(63 days)
NOT_APPLICABLE
No
The summary describes a mechanical device for facilitating tracheostomy tube placement and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
Explanation: This device is used for insertion of a tracheostomy tube, which is a procedural facilitation, not a direct treatment or therapy.
No
This device is an introducer used to facilitate percutaneous entry for placement of a tracheostomy tube, which is a surgical tool, not a diagnostic one.
No
The device description clearly states it is a physical introducer device used to facilitate percutaneous entry into the trachea, and performance studies involve physical testing (Withdrawal Force Testing and Tensile Testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "controlled elective subcricoid insertion of a tracheostomy tube." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as facilitating "percutaneous entry into the trachea for placement of a tracheostomy tube." This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose, monitor, or screen for diseases or conditions by examining these types of samples.
Therefore, the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a surgical/interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used for controlled elective subcricoid insertion of a tracheostomy tube.
Product codes
JOH
Device Description
The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a device used to facilitate percutaneous entry into the trachea for placement of a tracheostomy tube. A separate, sterile tracheostomy tube is also included in an optional set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Withdrawal Force Testing and Tensile Testing was presented to demonstrate that the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer meets applicable design and performance requirements. The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(k): Device Modification Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 05 November 2009
K093 4621-
510(k) SUMMARY
| Submitted By: | Susanne Galin, RAC | JAN - 8 2010 |
|---|---|---|
| Regulatory Affairs Specialist | ||
| Cook Incorporated | ||
| 750 Daniels Way, P.O. Box 489 | ||
| Bloomington, IN 47402 | ||
| (812) 339-2235 x 2296 | ||
| November 5, 2009 |
Device:
| Trade Name: | Ciaglia Blue Dolphin™ Balloon Percutaneous
Tracheostomy Introducer |
|-------------------------------|----------------------------------------------------------------------------------------------|
| Proposed Classification Name: | Tracheostomy tube and tube cuff
21 CFR §868.5800, Product Code JOH |
| Indications for Use: | Used for controlled elective subcricoid insertion of a
tracheostomy tube. |
| Predicate Devices: | Ciaglia Blue Dolphin™ Balloon Percutaneous
Tracheostomy Introducer, 510(k) number K072148 |
Device Description:
The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a device used to facilitate percutaneous entry into the trachea for placement of a tracheostomy tube. A separate, sterile tracheostomy tube is also included in an optional set.
1
Special 510(k): Device Modification Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 05 November 2009
Substantial Equivalence:
The identical indications for use, technological characteristics, materials of construction, and similar dimensions of the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer as compared to the predicate devices support a determination of substantial equivalence.
Test Data:
Withdrawal Force Testing and Tensile Testing was presented to demonstrate that the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer meets applicable design and performance requirements. The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 8 2010
Ms. Susanne Galin Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way Post Office Box 489 Bloomington, Indiana 47402
Re: K093469
Trade/Device Name: Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: December 10, 2009 Received: December 11, 2009
Dear Ms. Galin:
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 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. Galin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 05 November 2009
Indications for Use
| 510(k) Number (if known): | K093469 |
|---|---|
| Device Name: | Ciaglia Blue DolphinTM Balloon Percutaneous Tracheostomy |
| Introducer | |
| Indications for Use: | Used for controlled elective subcricoid insertion of a tracheostomy |
| tube. |
Prescription Use __ XX _______________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR Over-the-Counter Use :
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDR
L. Shullton
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
'ﺗ :
409346 510(k) Number: _______________________________________________________________________________________________________________________________________________________________