(234 days)
Not Found
No
The description focuses on traditional spectroscopy and signal processing techniques ("differential optical diffuse reflectance spectroscopy and fitting for background scattering") and does not mention AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an "adjunct monitor" and explicitly states it "should not be used as the sole basis for diagnosis or therapy," indicating it provides information for diagnosis and therapy but does not provide therapy itself.
Yes
Explanation: The device is described as an "adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%)" and provides measurements that can aid in identifying "reduced-flow and no-flow ischemic states." While it explicitly states "should not be used as the sole basis for diagnosis," its function is to provide physiological measurements that contribute to diagnostic assessment.
No
The device description explicitly states that the complete system consists of a disposable sensor probe connected to a software-driven electronic monitor. This indicates the presence of hardware components (sensor probe, electronic monitor) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed outside of the living body (in vitro).
- Spectros T-Stat™ 303 Function: The Spectros T-Stat™ 303 Microvascular Tissue Oximeter measures the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces. This is a measurement taken directly from the living body (in vivo), not from a specimen removed from the body.
- Method: The device uses Visible Light Spectroscopy (VLS) applied to the tissue itself, not to a sample of blood or other bodily fluid.
Therefore, based on its intended use and how it functions, the Spectros T-Stat™ 303 is an in vivo diagnostic or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectros T-Stat™ 303 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states.
The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.
Product codes
MUD
Device Description
The Spectros T-Stat™ 303 Tissue Oximeter is a broadband, multiwavelength, Visible Light Spectroscopy (VLS) monitoring system for measuring the saturation of hemoglobin with oxygen in the microvascular tissue spaces (StQ2%).
The complete system consists of a disposable sensor probe connected to a software-driven electronic monitor. Data collection, analysis, and display functions are provided by the monitor. Illumination of the tissue is provided by a visible light source in the sensor probe placed near, on, or into the target tissue to be studied. Reflected light is captured and returned to the monitor via a detachable connection at the monitor end of the patient probe. StO2% is estimated using differential optical diffuse reflectance spectroscopy and fitting for background scattering over a range of reflected visible wavelengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible Light Spectroscopy (VLS)
Anatomical Site
microvascular tissue spaces
Indicated Patient Age Range
infants, children, or adults
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)
In studies of T-StatTM:
- T-Stat™ accurately measured hemoglobin spectra and desaturation binding curves in peer-reviewed in vitro studies.
- T-Stat™ StO2% determined using VLS was unbiased in comparison to StO2% determined using NIRS predicates (StO2% Bias = - 1% ± 5%, p=N.S.), but VLS demonstrated significantly tighter ranges of normal in peer-reviewed animal and human studies (VLS normal range 62-75% vs. NIRS reported at 48-88%, p
§ 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
Spectros Corporation
NOV - 5 2004 4370 Alpine Road #108, Portola Valley CA 94028-7927 Phone 650.851.4040 Fax 650.851.4099
David A. Benaron, M.D. e-mail: dbenaron@spectros.com
Section 40 - 510(k) Summary
[This section supersedes and replaces Section 29 of the Application]
I. Applicant Information
| A. Date of Summary: | October 28, 2004 |
|---|---|
| B. Manufacturer | Spectros Corporation |
| 4370 Alpine Road, Suite 108 | |
| Portola Valley CA 94028 | |
| C. Official Contact: | David A. Benaron, MD |
| CEO and President | |
| Spectros Corporation | |
| Suite 108 | |
| 4370 Alpine Road | |
| Portola Valley CA 94028 | |
| D. Contact Info: | Phone: (650) 851-4040 |
| Fax: (650) 851-4099 | |
| E-mail: dbenaron@spectros.com |
II. Device Information
- A. Proprietary Name: T-Stat™ 303 Microvascular Tissue Oximeter B. Common Name: Tissue Oximeter C. Classification Name: Oximeter, Tissue (870.2700) D. Product Code: MUD E. Regulatory Class: Class II F. Panel: Cardiovascular
1
III. Predicate Devices
The following devices are cited as predicates:
Exhibit 40-1 Predicate Tissue Oximeter Devices Summaries
| # | Predicate Feature | Manufacturer | Device | K-Number |
|---|---|---|---|---|
| 1. | Tissue Oximeter | Hutchinson | InSpectra 325 | K023938 |
| 2. | Tissue Oximeter | Somanetics | Invos 5100 | K001842 |
| 3. | Relative Hemoglobin | Nellcor | N-395 | K991823 |
| 4. | Site-Specific: Oral | Olympus | XENF-DP | K011869 |
| 5. | Site-Specific: Colon | Olympus | LF-DP | K002231 |
| 6. | Site-Specific: Endo | Olympus | Thoracoscope / | |
| Laparoscope | K915857 |
IV. General Description
The Spectros T-Stat™ 303 Tissue Oximeter is a broadband, multiwavelength, Visible Light Spectroscopy (VLS) monitoring system for measuring the saturation of hemoglobin with oxygen in the microvascular tissue spaces (StQ2%).
The complete system consists of a disposable sensor probe connected to a software-driven electronic monitor. Data collection, analysis, and display functions are provided by the monitor. Illumination of the tissue is provided by a visible light source in the sensor probe placed near, on, or into the target tissue to be studied. Reflected light is captured and returned to the monitor via a detachable connection at the monitor end of the patient probe. StO2% is estimated using differential optical diffuse reflectance spectroscopy and fitting for background scattering over a range of reflected visible wavelengths.
V. Indications
The Spectros T-Stat™ 303 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states.
2
The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.
KO40684
6.315
VI. In Vitro and In Vivo Test Data
In studies of T-StatTM:
- T-Stat™ accurately measured hemoglobin spectra and desaturation binding curves in peer-reviewed in vitro studies.
- T-Stat™ StO2% determined using VLS was unbiased in comparison to StO2% determined using NIRS predicates (StO2% Bias = - 1% ± 5%, p=N.S.), but VLS demonstrated significantly tighter ranges of normal in peer-reviewed animal and human studies (VLS normal range 62-75% vs. NIRS reported at 48-88%, p File Source and Version: T-Stat 510(k) Ch 40 -- Summary (Rev 04.10.28a).doc
[End of Section 40]
[Remainder of This Page Blank]
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, hope, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
Spectros Corporation c/o David A. Benaron, M.D. CEO & President 4370 Alpine Road, Suite 108 Portola Valley, CA 94028
Re: K040684
K04064
Trade Name: Spectros T-Stat™ 303 Microvascular Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: MUD Dated: July 30, 2004 Received: August 9, 2004
Dear Dr. Benaron:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally manced product and Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chactinence with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval as provisions of the Act The and Cosmetic Act (Act) that do not require upprovine spension provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the genirents for annual registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the 7tet merade requirements of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis class a control states on the news can a may be subject to such additional controlis. Existing may on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition be lound in the Code of I ederal Regarders on the Federal Register.
6
Page 2 - Dr. David Benaron
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) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
7
Indications for Use
510(k) Number (if known): K 040684
Device Name: Spectros T-Stat™ 303 Microvascular Tissue Oximeter
Indications For Use: Spectros T-Stat™ 303 Microvascular The Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states.
The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.
Prescription Use XXX (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)
Bhimlame
(Division Sign-Off) Division of Cardiovascular Devices neloux 4 510(k) Number
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