ARAGON ONESHOT SYSTEM

K081312 · Aragon Surgical, Inc. · GEI · Oct 31, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081312
• Device Name: ARAGON ONESHOT SYSTEM
• Applicant: Aragon Surgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aragon Surgical System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

Device Story

Aragon Surgical RF System comprises RF generator, handheld bipolar instrument, foot pedal, and power cord. System delivers radiofrequency energy to seal and divide tissue during abdominal hysterectomy. Bipolar design eliminates need for patient return pad. Instrument is single-use and sterile. Software controls generator operation. Used in surgical settings by physicians. Output provides thermal energy for hemostasis and tissue division; enables sealing of vessels up to 7mm. Benefits include efficient vessel management during surgery.

Clinical Evidence

Bench and pre-clinical evaluations performed. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical system; RF generator; handheld instrument; single-use; sterile. Software-controlled. No specific material standards or connectivity protocols disclosed.

Indications for Use

Indicated for tissue sealing and division during abdominal hysterectomy; seals vessels up to 7mm. Contraindicated for tubal sterilization/coagulation.

Regulatory Classification

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.

Predicate Devices

• LigaSure Vessel Sealing System (K981916)
• LigaSure Open Dissector Divider (K041587)

Submission Summary (Full Text)

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Aragon Surgical, Inc.

Aragon Surgical RF System Premarket Notification

# KO 81312

Page 1 of 2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENE

#### REGULATORY AUTHORITY

OCT 3 1 200

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 System |
|------------------------|-------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical System |
| Device Product Code: | GEI |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories (21 CFR 878.4400) |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |

#### PREDICATE DEVICES

- · LiagSure TM Vessel Sealing System (K981916)
- · LigaSure™ Open Dissector Divider (K041587)

# DEVICE DESCRIPTION

The Aragon Surgical RF System consists of the Aragon Surgical Radiofrequency Energy (RF) Generator and a handheld Instrument, foot pedal, and power coad. The Aragon Surgical Instrument connects to the RF Generator. The Aragon Surgical Instrument is supplied sterile and is intended for single use. The Instrument uses a bipolar design, which means that a return pad is not required for operation.

Software is utilized in the operation of the Aragon Surgical RF Generator.

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Aragon Surgical, Inc.

K081312

Page 2 of ②

60098

#### INDICATION FOR USE STATEMENT

The Aragon Surgical System is indicated for tissue sealing and division during the performance of abdominal hysterectorny. The instrument can seal vessels up to 7mm.

This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

## SUBSTANTIAL EQUIVALENCE COMPARISON

#### Comparison to Predicate Devices

The technological characteristics and indications for use of the Aragon Surgical System 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 System 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 System 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 System 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2008

THE SEAT THE FOR FREE WANT SELL WAS THE WE WARE THE SECTION CAN BE COLLECT CARACT

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

Re: K081312

Trade/Device Name: Aragon Surgical Radiofrequency (RF) System and accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 10, 2008 Received: October 14, 2008

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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Alan Curtis, RAC

いたいときなくてきた時間には出来ました。

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.

のためのないですけど、その後には出になるということです。そのままあると、そうなイイ・

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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

Enclosure

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Aragon Surgical Inc.

School States of the state of the starter of the states

Aragon Surgical RF System Premarket Notification

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#### SECTION 4

#### INDICATIONS FOR USE STATEMENT

510(k) Number:

KO81312

Aragon Surgical Radiofrequency (RF) System Device Name:

Indications for Use:

The Aragon Surgical RF System is indicated for tissue sealing and division during the performance of abdominal hysterectomy. The instrument can seal vessels up to 7mm.

This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

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

Over-The-Counter Use Prescription Use or (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Net RP. Oglesby Forman

Division of General, Restorative, and Neurological Devices

510(k) Number