(23 days)
No
The summary describes a physical medical device (catheter, dilator, wire guide) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies section refers to quality system procedures and design specifications, not algorithmic performance metrics.
No
The device is used for emergency airway access, which is a life-sustaining intervention, but it does not treat or cure a disease or condition, which is a characteristic of a therapeutic device.
No
The device is described as an emergency airway access tool used when conventional intubation fails, indicating a therapeutic or interventional purpose rather than diagnosis.
No
The device description clearly outlines physical components (catheter, dilator, wire guide) and their dimensions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "emergency airway access when conventional endotracheal intubation and ventilation cannot be performed." This describes a surgical or medical procedure performed directly on a patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The device is a catheter, dilator, and wire guide used for creating an airway. This is a physical medical device used for intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, such as reagents, assays, or detection methods.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to establish an airway, which is a direct medical intervention.
N/A
Intended Use / Indications for Use
The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.
. In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.
Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.
Product codes
73 BWC, JOH
Device Description
The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
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
Specific performance of the device subject of this submission is assured through adherence to the firm's quality system procedures for device quality. Various device design specifications and quality specifications are used to produce a device that meets predetermined acceptance criteria. This is the same as for the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Melker Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated
DEC 2 0 2001
9 510K SUMMARY
Submitted By:
Heidi Masten, RT(T), MBA Regulatory Affairs Coordinator COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 (812) 339-2235
Device:
| Trade Name: | Melker Emergency Cricothyrotomy Catheter Set |
|---|---|
| Common/Usual Name: | Catheter, emergency airway access needle |
| Proposed Classification Name: | Emergency Airway Needle |
| 21 CFR Part 868.5090 | |
| Class II |
Intended Use:
The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.
- . In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.
Device Description:
The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.
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Melker Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to currently marketed devices. This device is the same with respect to indications for use, material and physical characteristics to the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.
Performance Information:
Specific performance of the device subject of this submission is assured through adherence to the firm's quality system procedures for device quality. Various device design specifications and quality specifications are used to produce a device that meets predetermined acceptance criteria. This is the same as for the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01.
Packaging Information:
Each unit is packaged and sealed within a Tyvek-Poly pouch and properly labeled.
Sterilization Information:
The Melker Emergency Cricothyrotomy Catheter Set will be sterilized using an Ethylene Oxide (ETO) gas cycle validated to assure a 10° sterility assurance level.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Ms. Heidi Masten Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489
Re: K013916
Melker Emergency Cricothyrotomy Catheter Set Regulation Number: 868.5090 and 868.5800 Regulation Name: Emergency Airway Needle and Tracheostomy Tube and Tube Cuff Regulatory Class: Class II (two) Product Code: 73 BWC, JOH Dated: November 26, 2001 Received: November 27, 2001
Dear Ms. Masten:
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 for abound in the 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 I ou mayy atterest, while Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Heidi Masten
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
I Dank Tille
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Melker Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated
INDICATIONS FOR USE
Melker Emergency Cricothyrotomy Catheter Set Device Name
Indications for Use:
..
Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | R013116 |
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
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