The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.

Device Description

The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers.

The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called neoClose. This submission focuses on establishing substantially equivalent to a previously marketed predicate device (neoClose, K123280), rather than outlining acceptance criteria and a study to prove new performance claims for an innovative device.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be directly extracted from this document. The document explicitly states that the technical characteristics of the applicant device are substantially equivalent to the predicate device, with the only change being an extension of shelf life. The "study" mentioned is primarily focused on demonstrating this equivalence rather than measuring new performance metrics against predefined acceptance criteria.

Here's an analysis of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, not on establishing and meeting new performance acceptance criteria for a novel device. The "performance" section states: "Design Verification bench testing support the use of the neoClose device and demonstrate that it is at least as safe and effective as the predicate device, neoClose (K123280)." This implies comparison to the predicate's performance, not to specific, new acceptance criteria.

Note: If specific performance criteria and results were provided for the predicate device (K123280) regarding the "delivery of absorbable AutoAnchors through soft tissues", then the bench testing for K131688 would have been compared against those. However, these details are absent from this summary.

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

The document mentions "Design Verification bench testing" and a "GLP Animal Study completed with the predicate device." It does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). The animal study was done with the predicate, not the present device, and is used to infer safety and effectiveness based on the very minor change to the current device (shelf life extension).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable/not available. The document describes a medical device for surgical procedures, not diagnostic software that requires expert-established ground truth. The equivalency is based on design, materials, and bench/animal testing, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/not available. Adjudication methods like 2+1 or 3+1 are typically used for diagnostic studies involving human readers, not for demonstrating substantial equivalence of a surgical device through bench and animal testing.

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

This information is not applicable/not available. MRMC studies are associated with diagnostic imaging or similar interpretation tasks, often involving AI assistance. This device is a surgical instrument, and the submission is for substantial equivalence, not a comparative effectiveness study involving human readers with and without AI.

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

This information is not applicable/not available. This is a physical surgical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" would implicitly be the performance characteristics of the predicate device (K123280), as the goal was to demonstrate that the modified device is "at least as safe and effective." For the GLP Animal Study, the "ground truth" would be the observed safety and effectiveness outcomes in the animal model for the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/not available. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not available. As this is not an AI/ML algorithm, there is no training set or ground truth in that context.

Summary

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K131688 page 1/2

3. 510(k) Summary

510(k) Summary -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

JUL 1 8 2013

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the neoClose Device

510(k) Number

Date Prepared	7 June 2013
Proprietary Name	neoClose Hasson and neoClose Universal
Common Name	Suture passer
Classification Name	§876.1500 Product code GCJEndoscope and Accessories.
Device Classification	Class II
Device Panel	General and Plastic Surgery Devices
Predicate Device	neoClose (K123280)
Submitter	neoSurgical Ltd.Block 12Galway Technology Park,Parkmore,Galway,IrelandPh: +353 (0)91 421 000
Contact Person	Orla BrennanBlock 12Galway Technology Park,Parkmore,Galway,IrelandPh: +353 (0)91 421 000

Device Description

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Intended Use

The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.

Summary of Technological Characteristics of Modified Device Compared to the Legally Marketed Predicate Device

The technical characteristics of the applicant device are substantially equivalent to the predicate device with respect to indications for use, product design, materials, packaging, labeling and sterilization methods.

Support of Substantial Equivalence

neoSurgical has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the neoClose device is substantially equivalent to the currently marketed predicate device. neoClose (K123280). A detailed justification for substantial equivalence was completed which includes a side-by-side comparison of the product attributes of the applicant device and predicate device. Design Verification bench testing supports the performance of the neoClose device and demonstrates that it is at least as safe and effective as the predicate device, neoClose (K123280).

. Intended Use
The neoClose components have the same intended use as the predicates.
. Physical Characteristics
There are no technological differences between the neoClose device and the predicate devices (neoClose K123280) affecting intended use or safety and effectiveness.
. Anatomical Sites The neoClose device and its predicates may be utilized in the same anatomical site.
. Performance

Design Verification bench testing support the use of the neoClose device and demonstrate that it is at least as safe and effective as the predicate device, neoClose (K123280).

. Safety Characteristics

The GLP Animal Study completed with the predicate device demonstrates the safety and effectiveness of both the modified neoClose device and the predicate neoClose device (K123280), because an extension of shelf life is the only change to the design of the modified device. Design Verification bench testing also demonstrates that the modified device is at least as safe and effective as the predicate device, neoClose (K123280).

The neoClose device is substantially equivalent to the predicate device since it has the same intended use, does not raise new concerns regarding safety and effectiveness and is at least as safe and effective as the predicate device when used in accordance with the Instructions for Use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wing segments, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 18, 2013

neoSurgical, Limited % Orla Brennan Quality Assurance and Regulatory Affairs Director Block 12 Galway Technology Park, Parkmore Galway, Ireland

Re: K131688

Trade/Device Name: neoClose Hasson, neoClose Universal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 07, 2013 Received: June 18, 2013

Dear Orla Brennan:

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 mislcading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Orla Brennan

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (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 Small Manufacturers, International and Consumer Assistance 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 2.

510(k) Number:K131688
Device Name:	neoClose
Indications for Use:		The neoClose device is intended to facilitate the delivery ofabsorbable AutoAnchors through soft tissues of the bodyduring endoscopic/ laparoscopic surgery.
Prescription Use______________________________________________________________________________________________________________________________________________________________(Per 21 CFR 801.109)	OR	Over-The-Counter Use_
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131688

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.