(182 days)
The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
The Microvasive CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters. Specific balloon sizes are printed on each package and hub label. The major components of the CRE™ Balloon Dilatation Catheter are the hub, catheter shaft, and the balloon.
The provided text describes a 510(k) premarket notification for the CRE™ Balloon Dilatation Catheter. This is a medical device submission, not an AI/ML device. Therefore, the standard acceptance criteria and study types typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets, etc.) are not applicable here.
The document discusses the following:
1. Acceptance Criteria and Device Performance:
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Acceptance Criteria for medical devices in 510(k) submissions like this primarily revolve around demonstrating substantial equivalence to a previously legally marketed predicate device. This means showing that the new device is as safe and effective as the predicate.
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Reported Device Performance: The document states:
- "Laboratory testing regarding characteristics was performed on the CRE™ Balloon Dilatation Catheter to verify its safety and performance."
- "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the CRE™ Balloon Dilatation Catheter with satisfactory results."
- "The information presented provides assurance that the CRE™ Balloon Dilatation Catheter will meet the minimum requirements that are considered acceptable for its intended use."
Table of Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) type submission):
| Acceptance Criteria (for 510(k) substantial equivalence) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as the predicate. | "Laboratory testing regarding characteristics was performed... to verify its safety." "A biocompatibility assessment was performed... with satisfactory results." The FDA's letter indicates the device is considered substantially equivalent for safety. |
| Performance/Effectiveness: Device performs as intended and is as effective as the predicate. | "Laboratory testing regarding characteristics was performed... to verify its performance." "A comparison of the descriptive characteristics... demonstrate the CRE™ Balloon Dilatation Catheter is equivalent in its indications for use, while being very similar in design and materials." The FDA's letter indicates the device is substantially equivalent for effectiveness. |
| Biocompatibility: Materials are safe for patient contact. | "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the CRE™ Balloon Dilatation Catheter with satisfactory results." |
| Manufacturing Quality: Compliance with quality systems. | The FDA letter states: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided as this is a medical device (catheter), not a software/AI device. The "testing" mentioned is likely mechanical, material, and biocompatibility testing, not "test set" in the AI/ML context.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided as it's not relevant to a physical medical device submission for substantial equivalence. "Ground truth" in the AI/ML sense is not established for this type of device.
4. Adjudication Method:
This information is not provided as it's not relevant to a physical medical device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done or reported. This type of study is for evaluating human performance, typically with or without AI assistance, and is not applicable to a physical medical device like a balloon catheter.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical balloon dilatation catheter, not an algorithm.
7. Type of Ground Truth Used:
Not applicable in the AI/ML sense. For this device, the "truth" is established by adherence to engineering specifications, material properties, and biological safety standards, as verified through laboratory and biocompatibility testing. The predicate devices serve as the benchmark for "truth" in terms of clinical utility and safety profile.
8. Sample Size for the Training Set:
Not applicable. No "training set" in the AI/ML sense is used for this physical device.
9. How Ground Truth for the Training Set was Established:
Not applicable.
In summary: The document establishes the device's conformance primarily through bench testing, biocompatibility assessment, and comparison to predicate devices to demonstrate substantial equivalence, rather than through clinical trials or AI/ML specific validation studies.
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OCT - 9 1997
SECTION 9 510(K) SUMMARY
1 7 1320 10+2
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket 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: | CRETM Balloon Dilatation Catheter | ||
| > CLASSIFICATION NAME &DEVICE CLASSIFICATION: | Class II | ||
| Name | Number | 21 CFR Ref. | |
| Dilator, Esophageal | 78 KNQ | 876.5365 | |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU)Gastro-Renal (GRDB) | ||
| > OWNER/OPERATOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 | ||
| > CONTACT PERSON: | Lisa M. Quaglia, Regulatory Affairs Manager |
Description of Device
The Microvasive CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters. Specific balloon sizes are printed on each package and hub label.
INDICATIONS FOR USE
The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the CRE™ Balloon Dilatation Catheter is substantially equivalent to the currently-marketed Microvasive Vector as well as its MaxForce™ The major components of the CRE™ Balloon Dilatation Catheter are the hub, catheter shaft, and
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the balloon. A thorough comparison of the descriptive characteristics between the CRE™ Balloon Dilatation Catheter and the predicate devices show equivalence.
Performance Characteristics
Laboratory testing regarding characteristics was performed on the CRE™ Balloon Dilatation Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the CRE™ Balloon Dilatation Catheter with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that CRE™ Balloon Dilatation Catheter is substantially equivalent to the currently-marketed Vector and MaxForce™. A comparison of the descriptive characteristics of these products demonstrate the CRE™ Balloon Dilatation Catheter is equivalent in its indications for use, while being very similar in design and materials. In addition. Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the CRE™ Balloon Dilatation Catheter will meet the minimum requirements that are considered acceptable for its intended use.
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Image /page/2/Picture/0 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 9 1997
Ms. Lisa Quaglia Regulatory Affairs Manager Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K971320
CRE™ Balloon Dilatation Catheter Dated: July 18, 1997 Received: July 21, 1997 Regulatory class: II 21 CFR §876.5365/Product code: 78 KNQ
Dear Ms. Quaglia:
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, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 531 through 542 of the Act for devices under 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 (2) CFR Part 801 and additionally 809.10 for in yitro 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/cdrh/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yiu, Ph.D.
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
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SECTION 1 INDICATIONS FOR USE
510(k) Number: To Be Determined
CRE™ Balloon Dilatation Catheter Device Name:
Indication for Use:
The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971320
Prescription Use
(Per 21 CFR 801.1091)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.