The Boston Scientific Corporation Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

Device Description

The Maxforce TTS Single-Use Balloon Dilator consists of a distal tip, balloon, catheter shaft, and proximal hub.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Maxforce TTS Single-Use Balloon Dilator. It is not a study report or a publication detailing a clinical trial with acceptance criteria and performance metrics in the way a diagnostic AI device might.

Instead, this submission is to add new contraindications to the existing device's Directions for Use, asserting that the device is substantially equivalent to a previously cleared predicate device (K934697) for its intended use. Since there are no new claims for improved performance or a new intended use, a performance study to prove the device meets acceptance criteria in the typical sense for a new diagnostic or AI-driven device is not applicable here.

The "Performance Data" section explicitly states: "FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison support a determination of substantial equivalence for the proposed device when compared to the predicate device." This indicates that the primary "proof" for this submission is based on the device's fundamental design, operating principle, materials, and intended use being the same as the predicate, rather than a clinical performance study with specific metrics.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/diagnostic device cannot be extracted from this document.

Here's an attempt to answer the questions based on the provided text, primarily noting what is not applicable or not specified given the nature of this 510(k) submission:

A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for an existing device with new contraindications and relies on substantial equivalence to a predicate, not performance against new acceptance criteria. No new performance data or acceptance criteria are presented as a direct numerical or statistical outcome in this document.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or clinical data is mentioned for this 510(k) submission. The basis for clearance is "physical comparison" to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment by experts is described in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is described in this submission.
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 physical medical device (balloon dilator), not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is established or discussed for this 510(k) submission. The claim is based on substantial equivalence to a predicate device's design and intended use.
The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/algorithmic device.
How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment is mentioned.

Summary

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K061787 Page 1 of 2

SEP 2 1 2006

510 (k) SUMMARY

SPONSOR:	Boston Scientific Corporation100 Boston Scientific WayMarlborough, MA 01752
CONTACT PERSON:	Wing NgRegulatory Affairs SpecialistBoston Scientific Corporation100 Boston Scientific WayMarlborough, MA 01752Tel: (508) 683-4141Fax: (508) 683-5939Date Prepared: June 23, 2006
DEVICE:
Trade Name:	Maxforce TTS Single-Use Balloon Dilator
Common Name:	Balloon Dilation Catheter
Classification:	Class II, per 21 CFR Part 876, Section 5365
PREDICATE DEVICE:	Boston Scientific Maxforce TTS Single-Use BalloonDilator (K934697).

DEVICE DESCRIPTION: The Maxforce TTS Single-Use Balloon Dilator consists
of a distal tip, balloon, catheter shaft, and proximal hub.

INTENDED USE:	The Boston Scientific Corporation Maxforce TTSSingle-Use Balloon Dilator is indicated for use in adultsand adolescent populations to endoscopically dilatestrictures of the esophagus.
---------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

DESCRIPTION OF
CHANGE FOR THIS
SUBMISSION:
The purpose of this premarket notification is to add four
new contraindications to the Directions for Use of this
device. The four new contraindications are as follows:
➤ Acute or incompletely healed perforation of the
esophagus.
➤ Severe coagulopathy.

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061787

ge 2 of 2

Acute severe abdominal symptoms.
Deeply ulcerated stenosis.

COMPARISON OF CHARACTERISTICS:

The proposed device is substantially equivalent to the currently marketed device, as they have the same fundamental design, operating principal, materials, and intended use.

PERFORMANCE DATA: FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison support a determination of substantial equivalence for the proposed device when compared to the predicate device.

SUBSTANTIAL EQUIVALENCE:

The proposed Maxforce TTS Single-Use Balloon Dilator is substantially equivalent to the predicate Maxforce TTS Single-Use Balloon Dilator (K934697).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a flame.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 1 2006

Mr. Wing Ng Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Way MARI-BOROUGH MA- 01752

Re: K061787

Trade/Device Name: Maxforce TTS Single-Use Balloon Dilator Regulation Number: 21 CFR 8876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: August 22, 2006 Received: August 23, 2006

Dear Mr. Ng:

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 ass battle and 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 either class II (Special Controls) or class III (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your r ipply rary 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are stars surrounding the text at the bottom of the logo. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

Promoting Public 9

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Page 2 -

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.

This teller with allow your to begin marketing your device as described in your Section 510(k) premarket 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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K061787

Special 510(k) Premarket Notification Maxforce™ TTS Single-Use Balloon Dilator Boston Scientific Corporation June 23, 2006

INDICATIONS FOR USE STATEMENT

510(k) Number	To be determined
Device Name	Maxforce TTS Single-Use Balloon Dilator
Indications For Use	The proposed Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Number .

Proprietary and Confidential Information of Boston Scientific Corporation

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.