(164 days)
The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
SterilMed's reprocessed pulse oximeter sensors consist of a sensor, integrated sensor cable, and a sensor plug which connects to the Pulse Oximeter. These devices feature 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.
The provided text describes a 510(k) summary for SterilMed, Inc.'s Reprocessed Pulse Oximeter Sensors. It details functional and safety testing, non-clinical tests, and clinical studies conducted to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Although specific numerical acceptance criteria (e.g., +/- 2% accuracy) are not explicitly stated in the document for SpO2 and pulse rate accuracy, the document indicates that the reprocessed sensors demonstrated "appropriate functional characteristics" and "SpO2 accuracy" in both bench and in vivo clinical validations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (Normal Perfusion) | Validated by bench testing and in vivo clinical studies |
| SpO2 Accuracy (Low Perfusion) | Validated by bench testing |
| Pulse Rate Accuracy (Normal Perfusion) | Validated by bench testing and in vivo clinical studies |
| Pulse Rate Accuracy (Low Perfusion) | Validated by bench testing |
| Structural Integrity after Reprocessing | Validated by physical tests |
| Sterilization Validation (ISO 11135, USP <71>) | Successfully validated |
| Ethylene Oxide Residual Testing (ISO 10993-7) | Successfully tested |
| Bioburden Testing | Successfully tested |
| Packaging Validation (ASTM D4169, ASTM F88) | Successfully validated |
| Shelf Life Validation (ASTM 1980-99) | Successfully validated |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in vivo clinical studies were conducted on both adult volunteers and neonatal subjects" but does not specify the sample size for these clinical studies. It also does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given the nature of a 510(k) submission for a reprocessed medical device, clinical studies are typically prospective to demonstrate the safety and efficacy of the reprocessed version.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical studies. For pulse oximetry, the ground truth for SpO2 and pulse rate is typically established through a co-oximeter analyzing arterial blood samples for SpO2, and an ECG or manual pulse check for pulse rate. Expertise would be required for proper blood gas analysis and clinical assessment, but the document does not elaborate on this.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set in the clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging devices) where human readers interpret output. Pulse oximeters provide direct quantitative measurements, so an MRMC study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in the context of a pulse oximeter sensor, its performance is inherently "standalone" in how it acquires and transmits raw physiological data (light absorption). The "algorithm" here refers to the internal processing within the oximeter (which is not part of this 510(k) submission) to convert light absorption into SpO2 and pulse rate. The tests described (SpO2 and pulse rate accuracy using a simulated tester, and in vivo clinical studies) are evaluations of the sensor's ability to accurately provide these measurements.
7. The Type of Ground Truth Used
The ground truth for the clinical studies would have been established using reference standard methods for measuring SpO2 and pulse rate. For SpO2, this typically involves arterial blood gas analysis (co-oximetry). For pulse rate, this could be from electrocardiography (ECG) or other accurate physiological monitoring. The document states "in vivo clinical studies were conducted... to demonstrate SpO2 accuracy," implying comparison against such a reference.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of device performance evaluation. For a reprocessed pulse oximeter sensor, there isn't typically a "training set" in the machine learning sense. The "training" here refers to the development and validation of the reprocessing protocol itself, and the document discusses "process validation testing" for sterilization and "validation of functional performance" for the reprocessed devices. However, no specific sample size for this developmental "training" is provided.
9. How the Ground Truth for the Training Set Was Established
Given that a "training set" in the machine learning sense is not applicable, the concept of establishing ground truth for it is also not applicable here. Instead, the ground truth for validating the reprocessing process is established by demonstrating that the reprocessed sensors meet the same functional and safety requirements as new devices. This is achieved through the various non-clinical tests (sterilization, bioburden, packaging, shelf life) and the functional bench testing and clinical studies mentioned.
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FEB 1 8 2011
II. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Garrett Ahlborg11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3483Fax: 763-488-2051 |
| Date Prepared: | September 3, 2010 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Name: | Oximeter, ReprocessedClassification Number: Class II, 21 CFR 870.2700 |
| Product Code: | NLE |
| Predicate Devices: | The SterilMed reprocessed pulse oximeter sensors are substantially equivalent to the Masimo LNCS® pulse oximeter sensors (K041815, K051212, & K060143). |
|---|---|
| Device Description: | SterilMed's reprocessed pulse oximeter sensors consist of a sensor, integrated sensor cable, and a sensor plug which connects to the Pulse Oximeter. These devices feature 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 in vivo clinical validations. 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. |
| Summary of Non-clinical Tests Conducted: | Specific non-clinical tests included: sterilization validation (ISO 11135, USP <71>), ethylene oxide residual testing (ISO 10993-7), bioburden testing, packaging validation (ASTM D4169, ASTM F88) and shelf life validation (ASTM 1980-99). In addition, validation of functional performance (bench testing) was performed and included the following tests: SpO2 and pulse rate accuracy (normal and low perfusion) using a simulated tester, SpO2 and pulse rate accuracy under varying environmental conditions, and physical tests to verify structural integrity after reprocessing. |
| Summary of Clinical Tests Conducted: | In vivo clinical studies were conducted on both adult volunteers and neonatal subjects to demonstrate SpO2 accuracy of the reprocessed sensors. |
| 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 performance and design (principles of operation), materials, clinical validation results, indications for use and methods of construction. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Garrett Ahlborg Regulatory Affairs Manager SterilMed, Incorporated 11400 7310 Avenue North Suite 100 Maple Grove, Minnesota 55369
FEB 18 201
Re: K102560
Trade/Device Name: Reprocessed Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: February 14, 2011 Received: February 15, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
Enclosure
Please be advised that FDA is 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/0 description: The image shows the logo for "SterilMed, INC." in a bold, sans-serif font. Below the company name, in a smaller font, are the words "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The text is black and the background is white.
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)
Aum Cottle 2/18/11
(Division Sign-Off)
(Divisi (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Devices
510(k) Number: K112568
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).