Caiman Seal and Cut Technology System 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 36cm and 44cm in length are indicated for laparoscopic procedures and instruments 24 cm in length are 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 System 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

The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, grasping, and dividing tissue enclosed within its dissection clips.

The reason for this submission is to capture modifications to the caiman 12 (24cm and 44cm) instruments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Aesculap Caiman 12 Seal and Cut Technology System". This is a regulatory submission for a medical device rather than an AI-driven system. Therefore, most of the requested information regarding AI-specific criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance) is not applicable or available in this document.

However, I can extract information related to the device's acceptance criteria and the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device, which is relevant to device performance and acceptance.

Here's the available information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Instrument Cycling Test
No pin walking shall be observed	Pass
Jaw Clamping Force Test
Jaw clamping force must remain within	Pass
specification 170 N - 350 N

Study Details (Non-Clinical Testing)

This document describes non-clinical testing verifying design changes to an electrosurgical device, not a study of an AI algorithm. Therefore, many of the AI-specific questions are not applicable.

Sample size used for the test set and the data provenance: Not explicitly stated as this is non-clinical testing of a physical device. The testing was conducted to verify design changes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and electrical performance is established through engineering specifications and objective measurements, not expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical device testing.
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 document is not about AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI algorithm.
The type of ground truth used: Engineering specifications and objective measurements based on the device's design and intended function (e.g., measuring force, observing mechanical stability).
The sample size for the training set: Not applicable. This is for a physical medical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Additional context from the document:

Purpose of Testing: "Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure the design changes met the predetermined acceptance criteria."
Methodology: "A risk analysis was completed to identify the risks associated with the modifications to the Caiman Seal and Cut Technology System. Verification testing was conducted to evaluate the modification."
Conclusion: "The conclusions drawn from the nonclinical tests demonstrate that the modifications described in this submission do not affect the intended use of the device or alter the fundamental scientific technology of the device."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2020

Aesculap Inc. Omunique Luke Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K203461

Trade/Device Name: Aesculap Caiman 12 Seal and Cut Technology System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 23, 2020 Received: November 24, 2020

Dear Omunique Luke:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm_identifies_combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203461

Device Name

Aesculap Caiman 12 Seal and Cut Technology System

Indications for Use (Describe)

Caiman Seal and Cut Technology System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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

Caiman 12 Seal and Cut Technology System December 17, 2020

COMPANY:	Aesculap, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Nikki Luke484-523-6868 (phone)nikki.luke@aesculapimplants.com610-791-6882 (fax)
TRADE NAME:	Aesculap® Caiman 12 Seal and Cut Technology System
COMMON NAME:	Electrosurgical, Cutting & Coagulation & Accessories
CLASSIFICATION NAME:	General and Plastic Surgery
REGULATION NUMBER:	21 CFR 878.4400
PRODUCT CODE:	GEI
DEVICE CLASS:	Class II per 21 CFR 878.4400

PREDICATE DEVICE

Caiman Seal and Cut Technology (K130596)

DEVICE DESCRIPTION

The reason for this submission is to capture modifications to the caiman 12 (24cm and 44cm) instruments.

INDICATIONS FOR USE

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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.

Caiman Seal and Cut Technology System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

TECHNOLIGICAL CHARACTERISTICS (compared to predicate devices)

The table below provides a summary of the device technological characteristics comparing the subject device and predicate device. The modifications made to these devices do not raise any new issues of safety and effectiveness, as confirmed by the testing and validation activities described in the submission.

