CPAP Cannulaide is indicated to aid in securing and positioning the nasal interface for neonates and infants undergoing non-invasive ventilation in an acute care setting.

CPAP Cannulaide is a disposable device and is for single patient use only.

Device Description

The CPAP Cannulaide® is a die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface for non-invasive ventilation. The Cannulaide® is applied above the lip and over the nose to provide a protective barrier between the nasal cannula and the patient's skin. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on neonates and infants. It is a non-sterile, single-patient use, disposable device.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "CPAP Cannulaide®" device and focuses on establishing substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance metrics as typically seen in AI/ML validation studies.

Therefore, many of the requested details about acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not present in this type of regulatory submission. This document primarily outlines the device's intended use, features, and how it compares to existing, legally marketed devices to demonstrate that it does not raise new questions of safety or efficacy.

However, I can extract the information that is available and explain why other information is missing.

Device: CPAP Cannulaide®
Regulation Number: 21 CFR 868.5905 (Noncontinuous Ventilator (IPPB) Accessory)
Regulatory Class: Class II
Product Code: BZD
Predicate Device: K100011, headgear accessory as part of Patient Nasal Interface of Fisher & Paykel Bubble CPAP System
Reference Device: K903539, Salter Labs Model # 1015 (Tender Grip)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for an AI/ML algorithm. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

The "reported device performance" is described through non-clinical performance testing intended to show that differences from the predicate device do not raise new safety or efficacy concerns. These are typically engineering and materials tests, not clinical performance metrics against a "ground truth" derived from patient data for diagnostic or treatment-guidance AI.

Acceptance Criterion (Implicit for 510(k) Equivalence)	Reported Device Performance / Evidence
Biocompatibility: Materials are safe for skin contact.	- Evaluated via ISO 10993-1 testing (Surface Contact, Skin, Prolonged Duration (> 24 h to 30 d)).- Tests performed: Cytotoxicity, Sensitization, Irritation.- Additionally, exhaustive Extractable and Leachable testing including a risk-based assessment.- Result: Materials found to be biocompatible and have limited reactivity. Supports no new safety/efficacy concerns compared to predicate.
Securement Performance: Ability to secure nasal interface.	- Comparative securement (peel) testing performed.- Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns and support claims. (Specific peel force values are not provided in this summary but would have been in the full submission).- Claim: Helps to prevent movement of the interface to maintain proper positioning.
Sealing Performance: Ability to aid in sealing nasal prongs.	- Comparative sealing of nasal prongs testing performed.- Seal maintenance testing performed.- Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns and support claims. (Specific seal metrics are not provided).- Claim: Provides a secondary seal around the nasal prongs.
Durability/Shelf-Life: Device maintains performance over time.	- Age / Shelf-life for 2 years testing performed.- Performance in high humidity conditions testing performed.- Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns. (Specific stability data not provided).
Overall Equivalence: Device is as safe and effective as the predicate.	- Substantial Equivalence Conclusion: The CPAP Cannulaide® based upon testing has been found to be substantially equivalent to the predicate accessory bonnet and straps of the F&P Infant Interface (K100011). The differences do not raise new questions of safety or efficacy.

2. Sample Sizes Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable/Not provided. This document describes engineering and biocompatibility testing for a medical device (a physical product), not a data-driven AI/ML model that would have a "test set" of patient data in the conventional sense. The "performance testing" refers to physical tests on the device's material properties and mechanical function, not a dataset of patient cases.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. As above, there isn't medical "data" in the context of patient images or clinical records for an AI/ML model. The tests are on the device itself.

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

Not applicable. There is no "ground truth" established by experts for a "test set" in the context of an AI/ML algorithm's diagnostic or predictive performance. The ground truth for biocompatibility is established by adherence to ISO standards and laboratory testing. The ground truth for mechanical performance (e.g., peel strength, seal integrity) is established through engineering test methods.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method is mentioned, as there is no human interpretation of a "test set" to establish ground truth for an AI/ML clinical application.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is not relevant for this type of physical medical device. MRMC studies are typically performed to assess the impact of an AI/ML system on human reader performance for diagnostic tasks (e.g., radiologists reading images).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical product, not a standalone algorithm.

