(87 days)
No
The summary describes a mechanical balloon dilator and does not mention any AI/ML components or capabilities.
Yes
The device is indicated for dilating strictures of the esophagus, which is a therapeutic intervention.
No
Explanation: The device is described as a "balloon dilator" used to "endoscopically dilate strictures of the esophagus," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components (distal tip, balloon, catheter shaft, proximal hub), indicating it is a hardware device, not software-only.
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, not a test performed on a sample taken from the body.
- Device Description: The description of the device components (tip, balloon, catheter shaft, hub) aligns with a device used for a physical intervention, not for analyzing a biological sample.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
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.
Product codes
KNQ
Device Description
The Maxforce TTS Single-Use Balloon Dilator consists of a distal tip, balloon, catheter shaft, and proximal hub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
adults 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific Maxforce TTS Single-Use Balloon Dilator (K934697)
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
K061787 Page 1 of 2
SEP 2 1 2006
510 (k) SUMMARY
| SPONSOR: | Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Wing Ng
Regulatory Affairs Specialist
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
Tel: (508) 683-4141
Fax: (508) 683-5939
Date 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 Balloon
Dilator (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 TTS
Single-Use Balloon Dilator is indicated for use in adults
and adolescent populations to endoscopically dilate
strictures 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.
1
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).
2
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
3
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
4
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