(125 days)
No
The device description focuses on the physical mechanism of measuring inductance based on belt stretch and does not mention any computational analysis or algorithms, let alone AI/ML. The performance studies also focus on physical and signal quality comparisons, not algorithmic performance.
No
The device is described as being for "diagnostic purposes only" and is intended to "assist in the diagnosis of sleep disorders or sleep related respiratory disorders," not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders." and "The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only".
No
The device description clearly outlines physical components including a belt, wire coil, buckle, and connection jacks, indicating it is a hardware device.
No, the Bluebird Single-Use Respiratory Effort Belt is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. Examples include blood tests, urine tests, and genetic tests.
- Bluebird's Function: The Bluebird belt measures respiratory effort by detecting the physical expansion and contraction of the chest and abdomen. This is a physiological measurement taken directly from the body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states it's to "measure respiratory effort" and "assist in the diagnosis of sleep disorders or sleep related respiratory disorders." This is done by providing a signal related to the patient's breathing movements, not by analyzing a biological sample.
Therefore, based on the provided information and the definition of an IVD, the Bluebird Single-Use Respiratory Effort Belt is a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest and abdomen
Indicated Patient Age Range
patients greater than 2 years of age
Intended User / Care Setting
hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
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)
Nonclinical tests were performed on the subject device in order to show the technological equivalency to the predicate device and to verify the compliance to design requirements. No special controls exist for this type of device. Device testing included dimensional requirements, continuity, belt buckle function, ability to connect the subject device to a standard PSG recording device, recorded respiratory effort signal quality, packaging testing and comparative performance testing to the predicate.
The comparative performance testing provided direct performance comparison to the actual recorded output signal of each device. Performance testing was performed for the Bluebird rip belt connected to a Cadwell recording device and simultaneously to an XactTrace belt, therefore both belts acting as passive devices, connected to the same Cadwell PSG recorder. The resulting waveforms are the same for both belts.
The passing results of the nonclinical tests and the technological and Indications for Use comparison demonstrate the Bluebird Single-Use Respiratory Effort Belt is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 18, 2024
Cadwell Industries, Inc. Jason Ford Regulatory Affairs Manager 909 North Kellogg St. Kennewick, Washington 99336
Re: K242424
Trade/Device Name: Bluebird Single-Use Respiratory Effort Belt Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: November 15, 2024 Received: November 15, 2024
Dear Jason Ford:
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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K242424
Device Name Bluebird Single-Use Respiratory Effort Belt
Indications for Use (Describe)
The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.
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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K242424 510(k) Summary
Submitter Information
| Submitter Name: | Cadwell Industries, Inc. |
|---|---|
| 909 N. Kellogg Street | |
| Kennewick, Washington 99336 | |
| Submitter Phone: | 509-735-6481 |
| Contact Person: | Jason Ford |
| Regulatory Affairs Manager | |
| Date Summary Prepared: | November 15, 2024 |
| Subject Device |
Trade Name: Common Name: Classification Name:
Bluebird Single-Use Respiratory Effort Belt Respiratory Effort Sensor 21 CFR 868.2375. Ventilatory Effort Recorder, Breathing Frequency Monitor Class II MNR
Product Code:
Predicate Device
510(k) Number: Trade Name: Submitter Name: Classification Name: Product Code:
K173793 XactTrace® Single Use Respiratory Effort Belt System Natus Neurology 21 CFR 868.2375, Breathing Frequency Monitor MNR
Reference Predicate Device
| 510(k) Number: | K151361 |
|---|---|
| Trade Name: | Nox RIP Belts and Nox RIP Belt Cables |
| Submitter Name: | Nox Medical |
| Classification Name: | 21 CFR 868.2375, Breathing Frequency Monitor |
| Product Code: | MNR |
Device Description
The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil.
5
VELL K242424 510(k) Summary
Indications for Use
The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.
Summary of Technological Characteristics and Comparison to the predicate device
The Bluebird employs the same technological characteristics as the predicate device. The following table provides a side-by-side comparison of the Indications for Use and technological characteristics of the subject and predicate devices.
| Feature | XactTrace Single-Use
Respiratory Effort Belt System
(Predicate K173793) | Bluebird Single-Use Respiratory
Effort Belt
(Subject Device) | Equivalence Comments,
Discussion |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The XactTrace® Single Use
Respiratory Effort Belt System is
intended to measure respiratory
effort to assist in the diagnosis of
sleep disorders or sleep related
respiratory disorders. The
respiratory effort signals
measured are processed to
provide electrical signals
suitable for connection to the
inputs of physiological recording
equipment. The intended
environments are hospitals,
institutions, sleep centers, sleep
clinics. The XactTrace Single
Use Respiratory Effort Belt
System is intended for
diagnostics purposes only and is
not intended to be used as an
apnea monitor. | The Bluebird Single-Use
Respiratory Effort Belt is
intended to measure respiratory
effort to assist in the diagnosis
of sleep disorders or sleep
related respiratory disorders.
