(126 days)
Not Found
No
The summary describes a mechanical balloon dilatation catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for endoscopic dilation of strictures, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a dilatation catheter used to physically widen strictures in the alimentary tract and Sphincter of Oddi. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly details a physical catheter with a balloon, guidewire, and locking device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Balloon Dilatation Catheter" used to "endoscopically dilate strictures of the alimentary tract" and the "Sphincter of Oddi." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of Diagnostic Elements: The description does not mention any analysis of biological samples, detection of biomarkers, or any other diagnostic function.
Therefore, the CRE™ Wireguided Balloon Dilatation Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CRE(TM) Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Product codes (comma separated list FDA assigned to the subject device)
KOG, KNQ, FGE
Device Description
The CRE(TM) Wireguided Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.
The CRETM Wireguided Balloon Dilatation Catheter is designed to pass through a 2,8mm or greater working channel of an endoscope and a 3.2 or 4.2 mm (depending on the balloon) or greater working channel of a duodenoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter.
A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, Sphincter of Oddi, biliary tree
Indicated Patient Age Range
adult and adolescent populations
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)
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
A clinical literature search was conducted and the resulting data supports the safety and effectiveness of the CRE(TM) Wireguided Balloon Dilatation Catheter for dilation of strictures of the biliary tree and the Sphincter of Oddi with or without prior sphincterotomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K112994.
pg. 1 of 2
FEB 1 0 2012
510(k) SUMMARY
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4560 Fax: 508-683-5939
Contact: Janis F. Taranto M.S., RAC Regulatory Affairs Specialist Date Prepared: October 9, 2011
2. Device
Trade Name: CRE Dilatation Balloon Common Name: CRE Wireguided Dilatation Balloon Classification Name: 1) Endoscope and/or accessories, 2) dilator, esophageal, 3) Catheter, Biliary, Diagnostic Regulation Number: 1) 876.5010, 2) 876.5365, 3) 876.5010 Product Code: 1) KOG, 2) KNQ, 3) FGE Classification: Class II
3. Predicate Devices
Trade Name: CRE Dilatation Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K110833 Classification Name: 1) Endoscope and/or accessories, 2) dilator, esophageal Regulation Number: 1) 876.5010, 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II
Trade Name: Hurricane RX Biliary Balloon Dilatation Catheter Manufacturer and Clearance Number: Boston Scientific Corporation K001338 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: II
Trade Name: Maxforce Biliary Manufacturer and Clearance Number: Boston Scientific Corporation, K910931 Classification Name: Catheter, Biliary, Diagnostic Regulation Number: 876.5010 Product Code: FGE Classification: II
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K.112994
Pg. 2 of 2
4. Device Description
The CRE™ Wireguided Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.
The CRETM Wireguided Balloon Dilatation Catheter is designed to pass through a 2,8mm or greater working channel of an endoscope and a 3.2 or 4.2 mm (depending on the balloon) or greater working channel of a duodenoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter.
A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.
5. Indication for Use:
The CRETM Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
6. Technological Characteristics:
The proposed CRE™ Wireguided Balloon Dilatation Catheter is identical in design, materials, and manufacturing processes to the predicate CRE™ Wireguided Balloon Dilatation Catheter (K110833).
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
A clinical literature search was conducted and the resulting data supports the safety and effectiveness of the CRE™ Wireguided Balloon Dilatation Catheter for dilation of strictures of the biliary tree and the Sphincter of Oddi with or without prior sphincterotomy.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed CRETM Wireguided Balloon Dilatation Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed CRE™ Wireguided Balloon Dilatation Catheter (K110833), Hurricane RX Biliary Balloon Dilatation Catheter (K001338) and Maxforce Biliary Balloon Dilatation Catheter (K910931).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Janis F. Taranto, M.S. RAC Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Way MARLBOROUGH MA 01752
FEB 1 0 2012
K112994 Re:
Trade Name: CRE™ Wireguided Balloon Dilatation Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 9, 2012 Received: February 10, 2012
Dear Ms. Taranto:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read or at hose 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
3
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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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Civiletti
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
STATEMENT
510(k) Number (if known): K112994
Device Name: CRETM Wireguided Balloon Dilatation Catheter
Indications for Use:
The CRE™ Wireguided Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Prescription Use _ X (Part 21 CFR 801 Part D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carolyn Y Newland for Herb Lenner
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112994