(124 days)
No
The description focuses on the mechanical design and function of a ligating clip, with no mention of AI or ML.
No
The device is described as a ligating clip used to occlude tubular structures during surgical procedures. It does not provide any therapeutic benefit to the patient, but rather assists surgeons in performing a procedure.
No
Explanation: The Europclip® is a metal ligating clip used in surgical procedures to occlude vessels or other tubular structures by compression. Its function is to physically block a structure, not to diagnose a condition.
No
The device description clearly describes a physical, sterile, pre-loaded clip, indicating it is a hardware device, not software.
Based on the provided information, the Europclip® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "surgical procedures on vessels or other tubular structures where a metal ligating clip is required." This describes a surgical tool used in vivo (within the body) to physically occlude structures.
- Device Description: The description details a physical clip designed for surgical application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the Europclip® is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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 in a disposable cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or other tubular structures
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)
The Europclip functions in the same manner as the predicates to occlude blood vessles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nexus Ligating Clips (K053255), Miltex Ligating Clips (K052018), Titanium Ligation Clip (K100090)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K11193D
、・・・・
510(k) Summary
| Date: | 28 October 2011 |
|---|---|
| Sponsor: | Ackermann Instrumente GmbH |
| Eisenbahnstrasse 65-67 | |
| 78604 Rietheim-Weilheim | |
| Germany | |
| Phone: +49 (0) 7461-966170 | |
| Fax: +49 (0) 7461-9661770 | |
| Contact Person: | Rolf Ackermann |
| President | |
| Proposed Trade | |
| Name: | 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 in | |
| a disposable cartridge. | |
| Intended 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. | |
| Materials: | The Europclip is manufactured from commercially pure titanium as |
| described 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 to |
| occlude blood vessles. | |
| Technological | |
| Characteristics: | The Europclip possesses the same technological characteristics as |
| one 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 the | |
| predicate systems) and | |
| The fundamental scientific technology of the Europclip is the same as | |
| previously cleared devices. Therefore the Europclip can be found | |
| substantially equivalent to the predicate devices. |
1
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
2
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
3
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