Who is the manufacturer of Aesculap Caiman 5 Seal and Cut Technology System?

Aesculap, Inc. filed the 510(k) submission for Aesculap Caiman 5 Seal and Cut Technology System (K202938).

What is the FDA product code for Aesculap Caiman 5 Seal and Cut Technology System?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Aesculap Caiman 5 Seal and Cut Technology System?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Aesculap Caiman 5 Seal and Cut Technology System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Aesculap Caiman 5 Seal and Cut Technology System

Q: What are the predicate devices for Aesculap Caiman 5 Seal and Cut Technology System?

Caiman Seal and Cut Technology (K151696).

K202938 · Aesculap, Inc. · GEI · Oct 30, 2020 · General, Plastic Surgery

Device Facts

Record ID	K202938
Device Name	Aesculap Caiman 5 Seal and Cut Technology System
Applicant	Aesculap, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Oct 30, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Sterile, single-use bipolar electrosurgical instrument; connects to dedicated bipolar RF generator. Device grasps, seals, and mechanically divides tissue/vessels. Operation: bipolar RF energy (coagulation) applied to vascular structures between jaws; integrated cutting blade manually actuated for tissue division. Used in OR by surgeons. Output: physical tissue seal and division. Benefits: efficient vessel ligation and tissue dissection in laparoscopic/open surgery. Modifications include updated jaw materials and articulation features.

Clinical Evidence

Bench testing only. No clinical data. Verification testing included life cycle (100 cycles), burst pressure (vessels up to 7mm), and cutting blade activation force (≤ 31 N). Thermal spread metrics (max ≤ 5mm, average ≤ 1mm) and sealing times (≤ 6.5s standard, ≤ 7.5s plus) met acceptance criteria.

Technological Characteristics

Bipolar electrosurgical instrument. Materials: 17-4 PH stainless steel (EN ISO 1.4542) jaws, molded thermoplastic handle, polyester/ETFE insulation, PEEK dissection clips. Sensing/Actuation: Bipolar RF energy; manual blade actuation. Form factor: 5mm diameter, 240mm-440mm lengths. Connectivity: Wired (10ft cable) to dedicated RF generator. Sterilization: Sterile, single-use.

Indications for Use

Indicated for general surgery (urologic, vascular, thoracic, thoracoscopic) and gynecologic procedures (e.g., vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, oophorectomy) requiring vessel ligation, tissue grasping, and dissection. Suitable for vessels up to 7mm and tissue bundles. 36cm/44cm lengths for laparoscopic; 24cm for open procedures. Contraindicated for tubal sterilization or tubal coagulation for sterilization.

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)

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K031011 — LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 · Valleylab, Inc. · May 29, 2003
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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 30, 2020 Aesculap Inc. Omunique (Nikki) Luke Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Re: K202938 Trade/Device Name: Aesculap Caiman 5 Seal and Cut Technology System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 23, 2020 Received: September 30, 2020 Dear Omunique (Nikki) Luke: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K202938 #### Device Name Aesculap Caiman 5 Seal and Cut Technology System #### Indications for Use (Describe) Caiman Seal and Cut Technology System consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. The Caiman 12 Plus (44cm) and the Caiman 5 (36cm and 44cm) are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) and the Caiman 5 (24cm) are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectory, adhesiolysis, bowel resection, and oophorectorny etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument. Caiman Seal and Cut Technology System has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the system for these procedures. | Type of Use (Select one or both, as applicable) | [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Paperwork Reduction Act (PRA) Staff {3}------------------------------------------------ #### 510(k) SUMMARY (as required by 21 CFR 807.92) #### Caiman Seal and Cut Technology System October 30, 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 Seal and Cut Technology System | | COMMON NAME: | Electrosurgical, Cutting & Coagulation & Accessories | | CLASSIFICATION NAME: | General and Plastic Surgery | | REGULATION NUMBER: | 21 CFR 878.4400 | | PRODUCT CODE: | GEI | | DEVICE CLASS: | Class II per 21 CFR 878.4400 | ### PREDICATE DEVICE Caiman Seal and Cut Technology (K151696) ### DEVICE DESCRIPTION The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, blunt dissection, grasping, and dividing tissue enclosed within its dissection clips. This reason for this submission is to capture modifications to the caiman blunt instruments. ### 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. {5}------------------------------------------------ | | Subject Device: Caiman Seal and Cut Technology System Product Code: GEI TBD | Predicate Device: Caiman Seal and Cut Technology System Product Code: GEI K151696 | Reference Device: Caiman Seal and Cut Technology System Product Code: GEI | | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | 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. | 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 to and including 7mm and bundles as large as will fit in the jaws of the instrument. | 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. Instruments 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 | 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. 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 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. | Same | | | 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. | 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 Insulation - polyester tube (Caiman 5) EFTE (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 | Handle - molded thermoplastic Shaft - stainless steel Insulation - polyester tube (Caiman 5) ETFE (Caiman 5 Articulating) Dissection clip - PEEK | Same | | Functional Use | Grasping Ligation and Coagulation | Grasping Ligation and Coagulation | Grasping Ligation and Coagulation | Same | | Surgical Approach | 240mm - Open 240mm, 360mm and 440mm - Laparoscopic | 240mm - Open 360mm and 440mm - Laparoscopic | 125mm and 170mm - Open 360mm and 440mm - Laparoscopic | Same | | Length | 240mm 360mm 440mm | 240mm 360mm 440mm | 125mm 170mm 360mm 440mm | Same | | Jaw | Upper Jaw Stainless-Steel Material: 17-4 PH (EN ISO 1.4542) Isolation Features: None Pivot Jaw Stainless-Steel Material: 17-4 PH (EN ISO 1.4542) Isolation Features: Standing ceramic features Jaw Shape: Straight | Upper Jaw Stainless-Steel Material: 1.4021 Isolation Features: Peek Stripes Pivot Jaw Stainless-Steel Material: 17-4 PH (EN ISO 1.4542) Isolation Features: None Jaw Shape: Straight | Jaw Shape: Curved | Same | | Diameter | 5mm | 5mm | 5mm | Same | | | | | | Same | | Articulation | 240, 360, and 440mm - non- articulating 240, 360, and 440mm - articulating | 240, 360, and 440mm - non- articulating 360mm - articulating | 125, 170, 360, and 440mm - non-articulating 360 and 440 - articulating | Same | | Number of Electrodes (Pairs) | 1 | 1 | 1 | Same | | Electrode Length | 2.65 cm | 2.65 cm | 21.5 mm | Same | | Electrode Width | 0.13-0.15 cm | 0.13-0.15 cm | 1.01- 1.63 mm - varies over the length of the jaw due to curve | Same | | Electrode Texture | Smooth with nonconductive (Alumina Titania) stop members on the Jaws, to maintain consistent gap between electrode surfaces. | Smooth, with PEEK stop members at the distal end of the jaw and Valox stop members at the proximal end of the jaw, to maintain consistent gap between electrode surface. | Smooth with conductive (steel) and non conductive (Alumina Titania) stop members on the Jaws, to maintain consistent gap between electrode surfaces. | Same | | Cable | 10ft | 10ft…