(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a titanium surgical clip, with no mention of AI or ML.
No
The device is a ligating clip used for occluding vessels or tubular structures during surgery, which is a surgical tool rather than a therapeutic device designed to treat a disease or improve a health condition.
No
The device is a ligating clip used in surgical procedures to occlude vessels or other tubular structures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the Nexus Ligating Clip is a titanium clip, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Nexus Ligating Clip Function: The Nexus Ligating Clip is a surgical device used during a surgical procedure to physically occlude vessels or tubular structures. It is applied directly to the patient's anatomy, not used to test a specimen taken from the patient.
The description clearly indicates its use in surgical procedures on the patient's body, which is the domain of surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Nexus Ligating Clip is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Nexus Ligating Clip is a titanium clip used during surgical procedures. The clips are supplied sterile in four sizes: small, medium-large, and large; six clips per cartridge. The size of clip should be chosen based on experience, judgment, and needs, ensuring that the tissue to be occluded fits completely within the clip. The devices are heart-shaped to provide a firm grip on the structure to be ligated, and there are transverse grooves on the inner surface of each clip to resist slippage.
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 sterilization cycle was validated in accordance with accepted international standards. Shelf life testing was performed to support the laboled shelf life period of five years. The results of all testing were within acceptable limits.
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
510(k) SUMMARY
K053255
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter's Name: MicroSurgical Laboratories, dba Wexler Surgical Supplies 11333 Chimney Rock Road, Suite 110 Houston, TX 77035 Telephone: (713) 723-6900 Fax: (713) 723-6906 Contact person: Mr. Danny Fishman, COO
Date of Summary: February 17, 2006
Device Names:
Trade Name: Nexus Ligating Clips Common Name: Titanium Hemostatic Clip Classification Name: Implantable Clip (21 CFR 878.4300, Product Code FZP)
Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate devices are the Horizon Ligation Clips (K982313) manufactured by Weck Closure Systems, determined to be substantially equivalent to a legally marketed (preAmentment) device on August 10, 1998.
Device Description: The Nexus Ligating Clip is a titanium clip used during surgical procedures. The clips are supplied sterile in four sizes: small, medium-large, and large; six clips per cartridge. The size of clip should be chosen based on experience, judgment, and needs, ensuring that the tissue to be occluded fits completely within the clip. The devices are heart-shaped to provide a firm grip on the structure to be ligated, and there are transverse grooves on the inner surface of each clip to resist slippage.
Intended Use: The Nexus Ligating Clip is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required.
Descriptive Summary of Technological Characteristics and Those of Predicate Device: The indications for use, principles of operation, and device design of the Nexus Ligating Clip are virtually identical to those of the predicate device. The Nexus devices are essentially a subset of the Horizon System, in that the Nexus Clip is offered in fewer sizes, only one cartridge capacity, and are made with titanium only, rather than titanium or tantalum. There are no significant differences in either technology nor performance specifications.
Performance Data: The sterilization cycle was validated in accordance with accepted international standards. Shelf life testing was performed to support the laboled shelf life period of five years. The results of all testing were within acceptable limits.
Conclusion: The information and data provided in this 510(k) Notification establish that the Nexus Ligating Clip is substantially equivalent to the legally marketed predicated device.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and two lines representing its legs.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroSurgical Laboratories, dba Wexler Surgical
MAR 1 4 2006
Supplies c/o Ms. Lisa S. Jones Regulatory Affairs Consultant Devices for the Future 540 College Street Bellaire, Texas 77401
Re: K053255
Trade/Device Name: Nexus™ Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: January 23, 2006 Received: January 24, 2006
Dear Ms. Jones:
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. Ilisting 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.
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 lisuing (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.
2
Page 2 - Ms. Jones
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.
Sincerely yours,
elmee
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K053255
Device Name: Nexus™ Ligating Clip
Indications for Use: The Nexus Ligating Clip is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
OR Over-The-Counter
(21 CFR 80
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CD ffice of Device Evaluation (ODE)
(Division Sign-Off
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_K053255
11333 Chimacy Rock, Suite 110 - Houston, Texas 77935 - Phone: 713.723.6900 - Toll Free: 800,414.1476 F-mail: sales@wexlersurgical.com - 17ax: 713.723.6906 - www.weslersurgical.com