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

Device Description

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 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.

AI/ML Overview

The provided document indicates that the AbClose - Port Site Closure Device has undergone performance testing to demonstrate that it meets performance specifications for its intended use. However, it does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for success/failure rates, mechanical strength, etc.) or provide detailed device performance data in a table format.

Instead, the document broadly describes the types of studies conducted and their general conclusions regarding device functionality and safety.

Here's an attempt to structure the information based on your request, with missing information clearly noted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Study Type)	Reported Device Performance
Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10-6.	Sterilization has been validated to achieve a SAL of 10-6.
Mechanical Testing: Demonstrate that design specifications are fulfilled; insertion portion remains intact during surgery; no safety concerns.	Mechanical function and structural integrity were tested and demonstrated that design specifications are fulfilled. Mechanical safety tests demonstrated the insertion portion remains intact during surgery and raises no safety concern.
Animal Test (Functionality): Demonstrate the device can deliver the intended function of application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.	The intended use has been conducted by animal test to demonstrate the AbClose - Port Site Closure Device can deliver the intended function.

Missing Information:

Specific, quantifiable acceptance criteria for mechanical tests (e.g., force thresholds, cycles to failure).
Specific, quantifiable acceptance criteria for animal tests (e.g., success rate of closure, absence of complications).
Detailed performance results (e.g., numerical data, statistical analysis) from any of these tests.

2. Sample Size Used for the Test Set and Data Provenance

Sterilization Validation: The document states "Sterilization validation was conducted." It does not specify the sample size (e.g., number of devices tested).
Mechanical Testing: The document states "Abclose - Port Site Closure Device's mechanical function and structure integrity were tested." It does not specify the sample size (e.g., number of devices tested).
Animal Test: The document states "The intended use has been conducted by animal test." It does not specify the sample size (number of animals, number of procedures).
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is in Taipei, Taiwan, it's plausible the studies were conducted there, but this is not confirmed. The context implies these were prospective studies designed to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The studies described (sterilization, mechanical, animal) do not typically involve human experts establishing "ground truth" in the same way, for instance, a clinical trial with diagnostic image interpretation would. For animal models, the "ground truth" would be established by the observed physiological and anatomical outcomes/observations by veterinary professionals/researchers, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the types of studies (sterilization, mechanical, animal) described in the document. Adjudication is typically used in studies involving subjective assessments or different interpretations (e.g., clinical trials, image reading).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes sterilization validation, mechanical testing, and an animal test. These are not MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the AbClose - Port Site Closure Device is a manual medical instrument, not an AI algorithm or a device with an automated "algorithm only" component. Performance is inherent to its mechanical function and interaction within an anatomical context.

7. The Type of Ground Truth Used

Sterilization Validation: The "ground truth" is measured against industry standards (ISO 11135:2014) for sterility, achieving a specified SAL.
Mechanical Testing: The "ground truth" is based on the device's design input specifications and the requirement for structural integrity and safety.
Animal Test: The "ground truth" is the successful physical approximation of tissues and percutaneous suturing for closing incision sites, assessed through direct observation and potentially histological examination in an animal model.

8. The Sample Size for the Training Set

This information is not applicable as the document describes a mechanical medical device, not a device that utilizes machine learning and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

{1}------------------------------------------------

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 (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 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

{2}------------------------------------------------

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)
	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: +886 2 2881 6686

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 +886 2 2881 6686 +886 2 2881 6685 greta@medeonbio.com

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

{4}------------------------------------------------

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

న్.

Special Conditions for Use Statement(s):

1. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
1. Materials

{5}------------------------------------------------

Table 1

Similarities
Device name	Subject device:AbClose - Port Site Closure Device	Predicate device:WECK EFx Endo Fascial ClosureSystem
Indications foruse	The AbClose - Port Site Closure Devicehas application in laparoscopicprocedures for approximation of tissueand percutaneous suturing for closingincision sites.	The WECK EFx Endo Fascial ClosureSystem has application in laparoscopicprocedures for approximation of tissueand percutaneous suturing for closingincision sites.
Target patientPopulation	Patient under laparoscopic surgery	Same
Target UserPopulation	Clinician who is qualified to participatea laparoscopic surgery.	Same
Anatomical Site	Abdominopelvic cavity	Same
Where Used	Hospital O.R. room	Same
Contraindications	Do not use where laparoscopictechniques are generally contraindicated	Same
Method ofIntroduction	-Suture Guide is introduced intoabdominopelvic cavity via a 10-15mmtrocar port site-Suture Passer is introduced intoabdominopelvic cavity by insertion	Same
CompatibilityOther Devices	Trocar: 10~ 15 mm	Same
Performance	Maintain pneumoperitoneum andfacilitate placement and withdrawal ofsuture loop	Same
Biocompatiblefor Intended Use	Limited exposure, externalcommunication device of tissue contact	Same
Differences
SterilizationMethod	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

{6}------------------------------------------------

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.

Regulation Number and Section

§ 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.