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 folding 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

This document describes the AbClose - Port Site Closure Device, which is a sterile, single-use device used in laparoscopic procedures for tissue approximation and percutaneous suturing to close incision sites.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance in a quantitative table. Instead, it states that various tests were performed and "all the results were passed," indicating that the device met the internal design specifications and requirements. The core acceptance is framed around demonstrating substantial equivalence to the predicate device (K160117).

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
Biocompatibility:
- Cytotoxicity	Passed (in accordance with ISO 10993-5:2009)
- Irritation and Skin Sensitization	Passed (in accordance with ISO 10993-10:2009)
- Systemic Toxicity	Passed (in accordance with ISO 10993-11:2006)
- Pyrogenicity	Passed (in accordance with USP Chapter <151>)
Mechanical Integrity & Functionality:
- Suture Guide Push Button Test	Passed
- Suture Guide Slider Test	Passed
- Suture Guide Durability Test	Passed
- Suture Guide Front Upper Cover Bonding	Passed
- Suture Guide Front Lower Cover Bonding	Passed
- Suture Passer Suture Button Test	Passed
- Suture Passer Suture Release Button Test	Passed
- Suture Passer Penetration Test	Passed
- Suture Passer Cover Bonding Test	Passed
- Suture Deployment Test	Passed
- Suture Guide Lock Mechanism Test	Passed
- Accelerated Aging Test (Sterile Barrier)	Passed
- Suture Guide Suture Catcher Torque Test	Passed (new test for modified device)
- Suture Passer Needle Retention Force Test	Passed (new test for modified device)
- Suture Passer Needle Torque Test	Passed (new test for modified device)
Functional Performance (Animal Model):
- Intended Use Fulfillment	Passed (demonstrated in animal model)
- No Alteration in Function/Intended Use	Passed (design modifications did not alter function/use)

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

The document does not specify the sample sizes used for each of the mechanical tests or the animal study. It only states that the tests were "successfully performed" with "all the results were passed."
Data Provenance: The animal study was mentioned, implying prospective data collection for the functional testing. The biocompatibility and mechanical tests are typically lab-based studies. The country of origin for the data is implied to be related to the manufacturer, Medeon Biodesign, Inc., which is based in Taipei, Taiwan.

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

This information is not provided in the document. The studies described are primarily engineering/laboratory tests and an animal model, not studies requiring human expert adjudication for ground truth (e.g., image interpretation).

4. Adjudication Method for the Test Set:

This information is not applicable/provided as the studies described do not involve human expert adjudication in the context of diagnostic accuracy or similar tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC study was not performed. The device described is a surgical instrument (port site closure device), not an AI-assisted diagnostic or interpretive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone performance study in the context of an algorithm or AI was not performed, as the device is a physical surgical tool. The functional animal study could be considered a "standalone" performance test of the device itself.

7. The Type of Ground Truth Used:

Biocompatibility: Ground truth is established by the well-defined scientific standards and recognized guidance (ISO 10993 series, USP Chapter <151>) which describe the expected biological responses to materials.
Mechanical Testing: Ground truth is established by the engineering design specifications and predefined pass/fail criteria for each test (e.g., minimum force, number of cycles, dimensional tolerances).
Functional Testing (Animal Model): Ground truth is established by the successful execution of the intended surgical function (approximating tissues, closing incision sites) in the animal model, as defined by appropriate veterinary/surgical endpoints. This typically involves observation of successful closure, absence of complications related to the device, and potentially histological examination of the tissue if relevant.

8. The Sample Size for the Training Set:

This is not applicable as the device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the reason stated in point 8.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 26, 2020

Medeon Biodesign, Inc. Tsung-Yu Hsieh Sr. Specialist of Regulatory, Quality and Clinical Affairs 7F, 116, HouGang St., Taipei, 11170 Tw

Re: K193652

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: December 26, 2019 Received: December 30, 2019

Dear Ms. Hsieh:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K193652

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)
Requisition Use (Part 21 CFR 601.21 and Part On-The-Market Use (21 CFR 601.2 and	Requisition Use (Part 21 CFR 601.21 and Part	Requisition Use (Part 21 CFR 601.21 and Part	On-The-Market Use (21 CFR 601.2 and	On-The-Market Use (21 CFR 601.2 and
Requisition Use (Part 21 CFR 601.21 and Part	Requisition Use (Part 21 CFR 601.21 and Part	On-The-Market Use (21 CFR 601.2 and	On-The-Market Use (21 CFR 601.2 and
Requisition Use (Part 21 CFR 601.21 and Part
On-The-Market Use (21 CFR 601.2 and

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

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.

