Linshom Continuous Predictive Respiratory Monitor System (CPRMS) 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.

The CPRMS 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.

CPRMS measurements are used as an adjunct to other clinical information sources.

Device Description

The Linshom CPRMS (Continuous Predictive Respiratory Monitoring System) is portable, reliable and an inexpensive system for precise detection of spontaneous respiration. It is non-invasive and is not corrupted by motion artifacts. The system autonomously adapts to the local thermal environment to deliver a usable signal without complicated hardware and firmware processing.

AI/ML Overview

The provided text details the FDA 510(k) clearance for the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS), demonstrating its substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance metrics in a table, or details regarding the study designs (sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical study effect sizes) that directly prove the device meets pre-defined quantitative acceptance criteria.

The document primarily focuses on:

Regulatory Clearance: The FDA's determination of substantial equivalence for the CPRMS to its predicate device (Linshom Respiratory Monitoring Device - LRMD).
Technological Comparison: A table comparing the characteristics of the subject device (CPRMS) and the predicate device (LRMD), highlighting their similarities.
Non-Clinical Testing Summary: A general statement about the types of non-clinical tests performed (e.g., Lifetime Test, Movement Test, Respiration Rate Test, Tidal Volume Trend Test) and conformance to various medical device standards. It mentions "Statistical analysis, including correlation methods, showed strong alignment with reference data, indicating that the device functions accurately and reliably within its intended use parameters," but does not provide the specific numerical results of these analyses or the acceptance thresholds.

Therefore, based solely on the provided text, I cannot complete many of the requested sections.

Here's a breakdown of what can be inferred from the text and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions specific accuracy for respiration rate and tidal volume trend for both the subject and predicate devices:

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Subject Device - CPRMS)
Respiration Rate	± 1 BPM	± 1 BPM
Tidal Volume TREND	~0.97 (r2 correlation)	~0.97 (r2 correlation)

Note: These are presented as specifications that are "Same" for both devices, implying the CPRMS met these already established performance levels of the predicate device. The text does not explicitly state them as "acceptance criteria" for a new study, but rather as inherent accuracy specifications of the device's mechanism.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document states "The subject device [K240271] underwent testing across the full range of physiological parameters, including respiratory rates from 0-60 breaths per minute (BPM)." This implies a test set was used, but its size or specific characteristics (e.g., number of subjects, number of data points) are not provided.
Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data. The testing mentioned appears to be laboratory/non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document outlines non-clinical testing focused on device performance against reference data, not human expert interpretation of clinical data for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not specified for this type of non-clinical device performance testing. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading).

5. 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 or human-in-the-loop study is mentioned. The device provides measurements (respiratory rate, seconds since last breath, tidal volume trend) as an adjunct to other clinical information sources, but the text does not describe a study where human readers/clinicians used the device and their performance was evaluated comparatively.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The "Non-Clinical and/or Clinical Tests Summary" describes tests where the device's measurements (respiration rate, tidal volume trend) were compared against "reference data," indicating a standalone evaluation of the algorithm's performance against a known standard.

7. The type of ground truth used

Reference Data: The document states "Statistical analysis, including correlation methods, showed strong alignment with reference data." This implies that the ground truth was derived from established, accurate measurement methods or simulated physiological parameters (e.g., a ventilator for tidal volume, a controlled breathing simulator for respiration rate). It's not explicitly stated as expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not specified. The document mentions "Proprietary Algorithm" for both subject and predicate devices but provides no details on how these algorithms were developed or trained, nor the size of any training datasets.

9. How the ground truth for the training set was established

Not specified. As no training set details are provided, the method for establishing its ground truth is also absent.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.

September 11, 2024

Linshom Medical Inc. William Stoll VP, Quality & Regulatory 2922 Excelsior Springs Court Ellicott City, Maryland 21042

Re: K240271

Trade/Device Name: Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: March 26, 2024 Received: March 26, 2024

Dear William Stoll:

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.

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"

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(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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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). 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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Binoy J. Mathews. The date of the signature is September 11, 2024. The time of the signature is 15:50:34 -04'00'.

