CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
Device Facts
| Record ID | K211579 |
|---|---|
| Device Name | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) |
| Applicant | Bolder Surgical, LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Sep 7, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
Device Story
CoolSeal Trinity is a bipolar electrosurgical instrument for vessel sealing and division. Input: vascular structures or tissue bundles interposed between device jaws. Operation: surgeon-actuated hand lever closes jaws to grasp tissue; RF energy from CoolSeal generator creates seal; surgeon-actuated trigger deploys blade to divide tissue. Used in OR by surgeons for minimally invasive or open procedures. Output: sealed and divided tissue. Benefits: provides hemostasis in various surgical procedures. Device features 5 mm diameter shaft in 30 cm, 37 cm, and 44 cm lengths. Bilateral jaw design facilitates tissue dissection and plane separation.
Clinical Evidence
No human clinical data. Evidence includes: ex-vivo porcine vessel burst pressure testing; in-vivo porcine model thermal spread comparison (histological assessment of seal dimensions); and chronic animal study (21-day survival) confirming hemostasis and healing. Biocompatibility per ISO 10993-1. Electrical safety/EMC per ANSI/AAMI/IEC 60601-1, 60601-2-2, and 60601-1-2.
Technological Characteristics
Bipolar electrosurgical instrument; 5 mm shaft diameter; 30/37/44 cm lengths. Materials: stainless steel, titanium, polymers, silicone, polymer adhesives, insulating coatings. Energy: RF bipolar. Sterilization: Ethylene Oxide (SAL 10^-6). Complies with ANSI/AAMI/IEC 60601-1, 60601-2-2, 60601-1-2.
Indications for Use
Indicated for ligation and division of vessels (arteries, veins, vascular bundles up to 7 mm), tissue bundles, and lymphatics in minimally invasive or open general surgery (urologic, vascular, gynecologic). Applicable to adult and pediatric populations (infants, children, adolescents). Contraindicated for ENT procedures and not indicated 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
- CoolSeal™ Trinity (K203183)
- LigaSure™ Maryland (K170869)
Related Devices
- K203183 — CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) · Bolder Surgical, LLC · May 6, 2021
- K231012 — CoolSeal Trinity · Bolder Surgical, LLC · Nov 15, 2023
- K152134 — Reprocessed Vessel Sealer · Sterilmed, Inc. · Jan 15, 2016
- K133338 — LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) · Covidien, Formerly Valleylab, A Division of Tyco H · Dec 20, 2013
- K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider · Stryker Sustainability Solutions · Apr 23, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2021
Bolder Surgical, LLC. Nicholas Wong Regulatory Affairs Manager 331 S. 104th Street, Suite 200 Louisville. Colorado 80027
## Re: K211579
Trade/Device Name: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 6, 2021 Received: August 9, 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/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,
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
4-2
510(k) Number (if known) K211579
Device Name CoolSeal Trinity
### Indications for Use (Describe)
The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
Type of Use (Select one or both, as applicable)
| <div> <span style="font-size:10pt"> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:10pt"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Image /page/3/Picture/0 description: The image shows the text 'K211579'. The text is in a sans-serif font and is black. The background is white.
Image /page/3/Picture/1 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is written in large, bold, blue letters. The letter "O" in "BOLDER" has a small, black, diamond shape inside of it. Below the word "BOLDER" is the word "SURGICAL" written in smaller, thinner, gray letters.
## 510(k) Summarv
## 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 19th, 2021
## DEVICES
Trade Name / Model #:
CoolSealTM Trinity
- o 30 cm / CSL-TR105-30
- 37 cm / CSL-TR105-37
- 44 cm / CSL-TR105-44
| Common or Usual Name: | Bipolar Vessel Sealing System |
|-----------------------|----------------------------------------------------------------|
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulatory Class: | II |
| Produce Code: | GEI |
## PREDICATE DEVICES
Trade Name: CoolSealTM Trinity 510(k): K203183
Trade Name: LigaSure™ Maryland 510(k) K170869
## DEVICE DESCRIPTION
## CoolSeal™ Trinity:
The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity 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. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.
