(30 days)
Not Found
Not Found
No
The device description focuses on mechanical components and functionality, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the "endoscopic ligation of esophageal varices," which is a therapeutic procedure to treat a medical condition.
No
The device is described as a ligator used for endoscopic ligation of esophageal varices, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines physical components like a ligating unit, rubber bands, adapters, a handle, and a sheath, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices. This is a procedure performed inside the body using an endoscope to physically treat a condition (ligation of varices).
- Lack of Sample Analysis: The device does not analyze any biological samples. It is a tool used for a therapeutic procedure.
Therefore, based on its intended use and description, the Bard® UltraView™ Multiple Band Ligator is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.
Product codes
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 rubber latex ligating bands. The ligating unit is attached to the handle by the activating sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm diameter.
Four endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 11.5 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. The X-large adapter fits 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician's hand
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 not completed as all material changes made were to nonpatient contacting components except for the color coded scope adaptors. Results of cytotoxicity testing of the colored scope adaptors showed no evidence of toxicity. Functionality testing, tensile testing and aspiration testing have demonstrated that the modified Bard® UltraView™ Multiple-Band Ligator is substantially equivalent to the current Bard® UltraView™ Multiple-Band Ligator and that the device is safe for its intended use and patient population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bard® UltraView™ Multiple Band Ligator
Reference Device(s)
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
K033245 Pgz 1 of 2
NOV - 6 2003
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/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.
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 - 4868 |
| Fax: | (978) 262 - 4878 |
| Contact Person: | Michael A. Patz |
| Date of Preparation: | September 29, 2003 |
| B. Device Name | |
| Trade Name: | Bard® UltraView™ Multiple Band Ligator |
| Common/Usual Name: | |
| Classification Name: | Ligator, Esophageal |
| C. Predicate Device Name(s) | |
| Trade Name: | Bard® UltraView™ Multiple Band Ligator |
- 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 rubber latex ligating bands.
1
K033245 Page 2 of 2
The ligating unit is attached to the handle by the activating sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm diameter.
Four endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 11.5 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. The X-large adapter fits 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 modified Bard UltraView ligator is comprised of similar medical grade plastics, stainless steels as the predicate and uses the identical band material.
The modified design differs from the predicate device in that the ligating tip has been modified to improve the sealing integrity of the lip seal during aspiration and to improve the smooth actuation of the Band Driver over the Band Carrier by the addition of 12 ribs to the Band Driver. The sheath attaches to the handle assembly, which can be held in the physician's hand or attached to the endoscope sheath outside of the patient. The bands are deployed by depressing the thumb paddle on the handle assembly causing the bands to be pushed/deployed off of the band carrier. The modified device mounts flush with the tip of the endoscope, as does the predicate device, to allow maximum visualization. The modified and current device tips extend beyond the distal tip of the endoscope allowing variceal tissue to be suctioned into the band carrier cylinder for ligation.
- G. Performance Data
Biocompatibility tests were not completed as all material changes made were to nonpatient contacting components except for the color coded scope adaptors. Results of cytotoxicity testing of the colored scope adaptors showed no evidence of toxicity. Functionality testing, tensile testing and aspiration testing have demonstrated that the modified Bard® UltraView™ Multiple-Band Ligator is substantially equivalent to the current Bard® UltraView™ Multiple-Band Ligator and that the device is safe for its intended use and patient population.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
NOV - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael A. Patz Regulatory Affairs Specialist Bard Endoscopic Technologies C. R. Bard, Inc. 129 Concord Road P.O. Box 7031 BILLERICA MA 01821-7031
Re: K033245
Trade/Device Name: Bard® UltraView™ Multiple Band Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 MND Dated: October 6, 2003 Received: October 7, 2003
Dear Mr. Patz:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
Page 2
4
K03 3245
Indications for Use Statement
Ko33245 510(k) Number (if known): なおり Device Name: Bard® UltraView™ Multiple Band Ligator Indications For Use: 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 V (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Nancy C. hodon
(Division Sign-C Division of Reproductive, Abdon and Radiological Devices 510(k) Number