Caiman 5 Maryland

K183180 · Aesculap, Inc. · GEI · Mar 12, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183180
• Device Name: Caiman 5 Maryland
• Applicant: Aesculap, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Caiman 5 Maryland is a sterile, single-use bipolar electrosurgical instrument for vessel sealing and tissue division. Used in open (12.5cm, 17cm, 24cm) and laparoscopic (36cm, 44cm) procedures. Device consists of a handle, stainless steel shaft, and curved jaws with bipolar electrodes. Operated by surgeons; connects to Lektrafuse RF generator. Surgeon places vessel/tissue between jaws; applies bipolar RF energy to seal; manually actuates cutting blade to divide tissue. Provides hemostasis via vessel ligation; facilitates dissection and grasping. Benefits include efficient vessel sealing and tissue division in various surgical specialties.

Clinical Evidence

Bench testing only. Performance validated through tissue-related performance tests for arteries, burst pressure testing for veins, jaw tissue stress testing, and usability validation. Electrical safety and EMC compliance verified per IEC 60601 series. Biocompatibility confirmed per ISO 10993-1.

Technological Characteristics

Bipolar electrosurgical instrument. Materials: molded thermoplastic handle, stainless steel shaft, polyester/ETFE insulation, PEEK dissection clip. Energy: Bipolar RF (via Lektrafuse generator). Dimensions: 5mm diameter, various lengths (12.5-44cm). Connectivity: Wired to generator. Sterilization: ISO 11137-2. Features: Curved jaw, non-articulating or articulating, single electrode pair.

Indications for Use

Indicated for general and gynecologic surgical procedures (including urologic, vascular, thoracic, and thoracoscopic) requiring vessel ligation, tissue grasping, and dissection. Applicable to vessels up to 7mm and tissue bundles. Not indicated for tubal sterilization or coagulation.

Regulatory Classification

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.

Predicate Devices

• Caiman Seal and Cut Technology (K151696)

Reference Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ms. Jessica Stigliano<br>610-984-9063 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| 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

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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,<br>and oophorectomy etc., or any<br>procedure where vessel ligation<br>(seal and cut), tissue grasping,<br>and dissection is performed.<br>The devices can be used on<br>vessels up to and including<br>7mm and bundles as large as<br>will fit in the jaws of the<br>instrument.<br>Caiman Seal and Cut<br>Technology has not been shown<br>to be effective for tubal<br>sterilization or tubal<br>coagulation for sterilization<br>procedures. Do not use the<br>system for these procedures. | and oophorectomy etc., or any<br>procedure where vessel ligation<br>(seal and cut), tissue grasping,<br>and dissection is performed.<br>The devices can be used on<br>vessels up to and including<br>7mm and bundles as large as<br>will fit in the jaws of the<br>instrument.<br>Caiman Seal and Cut<br>Technology has not been shown<br>to be effective for tubal<br>sterilization or tubal<br>coagulation for sterilization<br>procedures. Do not use the<br>system for these procedures. | (seal and cut), tissue grasping, and<br>dissection is performed. The<br>devices can be used on vessels up<br>to and including 7mm and bundles<br>as large as will fit in the jaws of<br>the instrument.<br>Caiman Seal and Cut Technology<br>has not been shown to be effective<br>for tubal sterilization or tubal<br>coagulation for sterilization<br>procedures. Do not use the system<br>for these procedures. | The Aragon Surgical Lektrafuse<br>RF System has not been shown to<br>be effective for tubal sterilization<br>or tubal coagulation for<br>sterilization procedures and<br>should not be used for these<br>procedures. |
| Material<br>Composition | Handle - molded thermoplastic<br>Shaft - stainless steel<br>Insulation - polyester tube<br>(Caiman 5)<br>ETFE (Caiman 5 Articulating)<br>Dissection clip - PEEK | Handle - molded thermoplastic<br>Shaft - stainless steel<br>Insulation - polyester tube<br>(Caiman 5)<br>EFTE (Caiman 5 Articulating)<br>Dissection clip - Valox HX 420<br>HP | Handle - molded thermoplastic<br>Shaft - stainless steel<br>Insulation - polyester tube<br>(Caiman 5)<br>Dissection clip – PEEK (Caiman<br>5) | Molded thermoplastic handle,<br>stainless steel shaft |
| Functional Use | Grasping Ligation and<br>Coagulation (unchanged) | Grasping Ligation and<br>Coagulation | Grasping Ligation and Coagulation | Grasping Ligation and<br>Coagulation |
| Surgical<br>Approach | 125mm and 170mm – Open<br>360mm and 440mm –<br>Laparoscopic (unchanged) | 240mm - Open<br>360 and 440mm - Laparoscopic | Caiman 12 Plus (44cm)-<br>Laparoscopic<br>Caiman 12 Plus (24cm)- Open<br>Caiman 5- Laparoscopic | Laparoscopic |
| Length | 125mm<br>170mm<br>360mm<br>440mm | 240mm<br>360mm<br>440mm | Caiman 12 Plus- 44cm<br>Caiman 12 Plus- 24cm<br>Caiman 5- 36cm | 36cm |
| Jaw Shape | Curved | Straight…