← Product Code [GCJ](/productcode/GCJ) · K253541

# EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (K253541)

_Medical Impact · GCJ · Jul 24, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253541

## Device Facts

- **Applicant:** Medical Impact
- **Product Code:** [GCJ](/productcode/GCJ.md)
- **Decision Date:** Jul 24, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The EZ-Close™ is indicated to close perforated peritoneum and fascia for trocar insertion during laparoscopic surgery.

## Device Story

EZ-Close™ is a single-use endoscopic tissue approximation device used in hospital operating rooms by surgeons. It consists of a body, needles, and a cartridge containing PGLA absorbable suture. The device facilitates the suturing of peritoneum and fascia at trocar sites following laparoscopic procedures. The surgeon operates the device to place sutures, which are then absorbed by the body via hydrolysis over 56 to 70 days. The device is available in different sizes (EZ Close, EZ Close MAX, EZ Close II) to accommodate various trocar diameters (8-15 mm). By enabling secure closure of port sites, the device helps restore abdominal wall integrity post-surgery. It is provided sterile and is not reprocessable.

## Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), mechanical performance (operation, fastening, durability), and suture-specific testing (tensile strength, ring burst strength, residual tensile strength). Sterilization validation (ANSI/AAMI/ISO 11135) and packaging validation (ASTM F1980-16) were also performed.

## Technological Characteristics

Materials: PGLA absorbable suture (90% glycolide, 10% L-lactide) coated with poly(glycolide-co-lactide) and calcium stearate. Sensing/Actuation: Mechanical manual operation. Form factor: Handheld endoscopic device with needle and cartridge. Sterilization: Ethylene Oxide (SAL 10^-6). Biocompatibility: ISO 10993-1 compliant. Single-use, disposable.

## Regulatory 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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- WECK EFx Endo Fascial Closure System ([K132362](/device/K132362.md))

## Reference Devices

- NeoClose ([K142903](/device/K142903.md))
- CRYLREX® ([K161629](/device/K161629.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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[LOGO]

FDA

U.S. FOOD & DRUG

ADMINISTRATION

July 24, 2026

Medical Impact

Hanna Kim

Quality Management Representative

2314, 2214, 2217~2219, 122, Jomaru-Ro 385beon-Gil

Bucheon-Si

Gyeonggi-Do, 14556

Republic Of Korea

Re: K253541

Trade/Device Name: EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)

Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope And Accessories

Regulatory Class: Class II

Product Code: GCJ, OCW

Dated: June 15, 2026

Received: June 16, 2026

Dear Hanna Kim:

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 (the 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 available 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

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K253541 - Hanna Kim

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

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K253541 - Hanna Kim

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(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-devices/device-advice-comprehensive-regulatory-assistance/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,

TEK N. LAMICHHANE -S

Tek N. Lamichhane, Ph.D.

Assistant Director

DHT4B: Division of Plastic and

Reconstructive Surgery Devices

OHT4: Office of Surgical and

Infection Control Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

Submission Number (if known)

K253541

Device Name

EZ-Close™

(EZ Close Port Site Closing Device,

EZ Close MAX Port Site Closing Device,

EZ Close II Port Site Closing Device)

Indications for Use (Describe)

The EZ-Close™ is indicated to close perforated peritoneum and fascia for trocar insertion during laparoscopic surgery.

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."

