(143 days)
No
The summary describes a standard bipolar electrosurgical instrument and does not mention any AI or ML components or capabilities.
Yes.
The device is a bipolar electrosurgical instrument used for ligation and division of vessels and tissue, which are procedures aimed at treating or mitigating disease/injury by surgical means.
No
This device is an electrosurgical instrument used for sealing and dividing vessels and tissue during surgical procedures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "sterile, single-use, hand-held bipolar vessel sealing device" with a physical form factor (shaft diameter, shaft length, jaw style, blade). This indicates it is a hardware device, not software only.
Based on the provided information, the CoolSeal™ Reveal is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use in open surgical procedures in adults and pediatrics for the ligation and division of vessels, tissue bundles, and lymphatics. This is a therapeutic and surgical application, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a hand-held bipolar electrosurgical instrument used to apply energy to tissue in vivo (within the living body) during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the living body) to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on surgical outcomes like vessel burst pressure, thermal spread, and chronic hemostasis, which are relevant to surgical device performance, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The CoolSeal™ Reveal operates directly on tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal for these procedures.
Product codes
GEI
Device Description
The CoolSeal™ Reveal device is a sterile, single-use, hand-held bipolar vessel sealing device designed for use with the CoolSeal™ Generator. The CoolSeal™ Reveal is a hemostat-style design with a 5 mm shaft diameter and 10 cm shaft length. The jaw is a curved Maryland-style jaw that rotates. The Reveal creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vessels, tissue bundles, and lymphatics
Indicated Patient Age Range
Adult and Pediatric in General Surgery.
Adult in ENT surgery.
Intended User / Care Setting
Surgeon
Operating Room
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)
Biocompatibility Testing: The biocompatibility evaluation for the CoolSeal™ Reveal was conducted in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," as recognized by FDA.
Electrical Safety and Electromagnetic Compatibility (EMC): The CoolSeal™ Reveal complies with relevant clauses of the ANSI/AAMI/EC 60601-2-2 standards for electrical safety and ANSI/AAMI/IEC 60601-1-2 standard for EMC.
Mechanical and Functional Testing: Mechanical, electrical, and functional testing was carried out to verify that the proposed device performed as expected.
Ex-vivo and In-vivo Vessel Burst Pressure: Ex-vivo burst pressure testing of excised fresh porcine blood vessels was conducted on the subject device and primary predicate to demonstrate effective bipolar electrosurgical vessel sealing performance. Additionally, in-vivo burst pressure testing of lymphatics was conducted on the subject device and primary predicate to demonstrate effective bipolar electrosurgical vessel sealing performance.
In-vivo Thermal Spread Comparison: Open laparotomy was performed in porcine and oving the subject device and primary predicate device. Each device was used to seal vessels and tissue bundles. Samples were excised for three-dimensional histological assessments (e.g., length, width, and depth) to quantify thermal spread in seals created by both demonstrated that the subject device is as safe and effective as the predicate device.
Chronic Animal Study: A chronic study was conducted to assess the safety and performance of bipolar vessel sealing with the subject device of 23 days. All animals survived 23 days post-op without any complications. All vessel sealing effects on tissue maintained chronic hemostasis and healed as anticipated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
May 6, 2021
Bolder Surgical, LLC Nicholas Wong Regulatory Affairs Manager 331 S. 104th Street, Suite 200 Louisville, Colorado 80027
Re: K203640
Trade/Device Name: CoolSeal Reveal Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 9, 2021 Received: April 12, 2021
Dear Nicholas Wong:
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 (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 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/cdrl-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
2
Indications for Use
510(k) Number (if known) K203640
Device Name CoolSeal Reveal
Indications for Use (Describe)
The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The CoolSeaT™ Reveal is also indicated for open ENT procedures in adults (thyroidectorny, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermallysensitive structures such as nerves and parathyroid glands.
The CoolSeal™ Reveal has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal 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 Paperwork Reduction Act (PRA) Staff 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."
3
Image /page/3/Picture/0 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is in large, bold, blue letters. The word "SURGICAL" is in smaller, thinner, blue letters below the word "BOLDER". The letter "O" in "BOLDER" has a black diamond shape in the upper left quadrant.
