(266 days)
The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
The TigerPaw Pro is a flexible, implantable occlusion fastener to be placed on the ostium of the left atrial appendage (LAA) during open cardiac surgical procedures. TigerPaw Pro consists of a Fastener implant that is pre-loaded onto a Delivery Tool and is for single use only. It is designed to provide an alternative to conventional suture and surgical staplers for occlusion of the ostium of the LAA. The TigerPaw Pro implantable fastener comes in two lengths; 35mm and 45mm. Surgeon judgment based on patient anatomy should determine what length fastener to apply.
The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for the TigerPaw Pro Left Atrial Appendage Occlusion Fastener and Delivery Tool, which outlines the device's indications for use, technological characteristics, and safety and performance testing conducted to demonstrate substantial equivalence to a predicate device.
While it mentions various performance tests and an animal study, it does not provide:
- A table of acceptance criteria and reported device performance: The document lists several performance tests (e.g., ability to completely close the fastener, tensile strength of barbs, force required to actuate, corrosion testing) but does not present specific quantitative acceptance criteria or their corresponding results in a table format.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or how ground truth was established for these specific criteria. The animal study details the sample size (7 canines) and that a board-certified pathologist performed the necropsy, indicating the ground truth assessment method. However, these details are for the animal study, not explicitly linked to acceptance criteria in the tabular form or for a human-in-the-loop or standalone AI performance study.
Information that is present regarding studies and their findings:
-
GLP Animal Study:
- Sample size: 7 canines.
- Data provenance: Acute Good Laboratory Practices (GLP) animal study.
- Ground truth experts: Board-certified pathologist for full necropsy examination of local tissues post device implantation.
- Ground truth type: Pathology and visual assessment of the device's usability, safety, and performance during and after deployment.
- Results: "All acceptance criteria were met for this animal study performed using the market version of this device."
- Purpose: To evaluate the usability of the device and the risk of tissue injury on the LAA during deployment and securement of the fastener.
-
Performance Testing (In-vitro):
- Included tests such as:
- Ability to completely close the fastener after deployment and prevent leakage from a mock LAA.
- Tensile strength of individual fastener barbs after closure.
- Assessment of Delivery Tool jaw component characteristics (e.g., angle measurements).
- Force required to actuate the Delivery Tool trigger, unlock button, and torque for shaft rotation.
- Corrosion testing (ISO 10555-1 Annex A).
- Comparison of TigerPaw II and TigerPaw Pro's tool jaw resistance to flexure on a worst-case thickness mock LAA ostium.
- Comparison of TigerPaw II and TigerPaw Pro's ability to deploy and secure fasteners under different worst-case rotational forces on a mock ostium.
- Results: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the previously cleared TigerPaw System II."
- Included tests such as:
The document concludes that "The performance and other testing established that the TigerPaw Pro is substantially equivalent to the predicate device," but it does not provide the specific acceptance criteria and detailed quantitative results for each test in a format that directly addresses all parts of your request.
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December 26, 2019
Datascope Corp. Mark Dinger Sr. Regulatory Affairs Specialist 15 Law Drive Fairfield, New Jersey 07004
Re: K190884
Trade/Device Name: TigerPaw Pro Left Atrial Appendage Occlusion Fastener and Delivery Tool Regulation Number: 21 CFR 878.4750, 21 CFR 870.3470 Regulation Name: Implantable staple, Staple Line Reinforcement Material Regulatory Class: Class II Product Code: GDW, FTL Dated: April 2, 2019 Received: April 4, 2019
Dear Mr. Dinger:
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
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
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Indications for Use
510(k) Number (if known) K190884
Device Name
TigerPaw Pro Flexible LAA Occlusion Fastener and Delivery Tool
Indications for Use (Describe)
The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
| 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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TigerPaw Pro Left Atrial Appendage Occlusion Fastener and Delivery Tool 510(k) Summary
Prepared in accordance with 21 CFR Part 807.92
| 510(k) Number: | K190884 |
|---|---|
| Date Prepared: | 23 December 2019 |
| Submitter: | Datascope Corp.15 Law DriveFairfield NJ 07004United States of America |
| Contact Person: | Mark Dinger |
| Title: | Sr. Regulatory Affairs Specialist |
| Email: | mark.dinger@getinge.com |
| Phone: | 973-709-7691 |
| Fax: | 973-909-9954 |
| Trade Name: | TigerPaw Pro Left Atrial Appendage Occlusion Fastener andDelivery Tool |
| Common Name: | Implantable Fastener and Accessories |
| Classification: | Class II |
| Classification Name: | Staple, Implantable, GDWStaple Line Reinforcement Material, FTL |
| Regulation Numbers: | 21 CFR 878.475021 CFR 870.3470 |
| Predicate Device: | (K111064) TigerPaw System II (SE: 11 May 2011) |
| Device Description: | The TigerPaw Pro is a flexible, implantable occlusion fastener tobe placed on the ostium of the left atrial appendage (LAA) duringopen cardiac surgical procedures. TigerPaw Pro consists of aFastener implant that is pre-loaded onto a Delivery Tool and is forsingle use only. It is designed to provide an alternative toconventional suture and surgical staplers for occlusion of the |
