Caiman Seal and Cut Technology System consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation 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 (36cm and 44cm) are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) and the Caiman 5 (24cm) are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectory, adhesiolysis, bowel resection, and oophorectorny 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 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, blunt dissection, grasping, and dividing tissue enclosed within its dissection clips. This reason for this submission is to capture modifications to the caiman blunt instruments.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Aesculap Caiman 5 Seal and Cut Technology System. This document outlines the device's technical characteristics, intended use, and the results of non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Tissue Related Performance Test - Life Cycle	The Instrument must be capable of 100 complete rotating, closing, sealing, cutting and releasing cycles. For articulating instruments, the 100 sealing cycles shall include at least 25 articulated sealing cycles. During sealing, visual sparking shall be acceptable if the sparking does not cause stickiness of sealed tissue to the jaws or tear the tissue as it is removed. Average Sealing Time for Standard Mode shall be ≤ 6.5 s. For Plus Mode, it shall be ≤ 7.5 s. The blade should cut completely, not leaving tissue tags anywhere along the cutting length. The cutter shall be designed to divide all unilateral tissue including vessels up to and including 7 mm OD. The cutting blade shall remain in its track during cutting. Maximum Thermal Spread should be ≤ 5 mm beyond the jaws (when measured with the jaws closed). Average Thermal Spread should be ≤ 1 mm beyond the jaws (when measured with the jaws closed).	Pass
Tissue Related Performance Test - Burst Pressure	Instrument must be capable of sealing vessels up to and including 7 mm OD.	Pass
Tissue Related Performance Test - Cutting Blade Activation	The force required to operate the cutting blade shall not exceed 31 N (measured in used condition without tissue in the jaws).	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the specific sample sizes for the test set used in the non-clinical performance tests (Tissue Related Performance, Burst Pressure, and Cutting Blade Activation). It refers to "testing and validation activities" and "design verification table" but does not provide details on the number of devices or trials performed for each test.

The data provenance is not mentioned. As this is a premarket notification for a medical device in the US (FDA 510(k)), the testing would typically be conducted by the manufacturer (Aesculap, Inc., based in Center Valley, Pennsylvania) or a contracted lab. The tests are non-clinical, implying laboratory or bench testing rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. The performance testing described is for a surgical instrument (electrosurgical cutting and coagulation device). The "ground truth" for this type of device is established through objective physical and functional measurements (e.g., sealing time, thermal spread, cutting force, burst pressure on vessels), not through expert interpretation of images or other subjective assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are typically used in clinical studies or studies where subjective assessments (e.g., image interpretation) are made by multiple experts and a consensus is needed for ground truth. The tests described are objective, non-clinical performance tests.

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:

This is not applicable. The device is a surgical instrument, not an AI-powered diagnostic or interpretive tool that would involve human readers. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm, and it operates with a human surgeon in the loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the non-clinical tests is based on objective physical measurements and engineering specifications, primarily related to the device's ability to:

Perform a specified number of operational cycles (Life Cycle test).
Achieve a certain burst pressure strength on sealed vessels (Burst Pressure test).
Operate its cutting blade within a defined force range (Cutting Blade Activation test).
Control thermal spread within set limits.
Cut tissue completely without tags.

These are verifiable properties of the device's mechanical and electrical function as applied to tissue models, not clinical "outcomes data" or "pathology" in the diagnostic sense.

8. The sample size for the training set:

This is not applicable. The Aesculap Caiman 5 Seal and Cut Technology System is a physical electrosurgical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. Training for this type of device would involve design, manufacturing, and quality control processes.

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

This is not applicable as there is no training set for an AI/ML algorithm. The ground truth for the device's functional performance是在bench测试中由工程规格和测量仪器的结果建立的。

Summary

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October 30, 2020

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

Re: K202938

Trade/Device Name: Aesculap Caiman 5 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: September 23, 2020 Received: September 30, 2020

Dear Omunique (Nikki) Luke:

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. 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/cfpmn/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

for 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) K202938

Device Name

Aesculap Caiman 5 Seal and Cut Technology System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)	[X] 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 Seal and Cut Technology System October 30, 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 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 (K151696)

DEVICE DESCRIPTION

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.

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.

