Caiman Seal and Cut Technology 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.

Instruments 12.5 cm, 17 cm, and 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic procedures. The include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices 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 be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

Device Description

The Caiman® 5 Maryland instruments are seal and cut devices which are provided as sterile, single use 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 document is a 510(k) premarket notification for a medical device, the Caiman® 5 Maryland, an electrosurgical cutting and coagulation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials. Therefore, the document primarily details performance testing related to the device's technical specifications and safety, not a study evaluating human reader performance with or without AI assistance, or the performance of an AI algorithm.

Based on the provided text, here's an analysis of the acceptance criteria and the "study" (which are more accurately described as performance tests and verification activities) that proves the device meets them:

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

The document does not present explicit "acceptance criteria" in a quantitative, target-based manner (e.g., "burst pressure must be > X mmHg for Y% of samples"). Instead, it lists various performance tests and their outcomes, indicating a "Pass" result for each. The acceptance criteria are implicitly met by achieving a "Pass" in these design verification tests, which are presumably designed to demonstrate equivalence to the predicate and ensure safety and effectiveness.

Test Acceptance Criteria (Implicit - Resulting in "Pass")	Reported Device Performance
Tissue-related performance test for arteries: Device performs according to technical requirements and user needs, demonstrating life cycle for typical applications.	Pass
Burst Pressure testing for veins: Device generates burst pressure data for relevant vein diameters consistent with safe and effective sealing.	Pass
Jaw Tissue stress test: Durability of Maryland instruments is comparable to predicate devices under specified load conditions.	Pass
Validation of usability: User needs related to usability are met through structured user survey, demonstrating usability in accordance with applicable standards.	Pass
Electrical Safety: Conforms to IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1, and IEC 60601-2-18 standards.	Conforms (Indicated by compliance with listed standards)
Biocompatibility: Conforms to ISO 10993-1.	Conforms (Indicated by compliance with listed standard)
Sterilization: Sterilization process is in accordance with ISO 11137-2 - method 1, and instruments remain sterile.	Conforms (Indicated by compliance with listed standard and no changes from predicate)

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 specify the sample sizes used for the design verification tests (e.g., how many arteries/veins were tested, how many instruments were used for stress testing). The data provenance (country of origin, retrospective/prospective) is also not stated. These tests are typically conducted in a laboratory setting as part of product development and verification.

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

The document does not involve a study where "ground truth" is established by experts in the context of medical image interpretation or clinical diagnosis. The performance tests described (tissue-related performance, burst pressure, jaw stress) are objective engineering and material science tests. For the "Validation of usability" test, a "user survey" was conducted, implying involvement of potential users (likely surgeons or healthcare professionals), but the number and qualifications of these users are not specified.

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

Adjudication methods like "2+1" or "3+1" are relevant to studies where human interpretation of data (e.g., medical images) is being assessed, often to establish a consensus ground truth. This document describes performance tests for a surgical instrument, not an AI algorithm or diagnostic tool involving human interpretation of complex medical data. Therefore, an adjudication method is not applicable here.

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

No MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a surgical instrument, not an AI-powered diagnostic or assistive tool. Thus, there is no mention of human readers, AI assistance, or effect sizes related to such a study.

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

No standalone algorithm performance study was done. As mentioned, this submission is for a physical surgical device, not an algorithm.

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

For the mechanical and electrical performance tests, the "ground truth" is based on established engineering principles, material science properties, and adherence to relevant international standards (e.g., IEC, ISO). For the "Usability" test, the ground truth is based on user feedback collected via a survey, indicating whether the device meets user needs for usability. There is no biological or diagnostic ground truth (like pathology or outcomes data) in the context of this submission.

8. The sample size for the training set

There is no mention of a training set or machine learning algorithms in this document. Therefore, no sample size for a training set is applicable.

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

As there is no training set for an AI algorithm, there is no ground truth establishment process for it described in this document.

