(146 days)
Not Found
No
The description details a mechanical device used for airway access and mentions the Seldinger technique, which is a manual procedure. There is no mention of AI, ML, image processing, or any data-driven components.
Yes
The device is used for emergency airway access and facilitates ventilation, which directly addresses a physiological dysfunction (inability to breathe) and restores a normal bodily function. This aligns with the definition of a therapeutic device.
No
Explanation: The device is used for emergency airway access, which is a therapeutic intervention, not a diagnostic one. It facilitates ventilation when conventional methods fail.
No
The device description clearly outlines physical components like a catheter, connector, tubing, dilator, and wire guide, indicating it is a hardware 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 procedural intervention performed directly on a patient's body.
- Device Description: The description details a catheter, dilator, and wire guide used for insertion into the body using the Seldinger technique. This is consistent with a medical device used for a procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to establish an airway, which is a therapeutic/procedural action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Arndt Cricothyroid Catheter is used for emergency airway access when conventional endotracheal intubation cannot be performed. It is provided in peel-open packages 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, 73 BTO
Device Description
The Arndt Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator provides a transition to a wire guide for insertion. The device is placed using the Seldinger technique. The catheter will be included in a set consisting of appropriately sized components.
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
Not Found
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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Arndt Emergency Cricothyrotomy Catheter Response to request for additional information COOK INCORPORATED
FEB 2 1 2002
Pertrach Inc. (K914743)
K01324/
Set
Safety and Effectiveness Information
| Submitted by: | Heidi Masten | |
|---|---|---|
| Regulatory Affairs Coordinator | ||
| COOK INCORPORATED | ||
| 750 Daniels Way | ||
| P.O. Box 489 | ||
| Bloomington, IN 47402-0489 | ||
| 812-339-2235 | ||
| Device: | Trade Name: | Arndt Cricothyroid Catheter |
| Proposed Classification: | Emergency Airway Needle | |
| Predicate Devices: | Melker Cuffed | Marketed & Distributed by |
| Cricothyroid Catheter | Cook Inc. (K010016) | |
| The Pertrach | Marketed and Distributed b |
Device Description:
The Arndt Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator provides a transition to a wire guide for insertion. The device is placed using the Seldinger technique. The catheter will be included in a set consisting of appropriately sized components.
Indications for Use:
The Arndt Cricothyroid Catheter is used for emergency airway access when conventional endotracheal intubation cannot be performed. It is provided in peel-open packages and is intended for one-time use.
Substantial Equivalence:
The Arndt Cricothyrotomy Catheter is similar in design and intended use to two legally marketed devices including: The Melker Cuffed Cricothyrotomy Catheter Set, manufactured by Cook Inc. and the Pertrach, manufactured by Pertrach Inc.
These devices are used for airway access, have similar technical characteristics and are made of similar materials.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2002
Ms. Heidi Masten Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489
Re: K013241
Arndt Emergency Cricothyrotomy Catheter Set Regulation Number: 868.5090, 868.5800 Regulation Name: Emergency Airway Needle, Tracheostomy Tube and Tube Cuff Regulatory Class: II (two) Product Code: 73 BWC, 73 BTO Dated: December 21, 2001 Received: December 26, 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 additional controls. Existing major regulations affecting your device can be
2
Page 2 - Ms. Heidi Masten
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 with all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); 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 the labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 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,
L. Darden Mell
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arndt Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated
INDICATIONS FOR USE
Arndt 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
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
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