Amsel Endo Occluder device is an endoscopic ligating clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Device Description

Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips. Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut. Amsel Endo Occluder contains two main components: Ligating (Occluder) Clips and Applier (device delivery).

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Amsel Endo Occluder device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner for specific device functions. Instead, it states that the device was tested to demonstrate compliance with international and FDA-recognized consensus standards and FDA guidance documents, and that it "Meets the acceptance criteria and is adequate for its intended use and specifications."

The provided information focuses on the type of tests conducted rather than specific numerical acceptance criteria and performance outcomes.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 14971:2007:2012 (Risk Management)	Demonstrated compliance.
Compliance with ISO 11135-1:2014 (Sterilization - Ethylene Oxide)	Demonstrated compliance (Sterility).
Compliance with ISO 10993-1:2009 (Biological Evaluation)	Demonstrated compliance (Biocompatibility).
Compliance with ANSI/AAMI/ISO 10993-7:2012 (Ethylene Oxide Sterilization Residuals)	Demonstrated compliance.
Compliance with ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems)	Demonstrated compliance (Sterility).
Compliance with AMI/ANSI/ISO 11607-1:2006 (Packaging for Sterilized Medical Devices)	Demonstrated compliance (Sterility).
Compliance with ASTM F-2063 (Wrought Nickel-Titanium Shape Memory Alloys)	Demonstrated compliance (Material properties).
Compliance with ASTM F899 – 12b (Wrought Stainless Steels for Surgical Instruments)	Demonstrated compliance (Material properties).
Compliance with ASTM 2129-17 (Cyclic Potentiodynamic Polarization Measurements - Corrosion Susceptibility)	Demonstrated compliance.
Compliance with ASTM F3044-14 (Galvanic Corrosion for Medical Implants)	Demonstrated compliance.
Occlusion Performance (Safety and Effectiveness)	Demonstrated safety and effectiveness during preclinical in-vivo tests.
Functionality and Performance Claims	All defined functionality requirements and performance claims were met.
Adequacy for Intended Use and Specifications	Adequate for its intended use and specifications.

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

The document states that "Preclinical in-vivo tests, including acute and chronic tests, were conducted." However:

Specific sample sizes for these in-vivo tests are not provided in the summary.
Data provenance (e.g., country of origin, retrospective or prospective) for the test set is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The summary focuses on preclinical testing and does not mention the involvement of experts for establishing ground truth as typically seen in clinical device evaluations involving human diagnosis or interpretation.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the preclinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Amsel Endo Occluder device did not require clinical studies to support equivalence." Biomedical devices like ligating clips are often cleared based on non-clinical performance and substantial equivalence to predicate devices, rather than comparative clinical efficacy studies with human readers.

6. Standalone Performance Study (Algorithm Only):

This section is not applicable as the Amsel Endo Occluder device is a mechanical medical device (ligating clip applier and clips), not an AI/algorithm-driven device.

7. Type of Ground Truth Used:

For the preclinical in-vivo tests, the ground truth was based on demonstrating the safety and effectiveness of occlusion performance. This would likely involve direct observation, measurement, and pathological analysis of the ligated vessels/structures in animal models or cadaveric tissue.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI/algorithm that requires a training set. The "training set" concept is typically for machine learning models.

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

This information is not applicable for the same reason as above (not an AI/algorithm).

Summary

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November 15, 2018

Amsel Medical Corporation % Mr. Leo L. Basta Northstar Biomedical Associates 171 Hamilton Street Cambridge, Massachusetts 02139

Re: K180650

Trade/Device Name: Amsel Endo Occluder device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: October 12, 2018 Received: October 15, 2018

Dear Mr. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K180650

Device Name Amsel Endo Occluder device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Amsel Medical. The logo features a stylized letter "A" on the left, with the word "AMSEL" in a larger, bolder font to the right. Below "AMSEL" is the word "MEDICAL" in a smaller font. The color scheme is primarily blue and gray.

510(K) SUMMARY AMSEL ENDO OCCLUDER DEVICE

Date prepared:

November 14, 2018

I. Submitter's name and address

Establishment name:	Amsel Medical Corp.
Establishment address:	171 Hamilton Street Cambridge, MA02139Tel:(617)395-8825Fax: (617) 608-9080
Establishment registration:	3008989837
Primary Contact person:	Leo BastaNorthstar Biomedical Associates93 Benefit Street Providence, RI 02904(617) 834.9866lbasta@northstarbiomedical.com

II. Device information	Amsel Endo Occluder device
Trade name:	Implantable Clip
Device Classification Name	Class II
Device Class	General & Plastic Surgery
Classification Panel	FZP
Product Code	21CFR 892.4300
Regulation Description

III. Device Description:

Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips.

