(58 days)
Not Found
No
The description focuses on optical measurement and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is indicated for "trending of regional hemoglobin oxygen saturation," which is a diagnostic or monitoring function, not a therapeutic one.
Yes
The device determines a patient's current regional oxygen saturation level, which is a physiological parameter used to diagnose conditions related to oxygenation.
No
The device description explicitly states that the device is an "optical device" that uses "dual-wavelength light" and includes a "light source" and "photodiodes," indicating it is a hardware device, not software-only.
Based on the provided information, 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 performed outside of the living body.
- Device Function: The description clearly states that the device is an "optical device" that uses light to measure oxygen saturation through the skin surface. This is a non-invasive measurement performed on the living body.
- Intended Use: The intended use is for "continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor." This is a physiological measurement taken directly from the patient.
Therefore, because the device operates by taking measurements directly from the patient's body rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.
Product codes
NMD
Device Description
Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical
Anatomical Site
the forehead and other appropriate portions of the body; brain or in other tissue beneath the sensor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals
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)
Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082327, K080769, K051274, K001842, K971628, K960614
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
510(k) Summary
JUN - 8 2011
K 111007
In accordance with 21 CFR Part 807.92, this summary is submitted by:
Midwestern Reprocessing Center 3995 Fashion Square Blvd. Suite 11 Saginaw, MI 48603 Registration Number: Not yet applied
Date Prepared:
- Contact Person
Scott Senner Consultant Phone: (205) 314-3920 Fax: (205) 314-3959 Email: scott.senner@hygia.net
- Name of Device
Oximeter, Tissue Saturation Classification Name: Oximeter, Cerebral/Somatic Common Name: Trade or Midwestern Reprocessing Center (MRC) Reprocessed Proprietary Name: Cerebral-Somatic Oximetry Sensors
3. Predicate Device
Corresponding Somanetics oximetry sensors legally marketed under various 510(k) premarket notifications:
| Somanetics Corp. | K082327 |
|---|---|
| Somanetics Corp., | K080769 |
| Somanetics Corp. | K051274 |
| Somanetics Corp. | K001842 |
| Somanetics Corp. | K971628 |
| Somanetics Corp. | K960614 |
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4. Device Description
Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
5. Device Intended Use
Midwestern Reprocessing Center (MRC) Reprocessed CSS are intended to be used in the same manner as the predicate devices. They are designed to be applied to the forehead and other appropriate portions of the body to measure regional oxygenation saturation during surgery or other applications related to the use of anesthesia. The devices are intended to be used in hospitals.
6. Technological Characteristics
The Midwestern Reprocessing Center (MRC) CSS are identical to the original OEM devices in reference to the technological characteristics.
7. Performance Data
Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective.
8. Conclusion
Based on the assessment of functional testing, cleaning validation, and biocompatibility data, Midwestern Reprocessing Center (MRC) concludes that the Midwestern Reprocessing Center (MRC) Reprocessed CSS are substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 8 2011
Midwest Reprocessing Center LLC % Hygia Health Services, Inc. Mr. Scott Senner 434 Industrial Lane Birmingham, Alabama 35211
Re: K111007
Trade/Device Name: Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensor (CSS) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NMD Dated: April 07, 2011 Received: April 11. 2011
Dear Mr. Senner:
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.
3
Page 2 – Mr. Scott Senner
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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if Known): K | | 00 ]
Device Name: Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensor (CSS)
Indications For Use:
The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.
Yes Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
. A
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sig -- Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111007
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