510(k) Summary
SUBMITTER
Bolder Surgical, LLC. 331 S. 104th Street, Suite 200 Louisville, CO 80027
Phone: 720-287-7130 Fax: 720-287-7135
Contact Person: Nick Wong Regulatory Affairs Manager
Date Prepared: May 6th, 2021
DEVICE
| Trade Name / Model #: | CoolSeal™ Reveal / CSL-RV105-10 |
|---|---|
| Common Name: | Bipolar Vessel Sealing System |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulatory Class: | II |
| Produce Code: | GEI |
PREDICATE DEVICES
| Trade Name: | LigaSure Exact Dissector, Nano-Coated |
|---|---|
| 510(k): | K173281 |
| Common or Usual Name: | Bipolar Vessel Sealing System |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulatory Class: | II |
| Produce Code: | GEI |
| Trade Name: | JustRight™ Sealer |
| 510(k) | K160602 |
| Common or Usual Name: | Bipolar Vessel Sealing System |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulatory Class: | II |
| Produce Code: | GEI |
DEVICE DESCRIPTION
CoolSeal™ Reveal:
The CoolSeal™ Reveal device is a sterile, single-use, hand-held bipolar vessel sealing device designed for use with the CoolSeal™ Generator. The CoolSeal™ Reveal is a hemostat-style
4
design with a 5 mm shaft diameter and 10 cm shaft length. The jaw is a curved Maryland-style jaw that rotates. The Reveal creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its iaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure.
INDICATIONS FOR USE
CoolSeal™ Reveal:
The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal for these procedures.
5
Image /page/5/Picture/0 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is in large, bold, blue font, with a circle in place of the letter "O". A small black diamond is in the upper left quadrant of the circle. Below "BOLDER" is the word "SURGICAL" in a smaller, thinner, black font.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Tables 1 and 2 below present the comparison of technological characteristics between the subject device and the two identified predicate devices.
| Description | CoolSeal™ Reveal (Subject Device) | LigaSure Exact (Primary Predicate) |
|---|---|---|
| Indications for Use | The CoolSeal™ Reveal is a bipolar electrosurgical | |
| instrument intended for use in open surgical procedures in | ||
| adults and pediatrics where ligation and division of | ||
| vessels, tissue bundles, and lymphatics is desired. The | ||
| CoolSeal™ Reveal can be used on vessels (arteries and | ||
| veins) up to and including 6 mm in diameter. It is | ||
| indicated for use in general surgery and in such surgical | ||
| specialties as urologic, thoracic, plastic, and | ||
| reconstructive. Procedures may include but are not limited | ||
| to, bowel resections, gall bladder procedures, Nissen | ||
| fundoplication, and adhesiolysis. | ||
| The CoolSeal™ Reveal is also indicated for open ENT | ||
| procedures in adults (thyroidectomy, radical neck | ||
| dissection, and parotidectomy) for ligation and division of | ||
| vessels, lymphatics and tissue bundles 2-3 mm away from | ||
| unintended thermally-sensitive structures such as nerves | ||
| and parathyroid glands. | ||
| The CoolSeal™ Reveal has not been shown to be effective | ||
| for tubal sterilization or tubal coagulation for sterilization | ||
| procedures. Do not use the CoolSeal™ Reveal for these | ||
| procedures. | The LigaSure Sealer/Divider is a bipolar electrosurgical instrument | |
| intended for use in open surgical procedures where ligation and | ||
| division of vessels, tissue bundles, and lymphatics is desired. The | ||
| LigaSure Sealer/ Divider can be used on vessels (arteries and veins) | ||
| up to and including 7 mm. It is indicated for use in general surgery | ||
| and in such surgical | ||
| specialties as urologic, thoracic, plastic, and reconstructive. | ||
| Procedures may include, but are not limited to, bowel resections, gall | ||
| bladder procedures, Nissen fundoplication, and adhesiolysis. | ||
| The instrument is also indicated for open ENT procedures in adults | ||
| (thyroidectomy, radical neck dissection, parotidectomy, and | ||
| tonsillectomy) for ligation and division of vessels, lymphatics and | ||
| tissue bundles 2-3 mm away from unintended thermally-sensitive | ||
| structures such as nerves and parathyroid glands. | ||
