(202 days)
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or functionalities.
Yes
The device is used for endoscopic ligation of esophageal varices and anorectal hemorrhoids, which directly treats these medical conditions.
No
The device is described as an endoscopic ligator used for therapeutic procedures (ligation of varices and hemorrhoids), not for diagnosis.
No
The device description clearly describes a physical device with hardware components (spool, crank-trip wire filament, ligating bands) that is attached to an endoscope. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic ligation of esophageal varices and anorectal hemorrhoids." This is a therapeutic procedure performed in vivo (within the living body) to treat a condition.
- Device Description: The description details a mechanical device attached to an endoscope for applying ligating bands. This is consistent with a surgical or therapeutic device, not a device used to examine samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RapidFire Multiple Band Ligator is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
Product codes
78 MND,78 FHN
Device Description
The RapidFire Multiple Band Ligator is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, anorectal
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, 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
Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989
ר3 וודאץ
OCT 16 1997
510(k) SUMMARY FOR THE BARD® RAPIDFIRE™ MULTIPLE BAND LIGATOR ୧.୦
As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting the safety and effectiveness follows.
- 6.1 General Information
- . Name and Address of Submitter:
Bard Interventional Products Division, C.R. Bard, Inc. 129 Concord Road, Building #3 Billerica, MA 01821-7031
-
. Contact:
Beth A. Rochette Regulatory Affairs Manager Phone: (508) 663-8989 Fax: (508) 670-9827 -
. Date of Summary:
February 25, 1997 -
Name of Device:
| Trade Name: | Bard® RapidFire™ Multiple Band Ligator |
|---|---|
| Common/Usual Name: | Esophageal Variceal Ligator/Hemorrhoidal |
| Ligator | |
| Classification Name: | Esophageal Variceal Ligator/21 CFR 876.440/ |
| 78 MND | |
| Hemorrhoidal Ligator/21 CFR 876.440/78 FHN |
-
Predicate Device(s):
Microvasive® Speedband™ Multiple Band Ligator and Bard Stiegmann-Goff™ Endoscopic Ligator -
Description and Intended Use:
The RapidFire Multiple Band Ligator is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
1
Summary of Similarities and Differences 6.2
The Bard RapidFire Multiple Band Ligator is substantially equivalent to the currently marketed Microvasive Speedband Multiple Band Ligator (K952262) manufactured by Microvasive, Boston Scientific Corporation and the Stiegmann-Goff Endoscopic Ligator manufactured by Bard® Interventional Products Division which received concurrence through K940661.
The indications for use of the RapidFire™ Multiple Band Ligator are equivalent to both the Microvasive® Speedband™ Ligator and the Stiegmann-Goff™ Endoscopic Ligator. The general design, materials and functionality of the RapidFire Multiple Band Ligator is equivalent to the Microvasive Speedband Ligator. All of the ligators are attached to the endoscope prior to introduction into the esophagus or rectum. The firing system of the RapidFire Ligator and the Microvasive Speedband Ligator include a spool with crank-trip wire filament. The dimensions of the RapidFire Multiple Band Ligator assemblies and bands are nearly identical to the Microvasive Speedband Ligator and both units use a single size scope adapter. The major differences are listed below:
-
- The RapidFire Multiple Band Ligator contains either five or eight ligating bands per ligating unit while the Microvasive ligator contains five ligating bands and the Bard Stiegmann-Goff Ligator contains one ligating band per cylinder, with five or ten cylinders per package.
-
- The RapidFire Ligator and the Microvasive Speedband Liaator do not use an overtube during the procedure, whereas, the Stiegmann-Goff Endoscopic Ligator recommends the use of an overtube for multiple intubations
The materials used in the RapidFire Multiple Band Ligator and the Microvasive Speedband Ligator units are nearly identical and are all commonly used in the medical device industry, however, biocompatibility testing will be completed to confirm that the different vendor materials used in the RapidFire Multiple Band Ligator are safe for limited and prolonged contact with mucosa and tissue.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 1997
Ms. Beth Zis Regulatory Affairs Manager C.R. Bard, Inc. Bard Interventional Products Division 129 Concord Road P.O. Box 7031 Billerica, Massachusetts 01821-7031
Re: K971137
Bard RapidFire Multiple Band Ligator Dated: July 21, 1997 Received: July 22, 1997 Regulatory class: II 21 CFR 8876.4400/Product code: 78 MND and FHN
Dear Ms. Zis:
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 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 (OS) 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. 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 predication 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 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,
sincerely, yours,
William Yu
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 (if known): Not Known
Device Name: Bard® RapidFire™ Multiple Band Ligator
The RapidFire™ Multiple Band Ligator is used for endoscopic ligation of esophageal Indications for Use: varices and anorectal hemorrhoids.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sutherg/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use OR
(Per 21 CFR 801.109)
Over-the-Counter Use_
(Optional Format 1-2-96)