The TigerPaw® System 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 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 completely exclude the LAA. The TigerPaw® System also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with triggers that when actuated close jaws that in turn mate the two sides of the permanently implanted Fastener together.

AI/ML Overview

Here's a summary of the acceptance criteria and the study used to demonstrate the device meets those criteria, as extracted from the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note: The document does not explicitly present a table of "acceptance criteria" against which a "device performance" is measured. Instead, it describes "primary effectiveness outcomes" and "secondary effectiveness endpoints" which serve as de facto acceptance criteria. The device's performance is then reported against these.

Acceptance Criteria (Effectiveness Outcome/Endpoint)	Reported Device Performance
Primary Effectiveness Outcome:
Percentage of patients with complete occlusion of the LAA assessed peri-operatively (visually).	Visually confirmed in 60/60 treated patients (100%).
Percentage of patients with complete occlusion of the LAA assessed peri-operatively via Transesophageal Echocardiography (TEE).	Confirmed in 56/60 patients. (One patient required adjunctive suture to achieve closure).
Percentage of patients with complete occlusion of the LAA assessed at 90 days post-procedure via TEE.	Confirmed in 54/54 evaluable patients followed up (100% of those evaluated at 90 days).
Absence of leaks or communication between the LAA and LA at 90 days post-procedure.	Zero leaks or communication observed.
Secondary Effectiveness Endpoint:
Assessment of the size of residual LAA cavity remaining after application of the TigerPaw® System compared with a pre-defined target (≤ 6 mm).	Not explicitly reported in this summary, other than 100% complete occlusion at 90 days, which implies meeting this criterion.
Primary Safety Outcome:
Rate of device-related adverse (AE) and serious adverse events (SAE) assessed peri-operatively and at 30 days post-procedure.	No unanticipated adverse events. One minor device-related tissue tear, repaired with suture. Zero incidences of bleeding or leakage from the device footprint area.
Secondary Safety Endpoints:
Major Adverse Cardiac Event (MACE) rates.	Not explicitly reported in this summary, but implies acceptable rates given overall safety findings.
Absence of late device-related AEs at 90 days.	Zero late device-related AEs.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 60 patients.
- Data Provenance: Clinical study, conducted prospectively (implies data collected during the study). The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting it might be a U.S.-based or international multi-center study for U.S. market approval.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the ground truth for LAA occlusion was primarily established through visual confirmation by the surgeon (peri-operatively) and Transesophageal Echocardiography (TEE). TEE interpretation would typically be performed by a qualified cardiologist or echocardiographer. The specific number of experts or their exact qualifications are not detailed in this summary.
Adjudication method for the test set:
- The document does not explicitly state an adjudication method (like 2+1 or 3+1) for the clinical study's effectiveness outcomes. The TEE assessments and visual confirmations would inherently involve expert interpretation but no multi-reader adjudication process is described.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical implant/tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This is a medical device for surgical intervention, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Effectiveness Ground Truth:
  - Visual confirmation by the operating surgeon (peri-operative).
  - Transesophageal Echocardiography (TEE) by qualified personnel (peri-operative and at 90 days).
- Safety Ground Truth:
  - Observation/reporting of adverse events by clinical staff and investigators.
  - Clinical outcomes data (e.g., absence of bleeding/leakage, absence of late AEs).
The sample size for the training set:
- This device is an implantable fastener system, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's development would have involved pre-clinical testing (bench, animal, cadaver) which could be considered a "training/development" phase for the physical device, but no separate "training set" as understood for AI is mentioned.
How the ground truth for the training set was established:
- As this is not an AI/ML device, there isn't a "training set" in that sense. The "ground truth" for the device's design and functionality would have been established through a combination of:
  - Engineering principles and biomechanical testing (bench testing).
  - Physiological responses and surgical observations (acute and chronic animal studies, cadaver evaluations).
  - Clinical experience and medical knowledge of LAA occlusion requirements.

