(88 days)
Not Found
Not Found
No
The summary describes a balloon dilatation catheter, a mechanical device, and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as being used to "endoscopically dilate strictures of the alimentary tract," which is a medical treatment.
No
Explanation: The device is a balloon dilatation catheter used to dilate strictures, which is a therapeutic rather than diagnostic function.
No
The device is a balloon dilatation catheter, which is a physical medical device, not software.
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 alimentary tract." This is a therapeutic procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to diagnose diseases or other conditions.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes based on laboratory analysis.
The device is a therapeutic medical device used for a physical intervention within the body.
N/A
Intended Use / Indications for Use
The Modificd CRE™ Balloon Dilatation Catheters are 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.
Product codes (comma separated list FDA assigned to the subject device)
78 KNQ, 78 KOG
Device Description
Boston Scientific Corporation believes that the Modified CRE™ Balloon Dilatation Catheter is substannally equivalent to the current CRE™ Balloon Dilatation Catheter and the Vector TTS™ Balloon Dilatation Catheter.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing regarding characteristics was performed on the Modified CRE™ Balloon Dilatation Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patientand fluid-contact materials of the Modified CRE™ Balloon Dilatation Catheter with satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 2 0 1998
510(K) SUMMARY
FOI RELEASABLE
Pursuant to § 513(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Prematket Notification " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
Common/Usual Names: Balloon Dilatation Catheter
TRADE/PROPRIETARY NAME: Modified CRE™ Balloon Dilatation Catherer
| ➤ CLASSIFICATION NAME &
| DEVICE CLASSIFICATION: | |||
|---|---|---|---|
| Class II | |||
| Name | Number | 21 CFR Re | |
| Dilator, Esophageal | 78 KNQ | 876.5365 | |
| Endoscope & Accessories | 78 KOG | 878.1500 | |
| ➤ DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| ➤ OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Owner/Operator No. 9912058 | |||
| ➤ CONTACT PERSON: | Daniel J. Dillon, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Modificd CRE™ Balloon Dilatation Catheters are 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.
CONTRAINDICATIONS
None known.
POTENTIAL COMPLICATIONS
Possible complications that may result from an alimentary tract procedure include, but may not be limited to; perforation; hemorrhage; hematoma; septicemia/infection; allergic reaction to contrast medium.
1
1974788 1202
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Modified CRE™ Balloon Dilatation Catheter is substannally equivalent to the current CRE™ Balloon Dilatation Catheter and the Vector TTS™ Balloon Dilatation Catheter.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on the Modified CRE™ Balloon Dilatation Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patientand fluid-contact materials of the Modified CRE™ Balloon Dilatation Catheter with satisfactory results.
PACKAGING, STERILIZATION, AND PYROGENICITY
The Modified CRETM Balloon Dilation Cather will be packaged both sterile and non-sterile in a Tyvek-Mylar pouch. The Modified CRETM Balloon Dilatation Catheter, when sterilized, will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Because the Modified CRE™ Balloon Dilatation Catheter will not normally contact blood, pyrogenicity testing will not be performed.
CONCLUSION
Boston Scientific Corporation believes that Modified CRETM Balloon Dilatation Cathere is substantially equivalent to the current CRE™ Balloon Dilatation Catheter and the Vector TTSTM Balloon Dilatation Catheter. Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Modified CRE™ Balloon Dilatation Catheter will meet the minimum requirements that are considered acceptable for its intended use.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 20 1998
Mr. Daniel J. Dillon Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K974788 Modified CRE™ Balloon Dilatation Catheter Dated: December 19, 1997 Received: December 22, 1997 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG 21 CFR 876.5365/Procode: 78 KNQ
Dear Mr. Dillon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsmaldsmamain.html".
Sincerely yours
Lillian Yin Ph D
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number:
Device Name: Modified Balloon Dilatation Catheter
Indication for Use:
The Modified Balloon Dilatation Catheters are 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.*
-
- The recommended application on the label may refer to any combination of esophageal, pyloric, and colonic dilatation.
Image /page/3/Figure/6 description: The image contains a thick, dark line that extends diagonally across the frame. The line starts from the upper-left corner and descends towards the lower-right corner. The background is plain white, which makes the dark line stand out prominently.
- The recommended application on the label may refer to any combination of esophageal, pyloric, and colonic dilatation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Ratting /
(Division Sign-Off)
eproductive, Abdominal, ENT.
510(k) Number K974588
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use