BARD RAPIDFIRE MULTIPLE BAND LIGATOR by C.R. BARD, INC.

The Bard RapidFire Multiple Band Ligator is a device used for endoscopic ligation. It is attached to the endoscope prior to introduction into the esophagus or rectum. The firing system includes a spool with crank-trip wire filament. It contains either five or eight ligating bands per ligating unit.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a modern regulatory submission would. Instead, this is a 510(k) summary from 1997, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined acceptance criteria through a specific study design.

Here's why and what information can be extracted if we interpret "acceptance criteria" and "study" in the context of this 1997 510(k) process:

Acceptance Criteria: In a 510(k) from this era, "acceptance criteria" for performance were often implicitly met by demonstrating that the new device was "substantially equivalent" to a legally marketed predicate device. This meant showing similar indications for use, fundamental technology, materials, and performance characteristics. The "performance" being evaluated was primarily its equivalence to already approved devices.
Study Proving Acceptance: The "study" in this context is the comparison itself, highlighting similarities and differences, and relying on the established safety and effectiveness of the predicate devices. There isn't a standalone clinical trial or performance study with defined endpoints and statistical analysis described.

Given these limitations, here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information for a modern device submission is absent:

Acceptance Criteria and Study to Prove Device Meets Criteria

No explicit acceptance criteria or a dedicated study with defined endpoints, sample sizes, and ground truth establishment, as would be expected in a modern performance study, are described in this 510(k) summary.

The document's purpose is to establish substantial equivalence to predicate devices. The "performance" discussed relates to design, materials, and functionality being "nearly identical" or "equivalent" to already approved devices.

If we interpret the comparison to predicate devices as the "study" and the demonstration of "equivalence" in design, materials, and intended use as meeting "acceptance criteria," then the following can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as stated in 510(k) Summary)
Similar Indications for Use	"The indications for use of the RapidFire™ Multiple Band Ligator are equivalent to both the Microvasive® Speedband™ Ligator and the Stiegmann-Goff™ Endoscopic Ligator."
Similar General Design	"The general design... of the RapidFire Multiple Band Ligator is equivalent to the Microvasive Speedband Ligator."
Similar Materials	"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..."
Similar Functionality	"The... functionality of the RapidFire Multiple Band Ligator is equivalent to the Microvasive Speedband Ligator."
Similar Firing System	"The firing system of the RapidFire Ligator and the Microvasive Speedband Ligator include a spool with crank-trip wire filament."
Similar Dimensions (Assemblies & Bands)	"The dimensions of the RapidFire Multiple Band Ligator assemblies and bands are nearly identical to the Microvasive Speedband Ligator..."
Biocompatibility	"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." (Commitment to complete, not performance reported yet).

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable. No test set (e.g., patient cases, specific measurements) for a performance study is described. The "sample" implicitly consists of the design specifications and components of the RapidFire Ligator being compared against those of the predicate devices.
Data Provenance: Not applicable. No "data" in the sense of clinical or performance data is presented. The provenance is the design and manufacturing specifications of the Bard RapidFire Ligator and the two predicate devices (Microvasive® Speedband™ Multiple Band Ligator and Bard Stiegmann-Goff™ Endoscopic Ligator).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of experts establishing ground truth for a test set in the context of this 510(k) summary. The "ground truth" for substantial equivalence is primarily based on the regulatory history and established performance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or implied. The document focuses on device design and function comparison, not on improvements in human reader performance with or without AI assistance, as AI was not a component of this device.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm is described. This device is a physical medical instrument, not an AI or software algorithm.

7. Type of Ground Truth Used

Inferred/Implicit Ground Truth: The "ground truth" relied upon is the established safety, effectiveness, and regulatory clearance of the predicate devices (Microvasive® Speedband™ Multiple Band Ligator and Bard Stiegmann-Goff™ Endoscopic Ligator). The substantial equivalence claim is built upon the premise that these predicates are safe and effective for their intended use.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above.

In summary: The provided 510(k) summary is typical for a device from 1997 seeking substantial equivalence. It highlights design and functional similarities to predicate devices as the basis for regulatory clearance, rather than presenting a detailed performance study against explicit acceptance criteria. Many of your questions are geared towards more modern regulatory submissions, especially those involving AI/ML components or complex clinical trials, which are not relevant to this historical document about a mechanical ligator.

Summary

{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/HemorrhoidalLigator
Classification Name:	Esophageal Variceal Ligator/21 CFR 876.440/78 MNDHemorrhoidal 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:

1. 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.
1. 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}------------------------------------------------

K971137

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)

Regulation Number and Section

§ 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.