Who is the manufacturer of Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Medical, Inc. filed the 510(k) submission for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K240271).

What is the FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

BZQ. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Respiratory Monitoring Device (LRMD) (K190734).

Who can help prepare an FDA 510(k) submission like Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

K240271 · Linshom Medical, Inc. · BZQ · Sep 11, 2024 · Anesthesiology

Device Facts

Record ID	K240271
Device Name	Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Applicant	Linshom Medical, Inc.
Product Code	BZQ · Anesthesiology
Decision Date	Sep 11, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2

Intended Use

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 Story

CPRMS is a non-invasive respiratory monitor for adult patients in healthcare facilities; operated by healthcare professionals. System uses thermistor sensor to detect spontaneous respiration via temperature changes; autonomously adapts to local thermal environment. Inputs: temperature signals; Outputs: respiratory rate, seconds since last breath, tidal volume trend displayed on GUI. Device serves as adjunct to other clinical information; provides continuous monitoring to assist clinicians in assessing patient respiratory status; benefits include precise, motion-artifact-free detection of respiration.

Clinical Evidence

Bench testing only. Performance verified across physiological range (0-60 BPM). Testing included lifetime (24hr), movement, human factors, sensor integrity, respiration rate, and tidal volume trend tests. Conformance to ISO 10993-1, ISO 18562-1, IEC 60601-1, and IEC 60601-1-2 demonstrated. Tidal volume trend correlation (r2) of ~0.97 reported.

Technological Characteristics

Thermistor-based sensing; 2-piece sensor assembly with compression connection. Operates in 18.3°C–29.4°C ambient range. Respiration range 5-60 BPM. Accuracy ± 1 BPM. Proprietary software algorithm. Complies with IEC 60601-1 (electrical/mechanical/thermal safety) and IEC 60601-1-2 (EMC). Biocompatibility per ISO 10993-1 and ISO 18562-1.

Indications for Use

Indicated for adult patients (at least 22 years of age) in healthcare facilities (procedural areas, recovery rooms) for non-invasive respiratory monitoring.

Regulatory Classification

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.

Predicate Devices

Linshom Respiratory Monitoring Device (LRMD) (K190734)

Related Devices

K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) · Linshom Medical, Inc. · Sep 26, 2025
K190734 — Linshom Respiratory Monitoring Device (LRMD) · Linshom Management, LLC · Jan 30, 2020
K192595 — ExSpiron 2Xi · Respiratory Motion · Dec 17, 2019
K100773 — KAI SPOT MODEL KMS 200 · Kai Medical, Inc. · Jun 23, 2010
K070375 — EARLYSENSE ES-16 SYSTEM · Earlysense, Ltd. · Nov 15, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240271 Device Name Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) Indications for Use (Describe) 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 Court Ellicott 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 monitor 21 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 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. ### Indications for Use 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. Linshom - Continuous Predictive Respiratory Monitoring System (CPRMS) - 510(k) Page 1 of 5 {5}------------------------------------------------ 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 Device Linshom CPRMS w/ 2-piece sensor | Predicate Device (K190734) LRMD | Comparison Outcome | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Respiratory Monitoring 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 Respiratory Monitoring Device (CPRMS) 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 22 years of age) patients. CPRMS is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rates and seconds since last breath, along with a trend of tidal volume. CPRMS measurements are used as an adjunct to other clinical information sources. | Linshom Respiratory Monitoring Device (LRMD) 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 22 years of age) patients. LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rates and seconds since last breath, along with a trend of tidal volume. LRMD measurements are used as an adjunct to other clinical information sources. | 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 trends for adults in healthcare settings. | Same | | Mechanism (General) | Thermistor | Thermistor | Same | | Characteristic | Subject Device Linshom CPRMS w/ 2-piece sensor | Predicate Device (K190734) LRMD | Comparison Outcome | | Assembly (Specifications) | 2 pieces | 1 piece | Same Function – Assembly has been Verified & Validated | | Connection (Specifications) | Compression | Epoxied | Same Function – Assembly has been Verified & Validated | | Measurements | Respiratory Rate Seconds Since Last Breath Tidal Volume Trend | Respiratory Rate Seconds Since Last Breath Tidal 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 to separate electronics box | Sensor attached to separate electronics box | Same | | Ambient Operating Temperature | 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 BPM Tidal Volume Trend | Respiration: 5-60 BPM Tidal Volume Trend: | Same | | Accuracy | Respiration: ± 1 BPM Tidal Volume TREND: ~0.97 (r2 correlation). | Respiration: ± 1 BPM Tidal Volume Trend: 0.97 (r2 correlation to ventilator) | Same. The structural differences between the subject device (CPRMS) and the predicate device (LRMD), such as the two- piece assembly and compression connection, have been validated and shown not to affect the device's safety or effectiveness. | | Weight (at point of measurement) | ~15g (Thermistor Sensor Assembly only) | ~15g (Thermistor Sensor Assembly only) | Same | | Characteristic | Subject Device Linshom CPRMS w/ 2-piece sensor | Predicate Device (K190734) LRMD | Comparison Outcome | | Dimensions (of unit as point of measurement) | 60mm H 254mm L 158mm W (ILM Core) | 60mm H 254mm L 158mm W (ILM Core) | Same | Table 1: Comparison of Technological Characteristics {6}------------------------------------------------ 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ - . 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.