WECK EFX ENDO FASCIAL CLOSURE SYSTEM

K132362 · Teleflexmedical, Inc. · OCW · Oct 8, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132362
• Device Name: WECK EFX ENDO FASCIAL CLOSURE SYSTEM
• Applicant: Teleflexmedical, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Oct 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WECK® EFx™ Endo Fascial Closure System has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Device Story

The WECK® EFx™ Endo Fascial Closure System is a surgical instrument used during minimally invasive laparoscopic procedures. It is designed to maintain pneumoperitoneum while facilitating the placement and withdrawal of suture loops to repair abdominal wall defects at port entry sites. The device is operated by trained surgeons in an operating room setting. By enabling precise percutaneous suturing, the system helps close incision sites, thereby preventing post-operative complications such as herniation. The device functions as a mechanical tool for tissue approximation; it does not involve electronic processing or automated decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through qualitative and quantitative testing, including material verification (ISO 10993-1 compliance), visual inspection, dimensional inspection, mechanical function testing, suture retention, and destructive testing of failure modes. Results demonstrated that the device met all pre-established specifications and exceeded maximum working load requirements.

Technological Characteristics

Mechanical tissue approximation device. Patient-contacting materials comply with ISO 10993-1. Features include dimensional and material modifications compared to the predicate. No energy source, software, or connectivity components. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring tissue approximation and percutaneous suturing for the closure of incision sites.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Axiom Fascial Closure System (K103412)

Submission Summary (Full Text)

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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: [phone] 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 Technology<br>Partners | 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

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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 | PASS<br>Materials were found to meet pre-established<br>specifications. |
| Qualitative | Visual Inspection for<br>Defects and<br>Cleanliness | PASS<br>All devices passed the inspections for defects<br>and cleanliness. |
| Quantitative | Dimensional<br>Inspection | PASS<br>Dimensions were found to meet pre-<br>established specifications. |
| Qualitative and<br>Quantitative | Mechanical<br>Inspection | PASS<br>Function of the device was verified against<br>pre-established specifications. |
| Qualitative and<br>Quantitative | Suture Retention | PASS<br>Function of the device was verified against<br>pre-established specifications. |
| Qualitative and<br>Quantitative | Destructive Testing<br>of Failure Modes | PASS<br>The device exceeded the maximum working<br>load 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 [phone] or [phone] 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 [phone] or [phone] 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:

K132362

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