(72 days)
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.
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.
The provided text describes the 510(k) summary for the Weck Auto Endo10 Automatic Endoscopic Clip Applier, a medical device for ligating vessels or tissue structures. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Weck Auto Endo5 Automatic Endoscopic 35cm Applier, K152081) and lists the non-clinical performance tests conducted. These tests confirm the device's physical properties, biocompatibility, sterilization, and packaging integrity, but not its clinical performance or accuracy in a diagnostic or interventional context that would typically involve specific acceptance criteria and detailed performance metrics.
Therefore, I cannot provide the requested information. The document is about a device (clip applier) which is an instrument, not an AI/ML-driven diagnostic or therapeutic device that requires detailed performance metrics like sensitivity, specificity, or reader studies.
If this were an AI/ML device, the following information would typically be present and is what the original request asks for:
- Table of acceptance criteria and reported device performance: This would list metrics like sensitivity, specificity, accuracy, F1-score, AUC, etc., along with the target values (acceptance criteria) and the actual performance achieved by the device.
- Sample size used for the test set and data provenance: Details on how many cases were in the test set, their origin (e.g., specific hospitals, countries), and whether the data was collected retrospectively or prospectively.
- Number of experts and their qualifications for ground truth: How many clinical experts (e.g., radiologists, pathologists) independently reviewed the test cases to establish the ground truth, and their experience level.
- Adjudication method for the test set: How disagreements among experts were resolved to determine the final ground truth (e.g., 2+1 means two experts agree, or a third adjudicator decides).
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If conducted, the effect size indicating the improvement in human reader performance (e.g., sensitivity, specificity, reading time) when assisted by the AI compared to reading without AI. This is a common requirement for AI in diagnostics.
- Standalone (algorithm only) performance: The performance of the AI algorithm independently, without human intervention.
- Type of ground truth used: Whether the ground truth was based on expert consensus, pathology reports (considered a gold standard), clinical outcomes data, or other methods.
- Sample size for the training set: The number of cases used to train the AI model.
- How ground truth for the training set was established: The process by which the training data was labeled or annotated.
None of this information is available in the provided text because the device is a surgical instrument (clip applier), not an AI/ML diagnostic or prognostic tool.
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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
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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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FOR FDA USE ONLY
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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 AutomaticEndoscopic 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 11135:2014ISO 10993-7:2008 | Pass |
| Packaging Verification | ISO 11607-1:2006 (A1:2014)ISO 11607-2:2006 (A1:2014)ASTM D4169-14ASTM F88/F88M-09ASTM F2096-11 | Pass |
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| Shelf Life Testing (OneYear) | ASTM F1980-07/(R)2011 | Pass |
|---|---|---|
| Biocompatibility Testing | ISO 10993-1:2009 | Pass |
| Benchtop Design Verification | N/A | Pass |
| Usability and DesignValidation (Animal Lab) | AAMI/ANSI HE75:2009(R)2013IEC 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.
§ 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.