7. The Type of Ground Truth Used:

Biocompatibility: Established by published international standards (ISO 10993-1) and laboratory testing methods (e.g., cytotoxicity assays, sensitization studies).
Performance: Established by engineering test methods (e.g., peel force measurements, seal integrity tests) designed to quantify the physical properties and functional aspects of the device against predefined specifications (though the numerical specifications themselves are not in this summary).

8. The Sample Size for the Training Set:

Not applicable/Not provided. This is a physical device, not an AI/ML model that is "trained" on a dataset.

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

Not applicable. As above, no training set or associated ground truth.

Summary of Device and its Role:

The CPAP Cannulaide® is a disposable, non-sterile device for neonates and infants undergoing non-invasive ventilation. Its purpose is to aid in securing and positioning the nasal interface and provide a protective barrier between the nasal cannula/interface and the patient's skin. It utilizes a hydrocolloid-coated polyurethane film with an integral hook strip.

The document demonstrates substantial equivalence to predicate devices by comparing:

Indications for Use
Environment of Use
Patient Population
Technology
Materials
Non-clinical performance testing (material biocompatibility, comparative securement, comparative sealing, seal maintenance, age/shelf-life, performance in high humidity).

The core of this 510(k) submission is to ensure the safety and effectiveness of this new physical device in its intended use, primarily through demonstrating that its materials and mechanical function are equivalent to or do not raise new concerns compared to legally marketed devices. It is not an AI/ML software device requiring performance metrics based on analysis of clinical data.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-002

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August 5, 2015

Salter Labs Ms. Aurelia Brownridge Regulatory Associate 2365 Camino Vida Roble Carlsbad, CA 92011

Re: K143700

Trade/Device Name: CPAP Cannulaide® Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 2, 2015 Received: July 6, 2015

Dear Ms. Brownridge:

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 (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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K143700

Device Name

CPAP Cannulaide®

Indications for Use (Describe)

CPAP Cannulaide is indicated to aid in securing and positioning the nasal interface for neonates and infants undergoing non-invasive ventilation in an acute care setting.

CPAP Cannulaide is a disposable device and is for single patient use only.

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

XX Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

Submitter: Salter Labs 2365 Camino Vida Roble Carlsbad. CA 92011 Telephone: (760) 795-7100 Fax: (760)-683-6797
Contact Person: Aurelia Brownridge, Regulatory Associate

Date Summary Prepared: August 4, 2015

Device:
Proprietary Name:	CPAP Cannulaide®
Common Name:	Securement and fixation device
Classification Name:	Noncontinuous Ventilator (IPPB) Accessory
Regulatory Class:	II
Product Code:	BZD
Regulation Number:	21CFR 868.5905

Predicate Device: K100011, headgear accessory as part of Patient Nasal Interface of Fisher & Paykel Bubble CPAP System

Reference: K903539, Salter Labs Model # 1015 (Tender Grip)

Device Description: The CPAP Cannulaide® is a die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface for non-invasive ventilation. The Cannulaide® is applied above the lip and over the nose to provide a protective barrier between the nasal cannula and the patient's skin. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on neonates and infants. It is a non-sterile, single-patient use, disposable device.

Indications For Use: CPAP Cannulaide® is indicated to aid in securing and positioning the nasal interface for neonates and infants undergoing non-invasive ventilation in an acute care setting.

CPAP Cannulaide is a disposable device and is for single patient use only.

Patient Population: The intended patient population is neonatal and infant.

Environment of Use: Hospitals. Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

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Substantial Equivalence Discussion

The CPAP Cannulaide® is viewed as substantially equivalent to the predicate device because:

Indications for Use

. Similar use to predicate, the accessory bonnet and straps of the F&P Infant Interface (K100011); both are intended to aid in securing the nasal interface when non-invasive CPAP is used.
For CPAP therapy, it is important to protect nasal area from patient interface device. The . CPAP Cannulaide® has the same intent as the predicate devices for positioning and securement of the CPAP patient interface device.