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| ostium of the LAA. The TigerPaw Pro implantable fastener comesin two lengths; 35mm and 45mm. Surgeon judgment based onpatient anatomy should determine what length fastener to apply. | |
|---|---|
| Indications for Use: | The TigerPaw Pro is indicated for the occlusion of the left atrialappendage, under direct visualization, in conjunction with otheropen cardiac surgical procedures. |
| Direct visualization, in this context, requires that the surgeon isable to see the heart directly, without assistance from a camera,endoscope, etc., or any other viewing technology. This includesprocedures performed by sternotomy (full or partial) as well asthoracotomy (single or multiple). | |
| TechnologicalCharacteristics | The TigerPaw Pro and the predicate device havethe following similarities: |
| the same intended use, the same operating principles, incorporates the same basic design and materials, sterilized using the same materials and processes has same packaging. The TigerPaw Pro and the predicate device have the followingdifferences: | |
| Delivery Tool The Delivery Tool handle was redesigned. The predicate device has two triggers which are actuated in sequence to deploy the fastener. The TigerPaw Pro Delivery tool contains one trigger with a trigger lock button to deploy the fastener. The internal components, jaw, clamp box, roller pins and trigger, were modified to prevent incomplete closure of the TigerPaw Fastener on the LAA. New patient-contacting materials were introduced into the delivery tool. The design of the TigerPaw delivery tool was modified to include a trigger lock mechanism and shaft rotator knob to make the device more user |
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| friendly and to ensure the user performs the deployment steps in the correct sequence. | |
|---|---|
| • | Fastener |
| o | The tips of the fastener needle barbs were blunted to reduce the risk of tissue injury during the procedure |
| The differences were made to improve device safety and are not considered technological differences that raise new questions of safety and effectiveness. | |
| Safety and Performance: | Datascope Corp., development process completed the following activities to ensure the TigerPaw Pro met its clinically relevant design input requirements and specifications: |
| o | Performance testing, which included the following: |
| o Ability to completely close the fastener after deployment and prevent leakage from a mock LAA | |
| o Tensile strength of the individual fastener barbs after closure | |
| o Assessment of TigerPaw Pro Delivery Tool jaw component characteristics, including angle measurements | |
| o Force required to actuate the Delivery Tool trigger, force required to unlock the Delivery Tool lock button, torque required to rotate the Delivery Tool shaft | |
| o Corrosion testing in accordance with ISO 10555-1 Annex A was performed on the delivery tool and fastener | |
| o A comparison of TigerPaw II and TigerPaw Pro's Tool jaw to resist flexure while deploying a fastener on a worst-case thickness mock LAA ostium | |
| o A comparison of TigerPaw II and TigerPaw Pro's ability to deploy and secure the fastener connectors under different worst-case rotational forces on a mock ostiumUsability testing on the TigerPaw Pro to obtain clinical user feedback and identify potential usability hazards | |
| o GLP animal study | |
| o An acute animal study was performed to evaluate the usability of the device and the risk of tissue injury on the LAA during deployment and securement of the fastener. This was demonstrated via an acute Good Laboratory Practices (GLP) animal study on seven canines. Atrial |
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appendage closure was performed on the right and left atrial appendages on each animal for a total of 14 deployed fasteners. Operative procedures that were evaluated included the ability to access the LAA ostium with the Delivery Tool, assessment of the Delivery Tool and Fastener safety- pre-deployment, ability to reposition the Delivery Tool, deploy the Fastener and remove the Delivery Tool, epicardial assessment of Delivery Tool and Fastener safety and performance-post-deployment and endocardial assessment of Delivery Tool and Fastener safety and performance, post-deployment. A full necropsy examination of the local tissues post device implantation was also performed by a board-certified pathologist. All acceptance criteria were met for this animal study performed using the market version of this device. Biocompatibility Testing in accordance with ISO 10993 which O included cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing Sterilization - Sterilization validation was completed for the TigerPaw Pro to the requirements of ISO 11135-1:2014. Sterilization is performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. Residual limits are in accordance with ISO 10993-7:2008. The results of the in-vitro tests conducted demonstrate that the
functionality and performance characteristics of the device are comparable to the previously cleared TigerPaw System II.
Based upon the information submitted in this Traditional 510(k) Conclusion: premarket notification, Datascope's TigerPaw Pro is substantially equivalent to the predicate device. The TigerPaw Pro is similar to the predicate device in the intended use and the fundamental scientific technology of the device. The performance and other testing established that the TigerPaw Pro is substantially equivalent to the predicate device.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.