(70 days)
The WECK® EFx™ Endo Fascial Closure System has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Laparoscopic ports are used to establish a port of entry into the abdominal cavity and gain access to the surgical site. Ports are positioned into patients during minimally invasive surgical procedures by trained surgeons in order to provide a pathway for the insertion and removal of surgical devices and removal of specimens. Following the laparoscopic procedure the injury to the abdominal wall defects at the site of the port entry puncture must be repaired and often entails suturing to prevent future complications and particularly herniation. The WECK® EFx™ Endo Fascial Closure System is designed to maintain pneumoperitoneum and facilitate placement and withdrawal of suture loops to perform these repairs.
Here's a breakdown of the acceptance criteria and study information for the WECK® EFx™ Endo Fascial Closure System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Response Type | Test Specification | Reported Device Performance (Result) |
|---|---|---|
| Qualitative | Material Verification | PASS (Materials were found to meet pre-established specifications.) |
| Qualitative | Visual Inspection for Defects and Cleanliness | PASS (All devices passed the inspections for defects and cleanliness.) |
| Quantitative | Dimensional Inspection | PASS (Dimensions were found to meet pre-established specifications.) |
| Qualitative and Quantitative | Mechanical Inspection | PASS (Function of the device was verified against pre-established specifications.) |
| Qualitative and Quantitative | Suture Retention | PASS (Function of the device was verified against pre-established specifications.) |
| Qualitative and Quantitative | Destructive Testing of Failure Modes | PASS (The device exceeded the maximum working load of the pre-established specifications.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily describes bench testing for material and dimensional modifications. It does not provide specific sample sizes for each test listed in the table, nor does it mention a "test set" in the context of clinical or image-based data. Therefore, the data provenance relates to the samples tested in the laboratory.
- Sample Size for Test Set: Not explicitly stated as a number of devices/units, but samples were used for material verification, visual inspection, dimensional inspection, mechanical inspection, suture retention testing, and destructive testing.
- Data Provenance: The tests were performed in a laboratory setting by the manufacturer (Teleflex Medical, Inc.) to verify performance. This is a form of prospective testing (as it was designed to evaluate the modified device) but within a non-clinical, controlled environment. Country of origin of the data is not specified beyond the applicant's address in Research Triangle Park, NC, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this submission. The tests performed are engineering-based bench tests, not clinical studies requiring expert interpretation of results for ground truth establishment. Specifications for materials, dimensions, and mechanical function serve as the "ground truth" or acceptance criteria for these tests.
4. Adjudication Method for the Test Set:
This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical or image-based studies where multiple human readers assess data and discrepancies need resolution. The tests here are objective measurements and evaluations against pre-established engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not conducted. This submission focuses on verification bench testing of product modifications against a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not conducted. This device is a mechanical surgical instrument, not an AI/software algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these bench tests was derived from pre-established specifications and predicate device performance.
- Pre-established specifications: These are internal engineering and quality control standards set by the manufacturer for materials, dimensions, mechanical function, and suture retention.
- Predicate device performance: The overall goal was to demonstrate that the modified device is "substantially equivalent" to the predicate device cleared under K103412. This implies that the predicate device's established performance implicitly serves as a benchmark for the new device's acceptable performance.
8. The Sample Size for the Training Set:
This information is not applicable. This submission details the premarket notification of a medical device (a surgical instrument), not an artificial intelligence or machine learning system. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8. There is no training set for an AI algorithm in this submission.