For

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of 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) K240271

Device Name Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Indications for Use (Describe)

The CPRMS 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.

CPRMS measurements are used as an adjunct to other clinical information sources.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows the word "Linshom" in a bold, blue font. Below the word "Linshom" is the phrase "Every Breath Counts" in a smaller, blue font. The logo appears to be for a company or organization related to respiratory health.

510(k) Summary 21 CFR 807.92

Submitter Information

Name	Linshom Medical, Inc.
Address	2922 Excelsior Springs CourtEllicott City, MD 21042
Phone Number	(716) 474-8572
Contact Person	William A. Stoll
	VP, Quality & Regulatory
Date Prepared	September 4, 2024

Subject Device Information

Trade Name	Linshom - Continuous Predictive Respiratory Monitoring System (CPRMS
Common Name	Respiratory Monitor
Classification	Breathing frequency monitor21 CFR 878.2375 (Product Code BZQ)
510(k) Number	K240271

Predicate Device Information

Device Name	Linshom Respiratory Monitoring Device (LRMD)
Classification	Breathing frequency monitor
	21 CFR 878.2375 (Product Code BZQ)

510(k) Number K190734

Device Description Summary

Indications for Use

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Image /page/5/Picture/1 description: The image shows the word "Linshom" in a blue, sans-serif font. There is a line going through the middle of the word that makes it look like it is broken. Below the word "Linshom" is the phrase "Every Breath Counts" in a smaller, sans-serif font. The TM symbol is next to the word "Counts".

The CPRMS 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.

CPRMS measurements are used as an adjunct to other clinical information sources.

Technological Comparison to Predicate Device

Characteristic	Subject DeviceLinshom CPRMSw/ 2-piece sensor	Predicate Device(K190734)LRMD	ComparisonOutcome
Trade Name	Continuous PredictiveRespiratory MonitoringSystem (CPRMS)	Linshom RespiratoryMonitoring Device(LRMD)	Same
Common Name	Respiratory Monitor	Respiratory Monitor	Same
510(K) Number	K240271	K190734
Regulation Classification(Product Code)	21 CFR 868.2375 (BZQ)	21 CFR 868.2375 (BZQ)	Same
Indications for Use	Linshom RespiratoryMonitoring Device(CPRMS) is indicated foruse by healthcareprofessionals in healthcarefacilities, such as post-operative care and criticalcare units, to monitorbreathing in adult, (at least22 years of age) patients.CPRMS is a non-invasivesystem that graphicallydisplays temperaturechanges against time andreports values ofrespiratory rates andseconds since last breath,along with a trend of tidalvolume.CPRMS measurements areused as an adjunct to otherclinical information sources.	Linshom RespiratoryMonitoring Device(LRMD) is indicated foruse by healthcareprofessionals in healthcarefacilities, such as post-operative care and criticalcare units, to monitorbreathing in adult, (at least22 years of age) patients.LRMD is a non-invasivesystem that graphicallydisplays temperaturechanges against time andreports values ofrespiratory rates andseconds since last breath,along with a trend of tidalvolume.LRMD measurements areused as an adjunct to otherclinical information sources.	Same
Intended Use	Non-invasive monitoringof respiration and tidalvolume trends for adultsin healthcare settings.	Non-invasive monitoringof respiration and tidalvolume trends for adultsin healthcare settings.	Same
Mechanism (General)	Thermistor	Thermistor	Same
Characteristic	Subject DeviceLinshom CPRMSw/ 2-piece sensor	Predicate Device(K190734)LRMD	ComparisonOutcome
Assembly(Specifications)	2 pieces	1 piece	Same Function –Assembly has beenVerified & Validated
Connection(Specifications)	Compression	Epoxied	Same Function –Assembly has beenVerified & Validated
Measurements	Respiratory RateSeconds Since LastBreathTidal Volume Trend	Respiratory RateSeconds Since LastBreathTidal Volume Trend	Same
Communication Method	GUI Interface	GUI Interface	Same
Software / Firmware	Proprietary Algorithm	Proprietary Algorithm	Same
Mask Type	Face mask	Face mask	Same
Mounting Design	Sensor attached toseparate electronics box	Sensor attached toseparate electronics box	Same
AmbientOperatingTemperature	65°F – 85°F (18.3°C –29.4°C)	65°F – 85°F (18.3°C –29.4°C)	Same
Working Range	Respiration: 5-60 BPMTidal Volume Trend	Respiration: 5-60 BPMTidal Volume Trend:	Same
Accuracy	Respiration: ± 1 BPMTidal Volume TREND:~0.97 (r2 correlation).	Respiration: ± 1 BPMTidal Volume Trend: 0.97(r2 correlation toventilator)	Same. The structuraldifferences between thesubject device (CPRMS) andthe predicate device(LRMD), such as the two-piece assembly andcompression connection,have been validated andshown not to affect thedevice's safety oreffectiveness.
Weight (at point ofmeasurement)	~15g (Thermistor SensorAssembly only)	~15g (Thermistor SensorAssembly only)	Same
Characteristic	Subject DeviceLinshom CPRMSw/ 2-piece sensor	Predicate Device(K190734)LRMD	ComparisonOutcome
Dimensions (of unit aspoint of measurement)	60mm H254mm L158mm W(ILM Core)	60mm H254mm L158mm W(ILM Core)	Same

