AMSEL OCCLUDER DEVICE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 23, 2015 Amsel Medical Corporation % Leo Basta NorthStar Biomedical Associates 93 Benefit Street Providence, Rhode Island 02904 Re: K140932 Trade/Device Name: Amsel Occluder Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: November 28, 2014 Received: December 1, 2014 Dear Leo Basta: 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 (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K140932 Device Name: Amsel Occluder Device ## Indications for Use: The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter. Prescription Use √ AND/OR Over-The-Counter Use (Part 21 C.F.R. 801 Subpart D) (21 C.F.R. 807 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Amsel Medical Corp. Rev A {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Amsel Medical. The logo features a stylized letter "A" in blue and gray, with a curved line running through it. To the right of the "A" is the text "AMSEL" in gray, with the word "MEDICAL" in blue underneath. The logo has a clean and professional design. Traditional Premarket Notification Submission - 510(k) 510(k) SUMMARY Amsel Occluder Device 510(k) Number K140932 Prepared January 22, 2015 ## 5.1 Company Name Amsel Medical Corp. 171 Hamilton Street Cambridge, MA 02139 Tel: (617) 395-8825 Fax: (617) 608-9080 ### 5.2 Contact Person Leo Basta NorthStar Biomedical Associates for Amsel Medical Corporation 93 Benefit Street Providence, RI 02904 617.834.9866 (phone) 401.454.1733 lbasta@northstarbiomedical.com And/or Orly Maor 25 A Sirkin Street Kfar-Saba 4442156, Israel Tel: 972-7453607 Fax: 972-153-9-7453607 oram.ma@gmail.com ## 5.3 Trade/Proprietary Name Amsel Occluder Device ## Classification Name 5.4 Clip Implantable ## ર.5 Product Code/Regulation No. Product code: FZP, Regulation No. 878.4300. Amsel Medical Corp. Rev A {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Amsel Medical. The logo features a stylized letter "A" on the left, with the word "AMSEL" in a larger font size to the right of the "A". Below "AMSEL" is the word "MEDICAL" in a smaller font size. The colors used in the logo are shades of blue and gray. ## 5.6 Device Classification Class II - 5.7 Panel General & Plastic Surgery ### 5.8 Predicate Devices - 1. Neurosel Medical Ltd. Twister Superelastic Ligating Clip cleared under K032238, (product code FZP, Regulation No. 878.4300). - 2. Ethicon Inc. LigaClip, cleared under K834267 (product code FZP, Regulation No. 878.4300). ### 5.9 Intended Use The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter. # 5.10 Device Description The Amsel Occluder Device involves the implantation of a mechanical occlusion device that penetrates into and through the target vessel structure and when compressed and locked, clamps the vessel shut. The device consists of a metallic clip construct comprised of two compression components and an interlocking implant rod that when compressed together as a unit and locked on either side of a vessel results in occlusion. The delivery device consists of a hand held syringe-like device loaded with the components of the implant construct. The device is for use in general surgical procedures. Once positioned correctly, the occlusion construct is actuated through a series of semiautomatic steps resulting in the two components becoming compressed on either side of the vessel and locked together to occlude the vessel. Once occlusion is achieved, the delivery system, which is mechanically locked to the implant rod, is detached from the implant and the needle is withdrawn leaving the occlusion construct implanted, permanently occluding the vessel. ### 5.11 Substantial Equivalence The Amsel Occluder Device is substantially equivalent to the legally marketed predicate devices for the following reasons: - The Amsel Occluder Device has the same intended use and similar ● indications for use as the predicate devices, {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Amsel Medical. The logo features a stylized letter "A" in blue and gray, with a curved line running through it. To the right of the "A" is the text "AMSEL" in gray, with the word "MEDICAL" in blue below it. The logo has a clean and professional design. - All devices use similar technology to deliver a clip to mechanically . compress the tissue, - . The Amsel Occluder employs similar or the same materials as its predicates, - The Amsel Occluder and the predicate devices use a delivery applicator that ● offers smooth, efficient deployment of the clip/s, and - All three devices share similar dimensional attributes. . The following table contains a summary of the descriptive and technological characteristics of the Amsel Occluder Device compared to the predicate devices. {6}------------------------------------------------ | | AMSEL OCCLUDER DEVICE | TWISTER SUPERELASTIC LIGATING<br>CLIP | LIGACLIP | SE | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Not yet known | K032238 | K834267 | Same | | Manufacturer | Amsel Medical Corp. | Neurosel Medical Ltd. | Ethicon Inc. | Same | | Product Code | FZP | FZP | FZP | Same | | CFR | 878.4300 | 878.4300 | 878.4300 | Same | | Intended Use &<br>Indications for Use | The Amsel Occluder Device is<br>intended for use in open general<br>surgery procedures on tubular<br>structures or vessels wherever a<br>metal ligating clip is indicated and<br>within the size range of 2.0mm to<br>7.0mm diameter. | The Twister Superelastic Ligating Clip,<br>Size M is intended for the permanent<br>occlusion or ligation of blood vessels<br>and other tubular body structures,<br>wherever a metal ligating clip is<br>indicated, and within the size range of<br>2.0 to 3.5mm diameter. | The LIGACLIP MULTIPLE CLIP<br>APPLIER is intended for use on<br>tubular structures or vessels wherever<br>a metal ligating clip is indicated. The<br>tissue being ligated should be<br>consistent with the size of the clip. | Similar. Size range for the<br>Amsel Occluder was<br>demonstrated through<br>animal testing performed<br>using the device. | | Environments of<br>Use | Hospitals and surgery center. | Hospitals and surgery center. | Hospitals and surgery center. | Same | | Pre Loaded \<br>Loaded in OR | Pre-loaded | Pre-loaded | Loaded in the OR | Same as Neurosel | | | AMSEL OCCLUDER DEVICE | TWISTER SUPERELASTIC