(61 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. The set consists of a balloon-tipped catheter loading dilator assembly, wire guide, introducer needle, needle holder cup, 14 French dilator, gauze pads, disposable syringe, measuring tape, disposable scalpel, lubricating jelly, and a large full-body drape with clear plastic window.
This 510(k) submission describes a device modification, specifically for the "Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer." Such submissions often focus on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device, rather than conducting extensive new clinical studies to establish novel performance criteria. The document provides information on mechanical/physical testing, but not clinical performance with respect to human-in-the-loop or standalone AI performance.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific quantitative acceptance criteria or reported performance for clinical outcomes. Instead, it focuses on engineering and material-based testing to demonstrate substantial equivalence to a predicate device.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (as described) |
|---|---|
| Mechanical/Physical Performance: | |
| Balloon compliance and burst resistance (Implied to be safe and effective) | "Balloon compliance and burst testing" (Results are not quantified, but stated to provide "reasonable assurance that the device is safe and effective.") |
| Failure load resistance (Implied to withstand expected forces) | "Failure load testing" (Results are not quantified, but stated to provide "reasonable assurance that the device is safe and effective.") |
| Withdraw force resistance (Implied to allow for removal) | "Withdraw force testing" (Results are not quantified, but stated to provide "reasonable assurance that the device is safe and effective.") |
| Tensile strength (Implied to withstand pulling forces) | "Tensile testing" (Results are not quantified, but stated to provide "reasonable assurance that the device is safe and effective.") |
| Clinical Performance: | |
| Safe and effective for controlled elective subcricoid insertion of a tracheostomy tube (Implied through substantial equivalence to predicate) | The device is "identical in terms of intended use and technological characteristics to the predicate Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer (K041044)," and "similar in terms of materials of construction." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify sample sizes for the mechanical/physical tests (e.g., how many balloons were tested for burst). For clinical performance, no dedicated human test set data is presented as this is a substantial equivalence submission based on a device modification.
- Data Provenance: The mechanical/physical testing data would originate from Cook Incorporated's internal labs. The document does not specify country of origin for any data or whether the data is retrospective or prospective. Given the nature of a 510(k) for device modification, it's highly likely the testing was conducted internally prior to submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For the mechanical/physical tests, ground truth is established by engineering specifications and objective measurements (e.g., pressure at burst, force required for failure). For clinical performance, no new ground truth was established; instead, substantial equivalence to a previously cleared device (which would have had its safety and effectiveness established) is the basis.
- Qualifications of Experts: Not applicable in the context of this submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests mentioned are objective engineering tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This is expected as the submission is for a device modification seeking substantial equivalence, not a new clinical claim requiring such studies. The device is a medical instrument, not an AI or imaging diagnostic tool that would typically involve MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No, a standalone performance study was not conducted or described. This device is a physical instrument for a medical procedure, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Mechanical/Physical Testing: The ground truth is based on engineering specifications and objective measurements (e.g., pressure, force, tensile strength).
- For Clinical Effectiveness: The ground truth is established by the predicate device's prior clearance, which presumably demonstrated its safety and effectiveness for its intended use through established clinical practice, pre-market data, or other regulatory pathways. The modified device's safety and effectiveness are inferred through its substantial equivalence to this predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical instrument, not an AI system. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Special 510(k): Device Modification Ciaglia Blue Dolphin" Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 02 August 2007
510(k) SUMMARY
Submitted By:
| Susanne Galin |
|---|
| Regulatory Affairs Specialist |
OCT 3 * 2007
Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x 2296 02 August 2007
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:
The Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer is identical in terms of intended use and technological characteristics to the predicate Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer (K041044), and similar in terms of materials of construction.
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}------------------------------------------------
The set consists of a balloon-tipped catheter loading dilator assembly, wire guide, introducer needle, needle holder cup, 14 French dilator, gauze pads, disposable syringe, measuring tape, disposable scalpel, lubricating jelly, and a large full-body drape with clear plastic window.
Substantial Equivalence:
The identical indications for use, technological characteristics, and similar materials of construction of the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer as compared to the predicate device supports a determination of substantial equivalence.
Test Data:
Testing data are presented to demonstrate that the Ciaglia Blue Dolphin™ Balloon Percutaneous Tracheostomy Introducer meets applicable design and performance requirements.
- Balloon compliance and burst testing .
- . Failure load testing
- Withdraw force testing .
- Tensile testing .
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susanne Galin Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way Post Office Box 489 Bloomington, Indiana 47402
OCT 3 2007
Re: K072148
Trade/Device Name: Ciaglia Blue Dolphin™ Balloon Percutancous Tracheostomy Introducer Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: August 31, 2007 Received: September 4, 2007
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 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.
{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); 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chris Lipe, P.E.
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
{4}------------------------------------------------
Special 510(k): Device Modification Ciaglia Blue Dolphin" Balloon Percutaneous Tracheostomy Introducer COOK INCORPORATED 02 August 2007
Indications for Use
| 510(k) Number (if known): | K072148 |
|---|---|
| Device Name: | Ciaglia Blue Dolphin™ Balloon Percutaneous TracheostomyIntroducer |
| Indications for Use: | Used for controlled elective subcricoid insertion of a tracheostomytube. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology | General Hospital, CDRH, Office of Device Evaluation (ODE) |
| Infection Control, Dental Devices |
4072148 510(k) Number: __ -Company Confidential-
§ 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.