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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

March 12, 2019

Aesculap, Inc. Ms. Jessica Stigliano Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K183180

Trade/Device Name: Caiman 5 Maryland Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 8, 2019 Received: February 9, 2019

Dear Ms. Stigliano:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is by Long H. Chen -S. The date of the signature is March 12, 2019, and the time is 13:03:43 -04'00'.

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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Indications for Use

510(k) Number (if known) K183180

Device Name Caiman 5 Maryland

Indications for Use (Describe)

Caiman Seal and Cut Technology has not 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K183180

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

Caiman® 5 Maryland

March 11, 2019

COMPANY:	Aesculap®®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Ms. Jessica Stigliano610-984-9063 (phone)610-791-6882 (fax)jessica.stigliano@Aesculapimplants.com
TRADE NAME:	Caiman® 5 Maryland
COMMON NAME:	Electrosurgical, Cutting & Coagulation & Accessories
REGULATION NUMBER:	21 CFR 878.4400
PRODUCT CODE:	GEI
REVIEW PANEL:	General and Plastic Surgery

PRIMARY PREDICATE

K151696 - Caiman Seal and Cut Technology

REFERENCE DEVICE

K130596 - Caiman Seal and Cut Technology K110824 - Aragon Surgical RF System - 5mm Laparoscopic Instrument

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Caiman® 5 Maryland is substantially equivalent to the primary predicate, Caiman® Seal and Cut Technology (K151696) and reference devices, Caiman® Seal and Cut Technology (K130596) and Aragon Surgical RF System - 5mm Laparoscopic Instrument (K110824).

DEVICE DESCRIPTION

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K 183180

are designed to be used with the dedicated Lektrafuse RF Generator and create vesselligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

INDICATIONS FOR USE

Instruments 12.5 cm, 17 cm, and 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.

TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s))