Table 1: Comparison of Technological Characteristics

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Image /page/6/Picture/1 description: The image contains the logo for Linshom. The logo is blue and features the word "Linshom" in a bold, sans-serif font. Below the word "Linshom" is the phrase "Every Breath Counts" in a smaller, sans-serif font. The letters in the word "Linshom" are connected.

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Image /page/7/Picture/0 description: The image shows the logo for Linshom. The logo is blue and features the word "Linshom" in a bold, sans-serif font. Below the word "Linshom" is the tagline "Every Breath Counts™" in a smaller font. The logo is simple and clean, and the blue color gives it a sense of trustworthiness and reliability.

K240271

As described above in Table 1 the technological differences between the CPRMS and LRMD devices do not raise different questions of safety or effectiveness. Performance testing further confirms that these differences do not affect safety and/or efficacy.

Non-Clinical and/or Clinical Tests Summary

The subject device [K240271] underwent testing across the full range of physiological parameters, including respiratory rates from 0-60 breaths per minute (BPM). These tests demonstrated that the subject device meets performance expectations and supports its substantial equivalence to the predicate device. Statistical analysis, including correlation methods, showed strong alignment with reference data, indicating that the device functions accurately and reliably within its intended use parameters.

The following non-clinical testing was performed to support the substantial equivalence of the subject device:

Lifetime Test (24hr)
Movement Test
Human Factors Test
. Sensor Integrity Testing
Respiration Rate Test: 5-60 BPM
Tidal Volume Trend Test

Testing was also performed to demonstrate substantial equivalence through conformance to the following standards/guidance documents:

. Biocompatibility
- ISO 18562-1
- ISO 10993-1
- Use of International Standard ISO 10993-1, "Biological evaluation of ● medical devices – Part 1: Evaluation and testing within a risk management process" – Guidance for Industry and Food and Drug Administration Staff, September 2023
. Electrical, Mechanical and Thermal Safety
- . IEC 60601-1
Electromagnetic Compatibility
- IEC 60601-1-2 .
- . Electromagnetic Compatibility (EMC) of Medical Devices – Guidance for Industry and Food and Drug Administration Staff, June 2022

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. Human Factors
- . Applying Human Factors and Usability Engineering to Medical Devices -Guidance for Industry and Food and Drug Administration Staff, February 2016
. Software
- . Content of Premarket Submissions for Device Software Functions – Guidance for Industry and Food and Drug Administration Staff, June 2023

Conclusions

This nonclinical testing demonstrates substantial equivalence of the subject device CPRMS being as safe, as effective, and performing as well as the LRMD predicate device.

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).