(51 days)
K/DEN number: None
Not Found
No
The summary describes a physical medical device (a catheter) for mechanical dilatation and does not mention any software, image processing, or AI/ML terms.
Yes
The device is described as a "Urological Balloon Dilatation Catheter" intended for "urological dilatation; ureteral and urethral", which are medical procedures for treatment, thus qualifying it as a therapeutic device.
No
The device is a catheter intended for urological dilatation, which is a therapeutic (treatment) procedure, not a diagnostic one.
No
The device description clearly states it is a "Urological 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 "urological dilatation; ureteral and urethral." This describes a procedure performed directly on the patient's body to widen a passage, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "Urological Balloon Dilatation Catheter." This is a physical instrument used in a medical procedure, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on laboratory testing
Therefore, the BD-3 Catheter is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
Product codes
78 EZN, 78 KOE
Device Description
The proposed modified devices are Substantially Equivalent to devices previously cleared by the FDA via the 510(k) Notification process and indicated for dilatation of the urinary tract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral and urethral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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
The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
K980795 plofl
APR 22 1998
ATTACHMENT H
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting to submit "rith this remaintent will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..."
The summary regarding the adverse health effects of the proposed BD-3 Catheters is as follows:
| Sponsor: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Linda S. Pollitz
Senior Regulatory Affairs Specialist
or
Lorraine M. Hanley
Manager, Regulatory Affairs |
| Submission Date: | February 24, 1998 |
| Common/Usual Names: | Urological Balloon Dilatation Catheter |
| Trade/Proprietary Name: | To Be Determined |
| Device Classification and Name: | According to Section 13 of the Federal Food, Drug and Cosmetic Act,
the device classification is Class II, Performance Standards
Product Code: 78 EZN and 78 KOE |
| Substantial Equivalence: | The proposed modified devices are Substantially Equivalent to devices
previously cleared by the FDA via the 510(k) Notification process and
indicated for dilatation of the urinary tract. |
| Performance: | The proposed modified device is Substantially Equivalent to the predicate
devices in terms of performance characteristics tested. |
1
Image /page/1/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1998
Ms. Linda S. Pollitz Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K980795 BD-3 Urological Balloon Dilatation Catheters Dated: February 27, 1998 Received: March 2, 1998 Regulatory class: II 21 CFR §876.5470/Product code 78 EZN 21 CFR §876.5520/Product code 78 KOE
Dear Ms. Pollitz:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 question 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.
William Yu, 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
2
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| 510(k) Number (if known): | T ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
มมากที่ 1977 เป็นที่มีสินค้ามา |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Device Name:
To Be Determined
Indications For Use:
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
ﻤﻨ ﻣ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
Robert D Mathing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
(Optional Format
510(k) Number K980795
(Optional Format 1-2-96)