(26 days)
Not Found
No
The description focuses on the mechanical design and function of a balloon catheter for dilation, with no mention of AI or ML capabilities.
Yes
The device is indicated for use in endoscopically dilating strictures of the alimentary tract, which is a therapeutic intervention.
No
The device is used to dilate strictures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines 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 In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the alimentary tract." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a balloon catheter designed for mechanical dilation. It is used to physically expand narrowed areas within the digestive system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the body, not to perform procedures within the body. This device is clearly designed for a therapeutic intervention.
N/A
Intended Use / Indications for Use
Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.
Product codes
FDT, FDF, KNQ
Device Description
The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. It is designed to pass through the working channel of an endoscope and 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 (esophageal, pyloric and colonic)
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
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized caduceus symbol, which is a symbol of medicine and health. The caduceus is depicted with a single snake winding around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
May 31, 2016
Boston Scientific Corporation Endoscopy Janis Taranto Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K110833
Trade/Device Name: CRETM Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDT, FDF, KNQ Dated (Date on orig SE ltr): March 22, 2011 Received (Date on orig SE ltr): March 25, 2011
Dear Janis Taranto:
This letter corrects our substantially equivalent letter of April 20, 2011
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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.
1
Page 2 - Janis Taranto
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 801); medical device reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetw/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 Industry and Consumer Education 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. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
SECTION 4 INDICATIONS FOR USE STATEMENT
KII 0833 510(k) Number (if known): To Be Delemined Device Name: CRETM Balloon Dilatation Catheter Indications for Use: Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.
000013
3
Prescription Use X (Part 21 CFR 801 Subpart 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)
Heidi Leus
ve, Gastro-Renal, and
Special 510(k) Premarket Notification, CRETM Balloon Dilatation Catheter
3
SECTION 5 510(k) SUMMARY
APR 2 0 2011
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: March 21, 2011
2. Proposed Device:
Trade Name: CRE™ Balloon Dilatation Catheter Classification Name: 1) Endoscope and/or accessories 2) Dilator, esophageal Regulation Number: 1) 876.1500 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II
3. Predicate Device:
K974788 Trade Name: CRE™ Balloon Dilatation Catheter Classification Name: CRE™ Balloon Dilatation Catheter Regulation Number: 1) -876.1500 2) 876.5365 Product Code: 1) KOG, 2) KNQ Classification: Class II
4. Proposed Device Description:
The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. It is designed to pass through the working channel of an endoscope and 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. Intended Use:
Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.
000014
Special 510(k) Premarket Notification, CRETM Balloon Dilatation Catheter
4
K 110833
p.g 20 f 2
6. Technological Characteristics:
The proposed CRE™ Balloon Dilatation Catheter is nearly identical in design, materials, and manufacturing processes to the predicate CRE™ Balloon Dilatation Catheter (K974788).
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.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed CRB™ Balloon Dilation Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed CRE™ Balloon Dilatation Catheter (K974788).
000015
Special 510(k) Premarket Notification, CRETM Balloon Dilatation Catheter