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# INDICATIONS FOR USE
# CoolSeal™ Trinity:
The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
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ਨੀ ਹੋਵੀ (
OMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATED DEVICES
able 1 below presents the comparison of technological characteristics between the two identified predic
| Table 1. presents the subject Device compared to its two predicates, CoolSeal Trinity (K203183) and LigaSure Maryland (K170869)Description | CoolSeal™ Trinity<br>(Subject Device) | CoolSeal™ Trinity<br>(Primary Predicate/K203183) | LigaSure Maryland (Secondary Predicate/K170869) |
|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The CoolSeal™ Trinity is a bipolar<br>electrosurgical instrument intended for<br>use in minimally invasive or open<br>surgical procedures where ligation and<br>division of vessels, tissue bundles, and<br>lymphatics is desired. The CoolSeal™<br>Trinity can be used on vessels (arteries,<br>veins, and vascular bundles) up to and<br>including 7 mm in diameter. It is<br>indicated for use in general surgery<br>procedures including urologic, vascular,<br>and gynecologic. It is indicated for use in<br>adult and pediatric populations (infants,<br>children, and adolescents). Procedures<br>may include, but are not limited to,<br>Nissen fundoplication, colectomy,<br>cholecystectomy, adhesiolysis,<br>hysterectomy, oophorectomy, etc. | The CoolSeal™ Trinity is a bipolar<br>electrosurgical instrument intended for<br>use in minimally invasive or open<br>surgical procedures where ligation and<br>division of vessels, tissue bundles, and<br>lymphatics is desired. The CoolSeal™<br>Trinity can be used on arteries up to and<br>including 6 mm, veins, and vascular<br>bundles up to and including 7 mm in<br>diameter. It is indicated for use in general<br>surgery procedures including urologic,<br>vascular, and gynecologic. It is indicated<br>for use in adult and pediatric populations<br>(infants, children, and adolescents). | The LigaSure Sealer/Divider is a bipolar<br>electrosurgical instrument intended for<br>use in minimally invasive or open<br>surgical procedures where ligation and<br>division of vessels, tissue bundles, and<br>lymphatics is desired. The LigaSure<br>Sealer/ Divider can be used on vessels<br>(arteries, veins, and vascular bundles) up<br>to and including 7 mm in diameter. It is<br>indicated for use in general surgery<br>procedures and such surgical specialties<br>as urologic, vascular, thoracic, and<br>gynecologic. Procedures may include, but<br>are not limited to, Nissen fundoplication,<br>colectomy, cholecystectomy,<br>adhesiolysis, hysterectomy,<br>oophorectomy, etc. |
| | The CoolSeal™ Trinity has not been<br>shown to be effective for tubal<br>sterilization or tubal coagulation for<br>sterilization procedures. Do not use the<br>CoolSeal™ Trinity for these procedures.<br>The device is contraindicated for use in<br>ENT procedures. | The CoolSeal™ Trinity has not been<br>shown to be effective for tubal<br>sterilization or tubal coagulation for<br>sterilization procedures. Do not use the<br>CoolSeal™ Trinity for these procedures.<br>The device is contraindicated for use in<br>ENT procedures. | The LigaSure system has not been shown<br>to be effective for tubal sterilization or<br>tubal coagulation for sterilization<br>procedures. Do not use the LigaSure<br>system for these procedures. |
| Where used<br>(environment) | Operating Room | | Operating Room |
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| Description | CoolSeal™ Trinity<br>(Subject Device) | CoolSeal™ Trinity<br>(Primary Predicate/K203183) | LigaSure Maryland (Secondary<br>Predicate/K170869) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Intended User | Surgeons | Surgeons | Surgeons |
| Anatomical<br>Sites | Vessels, tissue bundles, and lymphatics | Vessels, tissue bundles, and lymphatics | Vessels, tissue bundles, and lymphatics |
