The TigerPaw® System II 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, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

Device Description

The TigerPaw® System II consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and exclude the LAA. The TigerPaw System II also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with two triggers that when separately actuated, close opposing jaws thus mating the two sides of the permanently implanted Fastener, and, then allowing release of the Fastener and opening of the jaws for Delivery Tool removal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TigerPaw® System II, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical or AI-driven study.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established) are not applicable to this type of submission. This 510(k) is for a modification to an existing device, and the evaluation focuses on bench testing and biocompatibility to show that the modifications do not alter the safety or effectiveness of the device compared to its predicate.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with specific quantitative thresholds and corresponding device performance data in a clinical context. Instead, it relies on a comparison to the predicate device and in vitro bench testing for verification.

Acceptance Criteria Category (Implied)	Reported Device Performance
Design Specifications Met	"Verification testing provided proof that the modifications met all design specifications." (Specific specifications are not detailed in this summary)
Mechanical Performance	"Extensive bench evaluations were performed on the TigerPaw® II System. This testing consisted of in vitro bench testing, including connector tensile testing and pressure leak testing of fasteners." (Specific results or thresholds for these tests are not provided in this summary, but the implication is they met internal benchmarks equivalent to the predicate.)
Biocompatibility	"Biocompatibility testing provided evidence of continued biocompatibility of the revised device." (This confirms the material changes did not negatively impact biocompatibility compared to the predicate.)
Substantial Equivalence	"Based upon the intended use, product technical information, performance testing and biocompatibility information provided in this pre-market notification, the TigerPaw System II has been shown to be substantially equivalent to the currently cleared predicate device in terms of design, performance and intended use." (This is the overarching conclusion, indicating the device performs as expected and similarly to the previously cleared version, and thus meets the safety and effectiveness profile for its intended use.) The FDA's letter (K111064) confirms this determination: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

Evaluation of Sections Not Applicable to a 510(k) for Device Modification:

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

Not Applicable. This submission details in vitro bench testing and biocompatibility assessments, not a clinical study involving human patient data.

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)

Not Applicable. No human-interpreted "ground truth" was established as there was no clinical study or diagnostic imaging component. The evaluation relied on engineering and biocompatibility testing.

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

Not Applicable. No clinical test set or subjective interpretation requiring adjudication was involved.

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

Not Applicable. This is a hardware medical device (implantable fastener and delivery tool), not an AI-based diagnostic tool. No human reader or AI assistance is mentioned.

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

Not Applicable. This is a hardware medical device, not an algorithm.

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

Not Applicable. The "ground truth" for the engineering tests would be derived from physical measurements against defined engineering specifications, not clinical outcomes or expert consensus. For biocompatibility, it's adherence to relevant standards.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved a limited number of devices for bench evaluations.

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

Not Applicable. As there is no training set.

Summary

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K111064

Special 510(k): Device Modification TigerPaw® System II

510(K) SUMMARY

MAY 18 2011

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: TBD

Applicant Information:

Date Prepared: April 15, 2011

Name:	LAAx Inc.
Address:	151 Lindbergh Ave., Suite ILivermore, CA 94551
Phone:	925-449-4108

Contact Persons (Primary/Secondary):	Michael A. Daniel	/	Christopher R. Timmons
Office Phone Numbers:	925-254-5228	/	925-449-4108
Cell Phone Numbers:	415-407-0223	/	925-699-4072
Facsimile Numbers:	925-254-5187	/	925-449-1845

Device Information:

Classification: Class II Trade Name: TigerPaw® System II Common Name: Implantable Fastener and Accessories Classification Name: Staple, Implantable, GDW / Staple Line Reinforcement Material, FTL Regulation Number: 21 CFR 878.4750 21 CFR 870.3470

Predicate Devices:

The TigerPaw® System II is substantially equivalent in intended use and method of operation to the following predicate device:

LAAx, Inc. TigerPaw® System (K101961)

Device Description:

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two sides of the permanently implanted Fastener, and, then allowing release of the Fastener and opening of the jaws for Delivery Tool removal.

Indications for Use:

The TigerPaw® System II is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Comparison to Predicate Device(s):

The design of the TigerPaw® System II is essentially the same as the predicate device with design modifications to increase manufacturing efficiencies, make the system less expensive to produce, and add a 1st Trigger Closure visual indicator for redundant confirmation of first trigger closure. This continues to be a device designed to occlude the left atrial appendage under direct visualization. The products share common features such as identical operating principles, same scissor type jaw actuation, same fastener closure distance, and the same 15° angled jaw. The devices are packaged sterile and are for single use.

The TigerPaw® System II and the predicate device have the same intended use: Occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Device Evaluation:

Verification testing provided proof that the modifications met all design specifications. Extensive bench evaluations were performed on the TigerPaw® II System. This testing consisted of in virro bench testing, including connector tensile testing and pressure leak testing of fasteners, Biocompatibility testing provided evidence of continued biocompatibility of the revised device.

Summary:

Based upon the intended use, product technical information, performance testing and biocompatibility information provided in this pre-market notification, the TigerPaw System II has been shown to be substantially equivalent to the currently cleared predicate device in terms of design, performance and intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

LAAx, Inc. c/o Mr. Michael A. Daniel Regulatory and Clinical Affairs 151 Lindbergh Avenue, Suite I Livermore, CA 94551

MAY 18 2011

Re: K111064 TigerPaw® System II Regulation Number: 21 CFR 870.4750 Regulation Name: Staple, Implantable Regulatory Class: Class II (two) Product Code: GDW/FTL Dated: April 15, 2011 Received: April 18, 2011

Dear Mr. Daniel:

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.

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Page 2 - Mr. Michael Daniel

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

B. D. Zuker, M.P.

Bram D. Zuckeman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K11064

Device Name:

TigerPaw® System II

Indications For Use:

The TigerPaw® System II is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K110641

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Regulation Number and Section

§ 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.