(11 days)
Not Found
No
The summary describes a mechanical clip applier and does not mention any AI/ML components or functionalities.
No
Explanation: This device is used for ligation during surgical procedures, which is a supportive surgical tool, not a therapeutic device directly treating a condition.
No
The device is a clip applier used for ligation, which is a therapeutic function, not a diagnostic one. It is used to occlude structures, not to identify or analyze conditions.
No
The device description clearly states it is a physical instrument (a 5 mm endoscopic multiple clip applier) containing titanium clips, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use on tubular structures or vessels wherever a metal ligating clip is indicated." This describes a surgical procedure performed in vivo (within the body) to ligate or occlude structures.
- Device Description: The description details a surgical instrument designed for use through a trocar to apply clips within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples outside the body. This device is a surgical tool used inside the body.
N/A
Intended Use / Indications for Use
The 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The Ethicon Endo-Surgery Ligamax 5 is a 5 mm endoscopic multiple clip applier. This sterile, single patient use, instrument is designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The instrument contains 15 medium-large titanium clips for occluding tissue, structures, and vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tubular structures or vessels
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)
Bench testing was performed to demonstrate that the device will perform as intended.
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) Premarket Notification (Traditional) for Ligamax 5 MR 2 5 2011
510(k) Summary
Company
Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact
Emily Kruetzkamp, Regulatory Affairs Associate Ethicon Endo-Surgery, Inc Telephone: (513) 337-1546 Fax: (513) 337-2802 Email: ekruetzk@its.jnj.com
Date Prepared: March 9, 2011
Device Name
Trade Name: Ligamax™ 5 Common Name: Clip Applier
Classification Names Implantable Clip
Predicate Device
Ligamax™ 5, a 5 MM Endoscopic Multiple Clip Applier, cleared under K050344 on March 14, 2005 as Ligaclip 5 M/L
Device Description:
The Ethicon Endo-Surgery Ligamax 5 is a 5 mm endoscopic multiple clip applier. This sterile, single patient use, instrument is designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The instrument contains 15 medium-large titanium clips for occluding tissue, structures, and vessels.
Indication for Use:
The 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
Technological Characteristics:
The instrument configuration consists of a pistol handle portion, an actuation trigger, a rotation knob, and a shaft with an outer diameter of 5.5 mm and length of 33 xmg The shaft contains an etched line of demarcation, which aids the user's visualization when the device is adequately inserted through the trocar. At the distal end of the shaft are the jaws, which form ligating clips. The force to squeeze the trigger increases when there are no clips remaining in the device, this is known as the tactile last-clip lockout indicator.
Performance Data: Bench testing was performed to demonstrate that the device will perform as intended.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ms. Emily Kruetzkamp Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242
MAR 2 5 201
Re: K110699
.
Trade/Device Name: Ligamax™ 5 Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: March 10, 2011 Received: March 14, 2011
Dear Ms. Kructzkamp:
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
2
Page 2 - Ms. Emily Kruetzkamp
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 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 Pan 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.
A. 13. R.
fu
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ethicon Endo-Surgery, LLC
Indications for Use Form
Indications for Use
510(k) Number (if known): _ K (10699
Device Name: Ligamax™ 5
Indications for Use:
The 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. "
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NOT WRITE BELOW THIS LOE NEEDED OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Daniel Kane
(Division Sign-Off) Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K110699