The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired. The Applier is also intended for approximation of durotomies following open craniotomy and open spinal laminectomy procedures.

Device Description

AnastoClip GC Closure System is designed to create everting anastomoses of tissue. It includes the applier, clip remover, and atraumatic forceps. The AnastoClip GC applier consists of a rotating shaft and an integral cartridge containing titanium clips. As the levers of the applier are squeezed together, the clip is closed around the everted tissue edges. As the levers are released, a new clip is automatically loaded into the clip applier jaws. It is recommended, with each procedure, to use the atraumatic everting forceps to aid in the everting of the tissue edges. It is also recommended, with each procedure, to use the AnastoClip Remover for the removal of any AnastoClip GC clips when needed.

AI/ML Overview

The provided text describes the AnastoClip GC Closure System, a medical device. Based on the information presented, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for a specific study. Instead, it describes a preclinical study that aimed to demonstrate safety and substantial equivalence to a predicate device for an expanded indication. The "acceptance criteria" can be inferred from the successful outcomes of this study.

Here's an inferred table based on the preclinical study's reported findings:

Acceptance Criteria (Inferred from successful study outcomes)	Reported Device Performance (AnastoClip GC)
Absence of CSF leaks at cranial and spinal dural sites	No CSF leaks observed at both cranial and spinal dural sites after application.
No clinically significant changes in body weight, body condition score, or clinical pathology parameters	No clinically significant changes in body weight, body condition score, or clinical pathology parameters in any animal over the course of the study.
Absence of adverse responses (inflammation, infection) in CSF samples	No CSF sample exhibited any indication of adverse responses such as inflammation or infection.
Absence of hydrocephalus or other abnormalities via CT scan	No signs of hydrocephalus or other abnormalities noted from the CT scan evaluations.
Comparable histopathologic findings (minimal fibrosis, vascularization, hemorrhage, no necrosis, infection, or foreign body reaction) compared to predicate	Histologic findings were comparable to the predicate device (AnastoClip AC), with minimal fibrosis and vascularization, minimal hemorrhage, and no implant-associated necrosis, infection or foreign body reaction.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: 6 porcine models.
Data Provenance: The study was a "Pre-clinical GLP safety evaluation" performed in porcine models. The country of origin is not specified, but it's a prospective animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number of experts or their qualifications for establishing ground truth. It states that a "comprehensive necropsy was performed" and "histomorphologic evaluation" of cranial and spinal implant sites was conducted. These evaluations would typically be done by veterinary pathologists, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not provide details on any adjudication method for the test set. It simply states that a "comprehensive necropsy" and "histomorphologic evaluation" were performed.

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

The document describes a preclinical animal study for a medical device (surgical clip system), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not applicable.

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

This question is not applicable as the device is a physical surgical closure system, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the preclinical study was established through a combination of:

Direct observation: Absence of CSF leaks.
Clinical observation: Body weight, body condition score, clinical pathology parameters in animals.
Laboratory analysis: CSF sample analysis (for inflammation/infection).
Imaging: CT scan evaluations (for hydrocephalus/abnormalities).
Pathology/Histomorphology: Microscopic evaluation of cranial and spinal implant sites.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device and does not involve AI or machine learning that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is a physical medical device and does not involve AI or machine learning that requires a training set.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

March 8, 2018

LeMaitre Vascular, Inc. Xiang Zhang VP of Regulatory Affairs 63 Second Ave. Burlington, Massachusetts 01803

Re: K173323

Trade/Device Name: AnastoClip GC Closure System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP, HBT Dated: February 7, 2018 Received: February 8, 2018

Dear Xiang Zhang:

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Michael J. Hoffmann -S

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K173323

Device Name AnastoClip GC Closure System

Indications for Use (Describe)

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}------------------------------------------------

