(386 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of a medical device used for emergency airway access, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to establish emergency airway access, which is a medical intervention to treat a life-threatening condition (airway obstruction or inability to intubate).
No
This device is intended to establish emergency airway access, which is a treatment or intervention, not a diagnostic purpose.
No
The device description clearly outlines multiple physical components such as catheters, dilators, needles, and other surgical instruments. The performance studies also focus on the physical properties and performance of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to establish emergency airway access by creating an opening in the cricothyroid membrane. This is a surgical/procedural intervention performed directly on the patient's body.
- Device Description: The device components are instruments and tools used for a surgical procedure (catheters, needles, dilators, scalpel, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) to perform a medical procedure.
N/A
Intended Use / Indications for Use
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.
The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.
Product codes (comma separated list FDA assigned to the subject device)
BWC, OGP, JOH
Device Description
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set consist of an airway catheter, a loading dilator, a wire guide, a catheter needle, and an introducer needle. In addition to these components, standard preparation components, such as a syringe, scalpel, dilator forceps, gauze, drape, tracheostomy tape, and tracheal hook are included. The sets consist of any combination of components appropriate for either percutaneous or surgical placement of a cricothyrotomy tube, or both.
The curved cricothyrotomy catheter is manufactured as a 22 French catheter with a length of 9 centimeters and an inner diameter of 5 millimeters. The loading dilators are either 11 centimeters or 12 centimeters long. The stainless steel wire guide has a 0.038-inch diameter and a length of 40 centimeters. The catheter needle is a two-part needle comprised of a small hubbed catheter sheath covering a hubbed needle. The sheath of the catheter needle is manufactured from fluorinated ethylene propylene tubing. The catheter needle is manufactured using an 18 gage cannula with a length of 7 centimeters. The introducer needle is also manufactured from 18 gage stainless steel and has a length of either 5 centimeters or 7 centimeters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cricothyroid membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following tests have been conducted to ensure reliable design and performance under the specified design requirements:
- Evaluation of Durability of the Cuff (Zero-Time, Three-Year Accelerated Aging): The acceptance criterion was that the cuff must remain fully intact and without any leaks following insertion. The predetermined acceptance criterion was met.
- Tensile Test of the Shaft of the Dilator (Three-Year Real-Time): The acceptance criterion was that the dilator shaft must withstand a minimum force at break of 15 N. The predetermined acceptance criterion was met.
- Magnetically Induced Displacement Force Per ASTM F2052: The displacement force shall be less than or equal to the worst case displacement force due to the earth's gravity. The predetermined acceptance criterion was met.
- Magnetically Induced Torque Per ASTM F2213: The magnetically induced torque shall be less than or equal to the worst case torque due to earth's gravity. The predetermined acceptance criterion was met.
- Radiofrequency Induced Heating: The electrical conductivity of the Melker Emergency Cricothyromtomy Catheter must be
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2017
Cook Incorporated Kotei Aoki Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K160200
Trade/Device Name: Melker Cuffed Emergency Cricothyrotomy Catheter Set -Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set Regulation Number: 21 CFR 868.5090 Regulation Name: Emergency Airway Needle Regulatory Class: II Product Code: BWC, OGP, JOH Dated: January 13, 2017 Received: January 17, 2017
Dear Kotei Aoki:
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.
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tina Kiang
S
Tina Kiang, Ph.D. Acting 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) K160200
Device Name
Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set
Indications for Use (Describe)
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.
The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.
| Type of Use (Select one or both, as applicable) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| のバイト 【 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background is a rectangle with a diagonal cut on the bottom right corner.
510(k) Summary
Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set 21 CFR §868.5090 Date Prepared: 15 February 2017
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Kotei Aoki |
| Applicant Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x102630 |
| Contact Fax Number: | (812) 332-0281 |
Device Information
| Trade Name: | Melker Cuffed Emergency Cricothyrotomy Catheter Set – Percutaneous
Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Emergency airway needle |
| Classification Name: | Emergency airway needle; BWC (21 CFR §868.5090)
Cricothyrotomy Kit; OGP
Tracheostomy tube and tube cuff; JOH |
Predicate Device:
- K010016, Melker Cuffed Emergency Cricothyrotomy Catheter
Device Description:
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set consist of an airway catheter, a loading dilator, a wire guide, a catheter needle, and an introducer needle. In addition to these components, standard preparation components, such as a syringe, scalpel, dilator forceps, gauze, drape, tracheostomy tape, and tracheal hook are included. The sets consist of any combination of components appropriate for either percutaneous or surgical placement of a cricothyrotomy tube, or both.
