(13 days)
No
The summary describes a bipolar electrosurgical device for vessel sealing and cutting using RF energy and a cutting blade. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used to ligate and divide vessels during surgical procedures, not to treat a disease or condition for therapeutic benefit.
No
The device is described as an electrosurgical instrument for vessel ligation and division, which is a therapeutic function, not a diagnostic one. It does not gather information about the patient's condition or diagnose diseases.
No
The device description explicitly states it consists of a generator and sterile, single-use instruments, which are hardware components.
Based on the provided information, this device 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, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The Caiman Seal and Cut Technology is a surgical instrument used during surgical procedures to seal and cut vessels and tissue within the body. It directly interacts with the patient's anatomy.
- Intended Use: The intended use clearly states it's for "general surgery and gynecologic surgical procedures where ligation and division of vessels is desired." This is an in vivo (within the living body) application, not an in vitro (in glass or outside the body) diagnostic test.
- Device Description: The description details a surgical instrument and a generator used for applying energy to tissue, not for analyzing biological samples.
Therefore, the Caiman Seal and Cut Technology falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical 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.
Instruments 24cm in length are indicated for open procedures and instruments 36cm and 44 cm in length are indicated for laparoscopic procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological 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 (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
Caiman Seal and Cut Technology 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
Caiman Seal and Cut Technology consists of the Lektrafuse RF Generator and the sterile, single use Caiman devices. These devices are capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The devices are designed to be used with the dedicated Lektrafuse RF Generator and create 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed on the modified devices and found them to be substantially equivalent to the predicate devices. The Plus Mode performance verification on the Lektrafuse Generator with the Caiman 12mm and Caiman 5mm included the following tests:
-
- Seal Burst Pressure on three different tissue types
- Visual Arcing 2.
-
- Jaw Adhesion
- Thermal Spread 4.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap Incorporated Ms. Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
July 21, 2015
Re: K151858
Trade/Device Name: Caiman Seal and Cut Technology Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 6, 2015 Received: July 8, 2015
Dear Ms. Adams:
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CULAP.
Page 1 of 1
INDICATIONS FOR USE STATEMENT B.
Device Name: Caiman® Seal and Cut Technology
Indications for Use:
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical 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.
Instruments 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological 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 (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
Caiman Seal and Cut Technology has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
Prescription Use (per 21 CFR 801 Subpart D) (per 21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE (IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image shows the word "AESCULAP" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word appears to be a logo or brand name. There is a small dot after the P.
510(k) SUMMARY (as required by 21 CFR 807.92)
Caiman® Seal and Cut Technology July 15, 2015
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Denise R. Adams, RAC
610-984-9076 (phone)
610-791-6882 (fax) |
| TRADE NAME: | Caiman Seal and Cut Technology |
| COMMON NAME: | Electrosurgical, Cutting & Coagulation & Accessories |
| CLASSIFICATION NAME: | Electrosurgical Cutting and Coagulation Device and
Accessories |
| REGULATION NUMBER: | 21 CFR 878.4400 |
| PRODUCT CODE: | GEI |
SUBSTANTIAL EQUIVALENCE
Caiman Seal and Cut Technology is substantially equivalent to the Caiman Seal and Cut Technology System cleared via K140839.
DEVICE DESCRIPTION
Caiman Seal and Cut Technology consists of the Lektrafuse RF Generator and the sterile, single use Caiman devices. These devices are capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The devices are designed to be used with the dedicated Lektrafuse RF Generator and create vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.
4
INDICATIONS FOR USE
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical 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.
Instruments 24cm in length are indicated for open procedures and instruments 36cm and 44 cm in length are indicated for laparoscopic procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological 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 (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
Caiman Seal and Cut Technology has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
TECHNOLOGICAL CHARACTERISTICS (compared to predicate)
The modifications made to the Caiman Seal and Cut Technology system do not affect the fundamental scientific technology. The design, materials, and principal of operation have not changed for these devices. The modifications made to these devices do not raise any new issues of safety and effectiveness.
PERFORMANCE DATA
Bench testing was performed on the modified devices and found them to be substantially equivalent to the predicate devices. The Plus Mode performance verification on the Lektrafuse Generator with the Caiman 12mm and Caiman 5mm included the following tests:
-
- Seal Burst Pressure on three different tissue types
- Visual Arcing 2.
-
- Jaw Adhesion
- Thermal Spread 4.
Caiman Seal and Cut Technology is in compliance with the following safety standards:
- IEC 60601-2-2 1.
- IEC 60601-1-2 2.
- IEC 60601-1: 3rd Edition 3.
-
- IEC 62304
Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Phone: 800-258-1946 www.aesculapusa.com