(247 days)
Not Found
No
The device description and performance studies focus on mechanical function and standard testing, with no mention of AI or ML.
Yes
The device is used to permanently occlude blood vessels and ductal structures, which is a therapeutic intervention.
No
The device is described as an endoscopic ligating clip applier intended for permanent secure occlusion of blood vessels and ductal structures, indicating its use is for a therapeutic or interventional purpose, not for diagnosing conditions.
No
The device description clearly states it is a mechanical occlusion clip with two main components: Ligating (Occluder) Clips and Applier (device delivery), indicating it is a physical hardware device.
Based on the provided information, the Amsel Endo Occluder device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic ligating clips... for use on tubular structures or vessels wherever a metal ligating clip is indicated". This describes a device used within the body during a surgical procedure to physically occlude structures.
- Device Description: The description reinforces this by stating it's an "endoscopic ligating clip applier" used "during endoscopic procedures" for "permanent secure occlusion of blood vessels and ductal structures". It's a mechanical device that physically interacts with tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the Amsel Endo Occluder is a surgical device used for mechanical ligation during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FZP
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- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tubular structures or vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used only by trained surgeon under a physician order.
Hospitals and surgery center
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)
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 10993-7: 2012 Biological Evaluation of Medical 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 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: 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
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.
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.
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.
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.
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K180650
Device Name Amsel Endo Occluder device
Indications for Use (Describe)
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.
| 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, MA |
| 02139 | |
| Tel:(617)395-8825 | |
| Fax: (617) 608-9080 | |
| Establishment registration: | 3008989837 |
| Primary Contact person: | Leo Basta |
| Northstar Biomedical Associates | |
| 93 Benefit Street Providence, RI 02904 | |
| (617) 834.9866 | |
| lbasta@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 of
Clearance |
|----------------------|-------------------------------------------|------------------------------|---------|----------------------|
| Primary
predicate | LIGACLIP 5M/L
Endoscopic Multiple Clip | Ethicon | K050344 | March 14,
2005 |
| Predicate | Amsel Occluder Device | Amsel Medical
Corporation | K149032 | January
23,2015 |
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/L
Endoscopic Multiple
Clip (K050344) | Predicate
Amsel Occluder Device
(K149032) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Name | Clip, Implantable clip | Clip, Implantable clip | Clip, Implantable clip |
| Device Class | Class II | Class II | Class II |
| Classification
Panel | General and Plastic
Surgery | General and Plastic
Surgery | General and Plastic
Surgery |
| Product Code | FZP | FZP | FZP |
| Regulation
Description | Implantable clip | Implantable clip | Implantable clip |
| Regulation
Number | 21 CFR 878.4300 | 21 CFR 878.4300 | 21 CFR 878.4300 |
| Intended use | Vessel ligation or
occlusion | Vessel ligation or
occlusion | Vessel ligation or
occlusion |
| Indication for | 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 | LIGACLIP 5M/L 5mm
Endoscopic Multiple Clip
is intended for use on
tubular structures or
vessels wherever a metal
ligating clip is indicated.
The tissue being ligated
should be consistent with | 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 |
| Use | | | |
| | within the size range of
2.0mm to 7.0mm
diameter | the size of the clip. | 2.0mm to 7.0mm diameter. |
| Environment of
use | Hospitals and surgery
center | Hospitals and surgery
center | Hospitals and surgery
center |
| Clinical
procedure | Endoscopy procedure | Endoscopy procedure | Open general surgery |
| Pre-
loaded/Loaded
in OR | Pre -loaded | Loaded in the OR | Pre-loaded |
| Clip Size | One size | M,L | One Size |
| Length of
Clipping | 5.0mm | 5.5mm | 5.0mm |
| Compatible to
Trocar | Yes.
Trocar size 5mm | Yes.
Trocar size 5mm | No |
| Secure to vessel
mechanism | External compressive
force on the vessel (By
Press) | External compressive
force on the vessel (By
Press) | External compressive force
on the vessel (By Press) |
| Closure method | Penetrating through
(Transfixing) the vessel
using a needle and then
compressing and locking
the two occlusion
elements; external vessel
compression | External vessel
compression | Penetrating through
(Transfixing) the vessel
using a needle and then
compressing and locking
the two occlusion
elements; external vessel
compression |
| Clip Material | Nitinol and Titanium | Titanium | Nitinol and Titanium |
| Single Patient
use, Disposable | Yes | Yes | Yes |
| Sterilization | Sterilized by ETO | Sterilized by ETO | Sterilized by ETO |
| Prescription use | The device should be
used only by trained
surgeon under a physician
order. | The device should be
used only by trained
surgeon under a
physician order. | The device should be used
only by trained surgeon
under 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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Image /page/9/Picture/0 description: The image contains the logo for "AMSEL MEDICAL". The logo consists of a stylized letter "A" on the left, followed by the text "AMSEL" in a larger font size and "MEDICAL" in a smaller font size below it. The letter "A" is designed with a gradient effect, transitioning from a darker shade of blue at the top to a lighter shade at the bottom.
predicate device without raising any new safety and/or effectiveness concerns.