(110 days)
No
The document describes a standard electrosurgical instrument for vessel sealing and division using RF energy and a cutting blade. 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 described as a "bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired" and "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." These actions are directly involved in treating medical conditions, fitting the definition of a therapeutic device.
No
The device is described as a surgical instrument for ligating and dividing vessels and tissue, not for identifying or assessing a medical condition.
No
The device description explicitly states it is a "sterile, single use device" and a "laparoscopic instrument," which are physical hardware components. It also mentions being used with an "RF Generator."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Aragon Surgical Caiman 5 Laparoscopic Instrument is a surgical instrument used during procedures to ligate and divide vessels and tissue using bipolar electrosurgical energy and a cutting blade. It operates directly on tissue within the body.
- Intended Use: The intended use is for general surgical and gynecologic laparoscopic procedures, which are surgical interventions, not diagnostic tests performed on samples outside the body.
The device is a surgical tool used for treatment and manipulation of tissue in vivo, not for analyzing samples in vitro for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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 jaws 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, vascular structures, tissue bundles.
Procedures include: laparoscopically assisted vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, oophorectomy etc.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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-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 System
Caiman 5 Laparoscopic 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 (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 .
1
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.
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.
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, colectorny, 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 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
2
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.
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 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
4
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
5
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 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.
(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