| The LigaSure system has not been shown to be effective for tubal | ||
| sterilization or tubal coagulation for sterilization | ||
| procedures. Do not use the LigaSure system for these procedures. | ||
| Where used | ||
| (environment) | Operating Room | Operating Room |
| Intended User | Surgeon | Surgeon |
| Description | CoolSeal™ Reveal (Subject Device) | LigaSure Exact (Primary Predicate) |
| Anatomical Sites | Vessels, tissue bundles, and lymphatics | Vessels, tissue bundles, and lymphatics |
| Anatomical Size | Up to and including 6 mm diameter | Up to and including 7 mm diameter |
| Patient | ||
| Population | Adult and Pediatric in General Surgery. | |
| Adult in ENT surgery. | Not specified (Adults assumed) | |
| Power Source | Bipolar energy platform | Bipolar energy platform |
| Primary | ||
| Functions | Grasp, Dissect, Seal, Divide | Grasp, Dissect, Seal, Divide |
| Mechanism of | ||
| Grasping | Hand actuated lever allows user to open or close | Hand actuated lever allows user to open or close |
| Mechanism of | ||
| Dissection | ||
| (Separation) | Bilateral jaw allows user to separate planes of tissue | |
| Mechanism of | ||
| Action (Sealing) | Seal is created by application of RF energy to structures | |
| interposed between the jaws of the instrument. | Seal is created by application of RF energy to structures interposed | |
| between the jaws of the instrument. | ||
| Seal Activation | Button on the sealer instrument is activated by user finger | |
| depression. | Button on the sealer instrument is hand activated by closing the | |
| handles until the button is depressed. | ||
| Knife Activation | Cutting trigger – non-energized | Cutting trigger – non-energized |
| Automatic | ||
| sealing cycle | Yes | Yes |
| Rated Voltage | ||
| (Vpeak) | 190 Vpeak | 288 Vpeak |
| Shaft Diameter | 5 mm | N/A |
| Shaft Length | 10 cm | N/A |
| Jaw Rotation | $≤$ 335° | N/A |
| Jaw Dimensions | ||
| – Jaw Length | ||
| and Side Width | Jaw Length: 12 mm | |
| Proximal Side Width: 4.3 mm | ||
| Distal Side Width: 2.0 mm | Jaw Length: 20.6 mm | |
| Proximal Side Width: 4.2 mm | ||
| Distal Side Width: 2.3 mm | ||
| Jaw Dimensions |
- Tip Width
(proximal and
distal) | Proximal: 5.2 mm
Distal: 3.2 mm | Proximal: 6.7 mm
Distal: 3.6 mm |
| Seal Plate Width | Seal Plate Width: 1.8 mm throughout | Seal Plate Width: |
| Description | CoolSeal™ Reveal (Subject Device) | LigaSure Exact (Primary Predicate) |
| | | Proximal: 4.0 mm
Distal: 1.75 mm |
| Maximum size
structure (vessel,
tissue bundles,
lymphatic) for
sealing | Up to 6 mm | Up to 7 mm |
| Tissue Contact
Materials | Stainless steel, titanium, polymers, silicone, polymer
adhesives and insulating coatings | Stainless steel, titanium, polymers, silicone, polymer adhesives and
insulating coatings |
| Surgical
Approach | Open | Open |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Sterility
Assurance Level | 10-6 | 10-6 |
Table 1. CoolSeal™ Reveal vs. LigaSure™ Exact
6
7
Table 2. CoolSeal™ Reveal vs. JustRight™ Sealer Comparison Table
| Description | CoolSeal™ Reveal (Subject Device) | JustRight Sealer (Pediatric Predicate) |
|---|---|---|
| Indications for Use | The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. |
The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division | The JustRight Surgical® Vessel Sealing System is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required.
The device is contraindicated for use in ENT procedures. |
| Description | CoolSeal™ Reveal (Subject Device) | JustRight Sealer (Pediatric Predicate) |
| | of vessels, lymphatics and tissue bundles 2-3 mm away
from unintended thermally-sensitive structures such as
nerves and parathyroid glands.
The CoolSeal™ Reveal has not been shown to be
effective for tubal sterilization or tubal coagulation for
sterilization procedures. Do not use the CoolSeal™
Reveal for these procedures. | |
| Where used
(environment) | Operating Room | Operating Room |
| Intended User | Surgeon | Surgeon |
| Anatomical
Sites | Vessels, tissue bundles, and lymphatics | Vessels, and tissue bundles |
| Anatomical
Size | Up to and including 6 mm diameter | Up to and including 5 mm diameter |
| Patient
Population | Adult and Pediatric in General Surgery.
