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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Linshom Respiratory Monitoring Device (LRMD) based on the provided document:

Acceptance Criteria and Device Performance

Metric	Acceptance Criteria	Reported Device Performance
Respiratory Rate	± 1 BPM	± 1 BPM
Tidal Volume Trend	Not explicitly stated as a numerical criterion in the table, but indicated by comparison with predicate.	0.97 (r² correlation to ventilator)
Working Range (Respiration)	5-60 BPM	5-60 BPM
Working Range (Tidal Volume)	120-1000mL	120-1000mL
Ambient Operating Temperature	65°F - 85°F (18.3°C - 29.4°C)	65°F - 85°F (18.3°C - 29.4°C)

Study Information

The document describes performance data that includes both bench and clinical testing.

Sample sizes used for the test set and the data provenance:
- Respiratory rate:
  - 38 volunteer subjects (for respiratory rate)
  - 12 endoscopy subjects (for respiratory rate)
- Tidal Volume Trend:
  - 40 volunteer subjects (for tidal volume)
- Data Provenance: Not explicitly stated, but the mention of "volunteer subjects" and "endoscopy subjects" suggests prospective data collection within a clinical setting. Country of origin is not specified but is implied to be within the scope of FDA regulations (likely United States).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The ground truth for respiratory rate was compared to capnography, and for tidal volume trend, it was compared to a ventilator. This implies the use of established medical equipment as the gold standard, rather than expert consensus on observational data.
Adjudication method for the test set:
- Not explicitly stated. Given the use of objective medical equipment (capnography, ventilator) as the gold standard, a formal expert adjudication method (like 2+1 or 3+1) would likely not be applicable in the same way it is for subjective image interpretation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done, as this device focuses on direct physiological measurement rather than aiding human interpretation of complex data (e.g., medical images).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (accuracy of respiratory rate and tidal volume trend) reflects the standalone performance of the LRMD device. The device is designed to report values and display trends, implying its direct measurement capability. The indication for use notes that "LRMD measurements are used as an adjunct to other clinical information sources," but the reported accuracy metrics are for the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Respiratory Rate: Capnography (considered a gold standard for respiratory rate measurement).
- Tidal Volume Trend: Ventilator (presumably a ventilator with accurate tidal volume measurement capabilities, used as a gold standard).
The sample size for the training set:
- Not provided. The document focuses on performance testing for regulatory submission, not the development or training of the underlying algorithms.
How the ground truth for the training set was established:
- Not provided, as information about a training set is absent from the document.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K190734

Device Name

Linshom Respiratory Monitoring Device (LRMD)

Indications for Use (Describe)

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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510(k) Summarv – K190734

(per 21 CFR 807.92)

Submitter Information

Name	Linshom Management LLC
Address	2922 Excelsior Springs CourtEllicott City, MD 21042
Phone Number	(410) 480-2700
Contact Person	Ronen FeldmanPresident
Date Prepared	January 30, 2020

Device Information

Trade Name	Linshom Respiratory Monitoring Device (LRMD)
Common Name	Respiratory Monitor
Classification	Breathing frequency monitor21 CFR 878.2375 (Product Code BZQ)

Predicate Device Information

Primary Predicate	ExSpiron, K120087
Reference Device	ReDe Mask, K161953

Device Description

Indications for Use

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.

