(30 days)
Not Found
No
The summary describes a bipolar electrosurgical instrument for sealing and cutting tissue using RF energy and a mechanical blade. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is based on direct application of energy and mechanical action, not data analysis or learning algorithms.
Yes
The device is used in surgical procedures to ligate vessels and divide tissue, which are actions intended to treat or affect the structure or function of the body.
No
The device is intended for surgical procedures involving the ligation and division of vessels and tissue, not for diagnosing conditions.
No
The device description clearly states it consists of "sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator." These are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in surgical procedures to ligate and divide vessels and tissue. This is an in vivo application (within a living organism).
- Device Description: The description details a surgical instrument that grasps, seals, and cuts tissue using bipolar electrosurgical energy. This is a surgical tool, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing information about a patient's health status, diagnosis, or disease
- Using reagents or assays
- Performing tests on specimens
The device is a surgical instrument used directly on the patient during a procedure.
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 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.
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, 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.
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 and reference device, 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 outlined in the predicate device.
Tissue Related performance test- Life Cycle:
The Instrument must be capable of 100 complete rotating, closing, sealing, cutting and releasing cycles. For articulating instruments, the 100 sealing cycles shall include at least 25 articulated sealing cycles. During sealing, visual sparking shall be acceptable if the sparking does not cause Adhesiveness of sealed tissue to the jaws should not damage the seal or cause tearing of the tissue as it is removed from the jaws. Average Sealing Time for Standard Mode shall be ≤ 6.5 s. for Plus Mode it shall be ≤ 7.5 s. Blade should cut completely, not leaving tissue tags anywhere along cutting length. Cutter shall be designed to divide all unilateral tissue including vessels up to and including 7 mm OD. The cutting blade shall remain in its track during cutting Maximum Thermal Spread should be ≤ 5 mm beyond the jaws (when measured with the jaws closed) Average Thermal Spread should be ≤ 1 mm beyond the jaws (when measured with the jaws closed). Results: Pass
Tissue Related performance test- Burst Pressure:
Instrument must be capable of sealing vessels up to and including 7 mm OD. Results: Pass
Tissue Related performance test- Cutting Blade Activation:
The force required to operate the cutting blade shall not exceed 31 N (measured in used condition without tissue in the jaws). Results: Pass
The bench testing performed verified and validated that the Caiman Seal and Cut Technology System has met all its design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for performance metrics like Average Sealing Time, Maximum Thermal Spread, Average Thermal Spread, and force required to operate the cutting blade.
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.
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.
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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
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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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 | 10ft | Same |
| Sterile/Single Use | Yes | Yes | Yes | Same |
| Shelf Life | 2 years | 2 years | 2 years | Same |
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PERFORMANCE TESTING
Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate and reference device, 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 outlined in the predicate device.
See Design verification table below:
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Design verification
| Test | Acceptance Criteria | Results |
|---|---|---|
| Tissue Related | ||
| performance test- Life Cycle | The Instrument must be capable of 100 complete rotating, closing, sealing, cutting and releasing cycles. For articulating instruments, the 100 sealing cycles shall include at least 25 articulated sealing cycles. During sealing, visual sparking shall be acceptable if the sparking does not cause Adhesiveness of sealed tissue to the jaws should not damage the seal or cause tearing of the tissue as it is removed from the jaws. Average Sealing Time for Standard Mode shall be ≤ 6.5 s. for Plus Mode it shall be ≤ 7.5 s. Blade should cut completely, not leaving tissue tags anywhere along cutting length. Cutter shall be designed to divide all unilateral tissue including vessels up to and including 7 mm OD. The cutting blade shall remain in its track during cutting Maximum Thermal Spread should be ≤ 5 mm beyond the jaws (when measured with the jaws closed) Average Thermal Spread should be ≤ 1 mm beyond the jaws (when measured with the jaws closed) | Pass |
| Tissue Related | ||
| performance test- Burst Pressure | Instrument must be capable of sealing vessels up to and including 7 mm OD | Pass |
| Tissue Related | ||
| performance test- Cutting Blade Activation | The force required to operate the cutting blade shall not exceed 31 N (measured in used condition without tissue in the jaws) | Pass |
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The bench testing performed verified and validated that the Caiman Seal and Cut Technology System has met all its design specifications.
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.
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