(30 days)
Not Found
No
The document describes a mechanical device for applying surgical clips and does not mention any AI or ML components or functionalities.
No
The device is a delivery system for ligating clips used to ligate vessels or tissue, and it does not directly treat or cure any condition.
No
The device is described as a delivery device for ligating clips used to ligate vessels or tissue structures in surgical procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly describes a physical, sterile, disposable endoscopic applier with a trigger grip, shaft, and rotation knob, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are used to deliver ligating clips for the ligation of vessels or tissue structures during laparoscopic procedures. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for surgical ligation, not for diagnostic testing of biological samples.
Therefore, this device falls under the category of a surgical instrument or device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
Product codes
FZP
Device Description
The Auto Endo5 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok medium-large, nonabsorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49.37cm long with a working length of 35.2cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or tissue structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon or physician's assistant during laparoscopic procedures
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 has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support a change to the device's working length and ratcheting mechanism.
Usability and design validation of the Auto Endo5 5mm Automatic Endoscopic 35cm Applier in a porcine model was conducted to document that the clip applier performed to its intended use in vivo, the user was able to operate the system as intended, and the product conformed to user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/1 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 an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2015
Teleflex Medical Incorporated Ms. Ashlea Ricci Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K152081
Trade/Device Name: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: July 24, 2015 Received: July 27, 2015
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Weck Auto Endo5, 5mm Automatic Endoscopic 35cm Applier
Indications for Use (Describe)
Indications for Use (Describe)
Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as devices for West Auto Lludo I reali-e-lok mo actions clips. These appliers are designed for use with 5/5.5mm cannulas.
Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue stractives services as normals Hem-of-on mgainly crips are miculed for use in proceanse or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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510(k) SUMMARY
Weck® Auto Endo5® 5mm Automatic Endoscopic 35cm Applier
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical. Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-361-4071 Fax: 919-433-4996
B. Contact Person
Ashlea Ricci, MSRS, RAC Senior Regulatory Affairs Specialist
C. Date Prepared
August 5, 2015
D. Device Name
| Trade Name: | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier |
|---|---|
| Common Name: | Implantable Clip |
| Classification Name: | Clip, Implantable |
| Product Class: | Class 2 |
| Product Code: | FZP |
| Regulation Number: | 878.4300 |
E. Device Description
The Auto Endo5 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok medium-large, nonabsorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49.37cm long with a working length of 35.2cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
F. Indications for Use
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
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Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
G. Contraindications
Hem-o-lok Ligating Clips are not intended for use as a contraceptive tubal occlusion device.
Hem-o-lok Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
H. Environmental Conditions
Hem-o-lok Ligating Clips are "MR Safe" and pose no known hazards in MR environments. This claim was cleared under K133202, December 30, 2013.
-Substantial Equivalence
The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Weck Auto Endo5 Hem-o-lok | |||
| Ligating Clip Applier | Teleflex Medical | K142777 | 12/19/2014 |
J. Comparison To Predicate Devices
The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier has the same technology and functional characteristics as the predicate device. The modifications proposed within this submission include extending the device's working length by 5.5cm, a minor modification to the ratcheting mechanism to improve audible cues during use and a change in the color of the trigger from green to white.
K. Materials
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1.
L. Technological Characteristics
A comparison of the technological characteristics of the proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier and the predicate has been performed. The results of this comparison demonstrate that the Auto Endo5 5mm Automatic Endoscopic 35cm Applier is equivalent to the marketed predicate device.
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M. Performance Data
Non-clinical performance testing has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support a change to the device's working length and ratcheting mechanism.
Usability and design validation of the Auto Endo5 5mm Automatic Endoscopic 35cm Applier in a porcine model was conducted to document that the clip applier performed to its intended use in vivo, the user was able to operate the system as intended, and the product conformed to user needs.
N. Conclusion
Based upon the performance and comparative test results, the proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K142777. The modifications made to the Auto Endo5 5mm Automatic Endoscopic 35cm Applier do not introduce any new issues of safety and effectiveness.