(37 days)
Not Found
No
The summary describes a mechanical device (extraction balloon) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used for the endoscopic removal of stones in the biliary system, which constitutes a treatment of a medical condition.
No
The device is described as an "Extraction Balloon" used for "endoscopic removal of stones" and "contrast injection" in the biliary system. Its primary function is therapeutic (removing stones) and possibly imaging support (contrast injection), not diagnosing a medical condition.
No
The device description clearly states it is an "Extraction Balloon," which is a physical medical device used for endoscopic procedures. There is no mention of software as the primary component or function.
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 "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.
- Device Description: The device is an "Extraction Balloon" used for a physical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, this device falls under the category of a medical device used for a therapeutic procedure, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Tri-Ex Extraction Balloon with Multiple Sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.
Product codes
78 GCA
Device Description
The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing 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 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
FEB 27 2004
510(k) Summary of Safety and Effectiveness: K040129
| SPONSOR: | Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105 |
|---|---|
| CONTACT/SUBMITTER: | Marge Walls-Walker Regulatory Affairs Specialist [336] 744-0157 Ex.290 |
| DATE OF SUBMISSION: | February 13, 2004 |
| DEVICE: | Tri-Ex Extraction Balloon with Multiple Sizing |
| Trade Name: | Tri-Ex Extraction Balloon with Multiple Sizing |
| Common Name: | Extraction Balloon |
| Classification: | Catheter, Biliary, Surgical, Class II 21 CFR § 876.5010 78 GCA |
| PREDICATE DEVICES: | Wilson-Cook Triple Lumen Balloon Stone Extractor (K953951) |
| INTENDED USE: | Wilson-Cook's Tri-Ex Extraction Balloon with Multiple Sizing is for endoscopic removal of stones in the biliary system and for contrast injection. |
| DEVICE DESCRIPTION: | The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing is supplied sterile and intended for single use only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be substantially equivalent to currently marketed Wilson-Cook biliary extraction balloons as cleared by K953951 |
| PERFORMANCE DATA: | We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility. |
:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040129
Trade/Device Name: Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 GCA Dated: February 13, 2004 Received: February 17, 2004
Dear Ms. Walls-Walker:
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 cither 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.
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.
2
Page 2
This letter will allow you to begin marketing your device as described in your Section S10(k) I mis lotter 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _KO40129
Device Name: Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing
Indications for Use:
The Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Per 21 CFR § 801.109
OR
Over-the-Counter
Nancy broadon
(Division Sign-Off) / Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number