(205 days)
Not Found
No
The summary describes a device using Near-Infrared Spectroscopy (NIRS) to measure tissue oxygen saturation. There is no mention of AI, ML, or any algorithms that would typically be associated with these technologies for data processing or interpretation. The performance studies focus on comparing the device's readings to a predicate device and phantom, not on evaluating an AI/ML model's performance.
No
The device is described as a non-invasive tissue oximeter intended to estimate percent oxygen saturation. Its purpose is for monitoring and providing information on tissue oxygenation and hemodynamics, not for directly treating a condition or disease. The text explicitly states, "The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy."
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue" and is "indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation." Additionally, the "Device Description" section explicitly calls Near-Infrared Spectroscopy (NIRS) a "noninvasive diagnostic tool" in the context of this device's function. Although it also states it should not be used as the sole basis for diagnosis, its purpose is to provide information for "monitoring patients" and "examinations," which are diagnostic functions.
No
The device description explicitly lists several hardware components, including the OxiplexTS200 Unit with sensors, power cable, accessories, and optional modules. This indicates it is a hardware device with accompanying software, not a software-only medical device.
Based on the provided information, the OxiplexTS200 tissue oximeter 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.
- OxiplexTS200 Function: The OxiplexTS200 is described as a non-invasive device that estimates oxygen saturation in a volume of tissue using Near-Infrared Spectroscopy (NIRS). This means it takes measurements directly on the patient's body without requiring a sample to be removed.
Therefore, because the OxiplexTS200 operates non-invasively and does not analyze specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is a medical device used for in vivo (within the living body) monitoring.
N/A
Intended Use / Indications for Use
The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities.
The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.
Product codes
MUD
Device Description
The ISS Medical non-invasive tissue oximeter, OxiplexTS200, is intended for use as an adjunct monitor of regional oxy- and deoxy-hemoglobin concentration, and of hemoglobin oxygen saturation of blood in tissues during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
The OxiplexTS200 is a device for use in spot-checking as well as continuous monitoring of patients in healthcare facilities. It is not intended for home use or to be used for "out of hospital" transport.
The OxiplexTS200 is an instrument system and includes the following components:
- OxiplexTS200 Unit with two sensors and phantom block ●
- Power cable ●
- Accessories (straps for sensors; strap for phantom block; dark cloth) ●
- ISS flash memory
- Operation Manual
- Analoq Input module with USB cable (optional)
- . Analog Output module with USB cable (optional)
The OxiplexTS200 uses near-Infrared Spectroscopy (NIRS), a noninvasive diagnostic tool, to offer features for the assessment and monitoring of oxygenation in tissues such as brain and muscle. Near-infrared light (in the wavelength range 700-900 nm) can penetrate several centimeters into numerous body tissues. NIRS enables continuous real time measurements of changes in the hemoglobin oxygenation state, thus providing information on tissue oxygenation and hemodynamics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near-Infrared Spectroscopy (NIRS)
Anatomical Site
Skeletal muscle, brain, thenar of the thumb, brachioradialis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical Clinics, laboratories and outpatient facilities.
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
Bench Test:
The comparison measurements were acquired in the Biomedical Optics Research Laboratory directed by Professor Martin Wolf at the Department of Neonatology at University Hospital Zürich in Zürich, Switzerland. Measurements were made on a phantom containing human blood diluted in an optically scattering medium to simulate a physiologically appropriate level of tissue hemoglobin concentration [tHb] and a physiologically realistic optical scattering and absorption properties. Measurements were made at three levels; from physiological levels to increasingly higher concentrations.
Clinical Test:
25 human subjects.
Measurements were acquired over the brachioradialis, the largest muscle in the forearm, and over the thenar of the thumb, a complex region of small muscles and connective tissue. In addition to baseline measures of StO2, StO2 was varied by occluding blood flow to the arm both completely (venous and arterial occlusion) and partially (venous occlusion only), using a blood pressure cuff on the upper arm.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Study:
Type: Direct comparison between OxiplexTS200 and Vioptix ODISsey Tissue Oximeter (OXY-2) on a phantom.
Sample size: Not explicitly stated, but measurements were made at three different concentration levels.
Key results: For physiologically realistic tissue hemoglobin concentrations [tHb], both instruments reported nearly identical values over the range of 20% to 98% SO2. The presence of the pigmented "skin" filter had no discernable effect on either instrument.
