(260 days)
Not Found
No
The summary describes a mechanical device and its components, focusing on physical performance tests and biocompatibility. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
This device is a therapeutic device because its intended use is to provide emergency airway access to patients, which is a direct medical intervention to treat a life-threatening condition.
No
The device is described as an emergency airway access device used when conventional ventilation cannot be performed, and its purpose is to create an artificial airway. It does not perform any diagnostic function.
No
The device description clearly outlines a physical medical device with multiple hardware components (tube, dilator, scalpel, needle, syringe, guidewire, neckband, saline solution) and describes performance testing related to the physical properties and functionality of these components. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide emergency airway access, which is a direct intervention on the patient's body.
- Device Description: The device is a set of tools used to create an artificial airway. It involves physical manipulation and insertion into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples in vitro (outside the living organism). This device is used in vivo (within the living organism) to establish an airway.
N/A
Intended Use / Indications for Use
Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.
Product codes (comma separated list FDA assigned to the subject device)
BWC
Device Description
The Rusch EasyCric Emergency Cricothyrotomy Set is a sterile, single use emergency cricothyroidotomy set available in size 5 mm. The device employs the Seldinger technique to provide an emergency artificial airway when attempts to intubate the trachea fail. Cricothyroidotomy provides faster access in emergency situations than surgical or percutaneous tracheostomy, which are time consuming procedures. The device gains access by cutting the link between the cricoid cartilage and the thyroid cartilage into the ligamentum conicum. It is available uncuffed. Components of the set include the EasyCric tube and insertion dilator, scalpel, puncture needle, syringe, guidewire, comport neckband and saline solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway / cricothyroid membrane
Indicated Patient Age Range
Adult Patients
Intended User / Care Setting
Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital
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)
Performance - A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:
| Test | Reference to Standard (if applicable) | Principle of Test | Acceptance Criteria |
|---|---|---|---|
| Connector bonding strength | ISO 5366-1 Section 6.1 Machine end | The security of the attachment of the connector to the tracheostomy tube is tested by applying an axial separation force to the connector | Must be able to sustain axial force of 15 ± 1.5N without movement |
| Flange (neck-plate) bonding strength | ISO 5366-1 Section 6.2. Neck-plate | The security of the attachment of the neck-plate to the tracheostomy tube is tested by applying an axial separation force to the neck-plate (flange) | Must be able to sustain axial force of 15 ± 1.5N without movement |
| Connector Fit Test (ring gauge test) | ISO 5356: Section 5.1 | To ensure the connector is compatible with other supporting connectors and devices | The connector's leading edge shall lie between the minimum and maximum diameter steps of the gauge. |
| Coating consistency on the tube | N/A | Determines coating consistency | Smooth and even coating on the tube |
| Coating lubricity | N/A | Determines coating lubricity | Wear value of less than 150% |
| Visual Inspection of Saline, Scalpel and Neckband | N/A | Demonstrates these components remain intact | No torn packaging or damage to the product |
| Guidewire testing | N/A | Demonstrates guidewire remains compatible with the introducer and needle post worst case conditions | Smooth insertion without restriction |
| Biocompatibility testing | 10993-1 | Testing was performed based on mucosal/external communicating contact of limited duration ( |
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).
0
Name, Address, Phone and Fax Number of Applicant
· Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4908 Fax: 919-433-4996
Contact Person
NOV 0 6 2013
Lori Pfohl Regulatory Affairs Specialist
Device Name
Trade Name: Rusch EasyCric Emergency Cricothyrotomy Set
Common Name: Emergency Cricothyrotomy Kit
Classification Name: Emergency Airway Needle (Class II per 21 CFR 868.5090, Product Code BWC, Class 2)
Predicate Device
Melker Emergency Cricothyrotomy Catheter Set - K013916
Device Description
The Rusch EasyCric Emergency Cricothyrotomy Set is a sterile, single use emergency cricothyroidotomy set available in size 5 mm. The device employs the Seldinger technique to provide an emergency artificial airway when attempts to intubate the trachea fail. Cricothyroidotomy provides faster access in emergency situations than surgical or percutaneous tracheostomy, which are time consuming procedures. The device gains access by cutting the link between the cricoid cartilage and the thyroid cartilage into the ligamentum conicum. It is available uncuffed. Components of the set include the EasyCric tube and insertion dilator, scalpel, puncture needle, syringe, guidewire, comport neckband and saline solution.
Indications for Use
Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.
