(210 days)
Not Found
Not Found
No
The summary describes a mechanical device (ligator) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used to band esophageal varices or haemorrhoids, which are medical conditions, making it a therapeutic device.
No
The device is described as being used to "band esophageal varices or haemorrhoids in the colon," which is a therapeutic, not a diagnostic, action.
No
The intended use describes a device used to "band esophageal varices or haemorrhoids in the colon," which strongly implies a physical device (a ligator) that applies bands. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "band esophageal varices or haemorrhoids in the colon." This describes a surgical or therapeutic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The Auto-Band Ligator is a device used within the body for a therapeutic purpose, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.
Product codes
78 MND
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, colon
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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.
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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
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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)