(11 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical components and physical properties, with no mention of AI or ML.
Yes
The device is used for "endoscopic ligation of esophageal varices," which is a procedure to treat a medical condition.
No
Explanation: The device is used for "endoscopic ligation of esophageal varices," which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines physical components like a ligating unit, bands, adapters, and a scope gauge, 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 "endoscopic ligation of esophageal varices." This is a therapeutic procedure performed directly on the patient's body to treat a condition.
- Device Description: The device is a mechanical tool used to apply bands to tissue. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic or other information about a person's health. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.
Product codes (comma separated list FDA assigned to the subject device)
78 MND
Device Description
The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted natural rubber latex ligating bands. The ligating unit is attached to the handle by the activating cable sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm inner diameter.
Three endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 10.8 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. No adapter is required for 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal varices
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility tests were completed that demonstrate the device is safe for its intended use and patient population. Functionality testing, tensile testing and comparative endoscope aspiration and retention testing has demonstrated that the Bard® UltraView™ is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator.
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
§ 876.4400 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
K022434
page 1 of 3
AUG 0 5 2002
BARD ENDOSCOPIC TECHNOLOGIES
C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989
Image /page/0/Picture/4 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are evenly spaced and the word is centered in the image.
VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.
| A. Submitter Information | |
|---|---|
| Submitter's Name: | Bard Endoscopic Technologies |
| C.R. Bard, Inc. | |
| Address: | 129 Concord Road, Bldg. #3 |
| Billerica, MA 01821 | |
| Phone: | (978) 262 - 4866 |
| Fax: | (978) 262 - 4878 |
| Contact Person: | Beth A. Zis, R.A.C. |
| Date of Preparation: | June 17, 2002 |
| B. Device Name | |
| Trade Name: | Bard® UltraView™ Multiple Band Ligator |
| Common/Usual Name: | Ligator, Esophageal |
| Classification Name: | Hemorrhoidal Ligator |
| C. Predicate Device Name(s) | |
| Trade Name: | Wilson-Cook® Ten Shot Multi-Band |
| Ligator | |
| Bard® Steigmann-Goff™ Ligator |
1
- D. Device Description:
The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted natural rubber latex ligating bands. The ligating unit is attached to the handle by the activating cable sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm inner diameter.
Three endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 10.8 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. No adapter is required for 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope.
-
E. Intended Use:
The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices. -
F. Technological Characteristics Summary: The proposed Bard UltraView ligator is comprised of similar medical grade plastics, stainless steels and uses the same band material as the predicates.
The design differs from the predicate devices in that the actuation mechanism runs along the outside of the endoscope instead of through the working channel to allow maximum suction into the working channel. The cable sheath attaches to the handle assembly, which can be held in the physician or
2
assistants hand or mounted to the endoscope insertion sheath outside of the patient. The bands are deployed when the thumb paddle, on the handle assembly, is depressed all the way down. This causes the bands to be pushed/deployed off of the band carrier. Both the predicate devices use a trip wire mechanism located on the handle to pull the band off of the band carrier. The proposed device mounts flush with the tip of the endoscope to allow maximum visualization and is retained with friction fit scope adapters that mount inside of the device. The predicate device tips extend beyond the distal tip of the endoscope and cannot be retracted flush with the distal end of the endoscope.
- G. Performance Data
Biocompatibility tests were completed that demonstrate the device is safe for its intended use and patient population. Functionality testing, tensile testing and comparative endoscope aspiration and retention testing has demonstrated that the Bard® UltraView™ is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 5 2002
Re: K022434
Bard Endoscopic Technologies c/o Dr. Peter N. Ruys N.V. KEMA Utrechtseweg 310 NL-6812 AR Arnhem THE NETHERLANDS
Trade/Device Name: Bard® UltraView™ Multiple : 承: Band Ligator, Model #00700U Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 MND Dated: June 28, 2002 Received: July 25, 2002
Dear Dr. Ruys:
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 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) 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
KO22434 TBD
Device Name:
Indications For Use:
Bard® UltraView Multiple Band Ligator
The Bard® UltraView™ Multiple Band ligator is used for endoscopic ligation of esophageal varices. --------------. *
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
David A. DeJong
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K022434 |
|---|---|
| --------------- | --------- |
016