Clinical Study:
Type: Comparison of StO2 readings from OxiplexTS200 and Vioptix devices on human subjects.
Sample size: 25 human subjects
Key results: The rate of change of StO2 after both types of occlusions (complete and partial blood flow occlusion) was very similar for both instruments. Baseline measurements on the thenar were not statistically different. The two instruments gave different estimates of StO2 after two minutes of occlusion at both locations, and on the arm at baseline. These results are consistent with the in vitro comparison.
Human Factors Testing:
Type: Human factors testing to verify and demonstrate safety and effectiveness for intended users, use, and environment.
Sample size: Not specified.
Key results: The majority of users would be able to make successful and accurate measurements on first use of the device. The device could be used effectively without any changes to the user interface.
Pre-clinical Testing:
Type: Bench testing and biocompatibility testing for electrical safety, laser safety and electromagnetic compatibility.
Key results: All testing met specified requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (StO2):
50-100%: 2%
26-49%: 3%
0-25%: 10%
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
ISS Medical, Inc. Beniamino Barbieri President 1602 Newton Drive Champaign, Illinois 61822
Re: K232385
Trade/Device Name: OxiplexTS200 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: August 4, 2023 Received: August 9, 2023
Dear Beniamino Barbieri:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Tanisha L. Hithe -S 2024 03 01 Hithe -S 14:49:37 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232385
Device Name OxiplexTS200
Indications for Use (Describe)
The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities.
The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
ISS Medical 510(k) Premarket Notification OxiplexTS200
Section 5: 510(k) Summary
510(k) Summary and Certification
1. Submitter's Name/Contact Person
| Submitted by: | Contact Person: |
|---|---|
| ISS Medical, Inc. | |
| 1602 Newton Drive | |
| Champaign, IL 61822 | Beniamino Barbieri |
| President | |
| Tel: 217.359.8681 x 11 | |
| Fax: 217.359.7879 | |
| Email: beniamino.barbieri@iss.com |
Summary Date: July 31, 2017
2. General Information
- a. Proprietary Name: OxiplexTS200
- b. Common/Usual Name: Tissue Oximeter
- Classification Name: Oximeter C.
- d. Class: Il
- e. Product Code: 74MUD
- CFR Reference: 21 CFR 870.2700 f.
- g. Identification of Equivalent Devices:
InSpectra StO2Tissue Oxygenation Monitor, Model 650 (K100915) ViOptix ODISsey Tissue Oximeter (K042657)
3. Device Description
The ISS Medical non-invasive tissue oximeter. OxiplexTS200. is intended for use as an adjunct monitor of regional oxy- and deoxy-hemoglobin concentration, and of hemoglobin oxygen saturation of blood in tissues during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
The OxiplexTS200 is a device for use in spot-checking as well as continuous monitoring of patients in healthcare facilities. It is not intended for home use or to be used for "out of hospital" transport.
The OxiplexTS200 is an instrument system and includes the following components:
- OxiplexTS200 Unit with two sensors and phantom block ●
- Power cable ●
- Accessories (straps for sensors; strap for phantom block; dark cloth) ●
- ISS flash memory
- Operation Manual
5
ISS Medical 510(k) Premarket Notification OxiplexTS200
- Analoq Input module with USB cable (optional)
- . Analog Output module with USB cable (optional)
The OxiplexTS200 uses near-Infrared Spectroscopy (NIRS), a noninvasive diagnostic tool, to offer features for the assessment and monitoring of oxygenation in tissues such as brain and muscle. Near-infrared light (in the wavelength range 700-900 nm) can penetrate several centimeters into numerous body tissues. NIRS enables continuous real time measurements of changes in the hemoglobin oxygenation state, thus providing information on tissue oxygenation and hemodynamics.
4. Indications for Use
The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities. The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.
5. Comparison with Predicate Devices
ISS Medical's OxiplexTS200 System is compared to the InSpectra StO2Tissue Oxygenation Monitor, Model 650 and the ViOptix ODISsey Tissue Oximeter in Table 1 below.
| | OxiplexTS200 | InSpectra
StO2Tissue
Oxygenation
Monitor, Model
650 (K100915) | ViOptix ODISsey
Tissue Oximeter
(K042657) | Similar/
Same |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Indications for
Use | The OxiplexTS200
tissue oximeter is
intended to non-
invasively estimate
the percent oxygen
saturation (StO2) in
a volume of tissue.
