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.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for the CRE™ Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a predicate device after a minor material formulation change. This type of submission generally relies on non-clinical data (e.g., bench testing, biocompatibility) rather than extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.

Therefore, many of the requested categories (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific submission. The focus is on demonstrating that the revised device performs similarly to the predicate device in terms of safety and basic function, not on demonstrating a new clinical performance claim or diagnostic accuracy.

Here's a breakdown based on the information provided and what is typical for a Special 510(k):

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Biocompatibility	AAMI/ANSVISO 10993-1: 2009 standards	"Biocompatibility of the proposed device was confirmed via AAMI/ANSVISO 10993-1: 2009, and included Cytotoxicity, Sensitization Intracutaneous Reactivity (Irritation)."
In-vitro Testing (Functional/Mechanical)	"required specifications"	"all components, subassemblies, and/or full devices met the required specifications for the completed tests including: chemical analysis, biocompatibility and tensile strength."
Design and Manufacturing Process	Identical to predicate device	"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."

Study Details (Not Applicable/Not Provided for this Type of Submission)

This submission is a Special 510(k) for a minor change, which primarily focuses on bench testing and comparison to an already cleared predicate. Therefore, detailed clinical study information as requested is not available in this document.

Sample size used for the test set and the data provenance: Not applicable for a Special 510(k focused on material change and bench testing. No clinical test set details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as part of this type of submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical medical device (a balloon dilatation catheter), not an AI/imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is compliance with engineering specifications and biocompatibility standards.
The sample size for the training set: Not applicable. This device is a mechanical medical device, not an AI/machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of the Study and Conclusion from the Document:

The "study" described here is primarily a series of pre-clinical tests (biocompatibility and in-vitro functional/mechanical testing) and a design comparison to the predicate device.

Study Goal: To demonstrate that the proposed CRE™ Balloon Dilatation Catheter with a minor material formulation change to its flexible tip is substantially equivalent in terms of safety and effectiveness to the predicate CRE™ Balloon Dilatation Catheter (K971320).
Methods:
- Biocompatibility Testing: Conducted according to AAMI/ANSVISO 10993-1: 2009, including Cytotoxicity, Sensitization, and Intracutaneous Reactivity (Irritation).
- In-vitro Testing: Performed on components, subassemblies, and/or full devices to ensure they met required specifications for chemical analysis, biocompatibility, and tensile strength (likely referring to mechanical and material integrity tests).
- Design Comparison: The proposed device's design and manufacturing processes are stated to be identical to the predicate, with the exception of the minor material formulation change.
Results/Conclusion: Boston Scientific Corporation demonstrated that the proposed device, with its minor modifications, is substantially equivalent to the predicate device. This conclusion was based on the fulfillment of biocompatibility standards and in-vitro functional testing, coupled with the assertion of identical design and manufacturing except for the specified material change. The FDA's letter (K122924) confirms this determination of substantial equivalence.

Summary

{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 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}------------------------------------------------

Page 2 -

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,

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

Regulation Number and Section

§ 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.