Discussion: CPAP Cannulaide® is used in addition to the securement accessory of the predicate K100011 but secures the nasal prongs at the patient's nose and offers a physical barrier between the nasal interface and the septum and the skin.

This difference does not alter the intended use compared to the predicate, thus the CPAP Cannulaide® can be considered substantially equivalent.

Environment of Use

o The environments of use are identical to the predicate accessory bonnet and straps of the F&P Infant Interface (K100011).
Discussion: The environments of use are identical and thus can be considered substantially equivalent.

Patient Population

Similar patient population to the accessory bonnet and straps of the F&P Infant Interface o (K100011).
Patients who are treated with non-invasive ventilation requiring nasal prongs. ●

Discussion: Both the proposed device and the predicate have similar patient populations, neonate and infant, and thus can be considered substantially equivalent.

Technology

The technology of using an adhesive to adhere to the patient's skin and to secure a nasal o cannula is identical to the reference device.
The principles of operation of both the predicate and reference device are for o positioning and securement of nasal interfacing devices.

Discussion: The technology of using an adhesive to a patient's skin and to hold a nasal cannula in place is substantially equivalent to the reference device, Salter Tender Grip (K903539) and in principle to the predicate device, while the predicate accessory bonnet and straps of the F&P Infant interface (K100011) use a bonnet and straps.

Material

The materials used to adhere to the skin and secure the nasal interface have been ● evaluated via ISO 10993-1 testing as well as Extractable and Leachable testing. The materials were found to be biocompatible and have limited reactivity.
Same level of biocompatibility for intact skin surface devices, using established standards ● testing.

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Salter Labs K143700 CPAP Cannulaide®

Discussion: Testing has been conducted on the materials to address biocompatibility per ISO 10993-1. Biocompatibility results support that the materials do not raise any new safety or efficacy concerns compared to the predicate accessory bonnet and straps of the F&P Infant Interface (K100011).

Differences:

Indications for Use

The CPAP Cannulaide® is used in addition to the standard nasal interface securement ● accessory. It is designed to secure the nasal interface near the nose while the standard nasal interface securement accessories do not secure near the nose but along the head.
o The combination of these two securement means support each other to improve the securement and positioning of the nasal interface.

Materials:

. CPAP Cannulaide® uses a hydrocolloid barrier to protect the patient's skin which is recommended for these types of applications. While different than that of the predicate F&P accessory bonnet and straps, the materials have been evaluated via ISO 10993. Based on the biocompatibility results, the materials do not raise any new safety or efficacy concerns compared to the predicate accessory bonnet and straps of the F&P Infant Interface.

Non-clinical Performance Testing:

Material Biocompatibility

G95-1 and ISO 10993-1 classify the proposed device as Surface Contact, Skin, Prolonged Duration (> 24 h to 30 d)

The following tests were performed:

Cytotoxicity ●
Sensitization ●
o Irritation
Additionally, exhaustive Extractable and Leachable testing including a risk-based assessment was also performed

Performance Testing

We performed a number of tests to demonstrate that the changes do not raise any new safety or efficacy concerns, and support the claims. These tests included:

Comparative securement (peel) ●
Comparative sealing of nasal prongs ●
Seal maintenance
Age / Shelf-life for 2 years
o Performance in high humidity conditions

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Salter Labs K143700 CPAP Cannulaide®

Comparison Table:

