(154 days)
The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring. These devices are intended for prescription use.
The Midwestern Reprocessing Center reprocessed pulse oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
{
"acceptance_criteria_and_performance_table": null,
"study_summary": {
"sample_size_test_set": null,
"data_provenance": null,
"number_of_experts_ground_truth_test_set": null,
"qualifications_experts_ground_truth_test_set": null,
"adjudication_method_test_set": null,
"mrmc_comparative_effectiveness_study": false,
"effect_size_human_readers_mrmc": null,
"standalone_performance_study": true,
"type_of_ground_truth": "clinical testing and non-clinical functional testing (such as performance/functional testing, cleaning validation, and biocompatibility testing)",
"sample_size_training_set": null,
"ground_truth_establishment_training_set": null
},
"additional_notes": "The provided text indicates that 'Clinical Testing demonstrated that the reprocessed devices used with its compatible pulse oximeter perform as intended and are safe and effective' and 'Based on the assessment of clinical testing, non-clinical functional testing, cleaning validation, and biocompatibility testing performed, Midwestern Reprocessing Center concludes that the Midwestern Reprocessing Center reprocessed pulse Oximeter sensors are substantially equivalent to their predicate devices'. However, no specific acceptance criteria or quantitative performance metrics are provided to be presented in a table. The document focuses on demonstrating substantial equivalence through various tests rather than specific performance against numerical acceptance criteria. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text."
}
{0}------------------------------------------------
OCT - 7 2010
.
| 510K Summary | K101280 | |
|---|---|---|
| -- | -------------- | --------- |
| Submitter: | Midwestern Reprocessing Center, LLC3995 Fashion Square Blvd. Suite 11Saginaw, MI 48603Phone: (989) 583-4623Fax: (989) 583-4633 |
|---|---|
| Contact: | Jerome JamesConsultantPhone: (205) 314-3920Fax: (205) 314-3959Email: jerry.james@hygia.net |
| Date: | May 3, 2010 |
| Trade orProprietary Name: | Midwestern Reprocessing Center Reprocessed Sensors |
| Common Name: | Oximeter, Reprocessed |
| Classification: | 21 CFR 870-2700-OximeterNLF |
| Equivalent Device: | Corresponding Masimo LNCS, Nellcor OxiMax, and NellcorOxisensor II Pulse Oximeter Sensors and Hygia Health ServicesReprocessed Pulse Oximeter Sensors legally marketed under various510(k) premarket notifications. |
| Masimo 510(k) K041815Masimo 510(k) K051212Hygia Health Services 510(k) K080424Hygia Health Services 510(k) K041867Nellcor Puritan Bennett, Inc. 510(k) K012891Nellcor Puritan Bennett, Inc. 510(k) K863784Hygia Health Services 510(k) K012715 | |
| Device Description: | The Midwestern Reprocessing Center reprocessed pulse oximetersensors are non-invasive sensors used to provide continuous SpO2monitoring and pulse rate. The sensors contain a dual wavelengthlight emitting diode (LED), and an optical photodiode sensor whichare housed in a pad which attaches to the patient using adhesivematerial. The LED emits red and infrared light in alternate pulses, |
{1}------------------------------------------------
510K Summary of Safety & Effectiveness (Con't)
governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide Indications for Use: continuous SpO2 monitoring and pulse rate. Technological The predicate devices and the MRC reprocessed device contain dual Characteristics: wavelength LED and a photodiode. The LED and photodiode are encased in a pad which attaches to the patient using adhesive material. The sensors are connected to a cable and they terminate in a pin connector. Biocompatibility and performance/functional testing demonstrate that the devices are equivalent to their predicate devices Functional testing, cleaning validation, and biocompatibility testing Testing: demonstrates that the reprocessed devices perform as intended and are safe and effective. Clinical Testing demonstrated that the reprocessed devices used with its compatible pulse oximeter perform as intended and are safe and effective. Based on the assessment of clinical testing, non-clinical functional Conclusion: testing, cleaning validation, and biocompatibility testing performed, Midwestern Reprocessing Center concludes that the Midwestern Reprocessing Center reprocessed pulse Oximeter sensors are substantially equivalent to their predicate devices ..
3-3
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Midwest Reprocessing Center LLC C/O Mr. Jerome James Hygia Health Services, Incorporated 434 Industrial Lane Birmingham, Alabama 35211
Re: K101280
Trade/Device Name: MRC Reprocessed Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Reprocessed Oximeter Regulatory Class: II Product Code: NLF Dated: September 29, 2010 Received: October 1, 2010
Dear Mr. James:
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.
Image /page/2/Picture/9 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.
QCT - 7 2010
{3}------------------------------------------------
Page 2- Mr. James
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
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
Enclosure
{4}------------------------------------------------
Indications For Use
111280 OCT - 7 2010
| Applicant: | Midwestern Reprocessing Center, LLC (MRC) |
|---|---|
| 510 (k): | K |
| Device Name: | MRC Reprocessed Sensors |
Indications for Use:
The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring.
These devices are intended for prescription use.
L. Schattner
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K101280
§ 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).