510k Summary

Submitter's Information

Name:	LeMaitre Vascular, Inc.
Address:	63 Second Avenue, Burlington, MA 01803
Phone:	781-425-1729
Fax:	781-221-2253
Contact Person:	Xiang (Vic) ZhangVP of Regulatory AffairsLeMaitre Vascular, Inc.Email: xzhang@lemaitre.com
Date Prepared:	January 31, 2018
Device Name:	AnastoClip GC Closure System
Trade Name:	AnastoClip GC Closure System
Common Name:	Clip, Implantable
Regulation Number:	21CFR §878.4300; 21CFR §878.4800
Classification Panel:	Neurology
Class:	II (2)
Product Code:	FZP, HBT
EstablishmentRegistration:	1220948
Establishment:	63 Second AvenueBurlington, MA 01803
Predicate Device:	AnastoClip VCS Closure System K962043
Reference Device:	AnastoClip GC Closure System K091987
Device Description:	AnastoClip GC Closure System is designed to createeverting anastomoses of tissue. It includes the applier, clipremover, and atraumatic forceps. The AnastoClip GCapplier consists of a rotating shaft and an integral cartridgecontaining titanium clips. As the levers of the applier aresqueezed together, the clip is closed around the evertedtissue edges. As the levers are released, a new clip isautomatically loaded into the clip applier jaws. It isrecommended, with each procedure, to use the atraumaticeverting forceps to aid in the everting of the tissue edges. It
	is also recommended, with each procedure, to use theAnastoClip Remover for the removal of any AnastoClipGC clips when needed.
Intended Use:	The AnastoClip GC Closure System is intended for use inthe creation of everting anastomoses in blood vessels andother small tubular structures when tissue penetration isdesired. The applier is also intended for the approximationof dural tissue/durotomies following open craniotomy andopen spinal laminectomy procedures.
Summary of TechnologicalCharacteristics:	Comparisons of the AnastoClip GC Closure System withthe predicate AnastoClip VCS Closure System show thattechnological characteristics such as materials,biocompatibility, performance, sterilization, and packagingof the proposed device are substantially equivalent to thepredicate device. The design difference between theproposed device and the predicate device are:• The implantable clip of the AnastoClip GC ClosureSystem is designed with sharpened points.
Functional/Safety Testing:	The verification activities conducted indicate thatAnastoClip GC Closure System meets the productperformance requirements of the device specifications anddoes not raise any additional safety issues.
Sterilization:	The device is ethylene oxide (EO) sterilized according toANSI/AAMI/ISO 11135-1:2007, "Sterilization of MedicalDevices - Validation and Routine Control of EthyleneOxide Sterilization"
Biocompatibility:	The materials used in AnastoClip GC Closure System areidentical to those in the predicate device and referencedevice which have established biocompatibility. Thissubmission is to expand the indication with no change toproduct design or materials.
Summary of ProductTesting:	The following tests have been completed to evaluate thesafety and performance of the AnastoClip GC ClosureSystem for the additional indication:• Leak test• Grin test

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

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

Summary of Pre-clinical A GLP safety evaluation of the AnastoClip GC for cranial Study: and spinal dura closure study was performed in 6 porcine models. For each animal, subject device and the predicate device were used to close the dura defects created by surgical incision. On Day 90, the animals were euthanized and a comprehensive necropsy was performed. Cranial and spinal implant sites with associated brain/spinal cord were collected and processed for histomorphologic evaluation. No CSF leaks observed at both the cranial and spinal dural sites after application. There were no clinically significant changes in body weight, body condition score, or clinical pathology parameters in any animal over the course of the study. Regardless of time point, no CSF sample exhibited any indication of adverse responses such as inflammation or infection. There were no signs of hydrocephalus or other abnormalities noted from the CT scan evaluations. Microscopically, regardless of treatment group (AnastoClip GC or AnastoClip AC) or dural implant site (cranium or spinal cord), histologic findings were comparable. There was minimal fibrosis and vascularization, minimal hemorrhage and no implant-associated necrosis, infection or foreign body reaction. Conclusion: LeMaitre Vascular has demonstrated that the AnastoClip GC Closure System is substantially equivalent to the predicate devices based on its intended use and fundamental scientific technology.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.