(146 days)
Not Found
No
The device description and performance summary focus on mechanical components and physical testing, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is used for emergency airway access and addresses a medical condition (inability to perform intubation and ventilation), which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an emergency airway access device used for cricothyrotomy, which is a therapeutic procedure to establish an airway, not to diagnose a condition.
No
The device description clearly outlines physical components like a catheter, connector, tubing, dilator, and needle, indicating it is a hardware medical device, not software-only.
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 is a direct intervention on a patient's body for a medical procedure.
- Device Description: The device is a catheter designed for insertion into the airway. This is a surgical or procedural device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of specimens.
Therefore, the Patil Cricothyroid Catheter is a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Patil 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 (comma separated list FDA assigned to the subject device)
73 BWC, 73 BTO
Device Description
The Patil 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 over a needle is used for insertion. 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
The results of the tests performed provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a cricothyrotomy catheter.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Patil Emergency Cricothyrotomy Catheter Response to request for additional information COOK INCORPORATED
FEB 2 1 2002
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: | Patil Cricothyroid Catheter Se |
| | Proposed Classification: | Emergency Airway Needle |
| Predicate Devices: | Melker Cuffed
Cricothyroid Catheter | Marketed & Distributed by
Cook Inc. (K010016) |
| | The Pertrach | Marketed and Distributed by
Pertrach Inc. (K914743) |
Device Description:
The Patil 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 over a needle is used for insertion. The catheter will be included in a set consisting of appropriately sized components.
Indications for Use:
The Patil 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 Patil 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.
26
1
Test Data:
The results of the tests performed provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a cricothyrotomy catheter.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
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: K013252
Patil 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 wone reviewed your was your we device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in 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 and Councell Prov (110). - 100). - 100 are responsible to determine that the medical devices you prorisions of the Frea 110 it 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 May 20, 1973, and entires components in bulk (i.e., unfinished) and further process (e.g., sterilize) parenase your a ree 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
3
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 I lease be actived that I Dr. over device complies with other requirements of the Act that I DA has made a covernment in the maintistered 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 requirements as bet form in moduct 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) This icher will anow you to begin maing of substantial equivalence of your device to a legally prematicate 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 (21 Of Compliance at (301) 594-4648. Additionally, for questions on the promotion and Office of Compliance at (301) se contact the Office of Compliance at (301) 594-4639. Also, advertising or your devices, preference to premarket notification"(21 CFR please note the regulation on your responsibilities under the Act may be obtained I art 007.97). Other general 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,
Dakota
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Patil Emergency Cricothyrotomy Catheter Set 510(k) Premarket Notification Cook Incorporated
INDICATIONS FOR USE
Patil 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 K013252
ription Use OR Over-the-Counter Use
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________