(29 days)
Not Found
No
The document describes a device that uses near-infrared technology and optical fibers to measure tissue oxygen saturation. It mentions a microcontroller and internal software but provides no indication of AI or ML being used for data processing or interpretation. The description of the technology and components is purely hardware and basic software based.
No
The device is a monitoring system that measures oxygen saturation in tissue to diagnose circulatory issues; it does not provide treatment or therapy.
Yes
The device is described as a "non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2)" and is "indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation," which points to its use in diagnosing or aiding in the diagnosis of conditions related to tissue oxygenation.
No
The device description explicitly lists multiple hardware components including a monitor with an LCD screen, microcontroller, cooling fan, battery, data ports, a cable with light detection circuitry and optical fibers, and a single-use sensor with optical fibers and adhesive.
Based on the provided information, the Hutchinson Technology Incorporated's InSpectra™ StO2 Tissue Oxygenation Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue samples, outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The InSpectra™ StO2 Tissue Oxygenation Monitor is described as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). It uses near-infrared technology applied directly to the patient's skeletal muscle.
- No Specimen Handling: The description does not mention the collection or analysis of any biological specimens from the patient. The measurement is performed directly on the living tissue.
Therefore, because the device operates non-invasively and does not analyze specimens taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hutchinson Technology Incorporated's InSpectraTM StO2Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectraTM StO2Tissue Oxygenation Monitor is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
Product codes
74MUD
Device Description
The InSpectra" StO2 Tissue Oxygenation Monitor ("Model 650"), is a lightweight and transportable system that is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The Model 650 is composed of the following components:
InSpectra™ StO2 Tissue Oxygenation Monitor. The InSpectra™ StO2 Monitor contains an LCD screen, a microcontroller, cooling fan, back-up battery, and internal software. The monitor has an internal lithium ion battery and two external data ports. It is equipped with an adjustable C-clamp for attachment to an IV pole.
InSpectra™ StO2 Cable, which can be removed from the monitor and replaced, contains light detection circuitry, a microcontroller, one set of optical fibers to transmit light to the tissue, and a second set of optical fibers that receive light from the tissue and return it to a photosensitive detector and internal software.
The InSpectraTM StO2 Sensor. The single-use InSpectra™ StO2 Sensor, when connected to the InSpectra™ StO2 Cable, conducts the optical signal to the patient and back to the monitor. The sensor has a shield to protect the measurement from ambient light interference, a reinforced cable to protect the optical fibers, and an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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
K100915
510(k) Summary and Certification
1. Submitter's Name / Contact Person
| Submitted by: | Contact Person | APR 30 2010 |
|---|---|---|
| Hutchinson Technology, Inc. | Colin M McGraw | |
| BioMeasurement Division | Operations Manager | |
| 40 West Highland Park NE | Tel: (320) 587-1272 | |
| Hutchinson, MN 55350 | Fax: (320) 587-1671 |
Summary Date: March 30, 2010
| 2. General Information | |
|---|---|
| Proprietary Name | InSpectra™ StO₂ Tissue Oxygenation Monitor, Model 650 |
| Common / Usual Name | Tissue Oximeter |
| Classification Name | Oximeter |
| Class | II |
| Product Code | 74MUD |
| CFR Reference | 21CFR§870.2700 |
| Identification of Equivalent Devices | Hutchinson Technology, Inc. - InSpectra™ StO₂ Tissue |
| Oxygenation Monitor, Model 650 (K061619) | |
| Hutchinson Technology, Inc. - InSpectra™ Tissue Spectrometer | |
| System, Model 325 (K053618) |
3. Device Description
The InSpectra" StO2 Tissue Oxygenation Monitor ("Model 650"), is a lightweight and transportable system that is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The Model 650 is composed of the following components:
InSpectra™ StO2 Tissue Oxygenation Monitor. The InSpectra™ StO2 Monitor contains an LCD screen, a microcontroller, cooling fan, back-up battery, and internal software. The monitor has an internal lithium ion battery and two external data ports. It is equipped with an adjustable C-clamp for attachment to an IV pole.
InSpectra™ StO2 Cable, which can be removed from the monitor and replaced, contains light detection circuitry, a microcontroller, one set of optical fibers to transmit light to the tissue, and a second set of optical fibers that receive light from the tissue and return it to a photosensitive detector and internal software.
1
The InSpectraTM StO2 Sensor. The single-use InSpectra™ StO2 Sensor, when connected to the InSpectra™ StO2 Cable, conducts the optical signal to the patient and back to the monitor. The sensor has a shield to protect the measurement from ambient light interference, a reinforced cable to protect the optical fibers, and an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.
4. Intended Use
Hutchinson Technology Incorporated's InSpectra"" StO2Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectraTM StO2Tissue Oxygenation Monitor is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
5. Technological Characteristics
The InSpectraThe StO2Tissue Oxygenation Monitor has the same basic technological characteristics as the predicate device(s) based on near-infrared technology. The modified device is equivalent in terms of design, functionality, principles of operation, performance specifications and intended use. The labeling clarifications raise no new technological issues.
6. Substantial Equivalence Rationale
Based on design, technological characteristics, and intended use, HTI believes that the Model 650 with labeling clarifications is substantially equivalent to the predicate devices currently marketed under 510(k) K061619 and K053618.
7. Test Conclusions
HTI conducted a risk analysis to support the labeling clarification and concluded that no new testing was required. Based on information supplied in the 510(k), we conclude that the subject device with labeling clarifications is safe, effective, and substantially equivalent to the predicate device(s).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 30 2010
Hutchinson Technology, Inc. c/o Mr. Colin McGraw Biomeasurement Division 40 West Highland Park Dr., NE Hutchinson, MN 55350
Re: K100915
· Device Name: InSpectra™ StO2 Tissue Oxygenation Monitor, Model 650 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (Two) Product Code: MUD Dated: March 30, 2010 Received: April 1, 2010
Dear Mr. McGraw:
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. Colin McGraw
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k): InSpectra StO2 Tissue Oxygenation Monitor – Model 650 Hutchinson Technology, Inc
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): __
Device Name:
InSpectraTM StO2 Tissue Oxygenation Monitor, Model 650
Indications for Use:
Hutchinson Technology Incorporated's InSpectra™ StO2 Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectra™ StO2 Tissue Oxygenation Monitor is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Wanda
vascular Devi
510(k) Number K000715