(93 days)
Not Found
No
The device description and performance studies focus on the physical properties and compatibility of the ligating clips and appliers, with no mention of AI or ML technology.
No.
The device is used to ligate vessels or anatomic structures during surgical procedures, which is a structural intervention rather than a therapeutic treatment.
No
The device, Weck® Ligating Clips, is described as a single-use, non-absorbable, non-active implantable device used for vessel or tissue ligation in surgical procedures. Its purpose is therapeutic (ligation) rather than diagnostic.
No
The device description clearly states it is a physical, non-absorbable, non-active implantable device made of metal alloys, and includes physical accessories (appliers and removers). It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as a "single-use, non-absorbable, non-active implantable device designed for use in general surgical procedures that require vessel or tissue ligation." This further reinforces its use within a surgical context.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, providing diagnostic information, or any other activities typically associated with in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Weck® Ligating Clips are used directly on the patient's body during surgery.
N/A
Intended Use / Indications for Use
Weck® Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size, type and material of the clip based upon their experience, judgment and needs.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
Weck® Metal Ligating Clips are single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. Each product line possesses a unique design necessary for compatibility with its appropriate Weck® ligating clip applier. The clips are available in a range of sizes, allowing the end user to ligate a wide range of vessels and tissue structures. Weck® Metal Ligating Clips are manufactured from medical grade titanium, tantalum or stainless steel alloys and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Weck® Metal Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or anatomic 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)
Non-clinical performance testing was conducted to support the "MR Conditional" labeling claim in accordance with ASTM F2503-08. Standard Practice for Marketing Medical Devices and Other Items for Safety in the Magnetic Resonance Environment as well as the FDA quidance document. Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated August 21, 2008. The results of these tests demonstrate that the Weck® Ligating Clips are "MR Conditional" and may be safely used in environments of 3-Tesla or less.
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.
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K132658 Page 1/3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Weck® Metal Ligating Clips
NOV 2 7 2013
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8065 919-433-4996 Fax:
B. Contact Person
. .
Ashlea Ricci, RAC Senior Regulatory Affairs Specialist
Lorraine DeLong Manager RA/QE Surgical
C. Date Prepared
August 23, 2013
D. Device Name
| Trade Name: | Weck® Metal Ligating Clips |
|---|---|
| Common Name: | Implantable Clips |
| Classification Name: | Clips, Implantable |
E. Device Description
Weck® Metal Ligating Clips are single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. Each product line possesses a unique design necessary for compatibility with its appropriate Weck® ligating clip applier. The clips are available in a range of sizes, allowing the end user to ligate a wide range of vessels and tissue structures. Weck® Metal Ligating Clips are manufactured from medical grade titanium, tantalum or stainless steel alloys and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Weck® Metal Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
1
F. Indications for Use
Weck® Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size, type and material of the clip based upon their experience, judgment and needs.
G. Contraindications
Weck® Ligating Clips are not intended for use as a contraceptive tubal occlusion device.
Weck® Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
H. Environmental Conditions
Weck® Metal Ligating Clips are "MR Conditional" up to and including 3-Tesla MR environments.
I. Substantial Equivalence
The proposed Weck® Metal Ligating Clips are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Horizon™ Ligating Clip | Teleflex Medical | ||
| (Weck) | K982313 | 08/10/1998 | |
| Hemoclip® Traditional Ligating | |||
| Clip | Teleflex Medical | ||
| (Weck) | K841547 | 08/14/1984 |
J. Comparison To Predicate Devices
The proposed Weck® Metal Ligating Clips have the same technology and functional characteristics as the predicate system. The proposed modifications include the addition of magnetic resonance (MR Conditional) claims, addition of a contraindication for renal donor nephrectomy, addition of cleaning and sterilization instructions for reusable instrumentation, two line extensions, a change in packaging materials, and a change in the sterilization method of the Horizon™ Ligating Clips.
K. Materials
All patient contacting materials are in compliance with ISO10993-1.
L. Technological Characteristics
A comparison of the technological characteristics of the proposed Weck® Metal Ligating Clips and the predicates has been performed. The results of this comparison demonstrate that the Weck® Metal Ligating Clips are equivalent to the marketed predicate devices.
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K132658 Page 3/3
Traditional 510(k) Section 7 - Summary of Safety and Effectiveness
Weck® Metal Ligation Clips
M. Performance Data
Non-clinical performance testing was conducted to support the "MR Conditional" labeling claim in accordance with ASTM F2503-08. Standard Practice for Marketing Medical Devices and Other Items for Safety in the Magnetic Resonance Environment as well as the FDA quidance document. Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated August 21, 2008. The results of these tests demonstrate that the Weck® Ligating Clips are "MR Conditional" and may be safely used in environments of 3-Tesla or less.
N. Conclusion
Based upon the comparative test results, the proposed Weck® Metal Ligating Clips are substantially equivalent in performance to the predicate devices cleared to market via 510(k) K982313 and K841547. The modifications made to the proposed Weck® Metal Ligating Clips do not introduce any new issues of safety and effectiveness.
3
Image /page/3/Picture/0 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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Teleflex Medical Incorporated Ms. Ashlea Ricci, RAC Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
November 27, 2013
Re: K132658
Trade/Device Name: Weck® Metal Ligation Clips Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: August 23, 2013 Received: August 30, 2013
Dear Ms. Ricci:
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 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
4
Page 2 - Ms. Ashlea Ricci, RAC
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.htm.
For
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Page 1 of 1
510(k) Number:
Device Name:
Weck® Metal Ligation Clips
Indications for Use:
Weck® Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size, type and material of the clip based upon their experience, judgment and needs.
Prescription Use ਸ (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)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132658