| Anatomical Size | Arteries, veins, and vascular bundles up<br>to and including 7 mm in diameter | Arteries up to and including 6 mm,<br>veins, and vascular bundles up to and<br>including 7 mm in diameter | Arteries, veins, and vascular bundles up<br>to and including 7 mm in diameter |
| Patient<br>Population | Adult and pediatric populations (infants, children, and adolescents). | | Not specified |
| Power Source | Bipolar energy platform | Bipolar energy platform | Bipolar energy platform |
| Primary<br>Functions | Grasp, Dissect, Seal, Divide | 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 | Hand actuated lever allows user to open<br>or close |
| Mechanism of<br>Dissection<br>(Separation) | Bilateral jaw allows the user to separate planes of tissue | Unilateral jaw allows the user to separate planes of tissue | Unilateral jaw allows the user to separate<br>planes of tissue |
| Mechanism of<br>Action (Sealing) | Seal is created by application of RF energy to structures interposed between the jaws<br>of the instrument. | Seal is created by application of RF energy to structures interposed between the jaws<br>of the instrument. | Seal is created by the application of RF<br>energy to structures interposed between<br>the jaws of the instrument. |
| Seal Activation | Button on the sealer instrument handle activated by thumb | Button on the sealer instrument handle activated by thumb | Button on the sealer instrument handle<br>activated by full compression of the lever<br>or optional footswitch pedal |
| Knife Activation | Cutting trigger – non-energized | Cutting trigger – non-energized | Cutting trigger – non-energized |
| Automatic<br>sealing cycle | Yes | Yes | Yes |
| Rated Voltage<br>(Vpeak) | 190 Vpeak | | 288 Vpeak |
| Shaft Diameter | 5 mm | 5 mm | 5 mm |
| Shaft Length | 30 cm, 37 cm, 44 cm | 30 cm, 37 cm, 44 cm | 23 cm, 37 cm, 44 cm |
| Description | CoolSeal™ Trinity<br>(Subject Device) | CoolSeal™ Trinity<br>(Primary Predicate/K203183) | LigaSure Maryland (Secondary<br>Predicate/K170869) |
| Shaft Rotation | | >360° | 159°-359° |
| Seal Length | | 19 mm | 20 mm |
| How Supplied | | Single-use disposable | Single-use disposable |
| Tissue Contact<br>Materials | | Stainless steel, titanium, polymers, silicone, polymer adhesives, and insulating<br>coatings | Stainless steel, titanium, polymers,<br>silicone, polymer adhesives, and<br>insulating coatings |
| Surgical<br>Approach | | Open or laparoscopic | Open or laparoscopic |
| Sterilization | | Ethylene Oxide | Ethylene Oxide |
| Sterility<br>Assurance Level | | 10-6 | 10-6 |
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# BOLDER
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Image /page/8/Picture/2 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is in large, bold, blue letters, with a stylized "O" that has a black triangle in the upper left quadrant. Below "BOLDER" is the word "SURGICAL" in smaller, thinner, blue letters.
# PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
# Biocompatibility Testing
CoolSeal™ Trinity:
The biocompatibility evaluation for the CoolSeal™ Trinity 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™ system complies with relevant clauses of the ANSI/AAMI/IEC 60601-1 and ANSI/AAMI/IEC 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
CoolSeal™ Trinity:
Ex-vivo burst pressure testing of excised fresh porcine blood vessels was conducted on the subject device to demonstrate effective bipolar electrosurgical vessel sealing performance.
## In-vivo Thermal Spread Comparison
## CoolSeal™ Trinity:
Open laparotomy was performed in a porcine model using the subject device and predicate device. Each device was used to seal vessels and tissue bundles. Samples were excised for threedimensional histological assessments (e.g., length, width, and depth) to quantify thermal spread in seals created by both devices. This study demonstrated that the subject device is as safe and effective as the predicate device.
## Chronic Animal Study
## CoolSeal™ Trinity:
Chronic animal studies were conducted to assess safety and performance of bipolar vessel sealing with the subject device over the minimum 21-day survival period. All animals survived 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.
