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.

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the delivery system, which is mechanically locked to the implant rod, is detached from the implant and the needle is withdrawn leaving the occlusion construct implanted, permanently occluding the vessel.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria in a format that allows for a direct table as requested. The text describes a 510(k) submission for the Amsel Occluder Device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria of the new device.

However, based on the information provided, I can extract and infer some points regarding performance characteristics and testing without presenting a formal table of acceptance criteria and reported performance, as these specific quantifiable metrics are not explicitly stated for acceptance.

Here's a breakdown of the requested information based on the document:

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

This information is not explicitly provided in the document in a quantifiable table format for the Amsel Occluder Device's acceptance criteria. The document outlines the types of performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. It states that "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."

The following are performance characteristics that were verified or evaluated. While these imply underlying acceptance criteria, the specific quantitative targets and results against those targets for the Amsel device itself are not detailed.

Performance Characteristic (Type of Test)	Implied/Reported Performance
Clip Closure Distance	Verified "to ensure it is within the designed specification" (Specific specification not provided)
Clip Closure Repeatability and Reliability	Verified "the repeatable compression and locking of the occluder clip"
Strain Analysis	Purpose was "to analyze the maximal strain of the clips during occlusion" (Specific results not provided)
Corrosion Test (ASTM 2129-08, ASTM F3044-14)	Verification "that the device does not develop corrosion post implantation." (Implicitly, it passed these tests, no specific metrics provided)
Performance Evaluation (Simulated Model)	Verified "the performance of the Amsel Occluder device in a simulated model" (Specific performance metrics not provided)
Device to Implant Detachment Force	Verified "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" (Specific force value not provided)
Holding Pressure Evaluation	Verification of "occlusion performance by pressurizing occluded structure through pressures over 700mmHg" (Implicitly, it maintained occlusion at these pressures, no specific metrics provided for failure point or success rate)
Release Mechanism Function Testing	Verified "proper detachment of the delivery system from the implant during operation"
Deployment Force Testing	"The force required to deploy the Amsel Occluder Device was tested in comparison to a predicate. Results were that the device [performed acceptably, though specific results are truncated/unavailable in the provided text]."
Biocompatibility Testing	Verified "that all body contact materials are biocompatible for the contact and duration of contact" (Implicitly, all materials were found biocompatible)
Animal Study (Holding Pressure and Histology)	Evaluated "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" in comparison to a predicate device. (Deemed safe and effective)
MR Imaging Testing	"to support the MR conditional claim in the device's labeling." (Implicitly, it meets the criteria for MR conditional, no specific MR parameters provided)

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

Sample Size for Test Set: Not explicitly stated in terms of number of devices or cases for each specific test. The animal study mentions evaluating occlusion performance in "arteries and veins 2.0mm to 7.0mm".
Data Provenance: The general nature of the pre-clinical tests and animal studies suggests these were conducted in a controlled, prospective manner. The document does not specify the country of origin of the data, but the manufacturer is Amsel Medical Corp. (Cambridge, MA, USA) and the contact person is in Providence, RI, USA, while another contact is in Kfar-Saba, Israel. This suggests testing could have occurred in either region or elsewhere.

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 or qualifications of experts used to establish ground truth for the test set. For an animal study, typically veterinary surgeons and pathologists would be involved, but details are not provided.

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

The document does not specify any adjudication method for the test set results.

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

This information is not applicable/provided. The Amsel Occluder Device is a medical implant (a ligating clip), not an AI diagnostic or assistance tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance would not be relevant to this device.

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

This information is not applicable/provided. As above, the device is a mechanical implant, not an algorithm.

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

For the animal study, performance aspects like "occlusion performance" and "histology" were evaluated. This implies that pathology would be a key component of establishing ground truth for the histological analysis, along with direct observation and possibly pressure measurements (holding pressure evaluation) for occlusion performance.
For bench testing, the ground truth would be based on engineering specifications and measurements (e.g., force, distance, corrosion absence).

8. The sample size for the training set

This information is not applicable/provided. The Amsel Occluder is a mechanical device, not an algorithm that requires a training set in the machine learning sense. The "training set" for its development would be iterative design and testing, not a data set for model training.

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

This information is not applicable/provided for the same reason as point 8.

Summary

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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

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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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K140932

Device Name: Amsel Occluder Device

Indications for Use:

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

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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

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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).
1. Ethicon Inc. LigaClip, cleared under K834267 (product code FZP, Regulation No. 878.4300).

5.9 Intended Use

5.10 Device Description

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,

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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 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.

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	AMSEL OCCLUDER DEVICE	TWISTER SUPERELASTIC LIGATINGCLIP	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 &Indications for Use	The Amsel Occluder Device isintended for use in open generalsurgery procedures on tubularstructures or vessels wherever ametal ligating clip is indicated andwithin the size range of 2.0mm to7.0mm diameter.	The Twister Superelastic Ligating Clip,Size M is intended for the permanentocclusion or ligation of blood vesselsand other tubular body structures,wherever a metal ligating clip isindicated, and within the size range of2.0 to 3.5mm diameter.	The LIGACLIP MULTIPLE CLIPAPPLIER is intended for use ontubular structures or vessels wherevera metal ligating clip is indicated. Thetissue being ligated should beconsistent with the size of the clip.	Similar. Size range for theAmsel Occluder wasdemonstrated throughanimal testing performedusing the device.
Environments ofUse	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 LIGATINGCLIP	LIGACLIP	SE
Clip Size	One size	S,M,L	M,M-L, L	Clip size range tested inanimal and laboratorybench testing demonstratedsingle clip performs asintended through upperlimit labeled vessel size.
Vessel Size	2.0mm-7.0mm	2.0mm-3.5mm (M)	2.0mm-6.0mm	Clip size range tested inanimal and laboratorybench testing demonstratedsingle clip performs asintended over labeled vesselsize.
Length of clip	5.5mm	unknown	5.5mm	Similar. Testingdemonstrated that Amselclip length is sufficient forsafe and effective use.
Secured to vessel ortubular structure	Mechanical, by compressing theclip components (sliding andlocking two nitinol elements oneagainst the other on either side ofthe vessel and locked together witha titanium rod)	Mechanical compression	Mechanical compression	Same
Closure method	Penetrating through (transfixing)the vessel using a needle and thendeploying locking the vesselexternally	External vessel compression	External vessel compression	Similar. All occlude viaexternal compression of thevessel. Amsel closuretechnology demonstrated assafe and effective in animaland bench testing.

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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.

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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 LIGATINGCLIP	LIGACLIP	SE
Clip Material	Nitinol and titanium	Nitinol	Titanium	Similar. Amsel uses thesame and additionalmaterial. All materialstested for biocompatibilityand functionality and anydifferences do not adverselyaffect safety oreffectiveness.
Single Patient Use,Disposable	Yes	Yes	Yes	Same
Sterilization	Sterile for single use EtO	Sterile for single useEtO	Sterile for single useEtO	Same
Prescription Use	Yes. The device should be usedonly by trained surgeon.	Yes. The device should be used only bytrained surgeon.	Yes. The device should be used onlyby trained surgeon.	Same

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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

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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.

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.