The curved cricothyrotomy catheter is manufactured as a 22 French catheter with a length of 9 centimeters and an inner diameter of 5 millimeters. The loading dilators are either 11
4
Image /page/4/Picture/11 description: The image is the logo for Cook Medical. The logo is set on a red background. The word "COOK" is in white, bold, sans-serif letters. Below the word "COOK" is the word "MEDICAL" in white, sans-serif letters. The word "MEDICAL" is set on a red background that is slightly darker than the background for the word "COOK".
centimeters or 12 centimeters long. The stainless steel wire guide has a 0.038-inch diameter and a length of 40 centimeters. The catheter needle is a two-part needle comprised of a small hubbed catheter sheath covering a hubbed needle. The sheath of the catheter needle is manufactured from fluorinated ethylene propylene tubing. The catheter needle is manufactured using an 18 gage cannula with a length of 7 centimeters. The introducer needle is also manufactured from 18 gage stainless steel and has a length of either 5 centimeters or 7 centimeters.
Intended Use:
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.
The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.
The intended uses are same as that of the predicate device, the Melker Cuffed Emergency Cricothyrotomy Catheter (K010016).
Comparison to Predicate:
The Melker Cuffed Emergency Cricothyrotomy Catheter Set -Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set are substantially equivalent to the predicate device, the Melker Cuffed Emergency Cricothyrotomy Catheter (K010016), in that these devices have the same intended use, technological characteristics, materials of construction, and are similar in design. The subject device sets offer both percutaneous (Seldinger) and surgical techniques of establishing the airway, and contain sets of accessory components to support both surgical and percutaneous methods of performing emergency cricothyrotomy, as circumstances require.
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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font. Below "COOK" is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font.
Table 1, Table 2, and Table 3 provide the detailed comparison of each subject device to the predicate device.
| Catheter Set - Percutaneous | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Melker Cuffed Emergency | ||
| Cricothyrotomy Catheter | ||
| K010016 | Melker Cuffed Emergency | |
| Cricothyrotomy Catheter Set – | ||
| Percutaneous | ||
| Regulation Number | ||
| Product Code | 1) 21 CFR §868.5090 | |
| BWC |
- 21 CFR §868.5800
JOH | 1) 21 CFR §868.5090
BWC - 21 CFR §868.5800
OGP - 21 CFR §868.5800
JOH |
| Classification Name | 1) Emergency airway needle - Tracheostomy tube and tube cuff | Identical |
| Class | II | Identical |
| Intended Use | Used for emergency airway access
when endotracheal intubation
cannot be performed | Intended to establish emergency
airway access when endotracheal
intubation cannot be performed.
Airway access is achieved utilizing
the percutaneous entry (Seldinger)
technique via the cricothyroid
membrane.[1] |
| Product Illustrations | Image: Predicate Device Product Illustrations | Image: Subject Device Product Illustrations |
Table 1 Substantial Equivalence Comparison Chart for Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous
[1] Both the subject device and the predicate device establish the airway by the percutaneous access. The subject device specifies the access method clearly.
