(30 days)
Not Found
No
The 510(k) summary describes a mechanical balloon dilatation catheter and does not mention any AI or ML components or functionalities.
Yes
The device is clearly indicated for therapeutic use, as its purpose is to "endoscopically dilate strictures of the esophagus," which directly treats a medical condition.
No
The device is indicated for therapeutic use (dilating strictures) rather than for diagnosing a condition.
No
The device description clearly describes a physical medical device (catheter with a balloon, stainless steel core wire, flexible tip) and does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the esophagus." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon for mechanical dilation. It does not involve the analysis of biological samples (like blood, urine, or tissue) outside of the body, which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic tool used for a physical intervention.
N/A
Intended Use / Indications for Use
The CRE™ Balloon Dilatation Catheter is intended for use in adult and adolescent populations · to endoscopically dilate strictures of the esophagus.
Product codes
KNQ
Device Description
The proposed CRE™ 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. It is designed to be used through an endoscope having a 2.8mm or larger working channel. A stainless steel core wire extends through the entire length of the shaft. The wire is in tension within the balloon, which facilitates the removal of the catheter from the endoscope following balloon dilatation.
The proposed device incorporates a minor material formulation change for the flexible tip of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
adult and adolescent populations
Intended User / Care Setting
endoscopically
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
Biocompatibility of the proposed device was confirmed via AAMI/ANSVISO 10993-1: 2009, and included Cytotoxicity, Sensitization Intracutaneous Reactivity (Irritation),
In-virro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests including: chemical analysis, biocompatibility and tensile strength.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K122924 pg 1 of 2
SECTION 5 510(k) SUMMARY
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: September 21, 2012
2. Proposed Device:
Trade Name: CRE™ Balloon Dilatation Catheter Classification Name: Dilator, Esophageal Regulation Number: 876.5365 Product Code: KNQ Classification: Class II
3. Predicate Device:
Trade Name: CRETM Balloon Dilatation Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K971320 Classification Name: Dilator, Esophageal Regulation Number: 876. 5365 Product Code: 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. Specific balloon sizes are printed on each package and hub label. It is designed to be used through an endoscope having a 2.8mm or larger working channel. A stainless steel core wire extends through the entire length of the shaft. The wire is in tension within the balloon, which facilitates the removal of the catheter from the endoscope following balloon dilatation.
The proposed device incorporates a minor material formulation change for the flexible tip of the device.
5. Indication for Use:
The CRE™ Balloon Dilatation Catheter is intended for use in adult and adolescent populations · to endoscopically dilate strictures of the esophagus.
Special 510(k) Premarket Notification, CRE Fixed Wire Balloon Dilatation Catheter
1
6. Technological Characteristics:
The proposed CRE™ Balloon Dilatation Catheter is identical in design and manufacturing processes to the predicate CRE™ Balloon Dilatation Catheter (K971320) while incorporating a minor formulation change to the flexible tip.
7. Performance Data:
Biocompatibility of the proposed device was confirmed via AAMI/ANSVISO 10993-1: 2009, and included Cytotoxicity, Sensitization Intracutaneous Reactivity (Irritation),
In-virro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests including: chemical analysis, biocompatibility and tensile strength.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Boston Scientific CRETM Balloon Dilatation Catheter with minor device modifications is substantially equivalent to the predicate CRETM Balloon Dilatation Catheter (K971320).
1015
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized symbol resembling a bird or wing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 4 2012
Ms. Janis F. Taranto Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K122924
Trade/Device Name: CRE™ Balloon Dilatation Catheter Regulation Number: 21 CFR& 876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: September 21, 2012 Received: September 24, 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 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); 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 11 Jod attr.cl/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,
Sincerely yours,
Benjamin K. Twitchell
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
KI2292 4
SECTION 4 INDICATIONS FOR USE STATEMENT
To Be Decemine
510(k) Number (if known):
Device Name:
Indications for Use:
CRE™ Balloon Dilatation Catheter
The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C) 000013
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Semler
ivision Sign-Off ivision of Reproductive. Gastro-R urological Devices 510(k) Number
Special 510(k) Premarket Notification, CRE Fixed Wire Balloon Dilatation Catheter