(58 days)
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.
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.
The provided document is a 510(k) Summary for a reprocessed medical device, the Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study with acceptance criteria and clinical performance goals typical of novel devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the traditional sense of a new medical device approval. The submission relies on establishing that the reprocessed device performs identically and safely as the original predicate devices.
However, I can extract information related to the functional testing and the basis for the equivalence claim, which is the closest approximation to "performance data" in this context.
Here's a breakdown of what is and isn't present in the document:
1. Table of acceptance criteria and reported device performance:
* Not explicitly provided in the form of a table with specific quantitative acceptance criteria or numerical performance metrics.
* The document states: "Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective." This implies the "acceptance criteria" were that the reprocessed sensors demonstrated performance equivalent to the original OEM devices ("perform as intended").
2. Sample size used for the test set and the data provenance:
* Not specified. The document mentions "functional testing," "cleaning validation," and "biocompatibility data" without details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not mentioned. Since this is a reprocessing of an existing device, the "ground truth" performance is generally established by the original device's cleared performance. This submission focuses on ensuring the reprocessing process does not degrade that performance. There's no mention of experts establishing ground truth for a test set for this reprocessed device.
4. Adjudication method for the test set:
* Not applicable/Not mentioned. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
* No. This type of study is not relevant for a reprocessed oximetry sensor that claims identical technological characteristics and intended use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable directly. Oximetry sensors are hardware devices. The "algorithm" here is the underlying principle of dual-wavelength light measurement, which is identical to the OEM device. The focus is on the hardware's functionality after reprocessing, not on a standalone algorithmic performance test.
7. The type of ground truth used:
* Implicitly, the ground truth is the performance characteristics of the original, legally marketed OEM Somanetics oximetry sensors. The claim is that the reprocessed sensors are "identical to the original OEM devices in reference to the technological characteristics" and "perform as intended" (i.e., like the OEM).
8. The sample size for the training set:
* Not applicable/Not mentioned. There is no "training set" in the context of this device. It's a reprocessed medical device, not an AI or machine learning model.
9. How the ground truth for the training set was established:
* Not applicable/Not mentioned. See point 8.
Summary of what can be inferred about "acceptance criteria" and "study" from the document:
-
Acceptance Criteria (Implied): The reprocessed sensors must:
- Perform identically to the original OEM devices in terms of technological characteristics and functional output (regional oxygen saturation measurements).
- Be safe for patient use (demonstrated by biocompatibility data).
- Be effectively cleaned and sterilized (demonstrated by cleaning validation).
- Meet the same intended use as the predicate devices.
-
"Study" (referred to as Performance Data):
- The study comprised "Functional testing, cleaning validation, and biocompatibility data."
- The purpose of this testing was to demonstrate that the reprocessed sensors meet the implied acceptance criteria (perform as intended, safe, effective).
- No details on methodologies, quantitative results, sample sizes, or specific metrics are provided in this summary. The conclusion simply states that this data demonstrates the required performance.
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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.
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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
Page 1 of 1
§ 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).