Adult in ENT surgery. | Adult and Pediatric in General Surgery. |
| Power Source | Bipolar energy platform | Bipolar energy platform |
| Primary
Functions | Grasp, Dissect, Seal, Divide | Grasp, Dissect, Seal |
| Mechanism of
Grasping | Hand actuated lever allows user to open or close | Hand actuated lever allows user to open or close |
| Mechanism of
Dissection
(Separation) | Bilateral jaw allows user to separate planes of tissue | Bilateral jaw allows user to separate planes of tissue |
| Mechanism of
Action
(Sealing) | Seal is created by application of RF energy to structures
interposed between the jaws of the instrument. | Seal is created by application of RF energy to structures interposed
between the jaws of the instrument. |
| Seal Activation | Button on the sealer instrument is activated by user
finger depression. | Button on the sealer instrument is activated by user finger depression. |
| Knife
Activation | Cutting trigger – non-energized | No cutting functionality. |
| Description | CoolSeal™ Reveal (Subject Device) | JustRight Sealer (Pediatric Predicate) |
| Automatic
sealing cycle | Yes | Yes |
| Rated Voltage
(Vpeak) | 190 Vpeak | 190 Vpeak |
| Maximum
Output Power | 30 Watts | 25 Watts |
| Shaft Diameter | 5 mm | 3 mm |
| Shaft Length | 10 cm | 20 cm |
| Jaw Rotation | ≤ 335° | ≤ 340° |
| Jaw
Dimensions –
Jaw Length and
Side Width | Jaw Length: 12 mm
Proximal Side Width: 4.3 mm
Distal Side Width: 2.0 mm | Jaw Length: 10 mm
Proximal Side Width: 3.3 mm
Distal Side Width: 1.4 mm |
| Jaw
Dimensions –
Tip Width
(proximal and
distal) | Proximal: 5.2 mm
Distal: 3.2 mm | Proximal: 3.3 mm
Distal: 2.2 mm |
| Seal Plate
Width | Seal Plate Width: 1.8 mm throughout | Seal Plate Width:
Proximal: 3.3 mm
Distal: 1.4 mm |
| Thermal
Coating on
Jaws | Present | Present |
| Maximum size
structure
(vessel, tissue
bundles,
lymphatic) for
sealing | Up to 6 mm | Up to 5 mm |
| Tissue Contact
Materials | Stainless steel, titanium, polymers, silicone, polymer
adhesives, and insulating coatings | Stainless steel, titanium, polymers, silicone, polymer adhesives, and
insulating coatings |
| Description | CoolSeal™ Reveal (Subject Device) | JustRight Sealer (Pediatric Predicate) |
| Surgical
Approach | Open | Open and Laparoscopic |
| | Sterilization | Ethylene Oxide |
| Sterility
Assurance
Level | $10^{-6}$ | $10^{-6}$ |
8
Image /page/8/Picture/0 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is in large, bold, blue letters, with a black diamond shape inside the "O". Below "BOLDER" is the word "SURGICAL" in smaller, thinner, blue letters. The logo is simple and modern.
9
10
Image /page/10/Picture/0 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is in large, bold, blue letters, with a black diamond shape inside the "O". Below "BOLDER" is the word "SURGICAL" in smaller, thinner, black letters. The logo is simple and modern, and the use of blue and black gives it a professional look.
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the CoolSeal™ Reveal was conducted in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," as recognized by FDA.
Electrical Safety and Electromagnetic Compatibility (EMC)
The CoolSeal™ Reveal complies with relevant clauses of the ANSI/AAMI/EC 60601-2-2 standards for electrical safety and ANSI/AAMI/IEC 60601-1-2 standard for EMC.
Mechanical and Functional Testing
Mechanical, electrical, and functional testing was carried out to verify that the proposed device performed as expected.
Ex-vivo and In-vivo Vessel Burst Pressure
Ex-vivo burst pressure testing of excised fresh porcine blood vessels was conducted on the subject device and primary predicate to demonstrate effective bipolar electrosurgical vessel sealing performance. Additionally, in-vivo burst pressure testing of lymphatics was conducted on the subject device and primary predicate to demonstrate effective bipolar electrosurgical vessel sealing performance.
In-vivo Thermal Spread Comparison
Open laparotomy was performed in porcine and oving the subject device and primary predicate device. Each device was used to seal vessels and tissue bundles. Samples were excised for three-dimensional histological assessments (e.g., length, width, and
11
Image /page/11/Picture/0 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is in large, bold, blue font, with a stylized "O" that includes a black triangle. Below "BOLDER" is the word "SURGICAL" in a smaller, thinner, blue font.
depth) to quantify thermal spread in seals created by both demonstrated that the subject device is as safe and effective as the predicate device.
Chronic Animal Study
A chronic study was conducted to assess the safety and performance of bipolar vessel sealing with the subject device of 23 days. All animals survived 23 days post-op without any complications. All vessel sealing effects on tissue maintained chronic hemostasis and healed as anticipated.
CONCLUSIONS
Based on a review of performance data, comparison of the device classification, intended use, operating principles, technological characteristics, sterility, and biocompatibility, the subject device is safe, as effective, and performs as well as the legally marketed predicate devices.