(210 days)
The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.
Not Found
The provided 510(k) summary (K031236) for the Scandimed International Auto-Band Ligator is a clearance letter from the FDA. It declares the device substantially equivalent to legally marketed predicate devices.
Crucially, this document is a regulatory clearance letter and does not contain the details of a study proving the device meets specific acceptance criteria. This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials to establish de novo performance criteria.
Therefore, I cannot provide the information requested in your bullet points because the provided text does not contain a study report or clinical trial data.
To clarify what this document does provide:
- Device Name: Scandimed International Auto-Band Ligator
- Intended Use: Used to band esophageal varices or hemorrhoids in the colon. For single use only.
- Regulatory Classification: Class II, Product Code: 78 MND
- Predicate Device: Not explicitly named in this letter, but implied by the "substantial equivalence" determination.
Without a detailed clinical study report, it's impossible to answer your specific questions regarding acceptance criteria, sample sizes, expert qualifications, ground truth, or comparative effectiveness.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2003
Mr. Kristian Kargaard Jensen Scandimed International Slotsherrensvej 409 DK 2600 Glostrup Denmark
Re: K031236
Trade/Device Name: Scandimed International Auto-Band Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 MND Dated: August 15, 2003 Received: August 18, 2003
Dear Mr. Jensen:
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. Iisting 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.
{1}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
{2}------------------------------------------------
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page _____of
510(k) Number (if known): K031236
Device Name:
Auto-Band Ligator .
Indications For Use:
The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon.
For single use only.
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nancy C. Brogdon(Division Sign-Off)Division of Reproductive, Abdominal, and Radiological Devices510(k) NumberK031236 | Nancy C. Brogdon | (Division Sign-Off) | Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K031236 | ||||
| Nancy C. Brogdon | |||||||||
| (Division Sign-Off) | |||||||||
| Division of Reproductive, Abdominal, and Radiological Devices | |||||||||
| 510(k) Number | K031236 | ||||||||
| Prescription Use (Per 21 CFR 801.109) | OR 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.