The assigned 510(k) Number: K193652
Date Prepared:	March 4, 2020

1	Submitter
	MailingAddress	Medeon Biodesign, Inc7F, 116, HouGang St,Taipei, Taiwan 11170Phone: +886 2 2881 6686Establishment Registration No.: 3012452802
	Contact Person	Tsung-Yu, HsiehSr. Specialist of Regulatory, Quality & Clinical Affair
	Phone:	+886 2 2881 6686 ext.130
	Fax:	+886 2 2881 6907
	E-mail:	tsungyu.hsieh@medeonbio.com

2 Device Name

Common orUsual Name	Endoscopic tissue approximation device
Trade Name	AbCloseTM - Port Site Closure Device
Product Code	OCW, GCJ, HCF
Device	Endoscope and accessories
CFRClassification	CFR Part 876.1500
Device Class	II
ClassificationPanel	Gastroenterology/Urology

K160117

3 Predicate k number
The AbClose™ - Port Site Closure Device is a sterile, single-use 4 Device Description: 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

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

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 folding 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. The AbClose™ - Port Site Closure Device has application in 5 Indications for Use: laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites. Special For prescription use only Conditions for Use Statement(s): 6 Technological Modifications to design and material of the previously 510(k) cleared AbClose™ - Port Site Closure Device (K160117) to close the incision Characteristics created by 10 - 15mm trocar. The modifications include: and Substantial 1. Dimensional change: Change component dimension to improve the functionality of device, simplify the production process and Equivalence Comparison improve manufacturability. 2. Material change: Change material of Slider to improve with Predicate: manufacturability and use material of Button Lock with higher tensile and flexural strength. 3. Add visualization feature: Add visualization windows on Slider and add indication marks on Handle of Suture Passer and Suture Guide. 4. Package change: Dimensional and structure change of packaging components includes reducing the size of sterile barrier system, modifying the securing features of Blister, add Lid of Blister and reduce the size and change the structure of protective packaging material. A comparison of the device features, intended use, and other information demonstrates that the modified device is substantially equivalent to the predicate device as summarized in Table 1. The differences raise no different questions of safety or effectiveness.

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

Table 1: Substantially Equivalent Table
Similarities
Device name	Predicate device:AbCloseTM - Port Site ClosureDevice (Model: M12)(K160117)	Modified device:AbCloseTM - Port Site ClosureDevice (Model: M12)
Indicationsfor use	The AbCloseTM - Port SiteClosure Device has applicationin laparoscopic procedures forapproximation of tissues andpercutaneous suturing forclosing incision sites.	Same
Target patientPopulation	Patient under laparoscopicsurgery	Same
Target UserPopulation	Clinician who is qualified toparticipate a laparoscopic surgery.	Same
AnatomicalSite	Abdominopelvic cavity	Same
Where Used	Hospital O.R. room	Same
Contraindications	Do not use where laparoscopictechniques are generallycontraindicated	Same
Method ofIntroduction	-Suture Guide is introduced intoabdominopelvic cavity via a 10 –15 mm trocar port site-Suture Passer is introduced intoabdominopelvic cavity by insertion	Same
Performance	Maintain pneumoperitoneum andfacilitate placement and withdrawalof suture loop	Same
Biocompatiblefor IntendedUse	Limited exposure, externalcommunication device of tissuecontact.	Same
SterilizationMethod	Ethylene Oxide sterilization, SALof 10-6	Same
Energy source	No energy source	Same
Compatibility	Trocar: 10 – 15 mm	Same

Table 1: Substantially Equivalent Table

7. Performance Testing

The following performance testing for the design modification demonstrated substantial equivalence to the previously cleared predicate:

Biocompatibility testing

Per material change, the biocompatibility evaluation and testing of the AbClose™ - Port Site Closure Device was conducted in accordance with the following standards and guidance, as recognized by the FDA:

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

FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of . medical devices - Part 1: Evaluation and testing within a risk management process"
ISO 10993-5:2009, Biological evaluation of medical devices- Part 5: Tests for in vitro . cytotoxicity
. ISO 10993-10:2009, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
. ISO 10993-11:2006, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
. United State Pharmacopeia (USP) Chapter <151> Rabbit Pyrogen Test

Mechanical testing

The modified device's mechanical function and structure integrity were tested and demonstrated that the design specification from design input were fulfilled and the design modifications did not alter the device safety and function. The following mechanical tests have been successfully performed with the same test methods as for the predicate device, and all the results were passed, including Suture Guide Push Button Test, Suture Guide Slider Test, Suture Guide Durability Test, Suture Guide Front Upper Cover Bonding Test, Suture Guide Front Lower Cover Bonding Test, Suture Passer Suture Button Test, Suture Passer Suture Release Button Test, Suture Passer Penetration Test, Suture Passer Cover Bonding Test, Suture Deployment Test, Suture Guide Lock Mechanism Test, and Accelerated Aging test of sterile barrier system. In addition to the original tests conducted for the predicate device, three new tests have been conducted to verify the effectiveness of the modifications made in the modified device, including Suture Guide Suture Catcher Torque Test, Suture Passer Needle Retention Force Test, and Suture Passer Needle Torque Test. These mechanical tests have been successfully performed, and all the results were passed.

Functional testing

Device functionality was tested in the animal model to demonstrate that the intended use was fulfilled. Design modifications did not alter the device function and intended use. The animal study has been successfully performed with the same test method as that used for the predicate device, and the result was passed.

8. Conclusion

Based on the intended use, technological characteristics, performance testing and comparison to the predicate device, the modified device is substantially equivalent to the predicate device and raises no different questions of safety or effectiveness.

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.