(17 days)
No
The document describes a tissue spectrometer system that measures hemoglobin oxygen saturation using optical methods. There is no mention of AI or ML in the intended use, device description, or performance studies. The software described is for data display and trending, not for complex analysis or pattern recognition typically associated with AI/ML.
No.
The device is a monitoring system that measures oxygen saturation in tissue. It is not described as providing any form of therapy or treatment.
Yes
The device is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue. It is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation. While it measures a physiologic parameter, this measurement is used to assess and understand a patient's condition, which aligns with the definition of a diagnostic device. The statement "The value of these measurements in disease states has not been demonstrated" indicates it's used for monitoring, which can be part of a diagnostic process, even if it doesn't directly diagnose a disease.
No
The device description clearly lists multiple hardware components including a monitor, patient cable, patient interface, printer, optical converter, and set-up accessories, 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) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue samples, outside of the body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.
- InSpectra™ Function: The InSpectra™ Tissue Spectrometer System is described as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). It does this by transmitting light into the tissue and analyzing the reflected light.
- No Specimen Collection: The system does not involve the collection or analysis of any specimens taken from the patient's body. It interacts directly with the tissue in a non-invasive manner.
Therefore, because the InSpectra™ system operates by directly interacting with the patient's tissue without requiring the removal of a specimen, it falls outside the definition of an In Vitro Diagnostic device. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325. is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.
The value of these measurements in disease states has not been demonstrated.
Product codes (comma separated list FDA assigned to the subject device)
74 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;
- 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.
- 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal muscle, upper extremity, shoulder, or lower extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Hutchinson Technology, Inc. has conducted extensive testing of the new Inspectra™ Software to verify adherence to requirements. All test results verify that the software meets or exceeds all predetermined specifications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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.
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
Appendix C-1
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: | Thomas A. Dold
Regulatory Affairs Manager
Hutchinson Technology, Inc.
Phone: 320.587.1435
Fax: 320.587.1555 |
| Summary Date: | November 18, 2002 |
| Proprietary Name: | InSpectra™ Tissue Spectrometer System, Model 325 |
| Common Name: | Tissue Spectrometer |
| CFR Reference: | 21CFR§870.2700 |
| Class: | ll |
| Product Code: | 74 MUD |
| Equivalent marketed device: | InSpectra™ Tissue Spectrometer System, Model 325, (K012759) |
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.
Hutchinson Technology, Inc.
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;
- 미 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.
- 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:
Technology Incorporated's InSpectra™ Hutchinson Tissue Spectrometer System, Model 325. is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.
The value of these measurements in disease states has not been demonstrated.
2
Technological Characteristics:
The modified device has the same basic technological characteristics as the predicate device. The modification includes:
New software provided via compact disk that can be downloaded onto a personal computer. The software enables the user to view, store and chart the output measurement of the Inspectra System. The software does not alter the information already displayed on the predicate device. There is a one-way communication from the monitor to the user PC.
Substantial Equivalence Rationale:
HTI believes that the modified device is substantially equivalent to the unmodified predicate device. The unmodified device already provides the capability to display information through its output device (Optolink) to a thermal printer.
The predicate to our unmodified Inspectra device was the Hutchinson Technology, Inc. Biospectrometer NB Model 1111, FDA control # K963903. The Biospectrometer used a laptop personal computer for the primary display of StO2 and other output information including date and time, and allowed the data to be marked, saved and charted.
Test Conclusions:
Hutchinson Technology, Inc. has conducted extensive testing of the new Inspectra™ Software to verify adherence to requirements. All test results verify that the software meets or exceeds all predetermined specifications.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the image.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas A. Dold Regulatory Affairs Manager Hutchison Technology, Incorporated BioMeasurement Division 40 West Highland Park Drive NE Hutchinson, Minnesota 55350
Re: K023938
Trade/Device Name: InSprectra™ Tissue Spectrometer System, Model 325 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: November 18, 2002 Received: November 26, 2002
Dear Mr. Dold:
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.
4
Page 2 - Mr. Thomas A. Dold
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594- 4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/odrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
Indications for Use Statement
Device Name:
InSprectra™ Tissue Spectrometer System, Model 325
Indications For Use:
Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).
The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.
The value of these measurements in disease states has not been demonstrated.
DHWatehausen
Division Sign-Off) Division of Anesthesiology General Hospital. Infection Control, Dental Devices
OR
510(k) Number: KC
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Hutchinson Technology, Inc.