The modifications made to the Caiman instruments do not affect the fundamental scientific technology. 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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Attribute	Subject Device	Primary Predicate	Reference Device	Reference Device
	Caiman® 5 Maryland	Caiman Seal and Cut	Caiman Seal and Cut	Aragon Surgical RF System
		Technology (K151696)	Technology (K130596)	Caiman 5 Laparoscopic
				Instrument (K110824)
Indications for	Caiman Seal and Cut	Caiman Seal and Cut	Caiman Seal and Cut Technology	The Aragon Surgical Caiman 5
Use	Technology consists of	Technology consists of	consists of dedicated bipolar	Laparoscopic Instrument is a
	dedicated bipolar	dedicated bipolar	electrosurgical instruments	dedicated bipolar electrosurgical
	electrosurgical instruments	electrosurgical instruments	intended for use in general surgery	instrument intended for use in
	intended for use in general	intended for use in general	and gynecologic surgical	general surgical and gynecologic
	surgery and gynecologic	surgery and gynecologic	procedures where ligation and	laparoscopic procedures where
	surgical procedures where	surgical procedures where	division of vessels is desired. The	ligation and division of vessels is
	ligation and division of vessels	ligation and division of vessels	instruments create a seal by the	desired. The instrument creates a
	is desired. The instruments	is desired. The instruments	application of bipolar	seal by the application of bipolar
	create a seal by the application	create a seal by the application	electrosurgical RF energy	electrosurgical RF energy to
	of bipolar electrosurgical RF	of bipolar electrosurgical RF	(coagulation) to vascular structure	vascular structures (vessels)
	energy (coagulation) to vascular	energy (coagulation) to vascular	(vessels) interposed between the	interposed between the jaws of
	structure (vessels) interposed	structure (vessels) interposed	jaws of the device. A cutting blade	the device. A cutting blade is
	between the jaws of the device.	between the jaws of the device.	is actuated for the division of	actuated for the division of tissue.
	A cutting blade is actuated for	A cutting blade is actuated for	tissue.	Indications for use include
	the division of tissue.	the division of tissue.	The Caiman 12 Plus (44cm) and	general laparoscopic procedures,
	Instruments 12.5cm, 17 cm,	Instruments 24 cm in length are	the Caiman 5 are indicated for	including urologic, vascular,
	and 24 cm in length are	indicated for open procedures	laparoscopic procedures and the	thoracic, and thoracoscopic, and
	indicated for open procedures	and instruments 36 cm and 44	Caiman 12 Plus (24cm) is	gynecological laparoscopic
	and instruments 36 cm and 44	cm in length are indicated for	indicated for open procedures.	procedures where ligation and
	cm in length are indicated for	laparoscopic procedures. The	The indications for use include	division of vessels is performed.
	laparoscopic procedures. The	indications for use include	general surgical procedures,	These procedures include:
	indications for use include	general surgical procedures,	(including urologic, vascular,	laparoscopically assisted vaginal
	general surgical procedures,	(including urologic, vascular,	thoracic, and thoracoscopic), and	hysterectomies, Nissen
	(including urologic, vascular,	thoracic, and thoracoscopic),	gynecological procedures where	fundoplication, colectomy,
	thoracic, and thoracoscopic),	and gynecological procedures	ligation and division of vessels is	adhesiolysis, oophorectomy etc.
	and gynecological procedures	where ligation and division of	performed. These procedures	The Aragon Surgical Caiman 5
	where ligation and division of	vessels is performed. These	include: vaginal hysterectomies,	Laparoscopic Instrument can be
	vessels is performed. These	procedures include: vaginal	Nissen fundoplication, colectomy,	used on vessels up to and
	procedures include: vaginal	hysterectomies, Nissen	adhesiolysis, bowel resection, and	including 7mm, and tissue
	hysterectomies, Nissen	fundoplication, colectomy,	oophorectomy etc., or any	bundles as large as will fit in the
	fundoplication, colectomy,	adhesiolysis, bowel resection,	procedure where vessel ligation	jaws of the instrument.
	adhesiolysis, bowel resection,and oophorectomy etc., or anyprocedure where vessel ligation(seal and cut), tissue grasping,and dissection is performed.The devices can be used onvessels up to and including7mm and bundles as large aswill fit in the jaws of theinstrument.Caiman Seal and CutTechnology has not been shownto be effective for tubalsterilization or tubalcoagulation for sterilizationprocedures. Do not use thesystem for these procedures.	and oophorectomy etc., or anyprocedure where vessel ligation(seal and cut), tissue grasping,and dissection is performed.The devices can be used onvessels up to and including7mm and bundles as large aswill fit in the jaws of theinstrument.Caiman Seal and CutTechnology has not been shownto be effective for tubalsterilization or tubalcoagulation for sterilizationprocedures. Do not use thesystem for these procedures.	(seal and cut), tissue grasping, anddissection is performed. Thedevices can be used on vessels upto and including 7mm and bundlesas large as will fit in the jaws ofthe instrument.Caiman Seal and Cut Technologyhas not been shown to be effectivefor tubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use the systemfor these procedures.	The Aragon Surgical LektrafuseRF System has not been shown tobe effective for tubal sterilizationor tubal coagulation forsterilization procedures andshould not be used for theseprocedures.
MaterialComposition	Handle - molded thermoplasticShaft - stainless steelInsulation - polyester tube(Caiman 5)ETFE (Caiman 5 Articulating)Dissection clip - PEEK	Handle - molded thermoplasticShaft - stainless steelInsulation - polyester tube(Caiman 5)EFTE (Caiman 5 Articulating)Dissection clip - Valox HX 420HP	Handle - molded thermoplasticShaft - stainless steelInsulation - polyester tube(Caiman 5)Dissection clip – PEEK (Caiman5)	Molded thermoplastic handle,stainless steel shaft
Functional Use	Grasping Ligation andCoagulation (unchanged)	Grasping Ligation andCoagulation	Grasping Ligation and Coagulation	Grasping Ligation andCoagulation
SurgicalApproach	125mm and 170mm – Open360mm and 440mm –Laparoscopic (unchanged)	240mm - Open360 and 440mm - Laparoscopic	Caiman 12 Plus (44cm)-LaparoscopicCaiman 12 Plus (24cm)- OpenCaiman 5- Laparoscopic	Laparoscopic
Length	125mm170mm360mm440mm	240mm360mm440mm	Caiman 12 Plus- 44cmCaiman 12 Plus- 24cmCaiman 5- 36cm	36cm
Jaw Shape	Curved	Straight	Straight	Straight
Diameter	5mm (unchanged)	5 mm	Caiman 12 Plus- 12mm	5 mm