The respiratory effort belt
signals are suitable for
connection to
sleep/polysomnography (PSG)
systems. The intended
environments are hospitals,
institutions, sleep centers, sleep
clinics, or other test
environments, including the
patient's home.
The Bluebird Single-Use
Respiratory Effort Belt is
intended for diagnostic
purposes only on patients
greater than 2 years of age and
is not intended to be used as an
apnea monitor. | There are no significant differences
in the indications for use between the
subject and predicate device. The
specific use for patients 2 years and
older is the same as found in the
reference device, K151361. |
| Population of use | Adult and pediatric | greater than 2 years of age | No significant differences, see above
comment to reference predicate. |
| Environment of Use | Hospitals, institutions, sleep
centers, sleep clinics or other test
environments, including the
patient's home. | Hospitals, institutions, sleep
centers, sleep clinics, or other
test environments, including the
patient's home. | Equivalent |
| Single patient use | Yes | Yes | Equivalent |
| Duration of use | Duration of
clinical uses, anticipated to be ≤
12 hours. | Duration of
clinical uses, anticipated to be ≤
12 hours. | Equivalent |
| Fundamental
technology | Respiratory Inductive
Plethysmography (RIP) | Respiratory Inductive
Plethysmography (RIP) | Equivalent |
| Compatible
recording
technology | Physiological recording equipment | Physiological recording
equipment | Equivalent |
| Belt Length
Variations | Pre-sized | Pre - sized | Equivalent |
| Patient applied location | Abdomen and Thorax | Abdomen and Thorax | Equivalent |
| Pre-Sized Belt Sizes
(Circumference) | Pre-sized variations of large,
medium, small and pediatric
(inches).
Large: 40 to 75
Medium: 30 to 55
Small: 16 to 35
Pediatric: 11 to 22 | Pre-sized variations of large,
medium, small and pediatric
(inches).
Large: 40 to 75
Medium: 30 to 55
Small: 16 to 35
Pediatric: 11 to 22 | Equivalent |
| Patient contact | Not in direct contact with bare
skin. | Not in direct contact with bare
skin. | Equivalent |
| Belt connectors | Touchproof safety connection,
complying with DIN 42 802 for
Touchproof connection systems. | Touchproof safety connection,
complying with DIN 42 802 for
Touchproof connection systems. | Equivalent |
| Belt Material | Elastic Band with Wire | Elastic Band with Wire | Equivalent |
| Buckle Material | ABS | Polypropylene | Equivalent. Both materials are
commonly used for plastic mold
injection during the manufacturing
process. The differences in material
do not affect the safety or efficacy of
the device. |
| Performance Testing | Dimensional requirements
Buckle functionality
Compatibility with a PSG
recorder
Equivalence of breathing effort
signal output | Dimensional requirements
Buckle functionality
Compatibility with a PSG
recorder
Equivalence of breathing effort
signal output | The performance testing for the
subject device are equivalent to the
predicate within the characteristics
of Dimensional requirements,
Buckle functionality, Compatibility
with a PSG recorder and equivalency
of breathing signal output. |
6
/ 日_ K242424 510(k) Summary
7
K242424 510(k) Summary
humidity Resistance EMC compliance Cleaning
is not required since the subject device is a single use device. EMC and operational testing is not required for the subject device and is mitigated by the PSG recording device requirements. Therefore, these differences do not affect the safety or efficacy of the subject device.
Performance Testing
Nonclinical tests were performed on the subject device in order to show the technological equivalency to the predicate device and to verify the compliance to design requirements. No special controls exist for this type of device. Device testing included dimensional requirements, continuity. belt buckle function, ability to connect the subject device to a standard PSG recording device, recorded respiratory effort signal quality, packaging testing and comparative performance testing to the predicate.
The comparative performance testing provided direct performance comparison to the actual recorded output signal of each device. Performance testing was performed for the Bluebird rip belt connected to a Cadwell recording device and simultaneously to an XactTrace belt, therefore both belts acting as passive devices, connected to the same Cadwell PSG recorder. The resulting waveforms are the same for both belts.
Conclusion
The passing results of the nonclinical tests and the technological and Indications for Use comparison demonstrate the Bluebird Single-Use Respiratory Effort Belt is substantially equivalent to the legally marketed predicate device.