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 Seal andCut Technology SystemProduct Code: GEITBD	Predicate Device: Caiman Seal andCut Technology SystemProduct Code: GEIK151696	Reference Device: Caiman Sealand Cut Technology SystemProduct Code: GEI
Intended Use	Caiman Seal and Cut TechnologySystem instruments are intended foruse in general surgery andgynecologic surgical procedureswhere ligation and division of vesselsis desired.	Caiman Seal and Cut Technologyconsists of dedicated bipolarelectrosurgical instrumentsintended for use in general surgeryand gynecologic surgicalprocedures where ligation anddivision of vessels is desired.	Caiman Seal and CutTechnology consists ofdedicated bipolarelectrosurgical instrumentsintended for use in generalsurgery and gynecologicsurgical procedures whereligation and division of vesselsis desired.	Same
Indications for Use	Caiman Seal and Cut TechnologySystem consists of dedicated bipolarelectrosurgical instruments intendedfor use in general surgery andgynecologic surgical procedureswhere ligation and division of vesselsis desired. The instruments create aseal by the application of bipolarelectrosurgical RF energy(coagulation) to vascular structure(vessels) interposed between thejaws of the device. A cutting blade isactuated for the division of tissue.Instruments 36cm and 44cm inlength are indicated for laparoscopicprocedures and instruments 24 cm inlength are indicated for openprocedures. The indications for useinclude general surgicalprocedures, (including urologic,vascular, thoracic, andthoracoscopic), and gynecologicalprocedures where ligation anddivision of vessels is performed.These procedures include: vaginalhysterectomies, Nissenfundoplication, colectomy,adhesiolysis, bowel resection, andoophorectomy etc., or any procedurewhere vessel ligation (seal and cut),tissue grasping, and dissection isperformed. The devices can be usedon vessels up to and including 7mmand bundles as large as will fit in thejaws of the instrument.	Caiman Seal and Cut Technologyconsists ofdedicated bipolar electrosurgicalinstruments intended for use ingeneral surgery and gynecologicsurgical procedures whereligation and division of vessels isdesired. The instruments create aseal by the application of bipolarelectrosurgical RF energy(coagulation) to vascular structure(vessels) interposed between thejaws of the device. A cutting blade isactuated for the division of tissue.Instruments 24 cm in length areindicated for open proceduresand instruments 36 cm and 44 cm inlength are indicated for laparoscopicprocedures. The indications for useinclude general surgical procedures,(including urologic, vascular,thoracic, and thoracoscopic), andgynecological procedures whereligation and division of vessels isperformed. These proceduresinclude: vaginal hysterectomies,Nissen fundoplication, colectomy,adhesiolysis, bowel resection, andoophorectomy etc., or any procedurewhere vessel ligation (seal and cut),tissue grasping, and dissection isperformed. The devices can be usedon vessels up to and including 7mmand bundles as large aswill fit in the jaws of the instrument.Caiman Seal and Cut Technology	Caiman Seal and Cut Technologyconsists of dedicated bipolarelectrosurgical instruments intendedfor use in general surgery andgynecologic surgical procedureswhere ligation and division of vesselsis desired. The instruments create aseal by the application of bipolarelectrosurgical RF energy(coagulation) to vascular structure(vessels) interposed between thejaws of the device. A cutting blade isactuated for the division of tissue.Instruments 12.5 cm, 17 cm, and 24cm in length are indicated for openproceduresand instruments 36 cm and 44 cm inlength are indicated for laparoscopicprocedures. The indications for useinclude general surgical procedures,(including urologic, vascular,thoracic, and thoracoscopic), andgynecological procedures whereligation and division of vessels isperformed. These proceduresinclude: vaginal hysterectomies,Nissen adhesiolysis, bowel resection,and oophorectomy etc., or anyprocedure where vessel ligation (sealand cut), tissue grasping, anddissection is performed. The devicescan be used on vessels up to andincluding 7mm and bundles as largeaswill fit in the jaws of the instrument.	Same
	Caiman Seal and CutTechnology System has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use thesystem for these procedures.	has not been shown to be effectivefor tubal sterilization or tubalcoagulation 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 steelInsulation - polyester tube(Caiman 5)EFTE (Caiman 5 Articulating)Dissection clip - PEEK	Handle - molded thermoplasticShaft - stainless steelInsulation - polyester tube(Caiman 5)EFTE (Caiman 5 Articulating)Dissection clip - Valox HX 420	Handle - molded thermoplasticShaft - stainless steelInsulation - polyester tube(Caiman 5)ETFE (Caiman 5 Articulating)Dissection clip - PEEK	Same
Functional Use	Grasping Ligation and Coagulation	Grasping Ligation and Coagulation	Grasping Ligation and Coagulation	Same
Surgical Approach	240mm - Open240mm, 360mm and 440mm -Laparoscopic	240mm - Open360mm and 440mm - Laparoscopic	125mm and 170mm - Open360mm and 440mm - Laparoscopic	Same
Length	240mm360mm440mm	240mm360mm440mm	125mm170mm360mm440mm	Same
Jaw	Upper JawStainless-Steel Material: 17-4 PH(EN ISO 1.4542)Isolation Features: NonePivot JawStainless-Steel Material: 17-4 PH(EN ISO 1.4542)Isolation Features: Standing ceramicfeaturesJaw Shape: Straight	Upper JawStainless-Steel Material: 1.4021Isolation Features: Peek StripesPivot JawStainless-Steel Material: 17-4 PH(EN ISO 1.4542)Isolation Features: NoneJaw Shape: Straight	Jaw Shape: Curved	Same
Diameter	5mm	5mm	5mm	Same
				Same
Articulation	240, 360, and 440mm - non-articulating240, 360, and 440mm - articulating	240, 360, and 440mm - non-articulating360mm - articulating	125, 170, 360, and 440mm -non-articulating360 and 440 - articulating	Same
Number of Electrodes (Pairs)	1	1	1	Same
ElectrodeLength	2.65 cm	2.65 cm	21.5 mm	Same
ElectrodeWidth	0.13-0.15 cm	0.13-0.15 cm	1.01- 1.63 mm - varies over thelength of the jaw due to curve	Same
Electrode Texture	Smooth with nonconductive (AluminaTitania) stop members on the Jaws,to maintain consistent gap betweenelectrode surfaces.	Smooth, with PEEK stop members atthe distal end of the jaw and Valoxstop members at the proximal end ofthe jaw, to maintain consistent gapbetween electrode surface.	Smooth with conductive (steel) andnon conductive (Alumina Titania)stop members on the Jaws, tomaintain consistent gap betweenelectrode surfaces.	Same
Cable	10ft	10ft	10ft	Same
Sterile/Single Use	Yes	Yes	Yes	Same
Shelf Life	2 years	2 years	2 years	Same

