(25 days)
Not Found
No
The summary describes a mechanical device (extraction balloon) and does not mention any software, image processing, or AI/ML terms.
No
The device is used for removal of stones, which is a therapeutic intervention, but the document does not explicitly state that the device itself is a "therapeutic device" based on a commonly accepted definition. Rather, it is an accessory used during a therapeutic procedure.
No
The device is described as an "extraction balloon" used for "endoscopic removal of stones" and "contrast injection," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is an "extraction balloon," which is a physical, hardware component used in endoscopic procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic removal of stones in the biliary system and for contrast injection." This describes a procedure performed within the body (in vivo) to treat a condition, not a test performed outside the body (in vitro) on biological samples to diagnose a condition.
- Device Description: The description of an "extraction balloon" used endoscopically further supports its use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical or therapeutic device used in a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used for endoscopic removal of stones in the biliary system and for contrast injection.
Product codes
78 GCA, GCA
Device Description
The subject extraction balloon represents modifications made to existing extraction balloons currently marketed by Cook Endoscopy. The Fusion Quattro Extraction Balloon XL is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
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)
We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process. We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility.
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the text "K063677" on the top line. The second line of text says "PAGE 1 of 1". The text is black and the background is white.
Image /page/0/Picture/1 description: The image shows the word "COOK" in all capital letters. There is a registered trademark symbol after the K. The font is a serif font and the letters are black.
Cook Endoscopy
4900 Bethania Station Road Winston-Salem, NC 27105 Phone: 336 744-0157 Customer Service: 800 457-4500 Fax: 336 744-1147 • 800 743-1147 www.cookendoscopy.com
JAN - 6 2007
510(k) Summary
| Name: | Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road Winston-Salem, NC 27105 |
| Phone: | 336-744-0157 |
| Fax: | 336-201-5994 |
| Contact Person: | Scottie Fariole, Global Regulatory Affairs Specialist |
| Date: | December 8, 2006 |
| Trade Name: | Fusion Quattro Extraction Balloon XL |
| Common Name: | Extraction Balloon |
| Classification Name: | Catheter, Biliary, Surgical (21 CFR 876.5010, Product Code 78 GCA) |
| Legally Marketed Devices: | Tri-Ex Extraction Balloon with Multiple Sizing (K040129) |
| Description of the Device: | The subject extraction balloon represents modifications made to existing extraction balloons currently marketed by Cook Endoscopy. The Fusion Quattro Extraction Balloon XL is supplied sterile and intended for single use only. |
| Intended Use: | Used for endoscopic removal of stones in the biliary system and for contrast injection. |
| Comparison of Characteristics: | We believe the proposed device to be substantially equivalent to currently marketed predicate device as cleared by K040129. |
| Performance Data: | We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process. We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JAN 0 5 2007
Ms. Scottie Fariole Global Regulatory Affairs Specialist Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K063677
Trade/Device Name: Modified Fusion Quattro Extraction Balloon XL Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and Accessories Regulatory Class: II Product Code: GCA Dated: December 8, 2006 Received: December 11, 2006
Dear Ms. Fariole:
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 (Premarket Approval), 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.
Image /page/1/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular in shape and contains the letters FDA in a stylized font. The text is written in a decorative font.
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Page 2 -
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _KO63677
Device Name: Eusion Quattro Extraction Balloon XL
Indications for Use:
Used for endoscopic removal of stones in the biliary system and for contrast injection.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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