(139 days)
No
The device description and performance studies focus on a mechanical clip and applier system for tissue closure, with no mention of AI or ML capabilities.
Yes.
The device is used to create everting anastomoses in blood vessels and other small tubular structures and for the approximation of durotomies, which are therapeutic interventions.
No
The device is intended for creating anastomoses and approximating durotomies, which are surgical procedures. It is a surgical tool, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components (applier, clip remover, atraumatic forceps, titanium clips) and their mechanical function, indicating it is a hardware-based medical device.
Based on the provided information, the AnastoClip GC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within a living organism) for surgical procedures: creating anastomoses in blood vessels and other tubular structures, and approximating durotomies. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The description details a surgical tool (applier, clip remover, forceps) designed to physically manipulate and join tissues within the body.
- Anatomical Site: The specified anatomical sites are internal to the body (blood vessels, tubular structures, dura).
- Performance Studies: The performance study described involves in vivo animal models (porcine) and evaluates surgical outcomes and tissue responses within the body.
There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FZP, HBT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels, other small tubular structures, dural tissue/durotomies (cranial and spinal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A GLP safety evaluation of the AnastoClip GC for cranial 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AnastoClip VCS Closure System K962043
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
AnastoClip GC Closure System K091987
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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);
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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
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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) |
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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 |
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