(63 days)
Used for controlled elective subcricoid insertion of a tracheostomy tube.
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.
Here's the analysis of the provided text regarding the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer:
This 510(k) submission describes a device modification to an already cleared device, not a new device. Therefore, the information provided focuses on demonstrating that the modified device remains substantially equivalent to the predicate device and meets applicable design and performance requirements, rather than presenting a comprehensive study of its clinical effectiveness like one might see for a novel AI/software device.
As a result, many of the requested categories for AI/software device studies will not be present or applicable in this document.
Acceptance Criteria and Device Performance for Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer (K093469)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Performance and Safety/Effectiveness Requirements) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Withdrawal Force | Met applicable design and performance requirements. |
| Tensile Strength | Met applicable design and performance requirements. | |
| Overall Performance | Safety | Provides reasonable assurance that the device is safe for its intended use. |
| Effectiveness | Provides reasonable assurance that the device is effective for its intended use. | |
| Material/Design | Retention of identical indications for use, technological characteristics, materials of construction, and similar dimensions to predicate. | Confirmed as identical indications for use, technological characteristics, materials of construction, and similar dimensions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the Withdrawal Force Testing and Tensile Testing. It only states that these tests were performed. There is no information regarding data provenance (e.g., country of origin, retrospective/prospective), as this typically refers to clinical data, which is not primarily assessed here for a device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks, often found in AI/ML medical devices. The performance evaluation here relies on engineering and mechanical testing standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among human experts when establishing a ground truth for interpretive tasks (e.g., image reading). The testing here is mechanical/physical in nature.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/software device. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical tests would be the established engineering specifications and performance benchmarks for medical devices of this type, likely derived from internal design requirements and industry standards. For substantial equivalence, the performance of the predicate device also acts as a reference.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm. There is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set as per AI/ML paradigms.
Summary of the Study:
The study presented in this 510(k) submission for the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is a design verification study specifically addressing modifications to an already cleared device.
- Objective: To demonstrate that the modified device remains substantially equivalent to its predicate (K072148) and continues to meet applicable design and performance requirements for safety and effectiveness.
- Methods: The primary tests reported are:
- Withdrawal Force Testing: This likely assesses the force required to remove parts of the device or the device itself from a simulated environment, ensuring it functions as intended without premature failure or unintended dislodgement.
- Tensile Testing: This typically measures the maximum stress a material can withstand while being stretched or pulled before breaking, ensuring the structural integrity of the device components.
- Acceptance Criteria (Implicit): The tests were deemed successful because their results "provide reasonable assurance that the device is safe and effective for its intended use" and confirm the device "meets applicable design and performance requirements." This implies that the measured withdrawal forces and tensile strengths fell within pre-defined acceptable ranges, likely benchmarks from the predicate device and relevant engineering standards.
- Ground Truth: The "ground truth" for this type of evaluation is the engineering specifications, performance standards, and the known safe and effective performance of the predicate device.
- Conclusion: The testing supported the claim of substantial equivalence by verifying that the modified device's mechanical properties (withdrawal force and tensile strength) continue to meet the necessary requirements, consistent with the predicate device.
This document does not describe clinical studies, comparative trials, or expert consensus reviews, as it pertains to a physical device modification, not a diagnostic or AI-driven system.
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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 PercutaneousTracheostomy Introducer |
|---|---|
| Proposed Classification Name: | Tracheostomy tube and tube cuff21 CFR §868.5800, Product Code JOH |
| Indications for Use: | Used for controlled elective subcricoid insertion of atracheostomy tube. |
| Predicate Devices: | Ciaglia Blue Dolphin™ Balloon PercutaneousTracheostomy 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.
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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.
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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.
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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
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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 TracheostomyIntroducer |
| Indications for Use: | Used for controlled elective subcricoid insertion of a tracheostomytube. |
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: _______________________________________________________________________________________________________________________________________________________________
§ 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.