(21 days)
Predicate Device(s): K830503
No
The summary describes a purely mechanical device (titanium clips) and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as implantable clips used for approximating soft tissue, closing off vessels, and stopping bleeding, which are surgical and supportive functions, not primarily therapeutic in nature.
No
Explanation: The device is described as implantable clips used for approximating soft tissue, closing vessels, and stopping bleeding, which are all therapeutic or surgical functions, not diagnostic ones.
No
The device description explicitly states the device is composed exclusively of titanium and is supplied as sterile products in various sizes, indicating it is a physical medical device (ligation clips) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the clips are for use during procedures to approximate soft tissue, close off vessels, and connect internal tissues. This is a direct surgical intervention on the patient's body.
- Device Description: The description details the material (titanium) and form (implantable clips) of the device, which are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does none of that.
The information provided describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
Product codes (comma separated list FDA assigned to the subject device)
FZP, MCH
Device Description
The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, vessels and other 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB - 2 2010
510(k) Summary Statement
Submitters Name: GENICON 6869 Sta Point Court Suite #114 Winter Park, FL 32792 Ph: 1.321.297.1189 Fx: 1.407.679.0880
Contact Name: Melanie Murphy
Name of Device: Titanium Ligation Clip
Safety & Effectiveness Data Summary:
Classification Name: Clip, Implantable Common/Usual Name: Ligation Clip Proprietary Name: n/a at this time
Classification: Class II
| Implantable Clip: | #79 FZP | |
|---|---|---|
| Hemostatic Clip: | #79 MCH Reg. #878.4300 - 36-2 - 1. 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 " " " " " " " " " " " " " " " " " " " " " " " " " " |
Performance Standards: Devices are manufactured according to Good Manufacturing Practices (G.M.P.), Association for Advancement of Medical Instrumentation (A.A.M.I.) and American Society for Testing and Materials (A.S.T.M.) requirements and applicable Harmonized Standards ISO 13485.
Material Composition: A.S.T.M F-67 95, Grade I Titanium I.S.O. #5832-2-93, Grade I Titanium
Intended Use: The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
Device Description: The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".
Predicate Devices: Ethicon K830503
1
Comparison of Technological Characteristics: The titanium clip material and disposable holder material substantially equivalent to the predicate device. In function, the clips are the substantially equivalent to the predicate device as well.
ﻣﺎ ﺟ
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Safety and Efficacy Information: Titanium is well recognized as being safe and effective for long term implantation. Millions of titanium clips are applied yearly and since inception in the 1960's attest to the wide acceptance of this method of hemostatic and ligation control.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract emblem resembling an eagle or a stylized human figure, composed of three curved lines. The emblem is positioned to the right of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB - 2 2010
Genicon % Mr. Gary W. Haberland President 6869 Stapoint Court #114 Winter Park, Florida 32792
Re: K100090
Trade/Device Name: Genicon Ligation Clip Regulation Number: 21 CFR 878,4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP, MCH Dated: January 08, 2010 Received: January 12, 2010
Dear Mr. Haberland:
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
3
Page 2 - Mr. Gary W. Haberland
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/ResourcesforYou/Industry/default.lyfm
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
12,100090 510(k):
Section 4 - Indications for Use
·Device Name: GENICON Ligation Clip
Indications for Use:
The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing. -
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
00090
Daniel Keene for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number