It is indicated for
monitoring patients
during circulatory or
when there is a
suspicion of | Hutchinson
Technology
Incorporated's
InSpectra™
StO2Tissue
Oxygenation
Monitor is intended
for use as a
noninvasive
monitoring system
that measures an
approximated value | The ViOptix
ODISsey Tissue
Oximeter is
intended to
noninvasively
estimate the
percent oxygen
saturation (StO2) in
a volume of tissue. | |
Table 5-1: Comparison to Predicate Devices
6
ISS Medical 510(k) Premarket Notification OxiplexTS200
| | OxiplexTS200 | InSpectra
StO2Tissue
Oxygenation
Monitor, Model
650 (K100915) | ViOptix ODISsey
Tissue Oximeter
(K042657) | Similar/
Same |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Indications for
Use | compromised
circulation. The
device can be used
for monitoring in
Medical Clinics,
laboratories and
outpatient facilities.
The OxiplexTS200
should not be used
as the sole basis
for diagnosis or
therapy. The value
of these
measurements in
disease states has
not been
demonstrated. | of percent
hemoglobin oxygen
saturation in tissue
(StO2).
The InSpectra™
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. | This is performed in
medical
environments
including physician
offices, hospitals,
ambulatory care,
and Emergency
Medical Services.
The ODISsey
Tissue Oximeter is
indicated for use in
monitoring patients
during circulatory or
perfusion
examinations of
skeletal muscle or
when there is a
suspicion of
compromised
circulation. | Similar |
| | OxiplexTS200 | InSpectra
StO2Tissue
Oxygenation
Monitor, Model
650 (K100915) | ViOptix ODISsey
Tissue Oximeter
(K042657) | Similar/
Same |
| Principle of
Operation | Light is used to
probe the region of
the tissue under the
sensor. Light is
sent through the
issue at four
different locations; a
fraction of it returns
to the surface and it
is collected at set
distances from the
points of insertion.
Optical parameters
of the tissue are
determined and
hence the
concentration of
oxy- and deoxy-
hemoglobin. The
tissue oxygen
saturation is
derived. | Diffuse reflectance
spectroscopy. Light
is used to probe a
cross section of the
microvasculature of
tissue (mixed bed of
arterioles,
capillaries, and
venuoles). The light
returning from
tissue, after having
passed through
tissues, for
hemoglobin in its
oxygenated and
deoxygenated
forms in the
optically sampled
region. The tissue
oxygen saturation
(%StO2), a value
reflecting
percentage of
oxygenated
hemoglobin in the
sampled
microvasculature of
tissue is calculated. | Diffuse reflectance
spectroscopy. Light
is used to probe a
cross section of the
microvasculature of
tissue (mixed bed of
arterioles,
capillaries and
venuoles). The
light returning from
tissue, after having
passed through
tissues, for
hemoglobin in its
oxygenated and
deoxygenated
forms in the
optically sampled
region. The tissue
oxygen saturation
(%StO2), a value
reflecting
percentage of
oxygenated
hemoglobin in the
sampled
microvasculature of
tissue, is calculated. | Similar |
| Range (StO2) | 0-100% | 0-99% | 0-100% | Similar |
| Accuracy
[parameter
StO2] | 50-100%: 2%
26-49%: 3%
0-25%: 10% | 70-99%; 1.63 StO2
units
0-70%; 2.94 StO2
units | 80-100%: 2.7%
60-80%: 2.3%
40-60%: 5.2%
10-40%: 13.3% | Similar |
| Alarm Limit
Range | Visual alarms when
value is below
custom set
threshold. | Visual alarms for
error conditions | Audio and visual
alarms when
range limit is
exceeded | Same for
ViOptix;
different
for
InSpectra |
| Measures
Near-infrared
Wavelength | Yes | Yes | Yes | Same |
| | OxiplexTS200 | InSpectra
StO2Tissue
Oxygenation
Monitor, Model
650 (K100915) | ViOptix ODISsey
Tissue Oximeter
(K042657) | Similar/
Same |
| Sensor | Re-useable | Single use;
disposable | Single use;
disposable | Different |
| Sample
Acquisition | Fiber optic bundle
placed in contact
with skin. | Fiber optic probe
placed on intact
skin | Fiber optic probe
placed on intact
skin | Same |
| Features (e.g.,
alarms, display
and indicators,
modes) | Several errors and
alarms are reported
by the software
during the operation
of the instrument:
a. Overload
Warning (when
the signal from
the environment
saturates the
detectors);
b. Signal Strength
Warning
(regarding the
placement of the
sensors on the
patient;
c. Visual Alarm for
set thresholds of
[THC] and
oxygen
saturation;
d. Overvoltage
warning.
