(124 days)
The Europclip®is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required. The device is intended to occlude the tubular structure by compression.
The Europclip is a chevron-shaped clip having a heart-shaped cross-section and transverse grooves across the inner surface of the clip. The clips are supplied sterile, available in four sizes and pre-loaded in a disposable cartridge.
This document describes a 510(k) submission for the Europclip®, a ligating clip device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and clinical trials typically used for AI/ML devices.
Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone AI studies), ground truth establishment for AI models, and sample sizes for training/test sets are not applicable to this type of medical device submission.
Here's an attempt to address the request based on the provided information, noting where information is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from submission) | Reported Device Performance (from submission) |
|---|---|---|
| Intended Use | For use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required. Intended to occlude the tubular structure by compression. | The Europclip functions in the same manner as the predicates to occlude blood vessels and is intended for this use. |
| Basic Design | Chevron-shaped with heart-shaped cross-section. | Europclip has a chevron-shaped design with a heart-shaped cross-section. |
| Material | Commercially pure titanium (ISO 5382-2). | Europclip is manufactured from commercially pure titanium as described by ISO 5382-2. |
| Sizes | Dimensions comparable to predicate systems. | Available in four sizes, comparable to those offered by predicate systems. |
| Sterility | Supplied sterile. | Clips are supplied sterile. |
| Technological Characteristics | Possesses the same technological characteristics as one or more predicate devices. | The fundamental scientific technology of the Europclip is the same as previously cleared devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of design, materials, and intended use, rather than a clinical trial with a "test set" of patient data.
- Data Provenance: Not applicable. The "data" primarily consists of technical specifications and comparisons to existing devices, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no "test set" of data requiring expert ground truth establishment for this device submission.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. This device is a medical instrument (a ligating clip), not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study as would be done for an AI algorithm was not conducted. This device is a physical surgical instrument.
7. The Type of Ground Truth Used
- Not applicable in the context of AI/ML ground truth. The "ground truth" for this submission is effectively the established performance and safety profile of the predicate devices and the direct comparison to their specifications.
8. The Sample Size for the Training Set
- Not applicable. There is no AI/ML training set for this device.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
Summary of the Study (as presented in the 510(k) Summary):
The study described for the Europclip® is a demonstration of substantial equivalence to predicate devices (Nexus Ligating Clips, Miltex Ligating Clips, Titanium Ligation Clip). This is a regulatory pathway for medical devices that are similar in intended use, technological characteristics, and safety/effectiveness to a legally marketed predicate device.
The "study" asserts that:
- The Europclip functions in the same manner as the predicates to occlude blood vessels.
- It possesses the same technological characteristics as one or more predicate devices, including:
- Identical intended use.
- Basic design (chevron-shaped with heart-shaped cross-section).
- Material (titanium).
- Sizes (dimensions are comparable to those offered by predicate systems).
- The fundamental scientific technology of the Europclip is the same as previously cleared devices.
Based on these comparisons, the sponsor concludes that the Europclip is substantially equivalent to the predicate devices and thus meets the necessary criteria for FDA clearance. The FDA's outcome (K111930) confirms their agreement with this assessment, finding the device substantially equivalent.
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K11193D
、・・・・
510(k) Summary
| Date: | 28 October 2011 |
|---|---|
| Sponsor: | Ackermann Instrumente GmbHEisenbahnstrasse 65-6778604 Rietheim-WeilheimGermanyPhone: +49 (0) 7461-966170Fax: +49 (0) 7461-9661770 |
| Contact Person: | Rolf AckermannPresident |
| Proposed TradeName: | Europclip® |
| Device Classification | Class II |
| Classification Name: | Implantable clip, Haemostatic clip |
| Regulation: | 878.4300 |
| Device Product Code: | FZP, MCH |
| Device Description: | The Europclip is a chevron-shaped clip having a heart-shaped cross-section and transverse grooves across the inner surface of the clip.The clips are supplied sterile, available in four sizes and pre-loaded ina disposable cartridge. |
| Intended Use: | The Europclip is indicated for use in surgical procedures on vessels orother tubular structures where a metal ligating clip is required. Thedevice is intended to occlude the tubular structure by compression. |
| Materials: | The Europclip is manufactured from commercially pure titanium asdescribed by ISO 5382-2. |
| Predicate Devices: | Nexus Ligating Clips (K053255)Miltex Ligating Clips (K052018)Titanium Ligation Clip (K100090) |
| Performance Data: | The Europclip functions in the same manner as the predicates toocclude blood vessles. |
| TechnologicalCharacteristics: | The Europclip possesses the same technological characteristics asone or of the predicate devices. These include:• intended use (as described above)• basic design (chevron-shaped with heart-shaped cross-section),• material (titanium),• sizes (dimensions are comparable to those offered by thepredicate systems) andThe fundamental scientific technology of the Europclip is the same aspreviously cleared devices. Therefore the Europclip can be foundsubstantially equivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol in the center, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ackerman Instrumente GmbH % BackRoads Consulting, Inc. Karen E. Warden, PhD 8202 Sherman Road Chesterland, Ohio 44026-2141
Re: K111930
Trade/Device Name: Europclip® Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, MCH Dated: October 28, 2011 Received: October 31, 2011
Dear Dr. Warden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
NOV - 8 2011
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Page 2 - Karen E. Warden, PhD
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eunice D. Keith
Fy Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KIII1930 510(k) Number (if known):
Device Name: Europclip®
Indications For Use:
The Europclip®is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required. The device is intended to occlude the tubular structure by compression.
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keene for NKM
Page 1 of
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111930
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.