1
Patient Population: Adult Patients
Environment of Use: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital
Substantial Equivalence
The proposed device is substantially equivalent to the predicate device:
| Features | Proposed | Predicate |
|---|---|---|
| K013916 | ||
| Device | Rusch EasyCric Emergency | |
| Cricothyrotomy Set | Melker Emergency Cricothyrotomy | |
| Catheter Set | ||
| Indications for use | Rusch EasyCric Emergency | |
| Cricothyrotomy Set is indicated to | ||
| provide emergency airway access | ||
| when conventional intubation | ||
| cannot be performed | Melker Emergency Cricothyrotomy | |
| Catheter Set is used for emergency | ||
| airway access in patients whom | ||
| conventional endotracheal intubation | ||
| and ventilation cannot be performed | ||
| FDA Product Code | BWC 868.5090 | BWC 868.5090 |
| JOH 868.5800 | ||
| Class | II | II |
| Environment of Use | Hospital Operating Room, | |
| Intensive Care Unit, the | ||
| Emergency Room or out of the | ||
| Hospital | Not Stated | |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Technology applied | Seldinger Technique via the | |
| cricothyroid membrane | Same | |
| Single use | Yes | Same |
| Size (Main Tube) ID | 5 mm | 3.5mm, 4.0mm and 6.0mm |
| Main Tube length | 7cm | 3.8cm, 4.2cm, and 7.5cm |
| Cuff | No | Same |
| Available in sets | Yes | Same |
| Connection to | ||
| ventilation source | 15 mm connector | Same |
| Method of | ||
| Sterilization | Ethylene Oxide 10-6 SAL | Same |
| Basic Materials of | ||
| construction | Polypropylene | |
| Polyethylene | ||
| Nylon | ||
| PVC | ||
| ABS | ||
| Nickel | ||
| Stainless steel | PVC | |
| Remainder Unknown |
2
| Features | Proposed | Predicate
K013916 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Set Components | Main tube
Curved dilator
Guidewire with flexible tip
Scalpel
Metal Needle
Comfort Neckband
Syringe
Saline Pouch | Main tube
Curved dilator
Guidewire with flexible tip
Scalpel
TFE Catheter needle, Entry needle
Syringe
Trach tape |
| Performance testing | • Connector bonding strength
• Flange (neck-plate) bonding
strength
• Connector Fit Test (ring gauge
test)
• Coating consistency on the
tube
• Coating lubricity
• Visual Inspection of Saline,
Scalpel and Neckband
• Guidewire testing | Not Stated |
- Indications for Use The indications for use are identical for the proposed . device when compared to the predicate -- K013916. Each device is indicated for use in emergency airway management when conventional intubation cannot be performed.
- Technology and construction The design, fabrication, shape, size, etc. are . equivalent to the predicate - K013916. Both the proposed and predicate devices use the Seldinger technique to gain access to the airway.
- Environment of use The environments of use are equivalent to predicate -. K013916
- Patient Population -The patient population is equivalent to the predicate -. K013916
- Materials -All patient contacting materials are in compliance with ISO 10993-1. . Testing performed is listed in the performance summary table below.
3
Performance - A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:
| Test | Reference to
Standard (if
applicable) | Principle of Test | Acceptance
Criteria |
|---------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Connector bonding
strength | ISO 5366-1
Section 6.1
Machine end | The security of the
attachment of the
connector to the
tracheostomy tube is
tested by applying an
axial separation force to
the connector | Must be able to
sustain axial force
of 15 ± 1.5N
without movement |
| Flange (neck-plate)
bonding strength | ISO 5366-1
Section 6.2.
Neck-plate | The security of the
attachment of the neck-
plate to the tracheostomy
tube is tested by applying
an axial separation force
to the neck-plate (flange) | Must be able to
sustain axial force
of 15 ± 1.5N
without movement |
| Connector Fit Test
(ring gauge test) | ISO 5356:
Section 5.1 | To ensure the connector
is compatible with other
supporting connectors
and devices | The connector's
leading edge shall
lie between the
minimum and
maximum
diameter steps of
the gauge. |
| Coating consistency
on the tube | N/A | Determines coating
consistency | Smooth and even
coating on the
tube |
| Coating lubricity | N/A | Determines coating
lubricity | Wear value of less
than 150% |
| Visual Inspection of
Saline, Scalpel and
Neckband | N/A | Demonstrates these
components remain
intact | No torn packaging
or damage to the
product |
| Guidewire testing | N/A | Demonstrates guidewire
remains compatible with
the introducer and
needle post worst case
conditions | Smooth insertion
without restriction |
| Biocompatibility
testing | 10993-1 | Testing was performed
based on
mucosal/external
communicating contact
of limited duration (