(72 days)
Not Found
No
The device description and performance studies focus on mechanical function and usability, with no mention of AI or ML capabilities.
No
The device is described as an automatic endoscopic ligating clip applier used for delivering clips to ligate vessels or tissue structures. It is a tool used during a surgical procedure, not a device that directly treats or cures a disease or condition.
No
The device is a ligating clip applier used for surgical procedures to ligate vessels or tissue structures. It is a therapeutic device, not a diagnostic one, as it does not gather or interpret data to identify or monitor medical conditions.
No
The device description clearly describes a physical, disposable medical device (an automatic endoscopic clip applier) with specific dimensions and mechanical components, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the ligation of vessels or tissue structures during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a surgical instrument (an automatic endoscopic clip applier) used to deliver clips internally.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) 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 diagnostic information. This device is a surgical tool used for treatment (ligation).
N/A
Intended Use / Indications for Use
The Weck Auto Endo10 Hem-o-lok L automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok L non-absorbable polymer ligating clips. These appliers are designed for use with 10/11 mm cannulas.
Hem-o-lok ligating clips are intended for use involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the vessel or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Weck® Auto Endo10® Automatic Endoscopic Clip Applier is an automatic, endoscopic applier that is pre-loaded with twelve (12) Hem-o-lok large, nonabsorbable polymer ligating clips. The applier is an ethylene oxide (EO) 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 Endo10 Automatic Endoscopic Applier employs a pistol 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 10/11mm 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
Usability and design validation of the Auto Endo10 Automatic Endoscopic 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.
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 the line extension to add a large automatic applier. Benchtop testing for the Auto Endo10 Automatic Endoscopic Applier included visual inspection, device weighing, trocar compatibility, aperture check, clip retention, knob rotation, clip closure, and trigger force measurement.
Usability and design validation of the Auto Endo10 Automatic Endoscopic 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): 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
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing 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
September 7, 2016
Teleflex Medical Ms. Holly Hallock Senior Regulatory Affairs Specialists Surgical Business Unit 3015 Carrington Mill Blvd Morrisville. North Carolina 27560
Re: K161758
Trade/Device Name: Weck Auto Endo10 Automatic Endoscopic Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP, GDO Dated: June 24, 2016 Received: June 27, 2016
Dear Ms. Hallock:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161758
Device Name
Weck Auto Endo10 Automatic Endoscopic Clip Applier
Indications for Use (Describe)
Weck Auto Endo10 Hem-o-lok L automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok L non-absorbable polymer ligating clips. These appliers are designed for use with 10/11 mm cannulas.
Hem-o-lok ligating clips are intended for use involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the vessel 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY - K161758
Weck® Auto Endo10® Automatic Endoscopic Clip 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 919-433-4996 Fax:
B. Contact Person
Holly Hallock Senior Requlatory Affairs Specialist
C. Date Prepared
August 30, 2016
D. Device Name
Trade Name: Weck® Auto Endo10® Automatic Endoscopic Clip Applier Model Number: AE10LG Common Name: Implantable Clip Classification Name: Clip, Implantable Product Code: FZP Regulation: 878.4300
E. Device Description
The Weck® Auto Endo10® Automatic Endoscopic Clip Applier is an automatic, endoscopic applier that is pre-loaded with twelve (12) Hem-o-lok large, nonabsorbable polymer ligating clips. The applier is an ethylene oxide (EO) 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 Endo10 Automatic Endoscopic Applier employs a pistol 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 10/11mm 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 following indications for use are identical to those of the predicate, with the exception that they reference the larger size slip and the larger corresponding cannulas. These variations are due to the fact that the proposed Auto Endo10 delivers pre-loaded large clips and the predicate delivers medium-large clips.
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The Weck Auto Endo10 Hem-o-lok L automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok L nonabsorbable polymer ligating clips. These appliers are designed for use with 10/11mm 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.
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 Endo10 Automatic Endoscopic Applier is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Weck Auto Endo5 5mm Automatic | |||
| Endoscopic 35cm Applier | Teleflex Medical | K152081 | 08/26/2015 |
J. Comparison To Predicate Devices
The proposed Auto Endo10 Automatic Endoscopic Applier has the same technology and functional characteristics as the predicate device.
This submission discusses a line extension to add an automatic applier intended to deliver large Hem-o-lok Ligating Clips through a 10mm shaft during laparoscopic procedures. This differs from the predicate in that the Auto Endo5 device delivers medium-large Hem-o-lok clips through a 5mm shaft.
Additional differences include the addition of a lock pin in the subject device for the purposes of reducing movement of preloaded clips during distribution and storage as well as insert-molding of the actuator for the purpose of maintaining the design intent while utilizing a larger shaft.
The subject device is pre-loaded with twelve (12) ligating clips, whereas the predicate houses fifteen (15); this is due to the larger size of the clips. Channel spring fingers have been added as internal components to the device to support the
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larger size clips. Additionally, the larger size clips require a slight modification to the handle ratchet profile.
The rotation knob on the subject device is purple as opposed to green on the predicate device. Rotation knob color is consistent with the color-coding established for the Hem-o-lok Ligation family.
Lastly, the subject device's manufacturing location and sterilization facility have changed.
K. Materials
All patient contacting materials, including those with indirect patient contact, have been evaluated according to ISO 10993-1 and the FDA's Guidance Use of International Standard ISO 10993-1, dated June 16, 2016. All biocompatibility testing was successful.
L. Technological Characteristics
A comparison of the technological characteristics of the proposed Auto Endo10 Automatic Endoscopic Applier and the predicate has been performed. The results of this comparison demonstrate that the Auto Endo10 Automatic Endoscopic Applier is equivalent to the marketed predicate device.
M. Performance Data
Non-clinical performance testing has been conducted following product sterilization. environmental conditioning, and simulated distribution in order to support the line extension to add a large automatic applier. Benchtop testing for the Auto Endo10 Automatic Endoscopic Applier included visual inspection, device weighing, trocar compatibility, aperture check, clip retention, knob rotation, clip closure, and trigger force measurement.
Usability and design validation of the Auto Endo10 Automatic Endoscopic 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. Nonclinical Tests
The following nonclinical tests have been conducted on the proposed Auto Endo10:
| Test | Standard | Result |
|---|---|---|
| EO Sterilization Validation | ISO 11135:2014 | |
| ISO 10993-7:2008 | Pass | |
| Packaging Verification | ISO 11607-1:2006 (A1:2014) | |
| ISO 11607-2:2006 (A1:2014) | ||
| ASTM D4169-14 | ||
| ASTM F88/F88M-09 | ||
| ASTM F2096-11 | Pass |
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| Shelf Life Testing (One
| Year) | ASTM F1980-07/(R)2011 | Pass |
|---|---|---|
| Biocompatibility Testing | ISO 10993-1:2009 | Pass |
| Benchtop Design Verification | N/A | Pass |
| Usability and Design | ||
| Validation (Animal Lab) | AAMI/ANSI HE75:2009(R)2013 | |
| IEC 62366:2007(A1:2014) | Pass | |
| Supplemental Validation | ||
| (Hospital Setting) | N/A | Pass |
| Trocar Compatibility Testing | N/A | Pass |
O. Conclusion
Based upon the performance and comparative test results, the proposed Auto Endo10 Automatic Endoscopic Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K152081. The line extension discussed within this submission does not introduce any new issues of safety and effectiveness.