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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The word "MEDICAL" is smaller than the word "COOK".
| Table 1 Substantial Equivalence Comparison Chart for Melker Cuffed Emergency Cricothyrotomy | ||
|---|---|---|
| Catheter Set - Percutaneous (Continued) |
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Melker Cuffed Emergency | |||
| Cricothyrotomy Catheter | |||
| K010016 | Melker Cuffed Emergency | ||
| Cricothyrotomy Catheter Set - | |||
| Percutaneous | |||
| Airway | |||
| Catheter | Material | Polyvinylchloride with | |
| Polyethylene Cuff | Identical | ||
| Inner Diameter | 5 mm | Identical | |
| Outer Diameter | 22 French | Identical | |
| Length | 8 cm | 9 cm[2] | |
| Loading | |||
| Dilator | Material | Polyvinylchloride | Identical |
| Outer Diameter | 14 French | Identical | |
| Length | 14 cm | 12 cm[2] | |
| Tip Shape | Tapered | Identical | |
| Wire Guide | Material | Stainless Steel | Identical |
| Diameter | 0.038 in | Identical | |
| Length | 40 cm | Identical | |
| Catheter | |||
| Needle (if | |||
| applicable) | Catheter Material | Fluorinated Ethylene Propylene | Identical |
| Needle Material | Stainless Steel | Identical | |
| Gage | 18 gage | Identical | |
| Length | 7 cm | Identical | |
| Introducer | |||
| Needle (if | |||
| applicable) | Hub Material | Polycarbonate | Identical |
| Needle Material | Stainless Steel | Identical | |
| Gage | 18 gage | Identical | |
| Length | 7 cm | 5, 7 cm[2] | |
| Needle Coating | Silicone | Identical | |
| Accessory Components | Syringe, Scalpel | Syringe, Scalpel, Tracheostomy | |
| Tape[3] | |||
| MR Compatibility | Not indicated | MR Conditional[4] | |
| Packaging | Tyvek/polyethylene film pouch | Identical | |
| Sterilization | EtO | Identical |
[2] The dimensional variations are within the tolerances on the specifications of the predicate device.
Furthermore, the materials of construction in the respective components are identical.
[3] The Tracheostomy Tape is a legally marketed component and is an accessory for use with cricothyrotomy procedures.
[4] MR testing was not previously done for the predicate device and has been performed, as per FDA Guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Testing to support the MR Conditional status for this device has been provided.
In conclusion, the differences noted in the table above do not raise different questions of safety or effectiveness of the subject device, as compared to the predicate device.
7
Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters at the top. Below that, the word "MEDICAL" is in smaller, bold letters.
| Table 2 Substantial Equivalence Comparison Chart for Melker Cuffed Emergency Cricothyrotomy | |||
|---|---|---|---|
| Catheter Set - Surgical |
| Predicate Device | Subject Device | |
|---|---|---|
| Melker Cuffed Emergency | Melker Cuffed Emergency | |
| Cricothyrotomy Catheter | ||
| K010016 | Cricothyrotomy Catheter Set - | |
| Surgical | ||
| Regulation Number | ||
| Product Code | 1) 21 CFR §868.5090 | |
| BWC |
- 21 CFR §868.5800
JOH | 1) 21 CFR §868.5090
BWC - 21 CFR §868.5800
OGP - 21 CFR §868.5800
JOH |
| Classification Name | 1) Emergency airway needle - Tracheostomy tube and tube cuff | Identical |
| Class | II | Identical |
| Intended Use | Used for emergency airway access
when endotracheal intubation
cannot be performed | Intended to establish emergency
airway access when endotracheal
intubation cannot be performed.
Airway access is achieved utilizing
the surgical technique via the
cricothyroid membrane.[1] |
| Product Illustrations | Image: Predicate Device Product Illustrations | Image: Subject Device Product Illustrations |
| Method of airway access | Percutaneous | Surgical[1] |
[1]The subject device establishes the airway by the surgical access. The appropriate accessory components are provided with the subject device to establish the airway surgically. The Airway Catheter and the Loading Dilator, used in the surgical access, function in the same manner as those used in the percutaneous access. The Airway Catheter is as capable of being placed via the surgical access as via the percutaneous access.
