(23 days)
Not Found
Not Found
No
The device description details a purely mechanical system for ligating tissue using elastic bands triggered by a manual handle. There is no mention of any computational or data-driven components.
No
The device is described as a ligator used for endoscopic ligation of esophageal varices and anorectal hemorrhoids, which is a surgical procedure for treatment rather than a diagnostic or monitoring function.
No
The device is described as a Multiple Band Ligator used for endoscopic ligation of esophageal varices and anorectal hemorrhoids, which is a therapeutic procedure, not a diagnostic one. Its function involves firing elastic bands for treatment, not for identifying a medical condition.
No
The device description clearly outlines physical components like a ligating unit (cylinder, elastic bands) and a handle unit (plastic spool, trip wire, scope fastener, irrigation valve), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic ligation of esophageal varices and anorectal hemorrhoids." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a mechanical ligator used to apply elastic bands to tissue. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health, or determine compatibility. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Modified Speedband is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
Product codes
78 FHN, 78 MND
Device Description
The Microvasive Modified Speedband is a Multiple Band Ligator composed of two major components.
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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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, anorectal
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Currently-marketed Speedband.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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COMMON/USUAL NAMES: Hemorrhoidal Ligator, Esophageal Variceal Ligator
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Trade/Proprietary Name: Speedband Superview Multiple Band Ligator
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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 Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 |
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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.
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.
- Handle Unit with Trip Wire and Scope Fastener
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.
2
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
3
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 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.1091) | OR | Over-The-Counter Use |
|---|---|---|
| ---------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)