(132 days)
No
The summary describes a standard electrosurgical instrument for vessel sealing and cutting, with no mention of AI or ML capabilities in its function or design.
Yes
The device is described as a bipolar electrosurgical instrument for use in general surgical and gynecological laparoscopic procedures where ligation and division of vessels is desired, and it creates a seal by applying bipolar electrosurgical RF energy. This describes a medical intervention aimed at treating medical conditions.
No
The device description clearly states its functions are vessel sealing, blunt dissection, grasping, and dividing tissue using bipolar electrosurgical RF energy. These are therapeutic and surgical actions, not diagnostic ones.
No
The device description clearly states it is a sterile, single-use physical instrument with jaws, a cutting blade, and connects to an RF generator, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures (laparoscopic) involving the ligation and division of vessels using bipolar electrosurgical energy and a cutting blade. This is a direct intervention on the patient's body.
- Device Description: The description reinforces its use in surgical procedures for vessel sealing, dissection, grasping, and dividing tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical tool used during a procedure on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
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
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
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.
1
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
2
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
3
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
4
SECTION 4
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: Aragon Surgical RF System-L2 Instrument Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use X (Per 21 CFR 801.109)
or
00038
Concurrence of CDRH, Office of D exice Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number