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Image /page/4/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 a larger, bolder font and "MEDICAL" in a smaller font below it. The overall design is clean and professional, suggesting a company in the healthcare or medical field.

Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut.

Amsel Endo Occluder contains two main components:

Ligating (Occluder) Clips- each sterile clip consists of two "star" shaped compression . elements and titanium fine rod which connects and locks the compression element tighter.
Applier (device delivery)- a sterile, single patient use, disposable surgical applier . designed to provide a means of ligation through an appropriately sized trocar. The applier is pre-loaded with 4 clips.

IV. Intended use:

Amsel Endo Occluder device is an endoscopic ligating clip applier and clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

V. Predicate Devices:

The Amsel Endo Occluder device is substantially equivalent to the following market-cleared devices:

	Device Name	Manufacturer	510k No	Date ofClearance
Primarypredicate	LIGACLIP 5M/LEndoscopic Multiple Clip	Ethicon	K050344	March 14,2005
Predicate	Amsel Occluder Device	Amsel MedicalCorporation	K149032	January23,2015

Table 2-1 Predicates table

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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 the word "AMSEL" in a simple sans-serif font to the right of the letter. Below the word "AMSEL" is the word "MEDICAL" in a smaller font size.

The proposed Amsel Endo Occluder device and its primary predicate device, LIGACLIP 5M/L Endoscopic Multiple Clip (K050344) are substantially equivalent in regards to their intended uses, clinical indications, principle of operation and fundamental technology principles.

The proposed Amsel Endo Occluder device and its predicate device, Amsel Occluder Device (K149032) are substantially equivalent in regards to their clinical indications, principle of operation, device design and material and fundamental technology principles.

VI. Substantial Equivalence to Predicate Devices

Feature	The proposed device:Amsel Endo Occluder	Primary Predicate:LIGACLIP 5M/LEndoscopic MultipleClip (K050344)	PredicateAmsel Occluder Device(K149032)
DeviceClassificationName	Clip, Implantable clip	Clip, Implantable clip	Clip, Implantable clip
Device Class	Class II	Class II	Class II
ClassificationPanel	General and PlasticSurgery	General and PlasticSurgery	General and PlasticSurgery
Product Code	FZP	FZP	FZP
RegulationDescription	Implantable clip	Implantable clip	Implantable clip
RegulationNumber	21 CFR 878.4300	21 CFR 878.4300	21 CFR 878.4300
Intended use	Vessel ligation orocclusion	Vessel ligation orocclusion	Vessel ligation orocclusion
Indication for	Amsel Endo Occluderdevice is an endoscopicligating clip applier andclips, which is intendedfor use on tubularstructures or vesselswherever a metal ligatingclip is indicated	LIGACLIP 5M/L 5mmEndoscopic Multiple Clipis intended for use ontubular structures orvessels wherever a metalligating clip is indicated.The tissue being ligatedshould be consistent with	The Amsel OccluderDevice is intended for usein open general surgeryprocedures on tubularstructures or vesselswherever a metal ligatingclip is indicated and withinthe size range of
Use
	within the size range of2.0mm to 7.0mmdiameter	the size of the clip.	2.0mm to 7.0mm diameter.
Environment ofuse	Hospitals and surgerycenter	Hospitals and surgerycenter	Hospitals and surgerycenter
Clinicalprocedure	Endoscopy procedure	Endoscopy procedure	Open general surgery
Pre-loaded/Loadedin OR	Pre -loaded	Loaded in the OR	Pre-loaded
Clip Size	One size	M,L	One Size
Length ofClipping	5.0mm	5.5mm	5.0mm
Compatible toTrocar	Yes.Trocar size 5mm	Yes.Trocar size 5mm	No
Secure to vesselmechanism	External compressiveforce on the vessel (ByPress)	External compressiveforce on the vessel (ByPress)	External compressive forceon the vessel (By Press)
Closure method	Penetrating through(Transfixing) the vesselusing a needle and thencompressing and lockingthe two occlusionelements; external vesselcompression	External vesselcompression	Penetrating through(Transfixing) the vesselusing a needle and thencompressing and lockingthe two occlusionelements; external vesselcompression
Clip Material	Nitinol and Titanium	Titanium	Nitinol and Titanium
Single Patientuse, Disposable	Yes	Yes	Yes
Sterilization	Sterilized by ETO	Sterilized by ETO	Sterilized by ETO
Prescription use	The device should beused only by trainedsurgeon under a physicianorder.	The device should beused only by trainedsurgeon under aphysician order.	The device should be usedonly by trained surgeonunder a physician order.

