(33 days)
Not Found
No
The summary describes a device using near-infrared technology to measure tissue oxygenation and does not mention AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a non-invasive monitoring system that measures approximated values, rather than providing therapy. It is used for "circulatory or perfusion examinations" and when there is "suspicion of compromised circulation" to estimate oxygen saturation, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is intended for "monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation," which falls under diagnostic purposes. It measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2) to aid in identifying compromised circulation.
No
The device description explicitly lists hardware components: "Monitor and Optical Cable and The InSpectra StO2 Sensor." This indicates it is not a software-only device.
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. They are used to examine these samples outside of the body.
- Device Function: The InSpectra St02 Tissue Oxygenation Monitor is described as a non-invasive monitoring system that measures tissue oxygen saturation in vivo (within the living body) using near-infrared technology applied to skeletal muscle.
- Lack of Sample Analysis: The description does not mention the collection or analysis of any biological samples from the patient.
Therefore, since the device operates non-invasively on the patient's body rather than analyzing samples 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 InSpectra StO2 Tissue Oxygenation Monitor is intended for use as a noninvasive 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.
Product codes (comma separated list FDA assigned to the subject device)
74MUD, MUD
Device Description
The InSpectra StO2 Tissue Oxygenation Monitor is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2) The InSpectra StO2 is composed of the following components:
Monitor and Optical Cable: The monitor contains an LCD screen, light detection circuitry, a microprocessor, cooling fan, optical cable, back-up battery, and internal software. The optical cable, permanently connected to the monitor, is a fiber optic light integration cable that contains one set of optical fibers to integrate wavelengths of light and 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. Light emitting diodes in the monitor are the light sources. 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.
The InSpectra StO2 Sensor. The single-use InSpectra StO2 Sensor, when connected to the optical cable, conducts the optical signal to the patient and back to the monitor. The sensor shield protects the measurement from ambient light interference, protects the optical fibers, and has an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Test Conclusions: Hutchinson Technology, Inc. has conducted extensive testing of the InSpectra StO2 Tissue Oxygenation Monitor 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): 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.
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
5. 510(k) Summary
JUL 1 2 2006
chinson
INOLOGY
ter Therapies
Hutchinson Technology Incorporated BioMeasurement Division 40 W Highland Park Dr Hutchinson, MN 55350-9784 USA 800 419 1007 320 587 1555 Fax BioM.USA@hti.htch.com
510(k) Summary
- Hutchinson Technology, Inc. Submitted by: 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 Phone: 320.587.1926 FAX: 320.587.1555
Summary Date: 9 June, 2006
- Proprietary Name: InSpectra StO2 Tissue Oxygenation Monitor
- Common Name: Tissue Oximeter
- CFR Reference: 21CFR§870.2700
- Class: 11
Product Code: 74MUD
Hutchinson Technology 510(k) Submission
Section 5 of 22 Company Confidential
Page 12 of 43 6/7/2006
1
InSpectra Tissue Spectrometer System, Model 325 Equivalent Marketed Device: (K053618)
Device Description: The InSpectra StO2 Tissue Oxygenation Monitor is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2) The InSpectra StO2 is composed of the following components:
Monitor and Optical Cable: The monitor contains an LCD screen, light detection circuitry, a microprocessor, cooling fan, optical cable, back-up battery, and internal software. The optical cable, permanently connected to the monitor, is a fiber optic light integration cable that contains one set of optical fibers to integrate wavelengths of light and 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. Light emitting diodes in the monitor are the light sources. 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.
The InSpectra StO2 Sensor. The single-use InSpectra StO2 Sensor, when connected to the optical cable, conducts the optical signal to the patient and back to the monitor. The sensor shield protects the measurement from ambient light interference, protects the optical fibers, and has an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.
Page 2 of 3
Hutchinson Technology 510(k) Submission
tion 5 of Company Confidential Page 13 of 43 6/7/2006
2
KOGI619
Hutchinson Technology Incorporated's InSpectra StO2 Intended Use: Tissue Oxygenation Monitor is intended for use as a noninvasive 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.
Technological Characteristics: The InSpectra StO2 Oxygenation Monitor 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 predicate device. the subject device utilizes an integral LCD display, battery backup system and transmits and receives each wavelength of light serially through the probe rather than simultaneously.
Substantial Equivalence
Rationale: Based on design, technological characteristics, intended use and extensive testing, Hutchinson Technology believes that the subject device is substantially equivalent to the predicate device currently marketed under 510(k) K053618.
Test Conclusions: Hutchinson Technology, Inc. has conducted extensive testing of the InSpectra StO2 Tissue Oxygenation Monitor to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications.
Hutchinson Technology 510(k) Submission
Company Confidential
Page 14 of 43 6/7/2006
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Hutchinson Technology c/o Thomas A. Dold Regulatory Affairs Manager 40 West Highland Park NE Hutchinson, MN 55350
Re: K061619
Trade Name: InSpectra StO2 Tissue Oxygenation Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue Saturation Oximeter Regulatory Class: II (two) Product Code: MUD Dated: June 9, 2006 Received: June 9. 2006
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.
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. Thomas A. Dold
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
B/fommerfor
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 Statement 4.
Indications for Use
510(k) Number (if known): _ Kob (6 (9
Device Name:
InSpectra St02 Tissue Oxygenation Monitor
Indications for Use:
Hutchinson Technology Incorporated's InSpectra St02 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 St02 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Khummer
(Division Sign-Off) (Division of Cardlovascular Devices 510(k) Number
Hutchinson Technology 510(k) Submission
Section 4 of 22 Company Confidential Page 11 of 43 6/7/2006