Device	CPAP Cannulaide®	Predicate K100011 F&PHealthcare FlexiTrunk InfantInterface
Intended Use	CPAP Cannulaide® is a single use,non-sterile device that provides abarrier to protect the nasal area skinon neonates and infants undergoingnoninvasive ventilation, while aidingin positioning and securement, andenabling sealing of the nasal interfaceto the patient. CPAP Cannulaide isintended to be used by trainedclinicians.	The F&P Bubble CPAP infantinterface device is indicated toprovide CPAP to spontaneouslybreathing neonates and infants whorequire breathing support. It includesa nasal interface and means ofsecuring this, both of which areaccessories to the CPAP device.
Indications for Use	CPAP Cannulaide® is indicated to aidin securing and positioning the nasalinterface for neonates and infantsundergoing non-invasive ventilationin an acute care setting.CPAP Cannulaide® is a disposabledevice and is for single patient useonly.	F&P Bubble CPAP Patient NasalInterface is indicated to provideCPAP to spontaneously breathingneonates and infants who requirebreathing support.
Warnings	Do not use to secure endotrachealtubes.Do not use with low or high flowoxygen nasal cannulas.Do not use with nasal CPAP masks.Excess condensation in the CPAPcircuit and interface may interferewith the CPAP Cannulaide adhesionproperties. Follow your facility'sprocedure for managing circuitcondensation.	Not for use with non-spontaneouslybreathing infants, infants notrequiring CPAP support, gas flowsover 15L/min and in non-hospitalenvironments.
Principal ofOperation /Mechanism ofAction	The CPAP Cannulaide® adheres to apatient's skin and allows the nasalcannula to be secured to the CPAPCannulaide® keeping the cannula inplace.Utilizes hydrocolloid adhesive andhook and loop strips to attach to thepatient and secure the cannula.It is used in addition to the standardsecurement devices provided with theCPAP nasal interfaces.	A securing and anchoring accessory,bonnet and straps, are an accessoryto the nasal interface that consists ofprongs, FlexiTrunk, and bonnet withstraps to secure and keep the cannulain place.
Environment of Use	Hospitals, Neonatal Intensive CareUnit (NICU) and Pediatric IntensiveCare Unit (PICU).	Hospitals, clinical environmentssuch as the NICU and PICU.
Device	CPAP Cannulaide®	Predicate K100011 F&PHealthcare FlexiTrunk InfantInterface
Disposable /Reusable	Single patient use, disposable.	Single patient use.
Material BetweenPatient and Device	Adhesive - Hypoallergenic for skin-sensitive individuals.	Cotton / Nylon Blend,Nylon / Neoprene Laminate,Nylon / Polyurethane LaminateSilicone.
Patient Population	Neonates and infants.	Premature and full term neonates upto a weight of 10 kg.
Key Technological Feature
Hydrocolloid	The hydrocolloid helps to provide aprotective barrier between the CPAPinterface and the infant's skin.	The Bubble CPAP interface iscommonly taped to the skin.
Adhesive Strip forSecuring Device	Yes	Yes
Placement of Prongs	Helps to maintain placement of nasalprongs in the nares.	Recommended that placement ofprongs is in the center of nares.
Seal	The nasal opening of the CPAPCannulaide® provides a secondaryseal around the nasal prongs.The nasal prongs provide the primaryseal.	The F&P Nasal Prongs provide thefit and seal in the nares themselves.
Skin Barrier	The CPAP Cannulaide® acts as aprotective barrier between the nasalinterface and the patient's skin.	The F&P Nasal Interface restsdirectly on the skin.
Placement	The CPAP Cannulaide® helps tomaintain a space between the base ofthe nasal prongs and the septum.	The placement of the Patient NasalInterface by F&P is recommended tobe at least 2 mm from the septum,but there is no physical barrier toprevent direct contact with theseptum.
Securement	The hook and loop strips on theCPAP Cannulaide® helps to preventmovement of the interface to maintainproper positioning in addition to thestandard securement device suppliedwith the nasal interface.	The bonnet and side straps help tomaintain proper positioning of nasalinterface but there is no directsecurement of the prongs at thenares.

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Substantial Equivalence Conclusion

The CPAP Cannulaide® based upon testing has been found to be substantially equivalent to the predicate accessory bonnet and straps of the F&P Infant Interface (K100011).

The differences between the proposed device and the predicate do not raise new questions of safety or efficacy.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).