(224 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on thermal sensing and signal processing without indicating advanced algorithmic learning.
No.
The device is described as a monitor that displays temperature changes, respiratory rate, and tidal volume trends, used as an adjunct to other clinical information sources, not as a device that provides therapy.
No
The device monitors physiological parameters like respiratory rate and tidal volume, which are functional measurements rather than diagnostic determinations of a disease state. It provides adjunct information and does not diagnose conditions.
No
The device description explicitly mentions "complicated hardware and firmware processing" and describes a "system" that includes components beyond just software, implying a physical device is involved in the monitoring process. The performance studies also include tests like "Sensor Integrity Testing" and "Movement Test," which are typically associated with hardware components.
Based on the provided information, the Linshom Continuous Predictive Respiratory Monitor System (CPRMS) 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.
- CPRMS function: The CPRMS is described as a non-invasive system that monitors breathing by detecting temperature changes. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor breathing in patients, not to diagnose a disease or condition based on a biological sample.
Therefore, the CPRMS falls under the category of a medical device that monitors physiological parameters, but it is not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
BZQ
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.
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) patients.
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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"
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)
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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 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
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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 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
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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.
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.