(315 days)
No
The summary describes a thermistor-based device that measures temperature changes to determine respiratory parameters. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is described as a "monitoring device" and its intended use is to "monitor breathing". There is no indication that it is used to treat or alleviate a disease or condition.
No
The device is a monitoring device that provides information on respiratory rate, tidal volume trend, and seconds since the last breath. It is used as an adjunct to other clinical information sources and does not diagnose a condition.
No
The device description explicitly states that the LRMD includes hardware components: the Thermistor Sensor Assembly (TSA), Integrated Linshom Module (ILM) Core, and the power supply, in addition to the software.
Based on the provided information, the Linshom Respiratory Monitoring Device (LRMD) 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.
- LRMD Function: The LRMD is described as a non-invasive system that monitors breathing by detecting temperature changes. It measures respiratory rate, seconds since last breath, and tidal volume trend directly from the patient's breathing, not from a sample taken from the body.
- Intended Use: The intended use clearly states it monitors breathing in adult patients in healthcare facilities. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the LRMD falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients.
LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.
LRMD measurements are used as an adjunct to other clinical information sources.
Product codes
BZQ
Device Description
The Linshom Respiratory Monitoring Device (LRMD) is a medical device designed to monitor a patient's respiratory rate, tidal volume trend and seconds since last breath within a healthcare setting. The LRMD is a thermistor based respiratory monitor which includes the Thermistor Sensor Assembly (TSA), Integrated Linshom Module (ILM) Core, the power supply and software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult (at least 22 years of age)
Intended User / Care Setting
healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms
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)
Bench and clinical performance data were collected to support a substantial equivalence determination. This testing included mechanical lung data, patient movement simulation, 24-hour testing, clinical comparison of respiratory rate to capnography, and clinical comparison of tidal volume trend to a ventilator. These data suggest the LRMD is as safe and as effective as the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Respiration: ± 1 BPM
Tidal Volume Trend: 0.97 (r² correlation to ventilator)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
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January 30, 2020
Linshom Management LLC Ronen Feldman President 2922 Excelsior Springs Court Ellicott City, Maryland 21042
Re: K190734
Trade/Device Name: Linshom Respiratory Monitoring Device (LRMD) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: January 1, 2020 Received: January 2, 2020
Dear Ronen Feldman:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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). 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-device-advice-comprehensive-regulatoryassistance/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,
for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190734
Device Name
Linshom Respiratory Monitoring Device (LRMD)
Indications for Use (Describe)
Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients.
LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.
LRMD measurements are used as an adjunct to other clinical information sources.
| 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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3
510(k) Summarv – K190734
(per 21 CFR 807.92)
Submitter Information
| Name | Linshom Management LLC |
|---|---|
| Address | 2922 Excelsior Springs Court |
| Ellicott City, MD 21042 | |
| Phone Number | (410) 480-2700 |
| Contact Person | Ronen Feldman |
| President | |
| Date Prepared | January 30, 2020 |
Device Information
| Trade Name | Linshom Respiratory Monitoring Device (LRMD) |
|---|---|
| Common Name | Respiratory Monitor |
| Classification | Breathing frequency monitor |
| 21 CFR 878.2375 (Product Code BZQ) |
Predicate Device Information
| Primary Predicate | ExSpiron, K120087 |
|---|---|
| Reference Device | ReDe Mask, K161953 |
Device Description
The Linshom Respiratory Monitoring Device (LRMD) is a medical device designed to monitor a patient's respiratory rate, tidal volume trend and seconds since last breath within a healthcare setting. The LRMD is a thermistor based respiratory monitor which includes the Thermistor Sensor Assembly (TSA), Integrated Linshom Module (ILM) Core, the power supply and software.
Indications for Use
Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients.
LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.
LRMD measurements are used as an adjunct to other clinical information sources.
Technological Characteristics
As shown in Table 1, many technological similarities exist between the subject and predicate devices. The operating mechanism utilized in the LRMD is thermistor-based, similar to the cited reference predicate. Other technological characteristics of LRMD, including software, EMC and ES, and usability aspects, are similar to predicate devices.
4
| Characteristic | Subject Device
LRMD | Predicate Device
(K120087)
ExSpiron | Reference Device
(K161953)
ReDe Mask | Comparison |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Linshom Respiratory
Monitoring Device
(LRMD) | ExSpiron | ReDe Mask | |
| Common Name | Respiratory Monitor | Respiratory Monitor | Breathing Monitor | |
| 510(K) Number | K190734 | K120087 | K161953 | |
| Regulation Classification
(Product Code) | 21 CFR 868.2375 (BZQ) | 21 CFR 868.2375 (BZQ)
AND
21 CFR 868.1850 (BZK) | 21 CFR 879.2375 (PRK) | Same |
| Intended Use | Non-invasive monitoring
of respiration and tidal
volume trends for adults
in healthcare settings | Non-invasive monitoring
of respiration and tidal
volume for adults in
healthcare settings | Non-invasive monitoring
of respiration for adults
in healthcare settings | Same (ExSpiron) |
| Indications for Use | Linshom Respiratory
Monitoring Device (LRMD)
is indicated for use by
healthcare professionals in
healthcare facilities, such
as procedural areas and
recovery rooms, to
monitor breathing in adult
(at least 22 years of age)
patients.
LRMD is a non-invasive
system that graphically
displays temperature
changes against time and
reports values of
respiratory rate and
seconds since last breath,
along with a trend of tidal
volume.
LRMD measurements are
used as an adjunct to other
clinical information
sources. | ExSpiron is indicated for
use by healthcare
professionals in healthcare
facilities, such as post-
operative care and critical
care units, to monitor
breathing in adult (at least
21 years of age) patients.
