Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrosurgical device for sealing and cutting tissue using bipolar RF energy and a mechanical blade. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on mechanical and electrical properties, not algorithmic performance.

Therapeutic

Yes
The device is described as an electrosurgical instrument used in surgical procedures (e.g., general, gynecologic, urologic, vascular, thoracic) to ligate vessels, cut tissue, and perform dissection. These are therapeutic actions in a medical context.

Diagnostic

No

The device is described as a surgical instrument for vessel ligation and tissue division, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical instrument ("seal and cut devices which are provided as sterile, single use devices") that uses bipolar electrical RF energy and a cutting blade, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The Caiman Seal and Cut Technology is a surgical instrument used during surgical procedures to seal and cut blood vessels and tissue within the body. It directly interacts with the patient's anatomy.
Intended Use: The intended use clearly describes its application in general and gynecologic surgical procedures for vessel ligation, tissue grasping, and dissection. This is an in vivo (within the living body) application, not in vitro (in glass or outside the living body).
Device Description: The description reinforces its use as a surgical tool for vessel sealing, blunt dissection, grasping, and dividing tissue during open and laparoscopic procedures.

The device's function and intended use are entirely focused on surgical intervention within the body, which is the opposite of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GEI

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 vesselligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vessels

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design verification studies were performed:

Tissue-related performance test for arteries: Provide evidence of several technical requirements and a user need. Intended to verify the tissue-related requirements and demonstrate the life cycle for typical applications. Result: Pass.
Burst Pressure testing for veins: Generate burst pressure data for veins of all relevant diameters. Result: Pass.
Jaw Tissue stress test: Demonstrate that under load up to and beyond the load limit, the durability of the Maryland instruments is comparable to that of the predicate devices. Result: Pass.
Validation of usability: Validate user needs related to usability through a user survey in order to document the usability, and thus to ensure that the product under investigation meets the requirements for usability in accordance with the applicable standards. Result: Pass.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151696

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K130596, K110824

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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 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.

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 Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ms. Jessica Stigliano
610-984-9063 (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

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

4

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 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.	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.	(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.	The Aragon Surgical Lektrafuse
RF System has not been shown to
be effective for tubal sterilization
or tubal coagulation for
sterilization procedures and
should not be used for these
procedures.
Material
Composition	Handle - molded thermoplastic
Shaft - stainless steel
Insulation - polyester tube
(Caiman 5)
ETFE (Caiman 5 Articulating)
Dissection clip - PEEK	Handle - molded thermoplastic
Shaft - stainless steel
Insulation - polyester tube
(Caiman 5)
EFTE (Caiman 5 Articulating)
Dissection clip - Valox HX 420
HP	Handle - molded thermoplastic
Shaft - stainless steel
Insulation - polyester tube
(Caiman 5)
Dissection clip – PEEK (Caiman

                                                                                                                                                                                                                                                                 | Molded thermoplastic handle,

6

7

			Caiman 5- 5mm
Articulation	125, 170, 360, and 440mm –
non-articulating
360 and 440 - articulating	240, 360, and 440mm – no
360mm - yes	Caiman 12 Plus- yes
Caiman 5- no	No
Number of
Electrodes
(Pairs)	1	1	Caiman 12 Plus- 2
Caiman 5- 1	1
Electrode
Length	21.5 cm	2.65 cm	Caiman 12 Plus- 5cm
Caiman 5- 2.65cm	2.65 cm
Electrode
Width	1.01- 1.63 mm – varies over the
length of the jaw due to curve	0.13-0.15 cm	Caiman 12 Plus- 0.25cm
Caiman 5- 0.13-0.15cm	0.13-0.15cm
Electrode
Texture	Smooth with conductive (steel)
and non conductive (Alumina
Titania) stop members on the
Jaws, to maintain consistent gap
between electrode surfaces.	Smooth, with PEEK stop at the
distal end of the jaw and Valox
stop at the proximal end of the
jaw, to maintain consistent gap
between electrode surface.	Smooth with PEEK stops to
maintain consistent gap between
electrode surfaces	Smooth with PEEK stops to
maintain consistent gap between
electrode surfaces
Cable	10ft (unchanged)	10ft	10ft	10ft
Sterile/ Single
Use	Yes (unchanged)	Yes	Yes	Yes

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PERFORMANCE DATA

Design verification

Test	Test Method Study	Results
Tissue-related
performance test for
arteries	Provide evidence of several technical requirements
and a user need. Intended to verify the tissue-
related requirements and demonstrate the life cycle
for typical applications.	Pass
Burst Pressure testing
for veins	Generate burst pressure data for veins of all
relevant diameters	Pass
Jaw Tissue stress test	Demonstrate that under load up to and beyond
the load limit, the durability of the Maryland
instruments is comparable to that of the
predicate devices.	Pass
Validation of usability	Validate user needs related to usability through
a user survey in order to document the
usability, and thus to ensure that the product
under investigation meets the requirements for
usability in accordance with the applicable
standards	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.