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Characteristic	Subject DeviceLRMD	Predicate Device(K120087)ExSpiron	Reference Device(K161953)ReDe Mask	Comparison
Trade Name	Linshom RespiratoryMonitoring 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)AND21 CFR 868.1850 (BZK)	21 CFR 879.2375 (PRK)	Same
Intended Use	Non-invasive monitoringof respiration and tidalvolume trends for adultsin healthcare settings	Non-invasive monitoringof respiration and tidalvolume for adults inhealthcare settings	Non-invasive monitoringof respiration for adultsin healthcare settings	Same (ExSpiron)
Indications for Use	Linshom RespiratoryMonitoring Device (LRMD)is indicated for use byhealthcare professionals inhealthcare facilities, suchas procedural areas andrecovery rooms, tomonitor breathing in adult(at least 22 years of age)patients.LRMD is a non-invasivesystem that graphicallydisplays temperaturechanges against time andreports values ofrespiratory rate andseconds since last breath,along with a trend of tidalvolume.LRMD measurements areused as an adjunct to otherclinical informationsources.	ExSpiron is indicated foruse by healthcareprofessionals in healthcarefacilities, such as post-operative care and criticalcare units, to monitorbreathing in adult (at least21 years of age) patients.ExSpiron is a non-invasivesystem that graphicallydisplays lung volumeagainst time and reportsan approximate value of:· Tidal volume,· Respiratory rate, and· Minute ventilation.ExSpiron measurementsare used as an adjunct toother clinical informationsources.	The ReDe Mark is indicatedfor use by healthcareprofessionals in healthcarefacility procedural areasand recovery rooms as anadjunct to monitorbreathing in adult patientswho are sedated for adiagnostic or therapeuticprocedure. The ReDe Maskmeasures the time periodbetween the current andprevious exhalation andilluminates a colored lightduring the exhalation thatreflects the interval of timebetween breaths. If theinterval is less than 7.5seconds, the green lightilluminates duringexhalation; if the interval isgreater than 7.5 secondsbut up to 20 seconds, theyellow light illuminatesduring exhalation; and ifthe interval betweenbreaths is 20 seconds orlonger, the red light flashescontinuously. The ReDeMask is only to be usedwhen supplementaloxygen is provided by thefacemask. The ReDe Maskis not a standalone deviceand is only to be used asan adjunct to pulseoximetry.	Equivalent (ExSpiron)Minor text differences to not suggesta new or difference intended use.Justification: minor differences reflect minordifferences in devices but does not changethe use, users, or conditions of use
Mechanism (General)	Thermistor	Thoracic Bioimpedence	Thermistor	Same (ReDe Mask)
Measurements	Respiratory RateSeconds Since LastBreathTidal Volume Trend	Respiratory RateTidal VolumeMinute Volume	Seconds Since LastBreath	Equivalent (All)Justification: these parameters are all relatedto the breathing cycle
Characteristic	Subject DeviceLRMD	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 10993ISO 18562	unknown	Tested (maskcomponents)	EquivalentJustification: all devices addressbiocompatibility risks (albeit differentmechanisms)
Mask Type	Face mask	ExSpiron 1Xi PadSets	Face mask	Equivalent (ReDe Mask)Justification: LRMD utilizes a legally marketedfacemask while the ReDe Mask incorporatesits own mask; regardless, both devices attachto the patient face via an oxygen mask
Mounting Design	Sensor attached toseparate electronics box	Electrodes attached toseparate electronics box	Face mask andelectronics housingplaced on patient's face	Equivalent (ExSpiron)Justification: these are similar concepts justhave different electronics
Ambient OperatingTemperature	65°F -- 85°F(18.3°C - 29.4°C)	Unknown	16°C to 31°C	Equivalent (ReDe Mask)Justification: both devices demonstrate safeand effective performance at the extremes ofits stated operating range
Working Range	Respiration: 5-60 BPMTidal Volume: 120-1000mL	Respiration: 5-30 BPMTidal Volume: unknown	Unknown	Equivalent (ExSpiron)Justification: both devices have performancetesting that demonstrates safety andeffectiveness against a gold standard (e.g.,capnography) for the entire working range
Accuracy	Respiration: ± 1 BPMTidal Volume Trend: 0.97(r² correlation toventilator)	Respiration: 2%Tidal Volume: 3.9%	Unknown	Equivalent (ExSpiron)Justification: although LRMD reports itsaccuracy across the working range (viacorrelation), performance data showed thataccuracy is equivalent across working rangefor both respiration and tidal volume
Weight (at point ofmeasurement)	~15g (Thermistor SensorAssembly only)	unknown	40g	Within Range of Existing Products
Dimensions (of unit aspoint of measurement)	60mm H254mm L158mm W(ILM Core)	unknown	43.43mm H30.48mm W14.99mm D	Within Range of Existing Products
Performance Testing	Lifetime Test (24hr)Breathing Rate Test(Mechanical Lung)Movement Test38 volunteer subjects(for respiratory rate)12 endoscopy subjects(for respiratory rate)40 volunteer subjects(for tidal volume)Human Factors TestTidal Volume TrendBench Test	20 subjects (for all 3measures, comparedagainst spirometer)	Lifetime Test (8hr)Human Factors (foroverall use and for lightinterpretation)38 volunteer subjects(for detection ofexhalation and lowrespiratory ratecompared tocapnography)50 volunteer subjects(for detection ofexhalation and lowrespiratory ratecompared tocapnography)	Demonstrates subject device is assafe and as effective as predicatedevice.

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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.

Regulation Number and Section

§ 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).