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Image /page/6/Picture/0 description: The image shows the logo for Amsel Medical. The logo consists of a stylized letter "A" on the left, followed by the words "AMSEL" and "MEDICAL" stacked on top of each other on the right. The letter "A" is blue and gray, while the words "AMSEL" and "MEDICAL" are gray.

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Image /page/7/Picture/0 description: The image contains the logo for AMSEL MEDICAL. The logo features a stylized letter "A" in blue and gray on the left. To the right of the "A" is the text "AMSEL" in a light gray color, with the word "MEDICAL" underneath in a smaller font size and the same light gray color.

In conclusion, Amsel Medical Corporation believes that the Amsel Endo Occluder device does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate devices, LIGACLIP 5M/L Endoscopic Multiple Clip (K050344) and Amsel Occluder Device (K149032).

VII. Brief discussion of the nonclinical tests submitted, referenced or relied on

Non-clinical performance testing has been performed on Amsel Endo Occluder device and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

ISO 14971 :2007:2012	Medical devices – Application of risk management to medical devices
ISO 11135-1:2014	Sterilization of health care products -
	Ethylene oxide - Part 1: Requirements for the development, validation
	and routine control of a sterilization process for medical devices
	(Sterility)
ISO 10993-1:2009	Biological Evaluation of Medical Devices -- Part 1: Evaluation and
	Testing Within A Risk Management Process
ANSI/AAMI/ISO	Biological Evaluation of Medical
10993-7: 2012	Devices – Part 7: Ethylene Oxide Sterilization Residuals.
ASTM F1980-07	Standard Guide for Accelerated Aging of Sterile Barrier Systems for
	Medical Devices. (Sterility).
AMI / ANSI / ISO	Packaging for terminally sterilized medical devices - Part 1:
11607-1:2006	Requirements for materials (sterility).
ASTM F-2063	Standard Specification for Wrought Nickel-Titanium Shape Memory
	Alloys for Medical Devices and Surgical Implants
ASTM F899 – 12b	Standard Specifications for Wrought Stainless Steels for Surgical
	Instruments
ASTM 2129-17	Standard Test Method for Conducting Cyclic Potentiodynamic
	Polarization Measurements to Determine the Corrosion Susceptibility
	of Small Implant Devices
ASTM F3044-14	Test Method for Standard Test Method for Evaluating the Potential for
	Galvanic Corrosion for Medical Implants

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Image /page/8/Picture/0 description: The image contains the logo for Amsel Medical. The logo features a stylized letter "A" in blue and gray, with the word "AMSEL" in a sans-serif font to the right of the "A". Below "AMSEL" is the word "MEDICAL" in a smaller font size.

Amsel Endo Occluder device was tested in accordance with Amsel verification and validation processes. Verification and Validation tests have been performed to address its intended use, the technological characteristics claims, requirement specifications and the risk management results. The test results in this 510(k)-premarket notification demonstrate that Amsel Endo Occluder:

. Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
. Meets the acceptance criteria and is adequate for its intended use and specifications.

VIII. Brief discussion of clinical tests submitted, referenced or relied on

The subject of this premarket submission, Amsel Endo Occluder device did not require clinical studies to support equivalence.

Preclinical in-vivo tests, including acute and chronic tests, were conducted in order to demonstrate the safety and effectiveness of Amsel Endo Occluder device in terms of occlusion performance.

IX. The conclusions drawn from the nonclinical and clinical tests

Verification and Validation (V&V) activities required to establish performance and functionality of Amsel Endo Occluder device were performed. Testing performed demonstrated the Amsel Endo Occluder device meets all defined functionality requirements and performance claims.

X. Overall conclusion:

The Amsel Endo Occluder device is substantially equivalence to the identified predicate device, LIGACLIP 5M/L Endoscopic Multiple Clip (K050344) and Amsel Occluder Device (K149032) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.

Amsel Medical believes that the proposed device. Amsel Endo Occluder device, is substantially equivalent to its identified predicate device and is as safe and effective as its

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predicate device without raising any new safety and/or effectiveness concerns.

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.