The Aragon Surgical Caiman 5 Laparoscopic Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy to vascular structures (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

Indications for use include general laparoscopic procedures, including urologic, vascular, thoracic, and thoracsocopic, and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy etc.

The Aragon Surgical Caiman 5 Laparoscopic Instrument can be used on vessels up to and including 7mm, and tissue bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Lektrafuse RF System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Device Description

The Aragon Surgical Caiman 5 Laparoscopic Instrument is provided as a sterile, single use device. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its iaws during open and laparoscopic procedures. The device is designed to be used with the Aragon Surgical RF Generator (K093075) and creates vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

The Aragon Surgical Lektrafuse RF Generator is designed to be used with Aragon Surqical RF instrumentation only. The Aragon Surgical Lektrafuse RF Generator is not compatible with any other handheld RF surgical instrumentation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Aragon Surgical Caiman 5 Laparoscopic Instrument, not a study performing a comparative effectiveness or standalone performance evaluation against acceptance criteria in the manner typically associated with clinical trials or AI/software validation. The document states that "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical Lektrafuse RF Generator and Caiman 5 Laparoscopic Instrument are substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria."

This is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It does not contain the detailed information about specific acceptance criteria and a study design with sample sizes, expert ground truth, or MRMC studies that you are asking for in the context of device performance validation against specified criteria.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria (e.g., minimum burst pressure, maximum thermal spread) or corresponding quantitative reported device performance data in a table format. The "acceptance criteria" are generally implied to be that the device performs equivalently to the predicate devices in terms of design, materials, principle of operation, and product specifications, and meets general safety and effectiveness criteria.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (design, materials, principle of operation, product specifications)	"similar to those of the cited predicate electrosurgical devices... equivalent in terms of design, materials, principal of operation, and product specifications."
Meeting design, safety, and effectiveness criteria	"Results of bench and pre-clinical evaluations were used to demonstrate that... [the device] meets design, safety, and effectiveness criteria."
No new safety or effectiveness issues raised	"Any differences between the Aragon Surgical device and the predicate devices do not raise new issues regarding safety or effectiveness."

2. Sample size used for the test set and the data provenance

The document states "Results of bench and pre-clinical evaluations were used," but does not provide specific sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "bench and pre-clinical evaluations" likely involve engineering and possibly veterinary experts, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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

No such study (MRMC or involving AI assistance) is mentioned or implied in the document. This device is a surgical instrument, not an AI-powered diagnostic tool.

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

Not applicable, as this is a physical surgical instrument, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" used for demonstrating substantial equivalence would primarily be the established performance characteristics and safety profiles of the predicate devices, along with the results from the bench and pre-clinical evaluations on the new device. These evaluations would typically involve measurements of parameters like seal strength, burst pressure, thermal spread, and tissue effects. The document does not specify whether pathology, outcomes data, or expert consensus was used specifically as "ground truth" for these evaluations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would have a training set. The "training" in this context would refer to the development and testing of the physical device.

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

Not applicable. See point 8.

Summary of Limitations:

The provided text is a 510(k) summary for a physical medical device (a laparoscopic electrosurgical instrument), not a report on a clinical study or a validation study for an AI algorithm. Therefore, many of the questions related to clinical study design, expert evaluation, AI performance, and specific statistical metrics are not addressed in this type of regulatory document. The primary goal of this submission is to demonstrate "substantial equivalence" to already marketed predicate devices, usually through technical comparisons and non-clinical testing, rather than a novel clinical effectiveness study against predefined quantitative performance criteria.

Summary

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Aragon Surgical-Caiman 5 Laparoscopic Instrument Premarket Notification

JUL 1 1 2011

SECTION 5

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Alan Curtis Aragon Surgical, Inc. 1810 Embarcadero Road, Suite B Palo Alto, CA 94303

NAME OF DEVICE

Trade Name:	Aragon Surgical RF SystemCaiman 5 Laparoscopic Instrument
Common Name:	Electrosurgical System
Device Product Code:	GEI
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400)
Device Panel:	General Surgery/Restorative Devices
Device Classification:	Class II

PREDICATE DEVICES

Aragon Surgical RF System (K090306) .
ValleylabLigaSure™ LigaSure 5mm Laparoscopic Sealer . and Divider (K031011)
ValleylabLigaSure™ LigaSure 5mm Blunt Tip Laparoscopic Sealer . and Divider (K092879)
ValleylabLigaSure Vessel Sealing System (K981916) .
ValleyLab ForceTriad RF Generator (K070612) .

CONFIDENTIAL .

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DEVICE DESCRIPTION

INDICATION FOR USE STATEMENT

The Aragon Surgical Caiman 5 Laparoscopic Instrument is a dedicated bioolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy to vascular structures (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

The Aragon Surgical Caiman 5 Laparoscopic Instrument can be used on vessels up to and including 7mm, and tissue bundles as large as will fit in the iaws of the instrument.

The Aragon Surgical Lektrafuse RF System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

SUBSTANTIAL EQUIVALENCE COMPARISON

Comparison to Predicate Devices

The technological characteristics and indications for use of the Aragon Surgical Caiman 5 Laparoscopic Instrument are similar to those of the cited predicate electrosurgical devices, as well as the similar RF Systems distributed commercially by other manufacturers. These devices are equivalent in terms of design, materials, principal of operation, and product specifications. Any differences between the Aragon Surgical device and the predicate devices do not raise new issues regarding safety or effectiveness.

PERFORMANCE DATA

Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical Lektrafuse RF Generator and Caiman 5 Laparoscopic Instrument are substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria.

CONFIDENTIAL

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Aragon Surgical-Caiman 5 Laparoscopic Instrument Premarket Notification

CONCLUSION

Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical Lektrafuse RF Generator and Caiman 5 Laparoscopic Instrument are substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. Sufficient data were obtained to demonstrate that the device is substantially equivalent to the predicate devices and raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

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

Aragon Surgical. Inc. % Mr. Alan Curtis 3617 Scott Street San Francisco, California 94123

JUL 1 1 2011

Re: K110824

Trade/Device Name: Aragon Caiman 5 Laparoscopic Instrument, Model 50136 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 29, 2011 Received: July 5, 2011

Dear Mr. Curtis:

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.

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

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Page 2 - Mr. Alan Curtis

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/ReportalProblem/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 vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Aragon Surgical Lektrafuse RF System-Caiman 5 Laparoscopic Instrument

Indications for Use:

The Aragon Surgical Caiman 5 Laparoscopic Instrument can be used on vessels up to and including 7mm, and tissue bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Lektrafuse RF System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

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

Prescription Use X = _ ________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110824

CONFIDENTIAL

000015

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.