(69 days)
Not Found
No
The document describes a reprocessed optical sensor that measures oxygen saturation using dual-wavelength light and sends the signal to a monitor for calculation. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as an "adjunct trend monitor" that measures oxygen saturation. It does not provide any treatment or therapy.
Yes
The device provides a "trend monitor of regional hemoglobin oxygen saturation," which is a measurement of a physiological parameter used to inform and monitor a patient's condition. Although the OEM suggests it shouldn't be the sole basis for diagnosis or therapy, devices that measure physiological parameters for healthcare purposes often fall under the definition of diagnostic devices, even if they are intended as an adjunct.
No
The device is described as an "optical device" that uses "dual-wavelength light" and "photodiodes" to measure reflected light. This clearly indicates a hardware component (the sensor itself) is integral to the device's function.
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.
- Device Function: The description clearly states that the Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors are optical devices that use light to measure regional oxygen saturation noninvasively through the skin.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body using light.
Therefore, since the device operates noninvasively and does not analyze samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.
The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.
Product codes (comma separated list FDA assigned to the subject device)
NMD
Device Description
The Hygia Health Services 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
Not Found
Anatomical Site
Forehead and other appropriate portions of the body; brain or in other tissue beneath the sensor.
Indicated Patient Age Range
Pediatric patients weighing 40 kg
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K082327, K080769, K051274, K001842, K971628, K960614
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY - 4 2010
K 100523
In accordance with 21 CFR Part 807.92, this summary is submitted by:
Hygia Health Services, Inc. 434 Industrial Lane Birmingham, Alabama 35211 Phone: (205) 314-3920 Fax: (205) 314-3959
Date Prepared: February 23, 2010
- Contact Person
Mr. Lake Trechsel R&D Engineer Phone: (205) 314-3920 Fax: (205) 314-3959 Email: lake.trechsel(@hygia.net
- Name of Device
Classification Name: Oximeter, Tissue Saturation Common Name: Oximeter, Cerebral/Somatic Trade or Proprietary Name: Hygia Health Services Reprocessed 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 |
1
4. Device Description
The Hygia Health Services 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
The Hygia Health Services 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. Indications For Use
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.
The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.
7. Technological Characteristics
The Hygia Health Services CSS are identical to the original OEM devices in reference to the technological characteristics.
8. Performance Data
Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective.
9. Conclusion
Based on the assessment of functional testing, cleaning validation, and biocompatibility data, Hygia Health Services concludes that the Hygia Health Services Reprocessed CSS are substantially equivalent to the predicate devices.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAT - 4 2010
Hygia Health Services, Inc. % Mr. Lake Trechsel R & D Engineer 434 Industrial Lane Birmingham, Alabama 35211
Re: K100523
Trade/Device Name: Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensor (CSS) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NMD Dated: February 23, 2010 Received: February 25, 2010
Dear Mr. Trechsel:
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.
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
3
Page 2 - Mr. Lake Trechsel
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/CDRHQffices/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 yours,
Mark M. Millers
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if Known): K 100 523
Device Name:
Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensor (CSS)
Indications For Use:
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.
The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or noflow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.
Prescription Use Yes (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nuth Rp Qala for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100523
Page 1 of 1
5
| OEM
Catalog # | Hygia
Catalog # | Product
Description | Intended
Oximeter | Maximum
of Reprocessing
Cycles |
|------------------|--------------------|-----------------------------------------------|---------------------------|----------------------------------------|
| SAFB-SM | HHS-SAFB-
SM | Adult Cerebral-Somatic
Oximetry Sensor | Somanetics
INVOS 5100C | 2 |
| SPFB-
USA | HHS-SPFB-
USA | Pediatric Cerebral-Somatic
Oximetry Sensor | Somanetics
INVOS 5100C | 2 |
PRODUCT SUBMISSION CHART
Neil R.P. Gade, Sr. mem
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, Division of Surgers and Restorative Devices
510(k) Number K100523
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