing process includes visual and validated functional testing. |
| Validation of sterilization procedures | Process validation testing was performed. |
| Validation of device packaging | Process validation testing was performed. |
| Safety | Not explicitly detailed beyond functional equivalence and process validation, but implied by demonstrating substantial equivalence to legally marketed devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: The document states "Representative samples of reprocessed pulse oximeter sensors were tested..." but does not specify the exact sample size used for the in vivo clinical validation.
- Data Provenance: The document does not specify the country of origin of the data. It's a submission to the FDA in the United States, implying the study was likely conducted to support US regulatory requirements, but the specific location of the clinical validation is not stated. The data is prospective in nature, as it describes a clinical validation study conducted to support the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth in the context of interpreting the in vivo clinical validation results, nor does it specify the number or qualifications of clinicians involved in the study itself. For pulse oximetry, "ground truth" for SpO2 is typically established through co-oximetry of arterial blood samples, rather than expert interpretation of images or other subjective data. Similarly, pulse rate ground truth would be from a reference ECG or direct physiological measurement.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method as typically understood for studies involving expert consensus (e.g., 2+1, 3+1). This type of adjudication is usually relevant for subjective interpretations (like medical imaging), which is not the primary focus of validating a pulse oximeter sensor. For objective measurements like SpO2 and pulse rate, the comparison would be between the device's readings and a gold standard measurement technique.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic devices that rely on human interpretation of information (e.g., radiologists reading images). The validation for a pulse oximeter sensor focuses on its objective measurement accuracy against a reference standard, not on how human readers interpret its output or how it assists human decision-making. Therefore, there is no mention of an effect size for human readers improving with or without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the in vivo clinical validation described is essentially a standalone performance assessment. The study investigates the performance of the reprocessed sensors themselves, measuring their capability to accurately determine SpO2 and pulse rate. While a human would be monitoring the oximeter, the "performance" being evaluated is that of the sensor (the device), not a human's interpretation of its output in a clinical scenario or an AI algorithm's contribution to that interpretation. The reprocessed sensor itself is the "algorithm only" device being tested in this context.
7. The Type of Ground Truth Used
For pulse oximeter sensors, the most common "gold standard" or ground truth for oxygen saturation (SpO2) in clinical validation is:
- Co-oximetry of arterial blood samples. This involves drawing arterial blood and analyzing it with a co-oximeter to precisely measure the arterial oxygen saturation (SaO2). The SpO2 readings from the pulse oximeter are then compared to these SaO2 values.
- For pulse rate, the ground truth would typically be derived from a simultaneously measured electrocardiogram (ECG) or another highly accurate physiological monitor.
The document states "an in vivo clinical validation" but does not explicitly detail the specific gold standard or ground truth methods used (e.g., co-oximetry). However, based on standard practices for pulse oximeter validation, these are the expected ground truth methodologies.
8. The Sample Size for the Training Set
The document does not mention or describe a "training set." This is expected because the reprocessed pulse oximeter sensors are not an AI/machine learning device that requires a training phase. Their function is based on established optical principles, and the validation aims to confirm that the reprocessing does not compromise these principles or the sensor's performance.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable to this type of device, this question is not relevant to the information provided in the document.
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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 Ahlborg11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3483Fax: 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 |
| PredicateDevices: | The SterilMed reprocessed pulse oximeter sensors are substantially equivalent to the MasimoLNCS® pulse oximeter sensors (K041815, K051212, & K060143) and the Masimo LNOP®pulse oximeter sensors (K031330). |
|---|---|
| DeviceDescription: | 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. Thereprocessed Masimo LNOP® Pulse Oximeter Sensors consist of a sensor (two LED's and aphotodiode), connector extension and connector, but do not feature an integrated cable. Bothconfigurations have a sensor that uses an optical means to determine the light absorption offunctional arterial hemoglobin. The sensor contains three optical components: two lightemitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a lightreceiver. The oximeter sensor is positioned so that the LED's and photodiode oppose oneanother across the tissue. The sensor is connected via cable to a pulse oximeter, which providescontinuous noninvasive, self-calibrated measurements of both oxygen saturation of functionalhemoglobin and pulse rate.Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and anyother related equipment are not included in the scope of this submission. |
| Intended Use: | The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasivearterial oxygen saturation (SpO2) and pulse rate monitoring. |
| Functional andSafety Testing: | Representative samples of reprocessed pulse oximeter sensors were tested to demonstrateappropriate functional characteristics by utilizing the necessary bench testing and an in vivoclinical validation. Process validation testing was performed to validate the sterilizationprocedures as well as device packaging. In addition, the manufacturing process includes visualand validated functional testing of all products produced. |
| Conclusion: | The reprocessed pulse oximeter sensors are substantially equivalent to the Masimo pulseoximeter sensors.This conclusion is based upon the devices' similarities in functional design (principles ofoperation), 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.
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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
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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
Page 1 of 1
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
§ 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).