The Aragon Surgical Teleo Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic procedures where ligation and division of vessels is desired. The instrument creates 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 surgical procedures (including urologic, vascular, thoracic, and thoracoscopic), and gynecologic surgery 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 Teleo 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 RF Systems consists of two components: the Aragon Surgical Generator and the Aragon Surgical Teleo Instrument. The Aragon Teleo Instrument is provided as sterile and is intended for single use. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws.

AI/ML Overview

The provided text is a 510(k) summary for the Aragon Surgical Teleo Instrument. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. Therefore, it does not contain the kind of detailed information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them through empirical data.

Here's a breakdown of what can and cannot be extracted from the provided text based on your questions:

1. A table of acceptance criteria and the reported device performance

Cannot be provided: The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the Teleo Instrument, nor does it report detailed performance data from a specific study against such criteria. The basis of clearance is substantial equivalence to a predicate device (K090306), not a demonstration of novel performance against predefined metrics.

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

Cannot be provided: The document does not describe any specific "test set" in the context of an AI/algorithm evaluation. The "pre-clinical evaluation" mentioned is not detailed enough to extract sample size or data provenance.

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)

Cannot be provided: This information is not relevant to the type of 510(k) submission presented, which is not for an AI/CADe device requiring expert ground truth for image interpretation.

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

Cannot be provided: Same as above, not relevant or present.

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

Cannot be provided: The device is an electrosurgical instrument, not an AI/CADe system. Therefore, MRMC studies are not applicable or mentioned.

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

Cannot be provided: The device is not an algorithm.

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

Cannot be provided: No ground truth definition is relevant or provided in this context. The "pre-clinical evaluation" would likely involve engineering tests, animal studies, or cadaver studies, but specifics are not given.

8. The sample size for the training set

Cannot be provided: Not an AI device, so no training set.

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

Cannot be provided: Not an AI device.

Summary of available information from the document:

Device Name: Aragon Surgical RF System Teleo Instrument
Predicate Device: Aragon Surgical RF System/L2 Instrument (K090306)
Basis for Clearance: Substantial equivalence to the predicate device.
Key Statement regarding equivalence: "The technological characteristics of the Aragon Surgical Teleo Instrument are identical to those of the cited predicate electrosurgical device. K090306. This device is equivalent in terms of design, materials, and principal of operation. The modification between the Aragon Surgical Teleo Instrument and the predicate device does not raise new issues regarding safety or effectiveness."
Conclusion: "Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical Teleo Instrument is substantially equivalent to devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the Aragon Surgical Teleo Instrument raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance."

This 510(k) focuses on the "identity" of the device's technology and intended use with a previously cleared device, asserting that no new safety or effectiveness issues are raised by any modifications. It does not present de novo performance data against specific acceptance criteria.

Summary

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K093075

Aragon Surgical Inc.

Special Premarket Notification: Teleo Instrument

SECTION 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

JAN 2 1 2010

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 SystemTeleo 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/L2 Instrument (K090306) .

DEVICE DESCRIPTION

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INDICATION FOR USE STATEMENT

The Aragon Surgical Teleo Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired. The instrument creates 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 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 Teleo 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

Technological Characteristics

The technological characteristics of the Aragon Surgical Teleo Instrument are identical to those of the cited predicate electrosurgical device. K090306. This device is equivalent in terms of design, materials, and principal of operation. The modification between the Aragon Surgical Teleo Instrument and the predicate device does not raise new issues regarding safety or effectiveness.

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Indications for Use

Substantial equivalence is also supported for the Aragon Surgical Teleo Instrument by the predicate devices cleared for general surgery and gynecologic procedures where ligation and division of vessels is desired.

CONCLUSION

Based on the design, materials, function, intended use, and pre-clinical evaluation, the Aragon Surgical Teleo Instrument is substantially equivalent to devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the Aragon Surgical Teleo Instrument raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN 9 1 2010

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

Re: K093075

Trade/Device Name: Aragon Surgical RF System Teleo Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 8, 2010 Received: January 11. 2010

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Alan Curtis

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" (21.CFR 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark N. Milburn

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: K093075

Device Name:

Aragon Surgical RF System Teleo 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 Teleo 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)

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093075

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.