e. Warnings
resulting from
Error condition
tests (AC slope,
regression
coefficient,
phase standard
deviation, out of
range optical
parameters). | Audiovisual
•
high/low StO2
error condition,
• Defective LED
or cable sensor
• Communication
error
• Over
temperature
• Cable not
connected
Customizable StO2
alarm limits and
notification of error
conditions | System will perform
self-test when
power is turned on.
Visual and audible
alarms include: low
StO2, high StO2,
StO2 drop rate and
low battery. Visual
alarms include:
inadequate patient
contact, sensor
laser ON, and AC
power ON. Alarm
volume 50 to 80
dbA at 30cm (1
foot). Single-
channel (default) or
dual channel
(applies to consoles
with dual channel
option when 2
sensors are
attached.) 3-cell
Lithium Ion Battery
with 30 minute
minimum. | Similar |
| Time to first
reading | Continuous reading
with up to 8 hours
trended display.
Max display update
rate 0.5 seconds | Continuous reading
with up to 8 hours
trended display.
Display update rate
2 seconds. | ~20 seconds | Same for
InSpectra;
different
for
ViOptix |
| | OxiplexTS200 | InSpectra
StO2Tissue
Oxygenation
Monitor, Model
650 (K100915) | ViOptix ODISsey
Tissue Oximeter
(K042657) | Similar/
Same |
| Number of
different
wavelengths of
light emitted | Two (2); 690nm and
830nm | Four (4); 680, 720,
760, and 800nm | Two (2); 690nm and
830nm | Same for
ViOptix;
different
for
InSpectra |
| Battery | Not available,
(the instrument
does not operate
with a battery) | Lithium battery;
capacity 2 hours
(new/full charge);
Life 300 full
charge/discharge
cycles | Lithium battery | Different |
| Product Laser
Rating | Class I | Class I | Class 3R | Same for
InSpectra;
different
from
ViOptix |
7
ISS Medical 510(k) Premarket Notification OxiplexTS200
8
ISS Medical 510(k) Premarket Notification OxiplexTS200
9
ISS Medical 510(k) Premarket Notification OxiplexTS200
Similarities between the OxiplexTS200 and the predicates include:
-
- The intended use for all three devices is similar.
-
- The principles of operation are similar.
-
- The range and accuracy are similar.
-
- All three devices measure near-infrared wavelength.
-
- The sample acquisition is the same for all three devices.
-
- The safety specifications are the same.
-
- The features of the three devices are similar.
Differences between the OxiplexTS200 and the predicates include:
-
- The OxiplexTS200 and ViOptix have both audio and visual alarms; the InSpectra has only visual alarms.
-
- The InSpectra and ViOptix have disposable sensors; the OxiplexTS200 has reusable sensors.
-
- The OxiplexTS200 and InSpectra have continuous readings with up to 8 hours trending displayed; the ViOptix has 20 second time to read.
-
- The OxiplexTS200 and ViOptix have two (2) different wavelengths of light emitted; InSpectra has four (4).
-
- The InSpectra and ViOptix have battery option: OxiplexTS200 does not have a battery option.
-
- OxiplexTS200 is considered to be a Class I laser product (as the InSpectra), while the ViOptix is classified as a Class 3R laser product.
10
ISS Medical 510(k) Premarket Notification OxiplexTS200
6. Performance Test - Bench
The differences in the technological character between the OxiplexTS200 and the predicates do not raise new types of question regarding safety and effectiveness. In response to the reviewer's request that ISS Medical conducts a direct comparison of the OxiplexTS200 with a predicate instrument, it was arranged to compare it to the ODISey Tissue Oximeter model OXY-2 by Vioptix Inc. The comparison measurements were acquired in the Biomedical Optics Research Laboratory directed by Professor Martin Wolf at the Department of Neonatology at University Hospital Zürich in Zürich, Switzerland.
