The Ligating Unit: The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder.
Handle Unit with Trip Wire and Scope Fastener: The main components of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the endoscope. An irrigation valve is located on the side of the Handle Unit.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a medical device called the "Speedband Superview Multiple Band Ligator" (later referred to as "Modified Speedband"). It focuses on demonstrating substantial equivalence to a predicate device already on the market (the "currently-marketed Speedband") and does not describe a study with acceptance criteria and a detailed analysis of device performance as typically understood in a medical device clinical trial or performance study against specific metrics.

Instead, this submission addresses the regulatory requirements for showing the new device is as safe and effective as a legally marketed predicate device. The "performance characteristics" section refers to laboratory testing and biocompatibility assessments, which are not detailed in a way that allows for the creation of an acceptance criteria table with reported performance metrics.

Therefore, many of the requested items (sample size, experts, adjudication, MRMC study, standalone performance, ground truth establishment, training set size) are not applicable or cannot be extracted from this type of regulatory document.

However, based on the information provided, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or detailed reported device performance in the format of a clinical study. The performance evaluation mentioned is against the predicate device to demonstrate substantial equivalence, primarily through:

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (Summary from Document)
Safety: Biocompatibility of patient- and fluid-contact materials. Compliance with general controls.	A biocompatibility assessment was performed on the patient- and fluid-contact materials with satisfactory results.
Effectiveness: Equivalence in indications for use. Similar design and materials to a legally marketed predicate device.	"Modified Speedband is equivalent in its indications for use, while being very similar in design and materials" to the currently-marketed Speedband. Laboratory testing was performed to verify safety and performance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This document describes laboratory testing and biocompatibility assessment, not a clinical test set with human subjects for performance evaluation.
Data Provenance: Not specified beyond "Laboratory testing regarding characteristics was performed." No country of origin or retrospective/prospective nature is mentioned for this testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The document does not describe a test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a test set requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done or reported in this document. This device is a mechanical ligator, not an imaging analysis algorithm that would typically involve human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance)

Not applicable. This device is a medical instrument (ligator), not an algorithm. Therefore, "standalone" performance in this context refers to its intended mechanical function, as evaluated through laboratory testing.

7. Type of Ground Truth Used

Not applicable in the conventional sense of clinical trials. The "ground truth" for the declared substantial equivalence relies on:

The known safety and effectiveness profile of the predicate device.
Laboratory testing results (e.g., mechanical function, material properties).
Biocompatibility assessment.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary

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K981669 1 of 2

JUN 4 1998

SECTION 9 510(K) SUMMARY

FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

Date: May 11, 1998
COMMON/USUAL NAMES: Hemorrhoidal Ligator, Esophageal Variceal Ligator
Trade/Proprietary Name: Speedband Superview Multiple Band Ligator
Classification Name & DEVICE CLASSIFICATION: Class II

	Name	Number	21 CFR Ref.
	Ligator, Homorrhoidal	78 FHN	876.4400
>	DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU)Gastro-Renal (GRDB)
>	OWNER/OPERATOR: Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760

Contact Person: Lisa M. Quaglia, Regulatory Affairs Manager

DESCRIPTION OF DEVICE

The Microvasive Modified Speedband is a Multiple Band Ligator composed of two major components.

The Ligating Unit

The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder.

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1. Handle Unit with Trip Wire and Scope Fastener
  The main components of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the endoscope. An irrigation valve is located on the side of the Handle Unit.

INDICATIONS FOR USE

The Modified Speedband is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.

DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Modified Speedband is substantially equivalent to the currently-marketed Speedband. The major components of the Modified Speedband are the Ligating Unit and the Handle. A thorough comparison of the descriptive characteristics between the Modified Speedband and the currently-marketed Speedband show equivalence.

PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on the Modified Speedband to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Speedband with satisfactory results.

CONCLUSION

Boston Scientific Corporation believes that Modified Speedband is substantially equivalent to the currently-marketed Speedband. A comparison of the descriptive characteristics of these products demonstrate the Modified Speedband is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has performed laboratory testing and biocompatibility information. The information presented provides assurance that the Modified Speedband will meet the minimum requirements that are considered acceptable for its intended use.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/2 description: The image shows the logo of the Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged vertically along the left side of the logo, also in black.

JUN 4 1998

Ms. Lisa M. Quaglia Regulatory Affairs Manager Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Re: K981669

Speedband Multiple Ligator Dated: May 11, 1998 Received: May 12, 1998 Regulatory Class: II 21 CFR 876.4400/Procode: 78 FHN 78 MND

Dear Ms. Quaglia:

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 II (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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/cdrf/dsmaldsmamain.html".

Sincerely yours

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

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K981669

SECTION 1 INDICATIONS FOR USE

510(k) Number: To Be Determined

Device Name:

Modified Speedband

Indication for Use:

The Modified Speedband is indicated for use in endoscopic ligation of esophageal 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 D. Sathing /

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K981669
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Prescription Use (Per 21 CFR 801.1091)	OR	Over-The-Counter Use
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(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.