(79 days)
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel.
The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations.
The Auto-Band Ligator incorporates the following product features:
- Automatic Reverse Movement to START position after each release
- Snap Fixation system ensures stable fixation on the scope
- Adjustable Snap Fixation System facilitates fixation on all brands of scopes
- Precision One-Step Release Mechanism of bands
- Only a single band can be released at a time
- Latex or Latex Free Rubber Bands
- Available in 5, 6, 7, 8 or 10 band configurations
The provided 510(k) summary for the Scandimed International Auto-Band Ligator (K083556) is for a Special 510(k) Premarket Notification to address a material formulation change to the ligation bands and to expand the product line to include 6 and 8 band variations. This type of submission typically focuses on demonstrating that the modifications do not negatively impact the safety and effectiveness established for the predicate device.
Therefore, the study described is primarily performance testing to confirm the continued safety and effectiveness of the modified device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Safety and Effectiveness of the device (general regulatory standard) | "The results of the performance testing demonstrated the safety and effectiveness of the device." | This is a high-level statement. Specific quantitative criteria and results are not detailed in this summary. For a Special 510(k), the criteria would likely relate to maintaining the performance characteristics of the predicate device. |
| Performance characteristics (e.g., band release mechanism, fixation system, material integrity) | Stated that "technological characteristics such as materials, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices." | Implies that the modified device met the established performance standards of the predicate, but specific tests or numerical results are not provided. |
| Material compatibility/formulation change | Implied through "performance testing" that the new latex formulation met safety and performance standards. | No specific tests for material properties or biocompatibility are listed, though these would have been part of the underlying testing. |
| Functionality of new 6 and 8 band configurations | Implicitly confirmed through "performance testing" and comparison to predicate. | No specific tests for these new configurations are explicitly detailed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This type of information is not applicable to the performance testing described. The summary indicates physical performance tests of the device itself, not clinical studies requiring expert interpretation of data.
4. Adjudication Method for the Test Set
- Not applicable. The summary refers to performance testing of the device, not a clinical study involving human assessment and adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This 510(k) is for a physical device (ligator), not a diagnostic AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For the described performance testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. The tests would confirm that the modified device's performance aligns with these objective standards.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance testing involves physical samples of the device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
Summary of Device Performance and Study:
The 510(k) summary states that "The Auto-Band Ligator was subjected to relevant performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device." For a Special 510(k) for a material change and product line expansion, "performance testing" would typically involve:
- Functional testing: To ensure the band release mechanism, snap fixation system, and other features work correctly with the new band material and in the new 6/8 band configurations.
- Material properties testing: To ensure the new latex formulation meets required physical properties (e.g., elasticity, strength, durability) and biocompatibility standards.
- Dimensional verification: To confirm the new 6 and 8 band configurations fit and function as intended within the existing device design.
The claim of substantial equivalence relies on demonstrating that these modifications do not alter the fundamental technological characteristics, safety, or effectiveness established by the predicate device (Scandimed International Auto-Band Ligator #K031236 and #K081142). The details of these tests, including sample sizes and specific criteria, are not provided in this public summary.
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510(K) SUMMARY
FEB 1 9 2009
1. SUBMITTER:
Scandimed International Korsdalsvej 125 DK-2610, Roedovre, Denmark Establishment Registration Number: 3003376126 Official contact: Mr. Salah Chami, CEO Telephone: 011-45-4492-6444 Date Prepared: November 24, 2008
2. DEVICE:
Auto-Band Ligator Tradename: Classification Name: Hemorrhoidal Ligator Class II Classification: 78 MND Product Code: Regulation Number: 876.4400 Classification Panel: Gastroenterology
PREDICATE DEVICE: 3.
This Special 510(k) Premarket Notification is being submitted for a material formulation change to the ligation bands and to expand the product line to include 6 and 8 band variations. The predicate device used to determine substantial equivalence for this device was the Scandimed International Auto-Band Ligator (#K031236 and #K081142).
DEVICE DESCRIPTION: 4.
The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel.
The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations.
page 1 of 2
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The Auto-Band Ligator incorporates the following product features:
- Automatic Reverse Movement to START position after each release
- Snap Fixation system ensures stable fixation on the scope
- Adjustable Snap Fixation System facilitates fixation on all brands of scopes
- Precision One-Step Release Mechanism of bands
- Only a single band can be released at a time
- Latex or Latex Free Rubber Bands
- Available in 5, 6, 7, 8 or 10 band configurations
INTENDED USE: 5.
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
INDICATIONS FOR USE: 6.
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
COMPARISON OF CHARACTERISTICS: 7.
Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices.
PERFORMANCE DATA: 8.
The Auto-Band Ligator was subjected to relevant performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device.
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scandimed International c/o Mr. Stephen M. Page Regulatory Consultant MedReg Associates 29 Frigate Street JAMESTOWN RI 02835
...
FEB 1 9 2009
1000 Re: K083556
Trade/Device Name: Auto-Band Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: MND Dated: January 16, 2009 Received: January 21, 2009
Dear Mr. Page:
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). Youmay, therefore, market the device, subject to the general controls previsions of the Act. The gouveral controls provisions of the Activelyde 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 such 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.
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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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.
Sincerely yours,
anine M. M. STT Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): #K083556
Device Name: Auto-Band Ligator
Indications for Use:
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. : : الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم . : 、 . . For single use only.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lara Whalen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
(Posted November 13, 2003)
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§ 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.