(268 days)
Not Found
No
The summary describes a mechanical device for LAA exclusion and a sizing guide, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the exclusion of the heart's left atrial appendage, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as an "Exclusion System" intended for the "exclusion of the heart's left atrial appendage," which is a treatment or surgical procedure, not a diagnostic one.
No
The device description explicitly states that the system consists of a physical, implantable clip and a delivery system, which are hardware components.
Based on the provided information, the Syntheon LAA Exclusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Syntheon LAA Exclusion System Function: The Syntheon LAA Exclusion System is a surgical implant and delivery system used to physically exclude the left atrial appendage during cardiac surgery. It is a therapeutic device, not a diagnostic one. It does not analyze biological specimens to provide diagnostic information.
- Intended Use: The intended use is for the "exclusion of the heart's left atrial appendage," which is a surgical procedure, not a diagnostic test.
Therefore, the Syntheon LAA Exclusion System falls under the category of a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
Product codes (comma separated list FDA assigned to the subject device)
PZX
Device Description
The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart's left atrial appendage (LAA)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, cardiac surgical procedures
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)
Design verification and validation were performed to ensure that the Syntheon LAA Exclusion System meets its performance specifications and demonstrates substantial equivalence to the predicate device. There are no known performance standards for this device. The following tests were conducted to demonstrate equivalence to the predicate device:
- o Mechanical Testing
- Packaging Testing 0
- o Shelf-life Testing
- Bench-top Validation Testing ●
- Animal Validation Testing
All pre-determined acceptance criteria were met. The data demonstrate that the Syntheon LAA Exclusion System is substantially equivalent to the predicate device.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 28, 2022
Syntheon % Elena Jugo Regulatory Consultant Caraballo Consulting, LLC 11037 Bitternut Hickory Lane Boynton Beach, Florida 33437
Re: K220305
Trade/Device Name: Syntheon LAA Exclusion System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PZX Dated: September 27, 2022 Received: September 28, 2022
Dear Elena Jugo:
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220305
Device Name Syntheon LAA Exclusion System
Indications for Use (Describe)
The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
| 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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3
5 - 510(k) Summary
| Date Summary Prepared: | January 31, 2022 |
|---|---|
| Submitter: | Syntheon |
| 13755 SW 119 Avenue | |
| Miami, FL 33186 | |
| Primary Submission Contact: | Elena Jugo |
| Regulatory Consultant | |
| Caraballo Consulting | |
| 13755 SW 119 Avenue | |
| Miami, FL 33186 | |
| Telephone: 1-305-510-4398 | |
| Facsimile: 1-786-664-0026 | |
| E-Mail: Elena@Caraballoconsulting.com | |
| Secondary Submission Contact: | Toygar Unal |
| Director of Quality | |
| Syntheon | |
| 13755 SW 119 Avenue | |
| Miami, FL 33186 | |
| Telephone: 1-973-997-8532 | |
| Facsimile: 1-786-664-0026 | |
| E-Mail: tunal@syntheon.com | |
| Trade Name: | LAA Exclusion System |
| Regulation Number: | 21 CFR 878.4300 |
| Device Common or | |
| Classification Name: | Left Atrial Appendage Clip, Implantable |
| Product Class: | Class II |
| Product Panel: | Cardiovascular |
| Product Code: | PZX |
| Predicate Device: | K210293, AtriCure AtriClip LAA Exclusion System |
CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.
4
5.1 Device Description
The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.
5.2 Indications for Use
The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.
5.3 Technological Characteristics and Basis for Substantial Equivalence
The Syntheon LAA Exclusion System, subject of this 510(k) submission, is substantially equivalent in its intended use/indications for use, technology/principal of operation, biocompatibility of materials, sterilization method and performance to the predicate device, the AtriCure AtriClip LAA Exclusion System.
A comparison of the technological characteristics of the subject device and the predicate device is summarized in Table 5.3.1.
CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.
5
| Parameter | Subject Device
Syntheon LAA Exclusion
System | Predicate Device
AtriCure AtriClip LAA
Exclusion System
510(k) # K210293 | Equivalence
Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Syntheon LAA Exclusion
System is indicated for the
exclusion of the heart's left atrial
appendage, performed under
direct visualization and in
conjunction with other cardiac
surgical procedures.
Direct visualization, in this
context, requires that the surgeon
is able to see the heart directly,
with or without assistance from a
camera, endoscope, etc., or other
appropriate viewing technologies. | The AtriClip LAA Exclusion
System is indicated for the
exclusion of the heart's left
atrial appendage, performed
under direct visualization and
in conjunction with other
cardiac surgical procedures.
