(98 days)
Not Found
No
The document describes a mechanical device for tracheostomy insertion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is an introducer for a tracheostomy tube, which is a surgical procedure to create an opening in the trachea, not a treatment in itself.
No
The device is intended for the "controlled elective subcricoid insertion of a tracheostomy tube," which is a surgical procedure, not a diagnostic one.
No
The device description clearly outlines physical components like a balloon, catheter, needle, wire guide, dilator, and syringe, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "controlled elective subcricoid insertion of a tracheostomy tube." This is a surgical/interventional procedure performed directly on a patient.
- Device Description: The description details a physical device (catheter, balloon, wire guide, dilator, syringe) used for a procedural purpose.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not for direct intervention within the body.
N/A
Intended Use / Indications for Use
The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is intended for controlled elective subcricoid insertion of a tracheostomy tube.
The Ciaglia Cheetah™ Percutaneous Tracheostomy Introducer Set is intended for controlled elective subcricoid insertion of a tracheostomy tube.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The Ciaglia Blue Dolphin™ Balloon Percutancous Tracheostomy Introducer consists of an inflatable balloon on a double lumen 5 Fr inner coaxial catheter shaft; the loading section of the milalable Danbon on a double fullien 9 1 1 11.12 106. 27 and 28 French sizes. The length of the catheter shaft is 21.5 cm with a Luer port for inflation and a Luer port for the wire guide. The calleter shall is 21,5 on with a rated burst pressure of 6 atm. The set components include the balloon catheter, catheter access needle, 0.035" wire guide, dilator, 20 cc controlled syringe and balloon catherer, battleter doods insertion. The set is supplied sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcricoid
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)
Testing includes biocompatibility testing, tensile strength, fatigue, air and liquid leakage; burst pressure and inflation/deflation time.
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
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
JUL 2 9 2004
COOK®
Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
510(k) SUMMARY
| Submitted By: | COOK INCORPORATED
750 Daniels Way, P.O. Box 489
Bloomington, IN 47402-0489 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Bosley, MBA, RAC
Regulatory Affairs Coordinator
Tel: (812) 339-2235 Fax: (812) 332-0281 |
| Date Prepared: | July 27, 2004 |
| 510(k) #: | K041044 |
| Device: | |
| Trade Name: | Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer |
| Common/Usual Name: | Tracheostomy Tube Introducer |
| Classification Name: | Tracheostomy Tube and Tube Cuff, 21 CFR § 868.5800 |
| Class: | Class II |
| Product/Panel Code: | JOH—Anesthesiology Device Panel |
Intended Use:
The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is intended for controlled elective subcricoid insertion of a tracheostomy tube.
Substantial Equivalence:
The subject device is similar with respect to intended use and/or design features to the predicate I he subject device is smiller with substantial equivalence. The subject device is safe and effective and is substantially equivalent to the predicate devices.
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Cook Incorporated | Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer | Class I Exempt |
| Portex Ltd. | Portex Percutaneous Dilatational Tracheostomy Kit | K022212 |
Device Description:
Device Desertiption.
The Ciaglia Blue Dolphin™ Balloon Percutancous Tracheostomy Introducer consists of an inflatable balloon on a double lumen 5 Fr inner coaxial catheter shaft; the loading section of the milalable Danbon on a double fullien 9 1 1 11.12 106. 27 and 28 French sizes. The length of the catheter shaft is 21.5 cm with a Luer port for inflation and a Luer port for the wire guide. The calleter shall is 21,5 on with a rated burst pressure of 6 atm. The set components include the balloon catheter, catheter access needle, 0.035" wire guide, dilator, 20 cc controlled syringe and balloon catherer, battleter doods insertion. The set is supplied sterile and intended for one-time use.
Test Data:
I esting includes biocompatibility testing, tensile strength, fatigue, air and liquid leakage; burst pressure and inflation/deflation time.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2004
Ms. Jennifer Bosley Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402-0489
Re: K041044
Trade/Device Name: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: June 28, 2004 Received: June 29, 2004
Dear Ms. Bosley: ﺮ ﺍﻟﻤﺮﺍﺟﻊ
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.
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.
2
Page 2 -Ms. Bosley
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. or the Free of any 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 and houng (21 ce ready in the quality systems (QS) regulation (21 CFR Part 820); and if requireme as leverronic 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 premiumer hotellers and the 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), rr you dontact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Clus
Tricia Lynn, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K041044
Ciaglia Cheetah™ Percutaneous Tracheostomy Introducer Set Device Name:
Indications for Use:
The Ciaglia Cheetah™ Percutaneous Tracheostomy Introducer Set is intended for controlled elective subcricoid insertion of a tracheostomy tube.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aury Solem
Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control. Den
510(k) Number.__
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