CoolSeal Reveal
Device Facts
| Record ID | K203640 |
|---|---|
| Device Name | CoolSeal Reveal |
| Applicant | Bolder Surgical, LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | May 6, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
CoolSeal Reveal is a sterile, single-use, hand-held bipolar electrosurgical instrument for open surgery. Used by surgeons in ORs. Device features 5 mm shaft, 10 cm length, and curved Maryland-style rotating jaw. Input: RF energy from CoolSeal Generator applied to tissue/vessels between jaws. Operation: surgeon grasps tissue, activates RF via finger button for sealing, then uses manual trigger to actuate internal blade for division. Output: sealed and divided vessels/tissue bundles up to 6 mm. Benefits: provides hemostasis and tissue dissection; enables ligation near thermally-sensitive structures (nerves/parathyroid glands) in ENT procedures. Device includes automatic sealing cycle.
Clinical Evidence
Bench testing included ex-vivo/in-vivo vessel burst pressure testing on porcine models to verify sealing performance. In-vivo thermal spread comparison via histological assessment (length, width, depth) demonstrated safety comparable to predicate. Chronic animal study (23-day duration) confirmed maintained hemostasis and anticipated healing without complications.
Technological Characteristics
Materials: stainless steel, titanium, polymers, silicone, polymer adhesives, insulating coatings. Energy: Bipolar RF (190 Vpeak, 30W max). Form factor: 5 mm shaft, 10 cm length, 335° jaw rotation. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Connects to CoolSeal Generator.
Indications for Use
Indicated for ligation and division of vessels, tissue bundles, and lymphatics in open surgical procedures. Patient population: adults and pediatrics for general surgery; adults for ENT procedures (thyroidectomy, radical neck dissection, parotidectomy). Contraindicated for tubal sterilization/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
Submission Summary (Full Text)
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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
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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
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# 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)
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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
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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.
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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<br>instrument intended for use in open surgical procedures in<br>adults and pediatrics where ligation and division of<br>vessels, tissue bundles, and lymphatics is desired. The<br>CoolSeal™ Reveal can be used on vessels (arteries and<br>veins) up to and including 6 mm in diameter. It is<br>indicated for use in general surgery and in such surgical<br>specialties as urologic, thoracic, plastic, and<br>reconstructive. Procedures may include but are not limited<br>to, bowel resections, gall bladder procedures, Nissen<br>fundoplication, and adhesiolysis.<br>The CoolSeal™ Reveal is also indicated for open ENT<br>procedures in adults (thyroidectomy, radical neck<br>dissection, and parotidectomy) for ligation and division of<br>vessels, lymphatics and tissue bundles 2-3 mm away from<br>unintended thermally-sensitive structures such as nerves<br>and parathyroid glands.<br>The CoolSeal™ Reveal has not been shown to be effective<br>for tubal sterilization or tubal coagulation for sterilization<br>procedures. Do not use the CoolSeal™ Reveal for these<br>procedures. | The LigaSure Sealer/Divider is a bipolar electrosurgical instrument<br>intended for use in open surgical procedures where ligation and<br>division of vessels, tissue bundles, and lymphatics is desired. The<br>LigaSure Sealer/ Divider can be used on vessels (arteries and veins)<br>up to and including 7 mm. It is indicated for use in general surgery<br>and in such surgical<br>specialties as urologic, thoracic, plastic, and reconstructive.<br>Procedures may include, but are not limited to, bowel resections, gall<br>bladder procedures, Nissen fundoplication, and adhesiolysis.<br>The instrument is also indicated for open ENT procedures in adults<br>(thyroidectomy, radical neck dissection, parotidectomy, and<br>tonsillectomy) for ligation and division of vessels, lymphatics and<br>tissue bundles 2-3 mm away from unintended thermally-sensitive<br>structures such as nerves and parathyroid glands.<br>The LigaSure system has not been shown to be effective for tubal<br>sterilization or tubal coagulation for sterilization<br>procedures. Do not use the LigaSure system for these procedures. |
| Where used<br>(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<br>Population | Adult and Pediatric in General Surgery.<br>Adult in ENT surgery. | Not specified (Adults assumed) |
| Power Source | Bipolar energy platform | Bipolar energy platform |
| Primary<br>Functions | Grasp, Dissect, Seal, Divide | Grasp, Dissect, Seal, Divide |
| Mechanism of<br>Grasping | Hand actuated lever allows user to open or close | Hand actuated lever allows user to open or close |
| Mechanism of<br>Dissection<br>(Separation) | Bilateral jaw allows user to separate planes of tissue | |
| Mechanism of<br>Action (Sealing) | Seal is created by application of RF energy to structures<br>interposed between the jaws of the instrument. | Seal is created by application of RF energy to structures interposed<br>between the jaws of the instrument. |
| Seal Activation | Button on the sealer instrument is activated by user finger<br>depression. | Button on the sealer instrument is hand activated by closing the<br>handles until the button is depressed. |
| Knife Activation | Cutting trigger – non-energized | Cutting trigger – non-energized |
| Automatic<br>sealing cycle | Yes | Yes |
| Rated Voltage<br>(Vpeak) | 190 Vpeak | 288 Vpeak |
| Shaft Diameter | 5 mm | N/A |
| Shaft Length | 10 cm | N/A |
| Jaw Rotation | $≤$ 335° | N/A |
| Jaw Dimensions<br>– Jaw Length<br>and Side Width | Jaw Length: 12 mm<br>Proximal Side Width: 4.3 mm<br>Distal Side Width: 2.0 mm | Jaw Length: 20.6 mm<br>Proximal Side Width: 4.2 mm<br>Distal Side Width: 2.3 mm |
| Jaw Dimensions<br>- Tip Width<br>(proximal and<br>distal) | Proximal: 5.2 mm<br>Distal: 3.2 mm | Proximal: 6.7 mm<br>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<br>Distal: 1.75 mm |
| Maximum size<br>structure (vessel,<br>tissue bundles,<br>lymphatic) for<br>sealing | Up to 6 mm | Up to 7 mm |
| Tissue Contact<br>Materials | Stainless steel, titanium, polymers, silicone, polymer<br>adhesives and insulating coatings | Stainless steel, titanium, polymers, silicone, polymer adhesives and<br>insulating coatings |
| Surgical<br>Approach | Open | Open |
| Sterilization | Ethylene Oxide…