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	Subject Device: Caiman Sealand Cut Technology SystemProduct Code: GEIK203461	Predicate Device: Caiman Sealand Cut Technology SystemProduct Code: GEIK130596
Intended Use	Caiman Seal and Cut TechnologySystem instruments are intendedfor use in general surgery andgynecologic surgical procedureswhere ligation and division ofvessels is desired.	Caiman Seal and Cut Technologyconsists of dedicated bipolarelectrosurgical instrumentsintended for use in general surgeryand gynecologic surgicalprocedures where ligation anddivision of vessels is desired.	Same
Indications for Use	Caiman Seal and Cut TechnologySystem consists of dedicatedbipolar electrosurgical instrumentsintended for use in general surgeryand gynecologic surgicalprocedures where ligation anddivision of vessels is desired. Theinstruments create a seal by theapplication of bipolarelectrosurgical RF energy(coagulation) to vascular structure(vessels) interposed between thejaws of the device. A cutting bladeis actuated for the division oftissue.Instruments 36cm and 44cm inlength are indicated forlaparoscopic procedures andinstruments 24 cm in length areindicated for open procedures. Theindications for use include generalsurgical procedures, (includingurologic, vascular, thoracic, andthoracoscopic), and gynecologicalprocedures where ligation anddivision of vessels is performed.These procedures include: vaginalhysterectomies, Nissenfundoplication, colectomy,adhesiolysis, bowel resection, andoophorectomy etc., or anyprocedure where vessel ligation(seal and cut), tissue grasping,and dissection is performed. Thedevices can be used on vessels up	Caiman Seal and Cut Technologyconsists of dedicated bipolarelectrosurgical instrumentsintended for use in general surgeryand gynecologic surgicalprocedures where ligation anddivision of vessels is desired. Theinstruments create a seal by theapplication of bipolarelectrosurgical RF energy(coagulation) to vascular structure(vessels) interposed between thejaws of the device. A cutting bladeis actuated for the division oftissue.The Caiman 12 Plus (44cm) andthe Caiman 5 (36cm) are indicatedfor laparoscopic procedures andthe Caiman 12 Plus (24cm) isindicated for open procedures. Theindications for use include generalsurgical procedures, (includingurologic, vascular, thoracic, andthoracoscopic), and gynecologicalprocedures where ligation anddivision of vessels is performed.These procedures include: vaginalhysterectomies, Nissenfundoplication, colectomy,adhesiolysis, bowel resection, andoophorectomy etc., or anyprocedure where vessel ligation(seal and cut), tissue grasping,and dissection is performed. Thedevices can be used on vessels up	Same
	to and including 7mm and bundles	to and including 7mm and bundles
	as large as will fit in the jaws of the	as large as will fit in the jaws of the
	instrument.	instrument.
	Caiman Seal and Cut TechnologySystem has not been shown to beeffective for tubal sterilization ortubal coagulation for sterilizationprocedures. Do not use the systemfor these procedures.	Caiman Seal and Cut Technologyhas not been shown to be effectivefor tubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use the systemfor these procedures.
Material Composition	Handle - molded thermoplasticShaft - stainless steel and moldedthermoplasticJaw - stainless steelJaw Insulation Components -PEEK	Handle - molded thermoplasticShaft - stainless steel and moldedthermoplasticJaw - stainless steelJaw Insulation Components -PEEK	Same
Functional Use	Grasping Ligation and Coagulation	Grasping Ligation and Coagulation	Same
Surgical Approach	Caiman 12 (44cm)-LaparoscopicCaiman 12 (24cm)- Open	Caiman 12 (44cm)-LaparoscopicCaiman 12 (24cm)- Open	Same
Length	24 cm44 cm	24 cm44 cm	Same
Jaw	Upper Jaw AssemblyStainless-Steel Material: 420 SST(EN ISO 1.4021)Stainless-Steel Material: 304 (ENISO 1.4301)Electrical Insulation Features:PEEKLower Jaw AssemblyStainless-Steel Material: 17-4 PH(EN ISO 1.4542)Stainless-Steel Material: 304 (ENISO 1.4301)Electrical Insulation Features:PEEKJaw Shape: Straight	Upper Jaw AssemblyStainless-Steel Material: 420 SST(EN ISO 1.4021)Stainless-Steel Material: 304 (ENISO 1.4301)Electrical Insulation Features:PEEKLower Jaw AssemblyStainless-Steel Material: 17-4 PH(EN ISO 1.4542)Stainless-Steel Material: 304 (ENISO 1.4301)Electrical Insulation Features:PEEKJaw Shape: Straight	Same
Jaw Clamp Force	Within Specification 170 N - 350 N	Within Specification 170 N - 350 N	Same
Diameter	12mm	12mm	Same
Number of Electrodes (Pairs)	2	2	Same
ElectrodeLength	5 cm	5 cm	Same
ElectrodeWidth	0.25 cm	0.25 cm	Same
Electrode Texture	Smooth with PEEK stops tomaintain consistent gap betweenelectrode surfaces	Smooth with PEEK stops tomaintain consistent gap betweenelectrode surfaces	Same
Cable	10ft	10ft	Same
Sterile/Single Use	Yes	Yes	Same
Shelf Life	3 years	3 years	Same

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PERFORMANCE TESTING

Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure the design changes met the predetermined acceptance criteria. A risk analysis was completed to identify the risks associated with the modifications to the Caiman Seal and Cut Technology System. Verification testing was conducted to evaluate the modification. The following tests associated with the device modifications were performed on the subject device according to the methods and acceptance criteria as required per test protocol.

See Design verification table below:

Design verification

Test	Acceptance Criteria	Results
Instrument Cycling Test	No pin walking shall be observed	Pass
Jaw Clamping Force Test	Jaw clamping force must remain withinspecification 170 N - 350 N	Pass

The testing performed verified and validated that the Caiman 12 Seal and Cut Technology System has met all acceptance criteria.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the modifications described in this submission do not affect the intended use of the device or alter the fundamental scientific technology of the device.

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.