The Aragon Surgical Laparoscopic (L2) 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 instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

The indications for use include general laparoscopic procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, bowel resections, and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.

The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

Device Description

The Aragon Surgical Laparoscopic Instrument(L2) is provided as a sterile, single use device. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The device is designed to be used with the Aragon Surgical RF Generator (K081312) and creates vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

AI/ML Overview

Here's an analysis of the provided text regarding the Aragon Surgical Laparoscopic Instrument (L2) and its performance data, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not explicitly state specific acceptance criteria in measurable terms (e.g., "burst pressure of X mm Hg," "seal time of Y seconds"). Instead, it broadly states that:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices.	"Meets design, safety, and effectiveness criteria."
Meets design, safety, and effectiveness criteria for intended use.	"Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical L2 Instrument is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria."
No new issues regarding safety or effectiveness compared to predicate devices.	"Any differences between the Aragon Surgical device and the predicate devices do not raise new issues regarding safety or effectiveness."
Effective for vessel ligation (cutting and sealing) up to 7mm vessels.	"The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument."
Not effective for tubal sterilization/coagulation.	"The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench and pre-clinical evaluations" but does not specify the sample size for any test sets used. The data provenance is not explicitly stated as retrospective or prospective, nor does it detail country of origin, but it can be inferred that these were controlled evaluations conducted by the manufacturer, Aragon Surgical, Inc., presumably in a laboratory or animal setting ("pre-clinical").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study typically involves human readers (e.g., radiologists) evaluating cases with and without AI assistance to measure the effect size of AI on their performance. The device described here is a surgical instrument, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a surgical instrument, not an algorithm or AI system. Its performance is inherently linked to its physical interaction with tissue and the surgeon's use.

7. Type of Ground Truth Used

The document implies that the ground truth for the "bench and pre-clinical evaluations" would be based on direct measurements of physical properties of vessel seals (e.g., burst pressure, seal integrity) and visual or histological assessment of tissue effects in the pre-clinical (likely animal) models, compared to established predicate devices. However, the exact nature of the ground truth is not explicitly detailed.

8. Sample Size for the Training Set

The document describes "bench and pre-clinical evaluations" for performance data. As this is a physical medical device, not a machine learning algorithm, there is no concept of a "training set" in the traditional sense. The development and testing of such a device involve iterative design, prototyping, and testing, but not the training of an algorithm on a distinct dataset.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the context of this device. Therefore, the establishment of ground truth for a training set is not applicable.

Summary

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K090306

SECTION 5

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

JUN 18 2009

000040

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 System
	Laparoscopic (L2) Instrument
Common Name:	Electrosurgical System
Device Product Code:	GEI
Classification Name:	Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Device Panel:	General Surgery/Restorative Devices
Device Classification:	Class II

PREDICATE DEVICES

Aragon Surgical RF System (K081312) .
. LiagSure TM Atlas Laparoscopic Sealer/Divider (K010013)
◆ Valleylab LigaSure Vessel Sealing System (K981916)

DEVICE DESCRIPTION

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INDICATION FOR USE STATEMENT

The Aragon Surgical Laparoscopic Instrument (L2) is a dedicated bipolar electrosurgical instrument intended for use in general surgery and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

The indications for use include general laparoscopic procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (cutting and sealing), tissue grasping, and dissection is performed.

The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

SUBSTANTIAL EQUIVALENCE COMPARISON

Comparison to Predicate Devices

The technological characteristics and indications for use of the Aragon Surgical L2 Instrument are similar to those of the cited predicate electrosurgical devices, as well as the similar RF Systems distributed 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 L2 Instrument is substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria.

CONCLUSION

Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical L2 Instrument is 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.

" 000041

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

Public Health Service

JUN 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aragon Surgical, Incorporation % Mr. Alan Curtis, RAC Vice President. Regulatory/Clinical & Quality Affairs 1810 Embarcadero Road, Suite B Palo Alto, California 94303

Re: K090306

Trade/Device Name: Aragon Surgical RF L2 Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 5, 2009 Received: June 9, 2009

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.

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 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

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Page 2-Mr. Alan Curtis

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely vours.

For
Mark N. Melkerson

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 RF System-L2 Instrument Indications for Use:

The device can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Laparoscopic Instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

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

Prescription Use X (Per 21 CFR 801.109)

K090308

00038

Concurrence of CDRH, Office of D exice Evaluation (ODE)

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

510(k) Number

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.