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K132-362
Traditional 510(k) Section 7 - 510(k) SUMMARY
1 2 t
WECK® EFx™ Endo Fascial Closure System
510(k) SUMMARY WECK® EFx™ Endo Fascial Closure System
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-361-4071 919-433-4996 Fax:
B. Contact Person
Natalie Hichak Regulatory Affairs Specialist
ОСТ 0 8 2013
Manager RA/QE Surgical C. Date Prepared
Lorraine DeLong
July 16, 2013
D. Device Name
Trade Name: WECK® EFx™ Endo Fascial Closure System
Common Name: Endoscopic tissue approximation device
Classification Name: Endoscope and accessories
E. Device Description
Laparoscopic ports are used to establish a port of entry into the abdominal cavity and gain access to the surgical site. Ports are positioned into patients during minimally invasive surgical procedures by trained surgeons in order to provide a pathway for the insertion and removal of surgical devices and removal of specimens. Following the laparoscopic procedure the injury to the abdominal wall defects at the site of the port entry puncture must be repaired and often entails suturing to prevent future complications and particularly herniation. The WECK® EFx™ Endo Fascial Closure System is designed to maintain pneumoperitoneum and facilitate placement and withdrawal of suture loops to perform these repairs.
Teleflex Medical, Inc.
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F. Indications for Use
ﺔ
ﺷ
The WECK® EFxTM Endo Fascial Closure System has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
G. Contraindications
Do not use where laparoscopic techniques are generally contraindicated
H. Substantial Equivalence
The proposed WECK® EFx™ Endo Fascial Closure System is substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Axiom Fascial Closure System | Axiom TechnologyPartners | K103412 | December 30, 2010 |
I. Comparison To Predicate Devices
The proposed WECK® EFx™ Endo Fascial Closure System has the same technology, indications for use and functional characteristics as the predicate system. This submission is notification to the agency of the transfer in ownership of the 510(k).K 103412 from Axiom Technology Partners LLC to Teleflex Medical Incorporated and to update material and dimensional modifications incorporated subsequent to the clearance of 510(k) K103412 and prior to the transfer of ownership to Teleflex Medical Inc.
J. Materials
All patient contacting materials are in compliance with ISO10993-1.
K. Technological Characteristics
A comparison of the technological characteristics of the proposed WECK® EFx™ Endo Fascial Closure System and the predicate has been performed. The results of this comparison demonstrate that the WECK® EFx™ Endo Fascial Closure System is equivalent to the marketed predicate devices in performance characteristics.
L. Performance Data
The bench testing has been performed to verify that the performance of the proposed WECK® EFx™ Endo Fascial Closure System is substantially equivalent to the
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Traditional 510(k) Section 7 - 510(k) SUMMARY
י י
predicate device. The proposed material and dimensional modification was tested according to the scheme and specifications summarized below.
| Performance Data Results Summary | ||
|---|---|---|
| Response Type | Test Specification | Result |
| Qualitative | Material Verification | PASSMaterials were found to meet pre-establishedspecifications. |
| Qualitative | Visual Inspection forDefects andCleanliness | PASSAll devices passed the inspections for defectsand cleanliness. |
| Quantitative | DimensionalInspection | PASSDimensions were found to meet pre-established specifications. |
| Qualitative andQuantitative | MechanicalInspection | PASSFunction of the device was verified againstpre-established specifications. |
| Qualitative andQuantitative | Suture Retention | PASSFunction of the device was verified againstpre-established specifications. |
| Qualitative andQuantitative | Destructive Testingof Failure Modes | PASSThe device exceeded the maximum workingload of the pre-established specifications. |
L. Conclusion
Based upon the comparative test results, the proposed WECK® EFx™ Endo Fascial Closure System is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K 103412. The modifications made to the proposed WECK® EFxTM Endo Fascial Closure System do not introduce any new issues of safety and effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WObo-Goos Silver Spring, MD 20993-0002
October 8, 2013
Teleflex Medical. Incorporated Ms. Natalie Hichak Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
Rc: K132362
Trade/Device Name: WECK* EFx" Endo Fascial Closure System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Codes: OCW. GCJ, HCF Dated: July 29, 2013 Received: July 30, 2013
Dear Natalie Hichak.
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 10 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Natalie Hichak
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
510(k) Number:
Device Name:
WECK® EFx™ Endo Fascial Closure System
Indications for Use:
The WECK® EFx™ Endo Fascial Closure System has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.