LIGATING<br>CLIP | LIGACLIP | SE | | Clip Size | One size | S,M,L | M,M-L, L | Clip size range tested in<br>animal and laboratory<br>bench testing demonstrated<br>single clip performs as<br>intended through upper<br>limit labeled vessel size. | | Vessel Size | 2.0mm-7.0mm | 2.0mm-3.5mm (M) | 2.0mm-6.0mm | Clip size range tested in<br>animal and laboratory<br>bench testing demonstrated<br>single clip performs as<br>intended over labeled vessel<br>size. | | Length of clip | 5.5mm | unknown | 5.5mm | Similar. Testing<br>demonstrated that Amsel<br>clip length is sufficient for<br>safe and effective use. | | Secured to vessel or<br>tubular structure | Mechanical, by compressing the<br>clip components (sliding and<br>locking two nitinol elements one<br>against the other on either side of<br>the vessel and locked together with<br>a titanium rod) | Mechanical compression | Mechanical compression | Same | | Closure method | Penetrating through (transfixing)<br>the vessel using a needle and then<br>deploying locking the vessel<br>externally | External vessel compression | External vessel compression | Similar. All occlude via<br>external compression of the<br>vessel. Amsel closure<br>technology demonstrated as<br>safe and effective in animal<br>and bench testing. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Amsel Medical. The logo features a stylized letter "A" in blue and gray, with the words "AMSEL MEDICAL" in gray next to it. The word "AMSEL" is above the word "MEDICAL". There is a reflection of the logo below it. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Amsel Medical. The logo consists of a stylized letter A in blue and gray, followed by the words "AMSEL" in gray and "MEDICAL" in blue. The logo has a reflection effect below it. | | AMSEL OCCLUDER DEVICE | TWISTER SUPERELASTIC LIGATING<br>CLIP | LIGACLIP | SE | |-----------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clip Material | Nitinol and titanium | Nitinol | Titanium | Similar. Amsel uses the<br>same and additional<br>material. All materials<br>tested for biocompatibility<br>and functionality and any<br>differences do not adversely<br>affect safety or<br>effectiveness. | | Single Patient Use,<br>Disposable | Yes | Yes | Yes | Same | | Sterilization | Sterile for single use EtO | Sterile for single use<br>EtO | Sterile for single use<br>EtO | Same | | Prescription Use | Yes. The device should be used<br>only by trained surgeon. | Yes. The device should be used only by<br>trained surgeon. | Yes. The device should be used only<br>by trained surgeon. | Same | {9}------------------------------------------------ As demonstrated in the completed battery of preclinical tests that were conducted by the company minor technological differences between the Amsel Occluder Device and the predicate devices do not raise new questions of safety and effectiveness. Any minor differences in technological characteristics have been tested and reported on in this notification and demonstrate that such differences do not adversely affect the safety, effectiveness, or intended performance of the device. Therefore, the Amsel Occluder Device is substantially equivalent to the legally marketed predicate devices. Testing in support of the SE determination included laboratory bench testing, biocompatibility testing, shelf life testing and animal testing. # 5.12 Performance Characteristics of the Amsel Occluder Device The Amsel Occluder Device underwent a full battery of bench testing and animal testing to demonstrate its safe and effective performance in occluding vessels. It was concluded that the device is safe and effective for its intended use. Tests were performed in comparison to the predicate device. Specifically, testing included: - Clip Closure Distance to verify Clip closure distance to ensure it is within the designed specification Clip Closure Repeatability and Reliability ● to verify the repeatable compression and locking of the occluder clip ● Strain Analysis the purpose was to analyze the maximal strain of the clips during occlusion Corrosion Test ● Verification that the device does not develop corrosion post implantation. Testing was performed per ASTM 2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices and ASTM F3044-14 Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants Performance Evaluation ● to verify the performance of the Amsel Occluder device in a simulated model ● Device to Implant Detachment Force to verify that the force required to detach the clip from the delivery system is sufficiently robust to prevent inadvertent detachment of the delivery system from the clip ● Holding Pressure Evaluation verification of occlusion performance by pressurizing occluded structure through pressures over 700mmHg ● Release Mechanism Function Testing to verify proper detachment of the delivery system from the implant during operation {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Amsel Medical. The logo features a stylized letter "A" in blue and gray, with the word "AMSEL" in gray and "MEDICAL" in blue to the right of the letter. The logo is clean and modern, with a professional look. ## Σ Deployment Force Testing - The force required to deploy the Amsel Occluder Device """"""""""""""""""""""""""was tested in comparison to a predicate. Results were that """""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""" """""""""""""" the device - Biocompatibility Testing ● - to verify that all body contact materials are biocompatible for the contact and duration of contact - Animal study including holding pressure and histology - preclinical in-vivo use of the Amsel device compared to a predicate device to evaluate the safety and effectiveness of the Amsel device in terms of introduction, deployment, usability, and occlusion performance in arteries and veins 2.0mm to 7.0mm - . MR Imaging Testing - to support the MR conditional claim in the device's labeling. All testing performed demonstrated that the Amsel Occluder is a safe and effective device for vessel and tubular structure occlusion and is considered substantially equivalent to its predicate devices. # 5.13 Conclusion Amsel Medical believes that, based on the descriptive information and testing provided in this submission, the Amsel Occluder Device is substantially equivalent to its predicate devices.