ExSpiron is a non-invasive
system that graphically
displays lung volume
against time and reports
an approximate value of:
· Tidal volume,
· Respiratory rate, and
· Minute ventilation.
ExSpiron measurements
are used as an adjunct to
other clinical information
sources. | The ReDe Mark is indicated
for use by healthcare
professionals in healthcare
facility procedural areas
and recovery rooms as an
adjunct to monitor
breathing in adult patients
who are sedated for a
diagnostic or therapeutic
procedure. The ReDe Mask
measures the time period
between the current and
previous exhalation and
illuminates a colored light
during the exhalation that
reflects the interval of time
between breaths. If the
interval is less than 7.5
seconds, the green light
illuminates during
exhalation; if the interval is
greater than 7.5 seconds
but up to 20 seconds, the
yellow light illuminates
during exhalation; and if
the interval between
breaths is 20 seconds or
longer, the red light flashes
continuously. The ReDe
Mask is only to be used
when supplemental
oxygen is provided by the
facemask. The ReDe Mask
is not a standalone device
and is only to be used as
an adjunct to pulse
oximetry. | Equivalent (ExSpiron)
Minor text differences to not suggest
a new or difference intended use.
Justification: minor differences reflect minor
differences in devices but does not change
the use, users, or conditions of use |
| Mechanism (General) | Thermistor | Thoracic Bioimpedence | Thermistor | Same (ReDe Mask) |
| Measurements | Respiratory Rate
Seconds Since Last
Breath
Tidal Volume Trend | Respiratory Rate
Tidal Volume
Minute Volume | Seconds Since Last
Breath | Equivalent (All)
Justification: these parameters are all related
to the breathing cycle |
| Characteristic | Subject Device
LRMD | Predicate Device
(K120087)
ExSpiron | Reference Device
(K161953)
ReDe Mask | Comparison |
| Communication Method | GUI Interface | GUI Interface | Light Display (Red /
Yellow / Green) | Same (ExSpiron) |
| ES / EMC Testing | IEC 60601-1 & 60601-1-2 | IEC 60601-1 & 60601-1-2 | IEC 60601-1 & 60601-1-2 | Same |
| Material Biocompatibility | ISO 10993
ISO 18562 | unknown | Tested (mask
components) | Equivalent
Justification: all devices address
biocompatibility risks (albeit different
mechanisms) |
| Mask Type | Face mask | ExSpiron 1Xi PadSets | Face mask | Equivalent (ReDe Mask)
Justification: LRMD utilizes a legally marketed
facemask while the ReDe Mask incorporates
its own mask; regardless, both devices attach
to the patient face via an oxygen mask |
| Mounting Design | Sensor attached to
separate electronics box | Electrodes attached to
separate electronics box | Face mask and
electronics housing
placed on patient's face | Equivalent (ExSpiron)
Justification: these are similar concepts just
have different electronics |
| Ambient Operating
Temperature | 65°F -- 85°F
(18.3°C - 29.4°C) | Unknown | 16°C to 31°C | Equivalent (ReDe Mask)
Justification: both devices demonstrate safe
and effective performance at the extremes of
its stated operating range |
| Working Range | Respiration: 5-60 BPM
Tidal Volume: 120-
1000mL | Respiration: 5-30 BPM
Tidal Volume: unknown | Unknown | Equivalent (ExSpiron)
Justification: both devices have performance
testing that demonstrates safety and
effectiveness against a gold standard (e.g.,
capnography) for the entire working range |
| Accuracy | Respiration: ± 1 BPM
Tidal Volume Trend: 0.97
(r² correlation to
ventilator) | Respiration: 2%
Tidal Volume: 3.9% | Unknown | Equivalent (ExSpiron)
Justification: although LRMD reports its
accuracy across the working range (via
correlation), performance data showed that
accuracy is equivalent across working range
for both respiration and tidal volume |
| Weight (at point of
measurement) | ~15g (Thermistor Sensor
Assembly only) | unknown | 40g | Within Range of Existing Products |
| Dimensions (of unit as
point of measurement) | 60mm H
254mm L
158mm W
(ILM Core) | unknown | 43.43mm H
30.48mm W
14.99mm D | Within Range of Existing Products |
| Performance Testing | Lifetime Test (24hr)
Breathing Rate Test
(Mechanical Lung)
Movement Test
38 volunteer subjects
(for respiratory rate)
12 endoscopy subjects
(for respiratory rate)
40 volunteer subjects
(for tidal volume)
Human Factors Test
Tidal Volume Trend
Bench Test | 20 subjects (for all 3
measures, compared
against spirometer) | Lifetime Test (8hr)
Human Factors (for
overall use and for light
interpretation)
38 volunteer subjects
(for detection of
exhalation and low
respiratory rate
compared to
capnography)
50 volunteer subjects
(for detection of
exhalation and low
respiratory rate
compared to
capnography) | Demonstrates subject device is as
safe and as effective as predicate
device. |
5
6
Performance Data
Bench and clinical performance data were collected to support a substantial equivalence determination. This testing included mechanical lung data, patient movement simulation, 24-hour testing, clinical comparison of respiratory rate to capnography, and clinical comparison of tidal volume trend to a ventilator. These data suggest the LRMD is as safe and as effective as the identified predicate devices.
Conclusions
The LRMD and predicate devices have intended use and similar indications, both serving as medical devices to monitor respiration and tidal volume trend. As described above, the minor technological differences between the LRMD and its predicates do not present any new or different issues of safety or effectiveness. Based upon analysis and valid scientific evidence the LRMD is substantially equivalent to its predicate devices.