(31 days)
K0864102, K830503
Not Found
No
The description focuses on the mechanical function of a surgical clip applier and does not mention any computational or learning capabilities.
No.
The device is described as a surgical instrument for ligation, which is a procedural tool rather than a device intended to directly treat or cure a disease or condition therapeutically.
No
The device, LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier, is described as a surgical instrument used for ligation (tying off tubular structures or vessels) with metal clips. Its intended use is to deliver clips and form ligatures, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly outlines a physical surgical instrument with a handle, trigger, shaft, jaws, and 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 ligating tubular structures or vessels during surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical instrument designed to apply clips to tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical tool used for a therapeutic purpose (ligation) during a surgical procedure.
N/A
Intended Use / Indications for Use
The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
Product codes
FZP
Device Description
The LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier is a sterile, single patient use, disposable surgical instrument designed to provide a means of ligation through an appropriately sized trocar. The instrument configuration consists of a pistol grip hadle, an actuation trigger, a rotation knob, a shaft having an outer diameter of 5.5mm and a length of 33cm. At the distal end of the shaft is a set of jaws for forming ligating cligs. The device contains 15 clips.
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 ensure that the device performs as intended. All testing results demonstrated satisfactory performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0864102, K830503
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.
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K050344 Page 1/2
LIGACLIP® 5 M/L 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creck Rd. Cincinnati, OH 45242
MAR I 4 2005
Contact
Kimberly Shoemaker Manager, Regulatory Affairs
Date Prepared:
February 10, 2005
Name of Device
Trade Name: LIGACLIP® 5M/L Endoscopic Multiple Clip Applier Classification Name: Implantable Clip
Predicate Devices:
Trade Name: LIGACLIP® ERCA Endoscopic Rotating Multiple Clip Applier Cleared under 510(k) numbers K0864102 on November 5, 1986. The Titanium Clips used with the applier were cleared March 9, 1983 under K830503.
Device Description
The LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier is a sterile, single patient use, disposable surgical instrument designed to provide a means of ligation through an appropriately sized trocar. The instrument configuration consists of a pistol grip hadle, an actuation trigger, a rotation knob, a shaft having an outer diameter of 5.5mm and a length of 33cm. At the distal end of the shaft is a set of jaws for forming ligating cligs. The device contains 15 clips.
Indications for Use
The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
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K050344 Agycz/2
Technological Characteristics
The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is identical to the predicate device with respect to intended use. The device is operated in a manner similar to the predicate device.
Performance Data
Bench testing was performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an eagle with its wings spread, facing to the left. The eagle is a stylized representation, with three distinct lines forming its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Ms. Kimberly Shoemaker Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K050344
K030544
Trade/Device Name: LIGACLIP® 5M/L 5mm Endoscopic Multiple Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: February 10, 2005 Received: February 11, 2005
Dear Mr. Shoemaker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegantly the Medical Device Amendments. or to commerce provide to May 20, 1976, the enacement with the provisions of the Federal Food. Drug. devices that have been reclasined in asseroval of a premarket approval application (PMA). and Cosment Act (Tel) that to hot require appt to the general controls provisions of the Act. The r ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (500 above) this. Existing major regulations affecting your device can may be subject to subject to submitted and ever and the may be and . In addition. FDA may be found in the over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Drive issualites your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must or ally it catal statutes and regalations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY an 607), adomig (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Kimberly Shoemaker
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premitired notification. The FDA mining of cation 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 If you desire specific advice for your as not 15. Also, please note the regulation entitled. Comacit the Office of Compullios in (21CFR Part 807.97). You may obtain of Small other general miorination on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International und Ochsander 16.000 viedrh/industry/support/index.html
Sincerely yours,
sincerely yours,
Mark A. Millican
Miriam C. Provost. Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Ethicon Endo-Surgery, Inc., a Johnson & Johnson company. The logo includes a graphic element on the left and the company name and affiliation on the right. Below the company information is the address: 4545 Creek Road, Cincinnati, Ohio 45242-2839.
Indications for Use
510(k) Number (if known): 4050344
Device Name: 1.IGACLIP® 5.M/I. 5 mm Endoscopic Multiple Clip Applier
Indications for Use:
The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
| Prescription Use (Part 21 CFR 801 Subpart D) | x |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number