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Image /page/8/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in white, set against a red background. The red background extends behind the word "COOK".
| Table 2 Substantial Equivalence Comparison Chart for Melker Cuffed Emergency Cricothyrotomy | |||
|---|---|---|---|
| Catheter Set - Surgical (Continued) | |||
| Predicate Device | Subject Device | ||
| Melker Cuffed Emergency | Melker Cuffed Emergency | ||
| Cricothyrotomy Catheter | Cricothyrotomy Catheter Set - | ||
| K010016 | Surgical | ||
| Airway | |||
| catheter | Material | Polyvinylchloride with | |
| Polyethylene Cuff | Identical | ||
| Inner Diameter | 5 mm | Identical | |
| Outer Diameter | 22 French | Identical | |
| Length | 8 cm | 9 cm[2] | |
| Loading | |||
| dilator | Material | Polyvinylchloride | Identical |
| Outer Diameter | 14 French | Identical | |
| Length | 14 cm | 11 cm[2] | |
| Tip Shape | Tapered | Blunt[3] | |
| Wire Guide | Material | Stainless Steel | N/A |
| Diameter | 0.038 in | N/A | |
| Length | 40 cm | N/A | |
| Catheter | |||
| Needle (if | |||
| applicable) | Catheter Material | Fluorinated Ethylene Propylene | N/A |
| Needle Material | Stainless Steel | N/A | |
| Gage | 18 gage | N/A | |
| Length | 7 cm | N/A | |
| Introducer | |||
| Needle (if | |||
| applicable) | Hub Material | Polycarbonate | N/A |
| Needle Material | Stainless Steel | N/A | |
| Gage | 18 gage | N/A | |
| Length | 7 cm | N/A | |
| Needle Coating | Silicone | N/A | |
| Accessory Components | Syringe, Scalpel, Tracheostomy | ||
| Tape, Tracheal Hook, Dilator | |||
| Forceps[4] | |||
| MR Compatibility | Not indicated | MR Conditional[5] | |
| Packaging | Tyvek/polyethylene film pouch | Identical | |
| Sterilization | EtO | Identical |
[2] The dimensional variations are within the specifications of the predicate device. Furthermore, the materials of construction in the respective components are identical.
[3] As the surgical access to the airway does not utilize the wire guide, it also does not require a tapered Loading Dilator. The dilator tip is left blunt to help mitigate the risk of perforating the posterior tracheal wall (in the percutaneous access, the same risk is mitigated as the wire guide diverts the protruding tapered dilator tip).
- [4] The Tracheostomy Tape, the Tracheal Hook, and the Dilator Forceps are all legally marketed components and are accessories for use with the cricothyrotomy procedures using the surgical access.
- [5] MR testing was not previously done for the predicate device and has been performed, as per FDA Guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Testing to support the MR Conditional status for this device has been provided.
In conclusion, the differences noted in the table above do not raise different questions of safety or effectiveness of the subject device, as compared to the predicate device.
9
Image /page/9/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background.
Table 3 Substantial Equivalence Comparison Chart for Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set
| Predicate Device | Subject Device | |
|---|---|---|
| Melker Cuffed Emergency | ||
| Cricothyrotomy Catheter | ||
| K010016 | Melker Universal Cuffed | |
| Emergency Cricothyrotomy | ||
| Catheter Set | ||
| Regulation Number | ||
| Product Code | 1) 21 CFR §868.5090 | |
| BWC |
- 21 CFR §868.5800
JOH | 1) 21 CFR §868.5090
BWC - 21 CFR §868.5800
OGP - 21 CFR §868.5800
JOH |
| Classification Name | 1) Emergency airway needle - Tracheostomy tube and tube cuff | Identical |
| Class | II | Identical |
| Intended Use | Used for emergency airway access
when endotracheal intubation
cannot be performed | Intended to establish emergency
airway access when endotracheal
intubation cannot be performed.
Airway access is achieved utilizing
either the percutaneous entry
(Seldinger) technique or the
surgical technique via the
cricothyroid membrane.[1] |
| Product Illustrations | Image: Predicate Device Product Illustration | Image: Subject Device Product Illustration |
| Method of airway access | Percutaneous | Percutaneous, Surgical[1] |
[1] Both the subject device and the predicate device establish the airway by the percutaneous access. The subject device also allows for the surgical method of establishing the airway. The appropriate accessory components are provided with the subject device to establish the airway both percutaneously and surgically. The Airway Catheter and the Loading Dilator, used in the surgical access, function in the same manner as those used in the percutaneous access. The Airway Catheter is as capable of being placed via the surgical access as via the percutaneous access. Each Loading Dilator is easily identified by the tip shape.
