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.

The Caiman 12 Plus (44cm) and the Caiman 5 are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) is indicated for open 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 is a 510(k) summary for the Caiman® Seal and Cut Technology. It describes a medical device, and the evaluation for such devices often involves proving substantial equivalence to a predicate device through performance data, not necessarily meeting a predefined set of acceptance criteria with reported device performance in the same way an AI/ML device would be evaluated.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not provided in the context of a 510(k) for a non-AI/ML surgical device.

Here's an attempt to answer based on the provided text, highlighting where information is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (Aragon Surgical RF System Laparoscopic (L2) Instrument cleared via K090306, Aragon Surgical RF System Teleo Instrument cleared via K093075, Aragon Surgical RF System- 5mm Laparoscopic Instrument cleared via K110824)	"Bench testing was performed on the modified devices and found them to be substantially equivalent to the predicate devices."
Continued capability for vessel sealing, blunt dissection, grasping, and dividing tissue.	Demonstrated through bench testing to be substantially equivalent to predicate devices, implying these functionalities are maintained.
Creation of vessel ligation by bipolar electrical RF energy.	Demonstrated through bench testing to be substantially equivalent to predicate devices.
Tissue division with a cutting blade.	Demonstrated through bench testing to be substantially equivalent to predicate devices.
No new issues of safety and effectiveness from modifications.	"The modifications made to these devices do not raise any new issues of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions "Bench testing was performed on the modified devices." It doesn't detail the number of tests, specimens, or specific configurations tested.
Data Provenance: Not specified, but generally, bench testing would be conducted in a laboratory setting by the manufacturer (Aesculap, Inc.). It is not typically "retrospective" or "prospective" in the same way clinical data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable to a 510(k) for a surgical device based on bench testing for substantial equivalence. "Ground truth" in this context would be objective measurements of physical properties and performance characteristics, not expert interpretation of outputs like in an AI/ML study.

4. Adjudication method for the test set:

Not applicable. Performance is evaluated against objective standards and comparison to predicate devices, not through expert adjudication of disputed results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a non-AI/ML surgical device, so an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a surgical instrument, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this type of device performance would be physical measurements of parameters like seal strength, burst pressure, cutting effectiveness, thermal spread, and electrical properties, compared against established standards or performance of the predicate devices. The document does not explicitly state the specific types of measurements, but refers to "Bench testing."

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable (as above).

Summary

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K130596

MAR 2 2 2013

Page 1 of 2

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

Caiman® Seal and Cut Technology March 4, 2013

COMPANY:	Aesculap ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Denise R. Adams610-984-9076 (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 Aragon Surgical RF System Laparoscopic (L2) Instrument cleared via K090306, the Aragon Surgical RF System Teleo Instrument cleared via K093075 and the Aragon Surgical RF System- 5mm Laparoscopic Instrument cleared via K110824.

DEVICE DESCRIPTION

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Page 2 of 2

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INDICATIONS FOR USE

30596

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 predicates)

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized eagle or bird-like figure with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2013

Aesculap, Incorporated % Ms. Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K130596 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: March 04, 2013 Received: March 07, 2013

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.

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 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Peter D. Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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)

Long H. Chen-A
----------------

Digitally signed by Long H. Chen-A
ON: c=US, o=U.S. Government, ou=HHS,
o=FDA, ou=People, cn=Long H. Chen
6.9.2342.19200300.100.1.1=1300369056
Date: 2013.03.22 06:50:49 -04'00'

for MXM(Division Sign-Off)

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.