(42 days)
Not Found
No
The document describes a tissue spectrometer system that measures hemoglobin oxygen saturation. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The core technology appears to be based on spectroscopy.
No
The device is described as a "non-invasive monitoring system" and is "intended for use in monitoring patients." It measures a value and reflects perfusion, but it does not treat or directly intervene in a therapeutic manner.
Yes
The device measures a physiological parameter (percent hemoglobin oxygen saturation in tissue) to monitor patients during circulatory or perfusion examinations, which are diagnostic activities.
No
The device description explicitly lists multiple hardware components (Monitor, Patient Cable, Patient Interface, Printer, Optical Converter) in addition to the software.
Based on the provided information, the Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro - "in glass"). This device is described as a "non-invasive monitoring system" that measures tissue oxygen saturation in vivo (within the living body).
- The device description and intended use clearly indicate it's a monitoring system applied directly to the patient's tissue. It measures a physiological parameter within the body, not a substance extracted from the body.
Therefore, the InSpectra™ Tissue Spectrometer System, Model 325, falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is intended for use as a noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectra™ Tissue Spectrometer 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
MUD
Device Description
The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is composed of the following components.
- . Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, and associated electronics. It serves as the analytical and display instrument.
- . Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient;
- 비 Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements.
- Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes.
- 사 Optical Converter: An "Optolink™" RS232 Optical Converter -Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal.
- . Set-up Accessories: A "System Check™" module with both "High" and "Low" "Single Point References" are provided to verify proper system operation.
- . Inspectra System Software: Software provided on a compact disk for use on a personal computer that displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Skeletal muscle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Hutchinson Technology, Inc. has conducted extensive testing of the modified device to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
SMDA Summary -- Special 510(k) Modified Device
| Submitted by: | Hutchinson Technology, Inc.
BioMeasurement Division
40 West Highland Park NE
Hutchinson, MN 55350
Phone: 320.587.1926
Fax: 320.587.1555 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph P. Ortner
Manager, Product Research
Hutchinson Technology, Inc.
Phone: 320.587.1435
Fax: 320.587.1555 |
| Summary Date: | December 23, 2005 |
| Proprietary Name: | InSpectra™ Tissue Spectrometer System, Model 325 |
| Common Name: | Tissue Spectrometer |
| CFR Reference: | 21CFR§870.2700 |
| Class: | II |
| Product Code: | 74 MUD |
| Equivalent marketed device: | InSpectra™ Tissue Spectrometer System, Model 325, (K042020) |
| Device Description: | The InSpectra™ is designed to estimate the percent oxygen
saturation of hemoglobin in a volume of tissue (StO2). This value is a
reflection of localized perfusion of that tissue.
The InSpectra™ is composed of the following components. |
1
- . Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, and associated electronics. It serves as the analytical and display instrument.
- . Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient;
- 비 Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements.
- Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes.
- 사 Optical Converter: An "Optolink™" RS232 Optical Converter -Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal.
- . Set-up Accessories: A "System Check™" module with both "High" and "Low" "Single Point References" are provided to verify proper system operation.
- . Inspectra System Software: Software provided on a compact disk for use on a personal computer that displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file.
Intended Use:
Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is intended for use as a noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectra™ Tissue Spectrometer is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
Technological Characteristics:
The modified device has the same basic technological characteristics as the predicate device based on near-infrared technology. The modified device is equivalent in terms of design, functionality, principles of operation, performance specifications and intended use. When compared to the unmodified device, the modified device raises no new technological issues.
Hutchinson Technology, Inc.
2
Substantial Equivalence Rationale:
Based on design, technological characteristics, intended use, and extensive testing, HTI believes that the modified device is substantially equivalent to the unmodified predicate device currently marketed under 510(k) #042020.
The modified device raises no new issues of safety or effectiveness.
Test Conclusions:
Hutchinson Technology, Inc. has conducted extensive testing of the modified device to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications.
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is presented in black and white.
FEB 8 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hutchinson Technology, Inc. BioMeasurement Division c/o Mr. Joseph P. Ortner Manager, Product Research 40 West Highland Park NE Hutchinson, MN 55350
Re: K053618
Trade Name: InSpectra™ Tissue Spectrometer System, Model 325 Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue Saturation Oximeter Regulatory Class: Class II (two) Product Code: MUD Dated: December 23, 2005 Received: December 28, 2005
Dear Mr. Ortner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
4
Page 2 – Mr. Joseph P. Ortner
or any Federal statutes and regulations administered by other Federal agencies. You must of any Federal statutes and regulations adminitions on the limited to: registration and listing (21 compry with an the Act 3 requirements) memailing practice requirements as sen CFR Part 807), labeling (21 CFR Part 807), good imagation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section (Section ) our device as described in your Section 510(K) I his letter will anow you to begin manceang your article equivalence of your device to a legally premaired notincation: "The PDF mising of easification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for your accell 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Complanes at (21 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = Milsoraning of telefono to premation on your responsibilities under the Act from the Division of Small other general Information on your responsibilities and its toll-free number (800) 638-204) or Manufacturers, Internet and Octisenher : http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K053618
Device Name: InSpectra™ Tissue Spectrometer System, Model 325
Indications for Use:
Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, 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™ Tissue Spectrometer 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 AND/OR (Part 2) CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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