(29 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical components and bench testing, with no mention of AI/ML terms or image processing.
Yes
The device is used for endoscopic treatment, specifically for ligation of esophageal varices and anorectal hemorrhoids, which directly addresses and treats medical conditions.
No
The device is indicated for endoscopic ligation and treatment of esophageal varices and anorectal hemorrhoids, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines physical components like a ligating unit, handle assembly, bands, suture, and a tripwire, indicating it is a hardware device used for endoscopic procedures.
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 system for applying ligating bands. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
The Injection Speedband™ Superview Super 7 is indicated for endoscopic treatment of esophageal varices utilizing combination ligation therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.
The Injection Speedband™ Superview Super7 is indicated for use in endoscopic treatment of esophageal varices utilizing combination ligation/injection therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.
Product codes (comma separated list FDA assigned to the subject device)
78 FHN, 78 MND
Device Description
The Speedband Superview Super7 and Injection Speedband Superview Super7 consist of two main components; a ligating unit and a handle assembly. The ligating unit consists of a cylindrical housing with a flexible silicone endoscope adapter, and seven elastic ligating bands. Suture is threaded around each band and passes through suture slots around the perimeter of the housing. The suture enters the endoscope through the working channel of an endoscope and is secured the tripwire on the handle assembly durning set-up.
The handle assembly consists of a handle knob and plastic spool mounted on a bracket with a stem. A tripwire is attached to the spool and passes through the septum and into the stem. The stem fits into the working channel of the endoscope. The septum seals the channel so suction can be maintained. On the Injection models, the septum has a port for insertion of an injection therapy needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal varices, anorectal hemorrhoids
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)
Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed devices to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Page 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for Boston Scientific Microvasive. The words "Boston Scientific" are stacked on top of each other in a serif font, with a line underneath. Below that, the word "MICROVASIVE" is written in a bold, sans-serif font.
APR 1 2 2002
MA 01760-
Section 9 510(k) Summary
510(K) SUMMARY
1. SUBMITTER:
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760
Contact: Kathleen Morahan, Regulatory Affairs Manager Date Prepared: March 12, 2002
2. DEVICE:
Trade Name: Speedband™ Superview Super7 Injection Speedband™ Superview Super7
Common Name: Hemorrhoidal Ligator and Esophageal Variceal Ligator
Class: II
Classification Name: Ligator, Hemorrhoidal (78 FHN) Ligator, Esophageal (78 MND)
3. PREDICATE DEVICE:
Modified Injection Speedband TM Superview
Modified Speedband™ Superview
4. DEVICE DESCRIPTION:
The Speedband Superview Super7 and Injection Speedband Superview Super7 consist of two main components; a ligating unit and a handle assembly. The ligating unit consists of a cylindrical housing with a flexible silicone endoscope adapter, and seven elastic ligating bands. Suture is threaded around each band and passes through suture slots around the perimeter of the housing. The suture enters the endoscope through the working channel of an endoscope and is secured the tripwire on the handle assembly durning set-up.
Confidential
1
The handle assembly consists of a handle knob and plastic spool mounted on a bracket with a stem. A tripwire is attached to the spool and passes through the septum and into the stem. The stem fits into the working channel of the endoscope. The septum seals the channel so suction can be maintained. On the Injection models, the septum has a port for insertion of an injection therapy needle.
5. INTENDED USE:
The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
The Injection Speedband™ Superview Super 7 is indicated for endoscopic treatment of esophageal varices utilizing combination ligation therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.
6. TECHNOLOGICAL CHARACTERISTICS:
The intended use and the materials are identical predicate devices. The proposed ligating unit contains seven bands whereas the predicate device has up to eight bands. Other minor housing and band modifications were made. The proposed and predicate device handle assemblies are the same except for an increase in the handle knob diameter and shape for ergonomics.
7. PERFORMANCE DATA:
Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed devices to the predicate device.
8. CONCLUSION:
BSC has demonstrated that the Speedband Superview Super 7 and the Injection Speedband Superview Super 7 are substantially equivalent to the predicate devices.
2
510(k) Number:
KO20824
Device Name:
Speedband™ Superview Super7
Indication for Use:
The Speedband™ Superview Super7 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)
Prescription Use (Per 21 CFR 801.1091) (Optional Format 1-2-96) OR
Over-The-Counter Use
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of a human figure with three lines extending from the head, resembling wings or feathers.
APR 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Morahan Manager, Regulatory Affairs Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K020824
ﻬﺎ ﺑﻬ
Trade/Device Name: Injection Speedband™ Superview Super7TM, Model 4238 and Speedband™M Superview Super7TM, Model 4205 Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Codes: 78 FHN and 78 MND Dated: March 13, 2002 Received: March 14, 2002
Dear Ms. Morahan:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
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
5
K020824 510(k) Number:
Device Name: Injection Speedband™ Superview Super7
Indication for Use:
The Injection Speedband™ Superview Super7 is indicated for use in endoscopic treatment of esophageal varices utilizing combination ligation/injection therapy. The Injection Speedband™ Superview Super7 is also 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)
| Prescription Use
(Per 21 CFR 801.1091)
| (Optional Format 1-2-96) | |
|---|---|
| OR | Over-The-Counter Use __________ |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K020824 |
|---|---|
| --------------- | --------- |
Confidential
000029