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K253541

# 510(k) Summary
(K253541)

|  **Contact Details**  |   |   |
| --- | --- | --- |
|  Applicant Name | MEDICAL IMPACT  |   |
|  Applicant Address | 2314, 2214, 2217~2219, 122, Jomaru-ro 385beon-gil, Bucheon-si Gyeonggi-do 14556 Korea, South  |   |
|  Applicant Contact Telephone | 82 02 6225 3300  |   |
|  Applicant Contact | Ms. Hanna Kim  |   |
|  Applicant Contact Email | hnkim1217@medicalimpact.co.kr  |   |
|  Date Prepared | July 24, 2026  |   |
|  **Device Name**  |   |   |
|  Device Trade Name | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)  |   |
|  Common Name | Endoscopic tissue approximation device  |   |
|  Classification Name | Laparoscope, General & Plastic Surgery  |   |
|  Regulation Number | 876.1500  |   |
|  Product Code(s) | GCJ, OCW  |   |
|  **Legally Marketed Predicate Devices**  |   |   |
|  Predicate # | Predicate Trade Name | Product Code  |
|  K132362 | WECK EFx Endo Fascial Closure System | GCJ, OCW, HCF  |
|  **Reference Devices**  |   |   |
|  510(k) # | Reference Trade Name | Product Code  |
|  K142903 | NeoClose | GCJ  |
|  K161629 | CRYLREX® | GAM  |
|  **Device Description Summary**  |   |   |
|  EZ-Close™ is intended to be used to suture the peritoneum and fascia at the trocar insertion site during laparoscopic procedures. It consists of a body, needles, and a cartridge containing PGLA absorbable suture. All components of the device are made of materials that have passed ISO 10993 biocompatibility testing. The primary distinction between the EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, and EZ Close II Port Site Closing Device is the size of the device. EZ Close and EZ Close MAX are intended for use with trocars larger than 10 mm, while EZ Close II is designed for use with trocars larger than 8 mm in patients undergoing laparoscopic surgery. To achieve the intended clinical benefit, each product must be used in combination as follows: - EZ Close Port Site Closing Device: Uses Body & Needle (EZ01) with Cartridge (EZ02) together. - EZ Close MAX Port Site Closing Device: Uses Body & Needle (EZ03) with Cartridge (EZ04) together. - EZ Close II Port Site Closing Device: Uses Body & Needle (EZ05) with Cartridge (EZ06) together. The absorbable suture (Neosorb) conforms to USP 0 specifications, except for diameter, in accordance with international standards: <MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.>  |   |   |

- 1 / 6 -

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K253541

- U.S.P. Suture Size Designation : 0
- Maximum Oversize : 0.056mm

The absorbable suture is coated with poly (glycolideco-lactide) (30/70) and calcium stearate and is provided dyed (D&C Violet No.2). The absorbable suture gradually loses its tensile strength through hydrolysis, resulting in final absorption. The copolymer is broken down into glycolic acid and lactic acid during the hydrolysis process and is absorbed and metabolized in the body. The tensile strength of the suture maintains on average 65% of its original tensile strength two weeks after implantation.

During laparoscopic surgery, one to three (or more) port sites are typically created, and the surgeon determines whether each port should be sutured. This product can be used to suture multiple ports within a single procedure using one Body & Needle (EZ01, EZ03, or EZ05) and up to three Cartridges (EZ02, EZ04, or EZ06) for the same patient. As a single-use disposable device, the product must be discarded immediately after use, and no resterilization is performed.

### Intended Use/Indications for Use

The EZ-Close™ is indicated to close perforated peritoneum and fascia for trocar insertion during laparoscopic surgery.

### Indications for Use Comparison

This product is a device used to close incisions during laparoscopic surgery and is intended for patients who have abdominal incisions resulting from laparoscopic surgery. The indications for use and target patients for this product are the same as for predicate devices.

### Technological Comparison

We compared the device with the predicate device in various aspects using the Substantial Equivalence Comparison Table. While there were differences in the categories of Appearance, Anatomical Site, Applicable Trocar Size, Sterilization Method, and Suture Included or not, none of these differences affected the safety or effectiveness of the product.

1. Body and Needle[{"box_2d": [108, 556, 890, 924], "label": "table", "caption": ["<table><tr><td rowspan=\"2\">Category\\Device</td><td>Subject Device</td><td>Predicate Device</td><td>Reference Device</td><td rowspan=\"2\">Equivalence Discussion</td></tr><tr><td>EZ-CloseTM</td><td>WECK EFx Endo Fascial Closure System</td><td>NeoClose</td></tr><tr><td>510(K) No. (#)</td><td>K253541</td><td>K132362</td><td>K142903</td><td>-</td></tr><tr><td>Manufacturer</td><td>Medical Impact</td><td>Teleflex Medical, Inc.</td><td>neoSurgical Ltd.</td><td>-</td></tr><tr><td>Device Classification</td><td>Class II</td><td>Class II</td><td>Class II</td><td>Same</td></tr><tr><td>Product Code</td><td>GCJ, OCW</td><td>OCW, GCJ, HCF</td><td>GCJ</td><td>Same</td></tr><tr><td>Regulation No.</td><td>21 CFR 876.1500</td><td>21 CFR 876.1500</td><td>21 CFR 876.1500</td><td>Same</td></tr><tr><td>Classification Name</td><td>Endoscope and accessories</td><td>Endoscope and Accessories</td><td>Endoscope and Accessories</td><td>Same</td></tr><tr><td>Appearance</td><td>", {"box_2d": [290, 777, 342, 863], "label": "image"}, "</td><td>", {"box_2d": [645, 779, 728, 863], "label": "[{"box_2d": [461, 780, 534, 863], "label": "image"}, "</td><td>", {"box_2d": [461, 780, 534, 863], "label": "image"}, "</td><td>Different</td></tr><tr><td>Indications for Use</td><td>The EZ-CloseTM is indicated to close perforated peritoneum and fascia for trocar insertion</td><td>The WECK EFx Endo Fascial Closure System has application in laparoscopic procedures for</td><td>neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the</td><td>Same</td></tr></table>"]}]

