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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the "Bluebird Single-Use Respiratory Effort Belt" (subject device) and its equivalence to a predicate device, the "XactTrace® Single Use Respiratory Effort Belt System."

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format like a clinical trial. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance testing outlined serves to demonstrate that the subject device performs comparably to the predicate and meets design requirements.

Acceptance Criteria (Inferred from Performance Testing)	Reported Device Performance
Dimensional requirements	Passed
Buckle functionality	Passed
Compatibility with a PSG recorder	Passed
Equivalence of breathing effort signal output	"Resulting waveforms are the same for both belts." (Subject vs. Predicate)
Continuity	Passed
Packaging testing	Passed

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a sample size for the comparative performance testing. It mentions "Performance testing was performed for the Bluebird rip belt connected to a Cadwell recording device and simultaneously to an XactTrace belt." This suggests a comparative test, but the number of devices or data points isn't quantified.
Data Provenance: The document does not provide information on country of origin or whether the data was retrospective or prospective. It describes non-clinical laboratory testing ("Nonclinical tests were performed on the subject device").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As this is a non-clinical, performance-based study comparing a physical device to another, the concept of "ground truth" as established by medical experts for diagnostic accuracy studies does not directly apply here. The "ground truth" seems to be the expected physical and electrical performance characteristics of such a device, and its output signal, which were compared against the predicate.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple readers. This information is not applicable/provided as this is a non-clinical performance study comparing two medical devices' physical and electrical outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging devices where human readers interpret patient data. The Bluebird Single-Use Respiratory Effort Belt is a sensor intended to measure respiratory effort, not an interpretive AI tool.
Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) study was not done. This device is a physical sensor, not an algorithm. Its performance is about accurately capturing a physiological signal.

7. Type of Ground Truth Used

The "ground truth" in this context is the expected physical and electrical performance of a respiratory effort belt and its output signal, as demonstrated by the legally marketed predicate device.
The study aimed to show that the subject device's performance, particularly its breathing effort signal output, was equivalent to that of the predicate device. The statement "The resulting waveforms are the same for both belts" indicates that the predicate's output served as the benchmark.

8. Sample Size for the Training Set

Not applicable. This device is a physical sensor, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set was used for an AI/ML algorithm.

Summary

{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 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)
------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------

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}------------------------------------------------

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

{5}------------------------------------------------

VELL K242424 510(k) Summary

Indications for Use

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-UseRespiratory Effort Belt System(Predicate K173793)	Bluebird Single-Use RespiratoryEffort Belt(Subject Device)	Equivalence Comments,Discussion
Indications for Use	The XactTrace® Single UseRespiratory Effort Belt System isintended to measure respiratoryeffort to assist in the diagnosis ofsleep disorders or sleep relatedrespiratory disorders. Therespiratory effort signalsmeasured are processed toprovide electrical signalssuitable for connection to theinputs of physiological recordingequipment. The intendedenvironments are hospitals,institutions, sleep centers, sleepclinics. The XactTrace SingleUse Respiratory Effort BeltSystem is intended fordiagnostics purposes only and isnot intended to be used as anapnea monitor.	The Bluebird Single-UseRespiratory Effort Belt isintended to measure respiratoryeffort to assist in the diagnosisof sleep disorders or sleeprelated respiratory disorders.The respiratory effort beltsignals are suitable forconnection tosleep/polysomnography (PSG)systems. The intendedenvironments are hospitals,institutions, sleep centers, sleepclinics, or other testenvironments, including thepatient's home.The Bluebird Single-UseRespiratory Effort Belt isintended for diagnosticpurposes only on patientsgreater than 2 years of age andis not intended to be used as anapnea monitor.	There are no significant differencesin the indications for use between thesubject and predicate device. Thespecific use for patients 2 years andolder is the same as found in thereference device, K151361.
Population of use	Adult and pediatric	greater than 2 years of age	No significant differences, see abovecomment to reference predicate.
Environment of Use	Hospitals, institutions, sleepcenters, sleep clinics or other testenvironments, including thepatient's home.	Hospitals, institutions, sleepcenters, sleep clinics, or othertest environments, including thepatient's home.	Equivalent
Single patient use	Yes	Yes	Equivalent
Duration of use	Duration ofclinical uses, anticipated to be ≤12 hours.	Duration ofclinical uses, anticipated to be ≤12 hours.	Equivalent
Fundamentaltechnology	Respiratory InductivePlethysmography (RIP)	Respiratory InductivePlethysmography (RIP)	Equivalent
Compatiblerecordingtechnology	Physiological recording equipment	Physiological recordingequipment	Equivalent
Belt LengthVariations	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 75Medium: 30 to 55Small: 16 to 35Pediatric: 11 to 22	Pre-sized variations of large,medium, small and pediatric(inches).Large: 40 to 75Medium: 30 to 55Small: 16 to 35Pediatric: 11 to 22	Equivalent
Patient contact	Not in direct contact with bareskin.	Not in direct contact with bareskin.	Equivalent
Belt connectors	Touchproof safety connection,complying with DIN 42 802 forTouchproof connection systems.	Touchproof safety connection,complying with DIN 42 802 forTouchproof connection systems.	Equivalent
Belt Material	Elastic Band with Wire	Elastic Band with Wire	Equivalent
Buckle Material	ABS	Polypropylene	Equivalent. Both materials arecommonly used for plastic moldinjection during the manufacturingprocess. The differences in materialdo not affect the safety or efficacy ofthe device.
Performance Testing	Dimensional requirementsBuckle functionalityCompatibility with a PSGrecorderEquivalence of breathing effortsignal output	Dimensional requirementsBuckle functionalityCompatibility with a PSGrecorderEquivalence of breathing effortsignal output	The performance testing for thesubject device are equivalent to thepredicate within the characteristicsof Dimensional requirements,Buckle functionality, Compatibilitywith a PSG recorder and equivalencyof 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.

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).