(113 days)
Not Found
No
The summary describes a standard electrosurgical instrument and generator, focusing on its mechanical and electrical functions for vessel sealing and cutting. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation.
Yes
The device is used for surgical procedures to ligate and divide vessels, indicating its direct involvement in treating medical conditions.
No
Explanation: The device description states its intended use for "ligation and division of vessels" and "tissue grasping, and dissection." It is an electrosurgical instrument used for intervention (cutting and sealing tissue), not for diagnosing conditions or diseases.
No
The device description explicitly states it consists of two components: a generator (hardware) and an instrument (hardware), and describes physical actions like applying RF energy and actuating a cutting blade.
Based on the provided information, the Aragon Surgical Teleo Instrument is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Aragon Surgical Teleo Instrument's Function: The description clearly states the instrument is used during surgical procedures for the ligation and division of vessels and tissue within the body. It applies bipolar electrosurgical energy directly to the tissue.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze specimens taken from the body. Its function is entirely focused on manipulating and treating tissue in situ.
Therefore, the Aragon Surgical Teleo Instrument is a surgical instrument used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 System
Teleo 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/L2 Instrument (K090306) .
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.
1
.
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 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.
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.
2
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.
3
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
4
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
5
SECTION 4
INDICATIONS FOR USE STATEMENT
510(k) Number: K093075
Device Name:
Aragon Surgical RF System Teleo Instrument
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
or
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