- 2 / 6 -

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K253541

|   | during laparoscopic surgery. | approximation of tissue and percutaneous suturing for closing incision sites. | body during endoscopic/laparoscopic surgery. |   |
| --- | --- | --- | --- | --- |
|  Target patient Population | Patient under laparoscopic surgery | Patient under laparoscopic surgery | Patient under laparoscopic surgery | Same  |
|  Target User Population | It is to be used only by surgeons trained in endoscopic/laparoscopic surgery. | Clinician who is qualified to participate a laparoscopic surgery. | It is to be used only by surgeons trained in endoscopic/laparoscopic surgery. | Same  |
|  Target anatomical location | Fascial and abdominal wall | Abdominopelvic (abdominal) cavity | Abdominal wall | Similar  |
|  Where Used | Hospital O.R. room | Hospital O.R. room | Hospital O.R. room | Same  |
|  Contraindications | Do not use where laparoscopic technique is generally contraindicated. Sutures are absorbed within 56 to 70 days, so do not use them in areas that require long-term tissue sutures. | Do not use where laparoscopic techniques are generally contraindicated | No information | Same  |
|  Applicable Trocar size | 10 ~ 15 mm, 8 ~ 10 mm (EZ Close II: when adapter is removed) | 10 ~ 15 mm | 8 ~ 15 mm | Similar  |
|  Performance | We verified the following specifications: Material Verification, Visual Inspection (Appearance, Defects, and Cleanliness), Dimensional Inspection, Mechanical Inspection (Operation, Fastening, and Durability) In addition, the sutures were tested for the following specifications: Tensile Strength, Suture Ring Burst Strength, Residual Tensile Strength | The test specifications are as follows: Material Verification, Visual Inspection for Defects and Cleanliness, Dimensional Inspection, Mechanical Inspection, Suture Retention, Destructive Testing of Failure Modes | Bench Testing was conducted for the neoClose AutoAnchor Pack to demonstrate that it is at least as safe and effective as the predicate device. | Different  |
|  Biocompatibility | A biological evaluation was conducted in accordance with the International Standard ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by the FDA. The cartridge (with suture) is considered a permanent implant, while the Body and needle is considered tissue contacting for a duration that is less than 24 hours. | All patient contacting materials are in compliance with ISO 10993-1. | A biological evaluation was conducted for the neoClose AutoAnchor Pack in accordance with the FDA Blue Book Memorandum #G95-1 “Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing’” May 1, 1995, and International Standard ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by the FDA. | Same  |

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K253541

|   |  |  | The neoClose AutoAnchor is considered a permanent implant, while the neoClose Driver is considered tissue contacting for a duration that is less than 24 hours. |   |
| --- | --- | --- | --- | --- |
|  Sterilization Method | Ethylene Oxide | Radiation | Ethylene Oxide | Different  |
|  Assurance Level | SAL 10^{-6} | SAL 10^{-6} | No information | Same  |
|  Reprocessing | Single use only; not reprocessable | Single use only; not reprocessable | Single use only; not reprocessable | Same  |
|  Suture Included | Includes Suture - Absorbable suture (PGLA) | Suture Not Included | Includes Suture - Absorbable suture (PGA) - AutoAnchor: PGLA | Different  |

