AbClose - Port Site Closure Device

K160117 · Medeon Biodesign, Inc. · OCW · Sep 9, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160117
• Device Name: AbClose - Port Site Closure Device
• Applicant: Medeon Biodesign, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Sep 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Device Story

Sterile, single-use manual instrument for laparoscopic port site closure. Comprises Suture Guide and Suture Passer. Suture Guide features handle and pyramid-shaped Suture Catcher; Catcher folds into cylinder for insertion into 10-15mm trocar site, then expands to stabilize. Suture Passer features handle and stainless steel needle to pass suture through soft tissue into Suture Catcher. Clinician operates device in hospital OR. Suture Passer penetrates tissue, deploying suture ends into Suture Catcher. Guide is withdrawn by folding Catcher, capturing suture ends for knot tying. Facilitates unassisted fascial closure; maintains pneumoperitoneum during procedure. Benefits patient by enabling secure, standardized closure of laparoscopic incision sites.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (mechanical function, structural integrity, sterilization validation per ISO 11135:2014) and animal testing to demonstrate intended function of tissue approximation and percutaneous suturing.

Technological Characteristics

Manual surgical instrument. Components: Suture Guide (handle, foldable pyramid-shaped Suture Catcher) and Suture Passer (handle, stainless steel needle). Compatible with 10-15mm trocars. Biocompatible materials per ISO 10993-1. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring approximation of tissues and percutaneous suturing for closing incision sites. Contraindicated where laparoscopic techniques are generally contraindicated.

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

• WECK EFx Endo Fascial Closure System (K132362)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2016

Medeon Biodesign, Inc. Ms. Greta Chang Sr. Manager of Regulatory, Ouality & Clinical Affairs 7F, 116, HouGang St. Taipei Taiwan 11170 TW

Re: K160117

Trade/Device Name: Abclose - Port Site Closure Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, GCJ, HCF Dated: July 27, 2016 Received: July 28, 2016

Dear Ms. Greta Chang:

This letter corrects our substantially equivalent letter of September 9, 2016.

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

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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 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 [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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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) K160117

Device Name

AbClose - Port Site Closure Device

#### Indications for Use (Describe)

The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------|
| | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 510(k) Summary

#### 510(k) Nwmber Date Prepared

Submitter 1. Mailing Address

K160117 16 June 2016

### Medeon Biodesign, Inc

7F, 116, HouGang St, Taipei, Taiwan 11170 Phone: [phone]

#### Contact Person

Phone: Fax: E-mail: Date Prepared

2 Device Name Common or usual name Trade name Product Code Classification Name CFR Classification Device Class Classification Panel

#### 3 Predicate Device Name 510(k) number: Trade or proprietary or model name: Manufacturer:

4 Device Description: Greta Chang Sr. Manager of Regulatory, Quality & Clinical Affair [phone] [phone] [e-mail]

Endoscopic tissue approximation device AbClose-Port Site Closure Device OCW, GCJ, HCF Endoscope and Accessories CFR Part 876.1500 II Gastroenterology/Urology

K132362 WECK EFx Endo Fascial Closure System

Teleflex Medical, Incorporated

The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a

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commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures. facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher.

Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

The AbClose - Port Site Closure Device is intended to be used by clinicians through prescription use only.

Indications for Use: The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

For prescription use only

A Comparison of the device feature, intended use, and other information demonstrates that the AbClose - Port Site Closure Device is substantially equivalent to the predicate device as summarized in Table 1.

All patient contacting materials are in compliance with ISO 10993-1, as well as FDA Draft Guidance - Use of international Standard ISO 10993, "Biological Evaluation of Medical Devices, Part1: Evaluation and Testing", dated 04-23-2013

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Special Conditions for Use Statement(s):

- 6. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
- 7. Materials

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# Table 1

| Similarities | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Subject device:<br>AbClose - Port Site Closure Device | Predicate device:<br>WECK EFx Endo Fascial Closure<br>System |
| Indications for<br>use | The AbClose - Port Site Closure Device<br>has application in laparoscopic<br>procedures for approximation of tissue<br>and percutaneous suturing for closing<br>incision sites. | The WECK EFx Endo Fascial Closure<br>System has application in laparoscopic<br>procedures for approximation of tissue<br>and percutaneous suturing for closing<br>incision sites. |
| Target patient<br>Population | Patient under laparoscopic surgery | Same |
| Target User<br>Population | Clinician who is qualified to participate<br>a laparoscopic surgery. | Same |
| Anatomical Site | Abdominopelvic cavity | Same |
| Where Used | Hospital O.R. room | Same |
| Contraindicatio<br>ns | Do not use where laparoscopic<br>techniques are generally contraindicated | Same |
| Method of<br>Introduction | -Suture Guide is introduced into<br>abdominopelvic cavity via a 10-15mm<br>trocar port site<br>-Suture Passer is introduced into<br>abdominopelvic cavity by insertion | Same |
| Compatibility<br>Other Devices | Trocar: 10~ 15 mm | Same |
| Performance | Maintain pneumoperitoneum and<br>facilitate placement and withdrawal of<br>suture loop | Same |
| Biocompatible<br>for Intended Use | Limited exposure, external<br>communication device of tissue contact | Same |
| Differences | | |
| Sterilization<br>Method | Ethylene Oxide sterilization, 10-6 SAL | Radiation, 10-6 SAL |

## 7. Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specification for its intended use. The following tests were performed on the device.

#### Sterilization validation

Sterilization validation was conducted in accordance with ISO 11135:2014 "Sterilization of health-care products-Ethylene oxide -Requirement for the development, validation and

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routine control of a sterilization process for medical devices". Sterilization has been validated to achieve a Sterility Assurance Level (SAL) of 10-6.

#### Mechanical testing

Abclose - Port Site Closure Device's mechanical function and structure integrity were tested to demonstrate that the design specification from design input are fulfilled. Mechanical safety test were also conducted to demonstrate the insertion portion of the device remain intact during the surgery and raise no safety concern.

#### Animal test

The intended use has been conducted by animal test to demonstrate the AbClose - Port Site Closure Device can deliver the intended function of application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

#### 8. Conclusion

Base on the intended use and/ or indications for use, technological characteristics, performance testing and comparison to predicate device, the AbClose - Port Site Closure Device is substantially equivalent to the predicate device.