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K202938

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PERFORMANCE TESTING

Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate and reference device, 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 outlined in the predicate device.

See Design verification table below:

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Design verification

Test	Acceptance Criteria	Results
Tissue Relatedperformance test- Life Cycle	The Instrument must be capable of 100 complete rotating, closing, sealing, cutting and releasing cycles. For articulating instruments, the 100 sealing cycles shall include at least 25 articulated sealing cycles. During sealing, visual sparking shall be acceptable if the sparking does not cause Adhesiveness of sealed tissue to the jaws should not damage the seal or cause tearing of the tissue as it is removed from the jaws. Average Sealing Time for Standard Mode shall be ≤ 6.5 s. for Plus Mode it shall be ≤ 7.5 s. Blade should cut completely, not leaving tissue tags anywhere along cutting length. Cutter shall be designed to divide all unilateral tissue including vessels up to and including 7 mm OD. The cutting blade shall remain in its track during cutting Maximum Thermal Spread should be ≤ 5 mm beyond the jaws (when measured with the jaws closed) Average Thermal Spread should be ≤ 1 mm beyond the jaws (when measured with the jaws closed)	Pass
Tissue Relatedperformance test- Burst Pressure	Instrument must be capable of sealing vessels up to and including 7 mm OD	Pass
Tissue Relatedperformance test- Cutting Blade Activation	The force required to operate the cutting blade shall not exceed 31 N (measured in used condition without tissue in the jaws)	Pass

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The bench testing performed verified and validated that the Caiman Seal and Cut Technology System has met all its design specifications.

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.

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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.