(61 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical medical device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an introducer used to facilitate the placement of a tracheostomy tube, which is a procedural device rather than a therapeutic one itself. It does not directly treat a disease or condition.
No
Explanation: The device is described as an introducer used to facilitate the placement of a tracheostomy tube, which is an interventional procedure, not a diagnostic one. No mention of diagnostic capabilities (e.g., detecting, analyzing, or monitoring medical conditions) is made.
No
The device description explicitly lists multiple hardware components, including a catheter, wire guide, needles, dilators, and other physical items. The performance studies also focus on physical properties like balloon compliance, burst strength, and tensile testing, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled elective subcricoid insertion of a tracheostomy tube." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a tool used to facilitate entry into the trachea for placing a tracheostomy tube. It includes components like a catheter, wire guide, needles, dilators, etc., all designed for a surgical intervention.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
The device is clearly intended for a surgical procedure performed in vivo (within the living body), not for in vitro (in glass/outside the body) diagnostic testing.
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcricoid (for tracheostomy tube insertion)
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 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.
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 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 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:
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 Tracheostomy |
| Introducer | |
| Indications for Use: | Used for controlled elective subcricoid insertion of a tracheostomy |
| tube. |
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-