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			Caiman 5- 5mm
Articulation	125, 170, 360, and 440mm –non-articulating360 and 440 - articulating	240, 360, and 440mm – no360mm - yes	Caiman 12 Plus- yesCaiman 5- no	No
Number ofElectrodes(Pairs)	1	1	Caiman 12 Plus- 2Caiman 5- 1	1
ElectrodeLength	21.5 cm	2.65 cm	Caiman 12 Plus- 5cmCaiman 5- 2.65cm	2.65 cm
ElectrodeWidth	1.01- 1.63 mm – varies over thelength of the jaw due to curve	0.13-0.15 cm	Caiman 12 Plus- 0.25cmCaiman 5- 0.13-0.15cm	0.13-0.15cm
ElectrodeTexture	Smooth with conductive (steel)and non conductive (AluminaTitania) stop members on theJaws, to maintain consistent gapbetween electrode surfaces.	Smooth, with PEEK stop at thedistal end of the jaw and Valoxstop at the proximal end of thejaw, to maintain consistent gapbetween electrode surface.	Smooth with PEEK stops tomaintain consistent gap betweenelectrode surfaces	Smooth with PEEK stops tomaintain consistent gap betweenelectrode surfaces
Cable	10ft (unchanged)	10ft	10ft	10ft
Sterile/ SingleUse	Yes (unchanged)	Yes	Yes	Yes

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PERFORMANCE DATA

Design verification

Test	Test Method Study	Results
Tissue-relatedperformance test forarteries	Provide evidence of several technical requirementsand a user need. Intended to verify the tissue-related requirements and demonstrate the life cyclefor typical applications.	Pass
Burst Pressure testingfor veins	Generate burst pressure data for veins of allrelevant diameters	Pass
Jaw Tissue stress test	Demonstrate that under load up to and beyondthe load limit, the durability of the Marylandinstruments is comparable to that of thepredicate devices.	Pass
Validation of usability	Validate user needs related to usability througha user survey in order to document theusability, and thus to ensure that the productunder investigation meets the requirements forusability in accordance with the applicablestandards	Pass

Electrical Safe ty

The Caiman® 5 Maryland instruments conform to the following electrical safety and EMC standards:

. IEC 60601-2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-1-2 General requirements for basic safety and essential performance -● Collateral standard Electromagnetic compatibility - Requirements and tests
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 60601-2-18 Particular requirements for the basic safety and essential performance of endoscopic equipment

Biocompatibility

The Caiman® 5 Maryland instruments continue to confirm to ISO 10993-1, "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

Sterilization

There have been no changes to the sterilization of the Caiman® 5 Maryland instruments since the predicate device has been cleared in K151696. The instruments continue to be provided sterile. Sterilization of the instruments continue to be in accordance with ISO 11137-2 - method 1.

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CONCLUSION

The purpose of this 510(k) premarket notification is to gain marketing clearance for the new Caiman® 5 Maryland instruments presented in this submission. Aesculap® believes the new instruments are similar in indications, design / features, components offered, dimensional ranges, and fundamental scientific technology when compared to their predicates.

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.