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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Caiman Seal and Cut Technology." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving de novo safety and effectiveness through a clinical performance study involving human subjects or AI-based image analysis.

Therefore, the information required to answer your prompt, which pertains to the acceptance criteria and study proving an AI/ML device's performance (including sample sizes, expert ground truth establishment, MRMC studies, etc.), is not present in the provided text.

The text details the following:

Device Name: Caiman Seal and Cut Technology
Regulatory Classification: Electrosurgical cutting and coagulation device and accessories (Class II, Product Code GEI, Regulation Number 21 CFR 878.4400)
Purpose of Submission: K151858 – to demonstrate substantial equivalence to a previously cleared device (K140839).
Device Description: Bipolar electrosurgical instruments (with a cutting blade) designed for vessel sealing, blunt dissection, grasping, and dividing tissue using RF energy. Used with a dedicated Lektrafuse RF Generator.
Indications for Use: General surgery and gynecologic procedures where ligation and division of vessels up to 7mm are desired. Not for tubal sterilization.
Performance Data: States that bench testing was performed on modified devices and found them substantially equivalent to predicate devices.
- Tests performed: Seal Burst Pressure (on three tissue types), Visual Arcing, Jaw Adhesion, Thermal Spread. This is physical device performance testing, not AI/ML model performance.
Compliance with Standards: IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1: 3rd Edition, IEC 62304.

In summary, this document is for a traditional electrosurgical device, not an AI/ML device. Therefore, the specific criteria and study details you've requested regarding AI/ML performance are not applicable and thus not found in this regulatory submission.

Summary

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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.

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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

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K151858

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 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)

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510(k) SUMMARY (as required by 21 CFR 807.92)

Caiman® Seal and Cut Technology July 15, 2015

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Denise R. Adams, RAC610-984-9076 (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 andAccessories
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

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INDICATIONS FOR USE

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:

1. Seal Burst Pressure on three different tissue types
Visual Arcing 2.
1. 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.
1. IEC 62304

Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Phone: 800-258-1946 www.aesculapusa.com

Regulation Number and Section

§ 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.