(224 days)
No
The device description and performance studies focus on material properties, securement, and sealing, with no mention of AI or ML algorithms. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device aids in securing and positioning a nasal interface for non-invasive ventilation and provides a protective barrier; it does not directly treat a medical condition.
No
The device is described as an aid in securing and positioning a nasal interface for non-invasive ventilation and provides a protective barrier. Its function is entirely support and protective, not to identify or assess a medical condition.
No
The device description clearly states it is a physical, disposable device made of hydrocolloid-coated polyurethane film with an integral hook strip. It is applied to the skin and is subject to biocompatibility and performance testing related to its physical properties.
Based on the provided information, the CPAP Cannulaide is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- CPAP Cannulaide Function: The CPAP Cannulaide is a physical device applied externally to the skin to help secure and position a nasal interface for ventilation. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it's for securing and positioning a nasal interface, not for diagnosis.
- Device Description: The description details a physical product made of film and hook material, not a reagent, instrument, or kit for analyzing samples.
Therefore, the CPAP Cannulaide falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal area, nose, nasal prongs, septum, nares, skin
Indicated Patient Age Range
neonates and infants
Intended User / Care Setting
trained clinicians.
Hospitals, Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).
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
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
- 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
- Performance in high humidity conditions
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-002
Image /page/0/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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.
1
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
2
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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Page 1 of 1
3
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).
4
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.
Page 2 of 6
5
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
6
Salter Labs K143700 CPAP Cannulaide®
Comparison Table:
| Device | CPAP Cannulaide® | Predicate K100011 F&P
Healthcare FlexiTrunk Infant
Interface |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | CPAP Cannulaide® is a single use,
non-sterile device that provides a
barrier to protect the nasal area skin
on neonates and infants undergoing
noninvasive ventilation, while aiding
in positioning and securement, and
enabling sealing of the nasal interface
to the patient. CPAP Cannulaide is
intended to be used by trained
clinicians. | The F&P Bubble CPAP infant
interface device is indicated to
provide CPAP to spontaneously
breathing neonates and infants who
require breathing support. It includes
a nasal interface and means of
securing this, both of which are
accessories to the CPAP 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. | F&P Bubble CPAP Patient Nasal
Interface is indicated to provide
CPAP to spontaneously breathing
neonates and infants who require
breathing support. |
| Warnings | Do not use to secure endotracheal
tubes.
Do not use with low or high flow
oxygen nasal cannulas.
Do not use with nasal CPAP masks.
Excess condensation in the CPAP
circuit and interface may interfere
with the CPAP Cannulaide adhesion
properties. Follow your facility's
procedure for managing circuit
condensation. | Not for use with non-spontaneously
breathing infants, infants not
requiring CPAP support, gas flows
over 15L/min and in non-hospital
environments. |
| Principal of
Operation /
Mechanism of
Action | The CPAP Cannulaide® adheres to a
patient's skin and allows the nasal
cannula to be secured to the CPAP
Cannulaide® keeping the cannula in
place.
Utilizes hydrocolloid adhesive and
hook and loop strips to attach to the
patient and secure the cannula.
It is used in addition to the standard
securement devices provided with the
CPAP nasal interfaces. | A securing and anchoring accessory,
bonnet and straps, are an accessory
to the nasal interface that consists of
prongs, FlexiTrunk, and bonnet with
straps to secure and keep the cannula
in place. |
| Environment of Use | Hospitals, Neonatal Intensive Care
Unit (NICU) and Pediatric Intensive
Care Unit (PICU). | Hospitals, clinical environments
such as the NICU and PICU. |
| Device | CPAP Cannulaide® | Predicate K100011 F&P
Healthcare FlexiTrunk Infant
Interface |
| Disposable /
Reusable | Single patient use, disposable. | Single patient use. |
| Material Between
Patient and Device | Adhesive - Hypoallergenic for skin-
sensitive individuals. | Cotton / Nylon Blend,
Nylon / Neoprene Laminate,
Nylon / Polyurethane Laminate
Silicone. |
| Patient Population | Neonates and infants. | Premature and full term neonates up
to a weight of 10 kg. |
| Key Technological Feature | | |
| Hydrocolloid | The hydrocolloid helps to provide a
protective barrier between the CPAP
interface and the infant's skin. | The Bubble CPAP interface is
commonly taped to the skin. |
| Adhesive Strip for
Securing Device | Yes | Yes |
| Placement of Prongs | Helps to maintain placement of nasal
prongs in the nares. | Recommended that placement of
prongs is in the center of nares. |
| Seal | The nasal opening of the CPAP
Cannulaide® provides a secondary
seal around the nasal prongs.
The nasal prongs provide the primary
seal. | The F&P Nasal Prongs provide the
fit and seal in the nares themselves. |
| Skin Barrier | The CPAP Cannulaide® acts as a
protective barrier between the nasal
interface and the patient's skin. | The F&P Nasal Interface rests
directly on the skin. |
| Placement | The CPAP Cannulaide® helps to
maintain a space between the base of
the nasal prongs and the septum. | The placement of the Patient Nasal
Interface by F&P is recommended to
be at least 2 mm from the septum,
but there is no physical barrier to
prevent direct contact with the
septum. |
| Securement | The hook and loop strips on the
CPAP Cannulaide® helps to prevent
movement of the interface to maintain
proper positioning in addition to the
standard securement device supplied
with the nasal interface. | The bonnet and side straps help to
maintain proper positioning of nasal
interface but there is no direct
securement of the prongs at the
nares. |
7
8
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.