← Product Code [FZP](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP) · K173323 # AnastoClip GC Closure System (K173323) _LeMaitre Vascular, Inc. · FZP · Mar 8, 2018 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K173323 ## Device Facts - **Applicant:** LeMaitre Vascular, Inc. - **Product Code:** [FZP](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP.md) - **Decision Date:** Mar 8, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use 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 Story AnastoClip GC Closure System creates everting anastomoses in blood vessels and approximates dural tissue; used in open craniotomy and spinal laminectomy. System includes manual applier with rotating shaft, integral cartridge of titanium clips, clip remover, and atraumatic forceps. Physician squeezes applier levers to close clip around everted tissue; releasing levers automatically loads next clip. Device facilitates secure tissue approximation; reduces risk of CSF leaks; provides mechanical alternative to traditional suturing. Used in clinical/surgical settings by surgeons. ## Clinical Evidence GLP safety evaluation in 6 porcine models comparing subject device to predicate for cranial and spinal dura closure. Primary endpoints: CSF leakage, histomorphology, and clinical pathology at 90 days. Results: No CSF leaks observed; no clinically significant changes in body weight or pathology; histologic findings showed minimal fibrosis/hemorrhage and no necrosis, infection, or foreign body reaction. Comparable performance to predicate. ## Technological Characteristics Titanium clips; manual mechanical actuation; rotating shaft applier; ethylene oxide (EO) sterilized per ANSI/AAMI/ISO 11135-1:2007. Design features sharpened clip points for tissue penetration. Standalone manual surgical instrument. ## Regulatory Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - AnastoClip VCS Closure System ([K962043](/device/K962043.md)) ## Reference Devices - AnastoClip GC Closure System ([K091987](/device/K091987.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. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) 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. | 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) Zhang
VP of Regulatory Affairs
LeMaitre 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 | | Establishment
Registration: | 1220948 | | Establishment: | 63 Second Avenue
Burlington, 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 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. | | Intended Use: | The AnastoClip GC Closure System 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 the approximation
of dural tissue/durotomies following open craniotomy and
open spinal laminectomy procedures. | | Summary of Technological
Characteristics: | Comparisons of the AnastoClip GC Closure System with
the predicate AnastoClip VCS Closure System show that
technological characteristics such as materials,
biocompatibility, performance, sterilization, and packaging
of the proposed device are substantially equivalent to the
predicate device. The design difference between the
proposed device and the predicate device are:
• The implantable clip of the AnastoClip GC Closure
System is designed with sharpened points. | | Functional/Safety Testing: | The verification activities conducted indicate that
AnastoClip GC Closure System meets the product
performance requirements of the device specifications and
does not raise any additional safety issues. | | Sterilization: | The device is ethylene oxide (EO) sterilized according to
ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical
Devices - Validation and Routine Control of Ethylene
Oxide Sterilization" | | Biocompatibility: | The materials used in AnastoClip GC Closure System are
identical to those in the predicate device and reference
device which have established biocompatibility. This
submission is to expand the indication with no change to
product design or materials. | | Summary of Product
Testing: | The following tests have been completed to evaluate the
safety and performance of the AnastoClip GC Closure
System 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K173323](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K173323) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com