(87 days)
The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.
The Microvasive Modified Superview 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.
- Handle Unit with Trip Wire and Scope Fastener: The main component 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 handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.
The provided text is a 510(k) Summary for the Speedband Superview Multiple Band Ligator and does not contain a study comparing the device's performance against specific acceptance criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device. Therefore, I cannot complete a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria.
However, I can extract other relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided. The document focuses on demonstrating substantial equivalence rather than meeting specific performance acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data is described. The submission relies on laboratory testing and biocompatibility assessments, not a clinical study with a test set.
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)
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and thus no adjudication method is described.
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 medical instrument (ligator), not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth data is described for this submission. The submission references "Laboratory testing regarding characteristics was performed on the Modified Superview to verify its safety and performance" and "A biocompatibility assessment was performed... with satisfactory results." These are technical verifications, not clinical ground truth.
8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
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SECTION 10 510(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: | March 15, 1999 | ||
|---|---|---|---|
| > 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: | Abby Lipman, Senior Regulatory Affairs Specialist |
DESCRIPTION OF DEVICE
The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components.
1. 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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<990864
2. Handle Unit with Trip Wire and Scope Fastener
The main component 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 handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.
INDICATIONS FOR USE
The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation/injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Modified Superview is substantially equivalent to the currently-marketed Superview. The major components of the Modified Superview are the Ligating Unit and the Handle. A thorough comparison of the descriptive characteristics between the Modified Superview and the currently-marketed Superview show equivalence.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on the Modified Superview to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Superview with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that Modified Superview is substantially equivalent to the currently-marketed Superview. A comparison of the descriptive characteristics of these products demonstrate the Modified Superview 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 Superview will meet the minimum requirements that are considered acceptable for its intended use.
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Image /page/2/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 encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1999
Ms. Abby Lipman Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick. Massachusetts 01760
Re: K990864
Speedband Modified Superview Multiple Band Ligator Regulatory Class: II 21 CFR §876.4400 Product Codes: 78 KHN/78 MND Dated: March 15, 1999 Received: March 16, 1999
Dear Ms. Lipman:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, vou are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) vou must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Ms. Abby Lipman
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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting 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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SECTION 1 INDICATIONS FOR USE
To Be Determined 510(k) Number:
Modified Superview Device Name:
Indication for Use:
The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K990864
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.