## 2. PGLA suture

|  Division | Device | Subject Device | Reference Device | Equivalence Discussion  |
| --- | --- | --- | --- | --- |
|   |   | PGLA suture | CRYLREX®  |   |
|  510(K) No. (#) |  | XXXXXXX | K161629 | -  |
|  Manufacturer |  | Medical Impact | SM ENG CO., Ltd | -  |
|  Device Classification |  | - | Class II | -  |
|  Product Code |  | - | GAM | -  |
|  Regulation No. |  | - | 21 CFR 878.4493 | -  |
|  Design |  |  |  | -  |
|  Indications for Use |  | The EZ-Close™ is indicated to close perforated peritoneum and fascia for trocar insertion during laparoscopic surgery. | CRYLREX® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. | -  |
|  Raw Suture Material |  | Neosorb | Neosorb | Same  |
|  Manufacturer of Raw Suture Material |  | Samyang Biopharmaceuticals Corporation | Samyang Biopharmaceuticals Corporation | Same  |
|  Final Material Composition |  | 90% glycolide and 10% Llactide (PGLA) | 90% glycolide and 10% Llactide (PGLA) | Same  |
|  Coating material |  | Poly(glycolide-co-lactide) (30/70)+ Calcium Stearate | Poly(glycolide-co-lactide) (30/70)+ Calcium Stearate | Same  |
|  Color (Colorant) |  | Dyed (D&C Violet No.2) | Undyed (natural) or Dyed (D&C Violet No.2) | Same  |
|  Absorbable/ Nonabsorbable |  | Absorbable | Absorbable | Same  |

- 4 / 6 -

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K253541

|  Braided/Monofilament | Braided | Braided | Same  |
| --- | --- | --- | --- |
|  Suture Size | The proposed device is available in a single size (USP 0), which corresponds to the size identified in the currently recognized United States Pharmacopeia, except for diameter. | The proposed device is available in 8-0, 7-0, 6-0,5-0, 4-0,3-0,2-0, 0, 1 and 2, which are the sizes identified in the currently recognized United States Pharmacopoeia except for diameter | Similar  |
|  Length of Suture | 60cm (EZ02, EZ06), 70cm (EZ04) | 20cm, 30cm, 45cm, 60cm, 70cm, 75cm, 90cm, 100cm, 125cm, 140cm, 150cm, 250cm, | Similar  |
|  Diameter of Suture | Oversize | Oversize | Same  |
|  Tensile strength | The tensile strength complies with the requirements of USP. | The tensile strengths comply with the tensile requirement listed in USP 35 <881> Tensile Strength | Same  |
|  Biocompatibility | A biological evaluation was conducted in accordance with the International Standard ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by the FDA.The suture is considered a permanent implant. | A biological evaluation was conducted in accordance with the International Standard ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by the FDA.The suture is considered a permanent implant. | Same  |
|  Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same  |
|  Assurance Level | SAL \( 10^{-6} \) | SAL \( 10^{-6} \) | Same  |
|  Single Use | Yes | Yes | Same  |

### Non-Clinical and/or Clinical Tests Summary & Conclusions

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility

A biological evaluation was conducted for the EZ-Close™ in accordance with the International Standard ISO 10993-1 “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by the FDA.

The absorbable suture included in the cartridge are considered permanent implant, while the body and needles are considered tissue contacting for a duration that is less than 24 hours.

#### Bench Testing

Bench Testing was conducted for the EZ-Close™ and the absorbable suture to demonstrate.

The absorbable sutures meet the requirements of the "Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff." Sutures were tested, except for diameter, according to USP standards. Since the absorbable sutures we provide are supplied in cartridge form, needle attachment tests were not performed as they are not applicable.

Additionally, we also performed operation, fastening and durability test, suture ring burst strength, and residual tensile strength tests to demonstrate that our products perform as intended.

#### Sterilization & Packaging/Shelf-Life

Sterilization validation was performed in accordance with ANSI/AAMI/ISO 11135:2014/A1:2018.

Packaging validation was performed in accordance with ASTM F1980-16.

No clinical testing was required.

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K253541

The EZ-Close™ is considered substantially equivalent to the predicate device. It has the same intended use and does not raise new questions regarding safety or effectiveness. It is considered at least as safe and effective as the predicate device when used in accordance with the Instructions for Use.

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**Source:** [https://fda.innolitics.com/device/K253541](https://fda.innolitics.com/device/K253541)

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