(146 days)
Used for emergency airway access when conventional endotracheal . intubation and ventilation cannot be performed.
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.
The provided information does not contain any data regarding acceptance criteria or a study proving device performance in relation to such criteria. The document is a 510(k) premarket notification for the Arndt Emergency Cricothyrotomy Catheter Set, primarily focusing on its substantial equivalence to predicate devices and its intended use.
The text describes the device, its indications for use, and a comparison to existing predicate devices (Melker Cuffed Cricothyroid Catheter Set and The Pertrach). The FDA letter confirms the substantial equivalence determination, allowing the device to be marketed. However, no performance metrics, acceptance criteria, or study results are presented.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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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
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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
4
§ 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).