Summary

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510(k) Summary

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: K101961

Applicant Information:

Date Prepared: July 13, 2010

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

Contact Person:	Michael A. Daniel
Phone Number:	Office: 925-254-5228 / Cell 415-407-0223
Facsimile Number:	(925) 254-5187

Device Information:

Classification:	Class II
Trade Name:	TigerPaw® System
Common Name:	Implantable Fastener and Accessories
Classification Name:	Staple, Implantable, GDW / Staple Line Reinforcement Material, FTL
Regulation Number:	21 CFR 878.475021 CFR 870.3470

Predicate Devices:

The TigerPaw System is substantially equivalent in intended use and method of operation to a combination of the following predicate devices:

USGI Auto Suture TA & GIA Staplers	K032696
Synovis Surgical Innovations, Peri-Strips Staple Line Reinforcement	K040415

Device Description:

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consists of a pistol grip handle with triggers that when actuated close jaws that in turn mate the two sides of the permanently implanted Fastener together.

Intended Use:

The TigerPaw® System 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 is similar to the USGI device in that they are devices designed to place titanium or stainless steel staples in various types of tissue. The TigerPaw® System is similar to the Synovis predicate in they both use a non-absorbable material to reinforce suture-lines and staple-lines. All devices are packaged sterile and are for single patient use. Further, the TigerPaw® System and the predicate devices have the same or similar intended use.

Device Evaluation:

Extensive bench, animal, and cadaver evaluations were performed on the TigerPaw System. This testing consisted of in vitro bench testing, including connector tensile testing and pressure leak testing of fasteners; in vivo animal evaluation composed of a total of six acute canine and six chronic canine survived for six months with corresponding histopathology; and in situ cadaver evaluation comprising 14 specimens with varying disease history including gross pathology. Finally, a 60 patient clinical study was conducted.

Clinical study: This study was conducted to assess the safety and effectiveness of surgical Left Atrial Appendage (LAA) occlusion, using the LAAx, Inc. TigerPaw System (delivery system and implant/Fastener), as a concomitant procedure to other open chest cardiac surgery procedures including valve repair / replacement, coronary artery bypass grafting (CABG), and cardiac ablation procedures. The primary safety outcome was the rate of device related adverse (AE) and serious adverse events (SAE) assessed peri-operatively, and at 30 days post procedure. The primary effectiveness outcome was the percentage of patients with complete occlusion of the LAA assessed peri-operatively, both visually (implant/Fastener applied fully across the LAA Os) and via Transesophageal Echocardiography (TEE), and at 90 days post procedure also using TEE. Secondary safety endpoints included Major Adverse Cardiac Event (MACE) rates. Secondary effectiveness endpoints included the assessment of the size of residual LAA cavity remaining after application of the TigerPaw® System compared with a pre-defined target (≤ 6 mm).

There were no unanticipated adverse events (AE) with one minor device-related tissue tear repaired with suture. Complete Left Atrial Appendage (LAA) occlusion was visually confirmed in each of the 60 treated patients and confirmed by Transesophageal Echocardiography (TEE) in 56 patients with one patient requiring adjunctive use of suture to achieve LAA closure. There were zero incidences of bleeding or leakage from the area of the device footprint. Fifty-four out

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of 54 evaluable patients followed up at the final 90 day period were confirmed to have complete LAA occlusion via TEE with zero leaks or communication between the LAA and LA and no late device-related AEs.

Summary:

Based upon the intended use, descriptive information, and the in vitro, in vivo, in situ, and clinical performance evaluation provided in this pre-market notification, the TigerPaw System has been shown to be substantially equivalent to currently marketed predicate devices.

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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

OCT 2 9 2010

Re: K101961 LAAx Inc. TigerPaw® System Regulation Number: 21 CFR 870.4750 Regulation Name: Staple, Implantable Regulatory Class: Class II (two) Product Code: GOW Dated: September 13, 2010 Received: September 14, 2010

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 A. 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/CDRH/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,

Dmma D. V. hmer

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Bram D. Zuckerman, 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): K101961

Device Name: TigerPaw® System

Indications For Use:

The TigerPaw® System 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 stemotomy (full or partial) as well as thoracotomy (single or multiple).

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

sumer R. v. hines

(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number_K10 | Jle

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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.