(11 days)
The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.
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.
Here's an analysis of the provided text regarding the Bard® UltraView™ Multiple Band Ligator:
This document, K022434, describes a 510(k) premarket notification for a medical device. The 510(k) process is typically used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to establish strict acceptance criteria based on novel performance metrics. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one might expect for a new, groundbreaking technology with quantitative performance targets is not directly applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices through comparative performance data and other characteristics.
Therefore, many of the requested points below will reflect this aspect of substantial equivalence rather than a new device's performance against predefined quantitative benchmarks.
1. A table of acceptance criteria and the reported device performance
As mentioned, there aren't explicit quantitative "acceptance criteria" presented in the document in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied for Substantial Equivalence via Predicate Comparison) | Reported Device Performance (Summary from K022434) |
|---|---|
| Biocompatibility | Biocompatibility tests were completed that demonstrate the device is safe for its intended use and patient population. (Implied acceptance: device is biocompatible and safe.) |
| Functionality | Functionality testing demonstrated that the Bard® UltraView™ is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator. (Implied acceptance: device performs its intended mechanical actions comparably to predicates.) |
| Tensile Strength (Bands) | Tensile testing demonstrated that the Bard® UltraView™ (likely its bands) is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator. (Implied acceptance: bands have comparable mechanical integrity to predicates, preventing premature breakage or failure.) |
| Endoscope Aspiration and Retention | Comparative endoscope aspiration and retention testing demonstrated that the Bard® UltraView™ is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator. (Implied acceptance: device maintains secure fit on endoscope and allows for comparable aspiration/suction capabilities during use as predicates, crucial for proper ligation.) |
| Material Composition | The proposed Bard UltraView ligator is comprised of similar medical grade plastics, stainless steels and uses the same band material as the predicates. (Implied acceptance: materials are known and accepted for medical use in similar devices.) |
| Intended Use | Used for endoscopic ligation of esophageal varices, same as predicate devices. (Implied acceptance: device serves the same clinical purpose as existing devices.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the testing mentioned (biocompatibility, functionality, tensile, aspiration/retention). It simply states that these tests were completed.
The data provenance (country of origin, retrospective/prospective) is also not specified in this summary. These details would typically be found in more detailed test reports or study protocols, not usually in the 510(k) summary itself. The submitting company is Bard Endoscopic Technologies, C.R. Bard, Inc., based in the USA, but the contact person is from N.V. KEMA in The Netherlands, suggesting potential international collaboration or testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not relevant to this device's submission. The device is a mechanical ligator, not an AI or diagnostic imaging device that requires expert ground truth labeling of images or data. The "ground truth" for this device's performance would be the direct results of the physical and functional tests, compared against the performance of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and submission. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not the primary focus here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical tool, not an imaging or diagnostic aid, and therefore MRMC studies are not relevant. Its effectiveness is based on its mechanical function and ability to perform ligation, not on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, human-operated medical device. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like this, the "ground truth" or standard for comparison is embedded in the predicate devices themselves and the established understanding of their functional performance.
- Functionality: The "ground truth" for functionality is the successful and consistent operation of the predicate devices in performing ligation, aspiration, and band deployment. The new device is tested to perform these actions similarly.
- Tensile Strength: The "ground truth" is the established tensile strength properties of the bands used in the predicate devices, or industry standards for such materials in this application.
- Biocompatibility: The "ground truth" is adherence to established international standards for biocompatibility (e.g., ISO 10993 series) and no adverse biological reactions.
- Aspiration/Retention: The "ground truth" performance of aspiration and retention would be benchmarked against the known performance of the predicate devices on endoscopes.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have "training sets."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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
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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 TechnologiesC.R. Bard, Inc. |
| Address: | 129 Concord Road, Bldg. #3Billerica, 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-BandLigatorBard® Steigmann-Goff™ Ligator |
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- 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
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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.
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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.
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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
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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
§ 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.