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Image /page/10/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif letters on a red background that is a slightly darker shade than the background for the word "COOK".
Table 3 Substantial Equivalence Comparison Chart for Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set (Continued)
| Predicate Device | Subject Device | |||
|---|---|---|---|---|
| Melker Cuffed Emergency | ||||
| Cricothyrotomy Catheter | ||||
| K010016 | Melker Universal Cuffed | |||
| Emergency Cricothyrotomy | ||||
| Catheter Set | ||||
| Airway | ||||
| catheter | Material | Polyvinylchloride with | ||
| Polyethylene Cuff | Identical | |||
| Inner Diameter | 5 mm | Identical | ||
| Outer Diameter | 22 French | Identical | ||
| Length | 8 cm | 9 cm[2] | ||
| Loading | ||||
| dilator | Material | Polyvinylchloride | Identical | |
| Outer Diameter | 14 French | Identical | ||
| Length | 14 cm | 11, 12 cm[2] | ||
| Tip Shape | Tapered | Tapered, Blunt[3] | ||
| Material | Stainless Steel | Identical | ||
| Wire Guide | Diameter | 0.038 in | Identical | |
| Length | 40 cm | Identical | ||
| Catheter | ||||
| Needle | Catheter Material | Fluorinated Ethylene Propylene | Identical | |
| Needle Material | Stainless Steel | Identical | ||
| Gage | 18 gage | Identical | ||
| Length | 7 cm | Identical | ||
| Hub Material | Polycarbonate | Identical | ||
| Introducer | ||||
| Needle | Needle Material | Stainless Steel | Identical | |
| Gage | 18 gage | Identical | ||
| Length | 7 cm | Identical | ||
| Needle Coating | Silicone | Identical | ||
| Accessory Components | Syringe, Scalpel, Tracheostomy | |||
| Tape, Tracheal Hook, Dilator | ||||
| Forceps, Gauze, Drape[4] | ||||
| MR Compatibility | Not indicated | MR Conditional[5] | ||
| Packaging | Tyvek/polyethylene film pouch | Identical | ||
| Sterilization | EtO | Identical |
[2] The dimensional variations are within the specifications of the predicate device. Furthermore, the materials of construction in the respective components are identical.
[3] As the subject device allows both the percutaneous access and the surgical access to the airway, it provides all the appropriate accessory components required for both methods of airway access. Therefore, the subject device provides both the tapered tip dilator and the blunt tip dilator.
[4] The Tracheostomy Tape, the Tracheal Hook, the Dilator Forceps, the Gauze, and the Drape are all legally marketed components and are accessories for use with the cricothyrotomy procedures using either method of airway access.
[5] MR testing was not previously done for the predicate device and has been performed, as per FDA Guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Testing to support the MR Conditional status for this device has been provided.
In conclusion, the differences noted in the table above do not raise different questions of safety or effectiveness of the subject device, as compared to the predicate device.
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Technological Characteristics:
The following tests have been conducted to ensure reliable design and performance under the specified design requirements. These tests include:
- . Evaluation of Durability of the Cuff (Zero-Time, Three-Year Accelerated Aging) – The acceptance criterion was that the cuff must remain fully intact and without any leaks following insertion. The predetermined acceptance criterion was met.
- . Tensile Test of the Shaft of the Dilator (Three-Year Real-Time) – The acceptance criterion was that the dilator shaft must withstand a minimum force at break of 15 N. The predetermined acceptance criterion was met.
- Magnetically Induced Displacement Force Per ASTM F2052, the displacement . force shall be less than or equal to the worst case displacement force due to the earth's gravity. The predetermined acceptance criterion was met.
- Magnetically Induced Torque Per ASTM F2213, the magnetically induced . torque shall be less than or equal to the worst case torque due to earth's gravity. The predetermined acceptance criterion was met.
- Radiofrequency Induced Heating The electrical conductivity of the Melker . Emergency Cricothyromtomy Catheter must be