K Number
K203461
Device Name
Aesculap Caiman 12 Seal and Cut Technology System
Manufacturer
Date Cleared
2020-12-18

(24 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The description focuses on bipolar electrosurgical RF energy for sealing and a mechanical blade for cutting, with no mention of AI or ML in the device operation or modifications.

Yes
The device is intended for use in general surgery and gynecologic surgical procedures for ligation and division of vessels, creating a seal by applying bipolar electrosurgical RF energy, which directly treats medical conditions through a physical or mechanical action.

No

The device is described as an electrosurgical instrument for sealing and cutting tissue and vessels during surgical procedures, not for diagnostic purposes.

No

The device description explicitly states it consists of "sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator." This indicates the device includes hardware components (instruments and a generator) and is not solely software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
  • Device Function: The Caiman Seal and Cut Technology System is a surgical instrument used during surgical procedures to physically seal and cut vessels and tissue. It operates directly on the patient's body.
  • Intended Use: The intended use is for "general surgery and gynecologic surgical procedures where ligation and division of vessels is desired." This is a surgical function, not a diagnostic one performed on a specimen outside the body.

The device description and performance studies also focus on the mechanical and electrical performance of the instrument itself, not on the analysis of biological samples.

N/A

Intended Use / Indications for Use

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.

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

GEI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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.

Design verification:

  • Instrument Cycling Test: Acceptance Criteria - No pin walking shall be observed; Results - Pass
  • Jaw Clamping Force Test: Acceptance Criteria - Jaw clamping force must remain within specification 170 N - 350 N; Results - 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.

K130596

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.

Not Found

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

§ 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.

0

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

1

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 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.

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 Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Nikki Luke
484-523-6868 (phone)
nikki.luke@aesculapimplants.com
610-791-6882 (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 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.

INDICATIONS FOR USE

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

4

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
and Cut Technology System
Product Code: GEI
K203461 | Predicate Device: Caiman Seal
and Cut Technology System
Product Code: GEI
K130596 | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use | Caiman Seal and Cut Technology
System instruments are intended
for use in general surgery and
gynecologic surgical procedures
where ligation and division of
vessels is desired. | Caiman Seal and Cut Technology
consists of dedicated bipolar
electrosurgical instruments
intended for use in general surgery
and gynecologic surgical
procedures where ligation and
division of vessels is desired. | Same |
| Indications for Use | 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 | Caiman Seal and Cut Technology
consists of dedicated bipolar
electrosurgical instruments
intended for use in general surgery
and gynecologic surgical
procedures where ligation and
division of vessels is desired. The
instruments create a seal by the
application of bipolar
electrosurgical RF energy
(coagulation) to vascular structure
(vessels) interposed between the
jaws of the device. A cutting blade
is actuated for the division of
tissue.
The Caiman 12 Plus (44cm) and
the Caiman 5 (36cm) are indicated
for laparoscopic procedures and
the Caiman 12 Plus (24cm) is
indicated for open procedures. The
indications for use include general
surgical procedures, (including
urologic, vascular, thoracic, and
thoracoscopic), and gynecological
procedures where ligation and
division of vessels is performed.
These procedures include: vaginal
hysterectomies, Nissen
fundoplication, colectomy,
adhesiolysis, bowel resection, and
oophorectomy etc., or any
procedure where vessel ligation
(seal and cut), tissue grasping,
and dissection is performed. The
devices can be used on vessels up | 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 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. | 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. | |
| Material Composition | Handle - molded thermoplastic
Shaft - stainless steel and molded
thermoplastic
Jaw - stainless steel
Jaw Insulation Components -
PEEK | Handle - molded thermoplastic
Shaft - stainless steel and molded
thermoplastic
Jaw - stainless steel
Jaw Insulation Components -
PEEK | Same |
| Functional Use | Grasping Ligation and Coagulation | Grasping Ligation and Coagulation | Same |
| Surgical Approach | Caiman 12 (44cm)-Laparoscopic
Caiman 12 (24cm)- Open | Caiman 12 (44cm)-Laparoscopic
Caiman 12 (24cm)- Open | Same |
| Length | 24 cm
44 cm | 24 cm
44 cm | Same |
| Jaw | Upper Jaw Assembly
Stainless-Steel Material: 420 SST
(EN ISO 1.4021)
Stainless-Steel Material: 304 (EN
ISO 1.4301)
Electrical Insulation Features:
PEEK
Lower Jaw Assembly
Stainless-Steel Material: 17-4 PH
(EN ISO 1.4542)
Stainless-Steel Material: 304 (EN
ISO 1.4301)
Electrical Insulation Features:
PEEK
Jaw Shape: Straight | Upper Jaw Assembly
Stainless-Steel Material: 420 SST
(EN ISO 1.4021)
Stainless-Steel Material: 304 (EN
ISO 1.4301)
Electrical Insulation Features:
PEEK
Lower Jaw Assembly
Stainless-Steel Material: 17-4 PH
(EN ISO 1.4542)
Stainless-Steel Material: 304 (EN
ISO 1.4301)
Electrical Insulation Features:
PEEK
Jaw 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 |
| Electrode
Length | 5 cm | 5 cm | Same |
| Electrode
Width | 0.25 cm | 0.25 cm | Same |
| Electrode Texture | Smooth with PEEK stops to
maintain consistent gap between
electrode surfaces | Smooth with PEEK stops to
maintain consistent gap between
electrode 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

TestAcceptance CriteriaResults
Instrument Cycling TestNo pin walking shall be observedPass
Jaw Clamping Force TestJaw clamping force must remain within
specification 170 N - 350 NPass

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.