The staff and equipment there enabled us to conduct a series of simultaneous SO2 measurements using the Vioptix predicate device and the OxiplexTS200 on a phantom containing human blood diluted in an optically scattering medium to simulate a physiologically appropriate level of tissue hemoglobin concentration [tHb] and a physiologically realistic optical scattering and absorption properties. Measurements were made at three levels; from physiological levels to increasingly higher concentrations. The primary comparison of interest is the relation of the OxiplexTS200 percent oxygen saturation [SO2%] estimates with the Vioptix SO2% estimates. These are presented in section 19 performance bench testing where it can be seen that for physiologically realistic tissue hemoglobin concentrations [tHb] both instruments report nearly identical values over the range of 20% to 98% SO2. The presence of the pigmented "skin" filter had no discernable effect on either instrument.
7. Performance Testing- Clinical
We conducted testing using the OxiplexTS200 and the Vioptix devices to compare StO2 readings from a total of 25 human subjects.
Measurements were acquired over the brachioradialis, the largest muscle in the forearm, and over the thenar of the thumb, a complex region of small muscles and connective tissue. In addition to baseline measures of StO2, we varied StO2 by occluding blood flow to the arm both completely (venous and arterial occlusion) and partially (venous occlusion only), using a blood pressure cuff on the upper arm.
We found that the rate of change of StO2 after both types of occlusions was very similar for both instruments, and baseline measurements on the thenar were not statistically different, while the two instruments gave different estimates of StO2 after two minutes of occlusion at both locations, and on the arm at baseline.
These results are consistent with the results of our previous in vitro comparison of these two instruments which demonstrated that at physiologically realistic levels of [tHb] the OxiplexTS200™ and ViOptix ODISsey instruments provided essentially identical sensitive, reliable and accurate measurements of StO2.
11
ISS Medical 510(k) Premarket Notification OxiplexTS200
ISS Medical Inc. has also conducted human factors testing to verify and demonstrate the safety and effectiveness of the OxiplexTS200 for its intended users, use and environment.
Most of the tests mimic the actual daily use of the system. The primary goal of these studies was to evaluate if the device operators are able to accomplish routine tasks with the provided instructions and to assess the clarity of the Instructions For Use (IFU).
Based on the results of the usability studies, the majority of users would be able to make successful and accurate measurements on first use of the device. We conclude that the device could be used effectively without any changes to the user interface.
8. Performance Testing
Bench testing and biocompatibility testing was conducted to demonstrate that the OxiplexTS200 functions as intended. The OxiplexTS200 is designed to conform to the applicable requirements of electrical safety, laser safety and electromagnetic compatibility requirements as summarized below:
- . Evaluation of Risk Management in accordance with IEC 60601-1 3rd Ed. and ISO 14971.
- . Evaluation to 60601-1 (3.1 Edition) IEC, EN, ANSI/AAMI, and CSA. Includes European, US, and Canadian National differences.
- . Evaluation of Programmable Electrical Medical Systems (PEMS) compliance, using IEC 62304:2006 - (Software)
- . Laser classification testing according to IEC 60825-1 2nd Ed. for two laser diodes (830nm and 690nm)
- Evaluation of Usability compliance, using IEC 60601-1-6 :2010 . Collateral standard.
- Full EMC evaluation for mains powered device using EN/IEC 60601-. 1-2:2007.
- Testing for biocompatibility (ISO 10993-5:2009) ●
All testing met specified requirements. Test reports were provided in the submission as Appendices 4, 6 and 7.
9. Conclusions
The OxiplexTS200 device that is the subject of this 510k pre-market notification, is the same or similar in design, intended use, principles of operation, and technological
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ISS Medical 510(k) Premarket Notification OxiplexTS200
characteristics, compared to the predicate devices. Differences of the subject device's output parameters compared to those of the predicate devices' output parameters do not raise new types of questions regarding safety and effectiveness, and performance testing provided in this 510k supports that the device can be used safely and effectively for the proposed indications for use. The OxiplexTS200 device that is the subject of this 510K is considered to be substantially equivalent to the predicate devices.