Direct visualization, in this
context, requires that the
surgeon is able to see the heart
directly, with or without
assistance from a camera,
endoscope, etc., or other
appropriate viewing
technologies. | Same |
| Product Code | PZX | PZX | Same |
| Regulation No. | 21CFR878.4300 | 21CFR878.4300 | Same |
| Classification | Class II | Class II | Same |
| Components | Implantable clip and disposable
clip applier (delivery system) | Implantable clip and disposable
clip applier | Same |
| Principle of
Operation | The clip is comprised of two
springs biasing two bars together
with constant force for the
exclusion of the left atrial
appendage. | The clip is comprised of two
springs biasing two bars
together with constant force for
the exclusion of the left atrial
appendage. | Same |
| Clip Size | Clip Size LAA Size Range:
• 35 mm: 29-35 mm
• 40 mm: 34-40 mm
• 45 mm: 39-45 mm
• 50 mm: 44-50 mm | Clip Size LAA Size Range:
• 35 mm: 29-35 mm
• 40 mm: 34-40 mm
• 45 mm: 39-45 mm
• 50 mm: 44-50 mm | Same |
| Clip Opening | Tip opens to a minimum of 12
mm at the distal end. | Gillinov-Cosgrove Clip: Opens
12.5 mm $\pm$ 1.5 mm as
measured between the beams of
the clip.
PROV Clip: Opens to a
minimum of 12 mm at the
distal end and 4 mm at the
proximal end of the clip. | Same as PROV, design
verification testing for the
Syntheon LAA Exclusion
system has demonstrated
a proximal opening >4
mm for all implant sizes.
The implant functions as
intended. |
| Biocompatibility | Materials have been assessed
based on ISO 10993 and are | Materials have been assessed
based on ISO 10993 and are | Same |
| Table 5.3.1 - Comparison Between the Syntheon LAA Exclusion System and Predicate Device | |
|---|---|
CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.
6
| Parameter | Subject Device
Syntheon LAA Exclusion
System | Predicate Device
AtriCure AtriClip LAA
Exclusion System
510(k) # K210293 | Equivalence
Comparison |
|-------------------|----------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------|
| | commonly employed in tissue
contacting devices. | commonly employed in tissue
contacting devices. | |
| Single Use Only | Yes | Yes | Same |
| Sterilization | Gamma Radiation | Gamma Radiation | Same |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Same |
| MRI Compatibility | MR Conditional | MR Conditional | Same |
Table 5.3.1 - Comparison Between the Syntheon LAA Exclusion System and Predicate Device
5.4 Performance Data
Design verification and validation were performed to ensure that the Syntheon LAA Exclusion System meets its performance specifications and demonstrates substantial equivalence to the predicate device. There are no known performance standards for this device. The following tests were conducted to demonstrate equivalence to the predicate device:
- o Mechanical Testing
- Packaging Testing 0
- o Shelf-life Testing
- Bench-top Validation Testing ●
- Animal Validation Testing
All pre-determined acceptance criteria were met. The data demonstrate that the Syntheon LAA Exclusion System is substantially equivalent to the predicate device.
5.5 Biocompatibility Testing
The Syntheon LAA Exclusion System was assessed for biocompatibility in accordance with ISO 10993-1:2018, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The clip component of the LAA Exclusion System is an implantable device that is in long-term contact with the body (> 30 days), while the clip delivery system has limited contact ( 30 days) | Delivery System -
External Communicating, Limited
Contact (≤ 24 hours) |
|---------------------------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------|
| Chemical Characterization | ✓ | ✓ |
| Cytotoxicity | ✓ | ✓ |
| Sensitization | ✓ | ✓ |
| Irritation | ✓ | ✓ |
| Acute Systemic Toxicity | ✓ | ✓ |
| Pyrogenicity | ✓ | ✓ |
| Sub-Acute/Sub-Chronic Toxicity | ✓ | ✓ |
| Genotoxicity
• Ames Mutagenicity
• In Vitro Mouse Lymphoma
Mutagenesis | ✓ | N/A |
| Implantation
• 1-, 4-, and 13-weeks | ✓ | |
Table 5.5.1 - Biocompatibility Tests Performed on the LAA Exclusion System
5.6 Conclusion
Review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the Syntheon LAA Exclusion System, is substantially equivalent to the predicate AtriCure AtriClip LAA Exclusion System, K210293, cleared on March 3th, 2021. Any differences between the predicate devices do not raise any issues of safety and effectiveness.
CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.