(109 days)
Not Found
No
The summary describes a standard electrosurgical instrument for vessel sealing and division using RF energy and a mechanical blade. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on traditional medical device testing like biocompatibility, electrical safety, mechanical function, and ex-vivo/in-vivo performance metrics like burst pressure and thermal spread.
Yes.
Explanation: The device is an electrosurgical instrument used for ligation and division of vessels and tissue in surgical procedures to achieve hemostasis and tissue dissection, which directly treats medical conditions by performing therapeutic actions.
No
The device is an electrosurgical instrument used for ligation, division, and dissection of tissue and vessels during surgical procedures, not for diagnostic purposes.
No
The device description clearly states it is a bipolar electrosurgical instrument with a physical shaft, jaws, and blade, designed for use with a generator. This indicates it is a hardware device, not software-only.
Based on the provided information, the CoolSeal™ Trinity is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's a surgical instrument for ligation and division of vessels, tissue bundles, and lymphatics during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a surgical instrument with jaws and a blade for sealing and dividing tissue using electrosurgical energy. This is a physical tool used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The CoolSeal™ Trinity does not perform any such analysis of specimens.
Therefore, the CoolSeal™ Trinity is a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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 populations (infants, children, and adolescents).
Intended User / Care Setting
Surgeons / 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™ 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: 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: 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 three-dimensional 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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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
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/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
2
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)
| ☑ 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 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.
4
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.
5
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
(Subject Device) | CoolSeal™ Trinity
(Primary Predicate/K203183) | LigaSure Maryland (Secondary Predicate/K170869) |
|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
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 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 arteries up to and
including 6 mm, 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). | The LigaSure Sealer/Divider 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 LigaSure
Sealer/ Divider 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 and such surgical specialties
as urologic, vascular, thoracic, and
gynecologic. 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. | 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. | 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 |
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| ਖੱ | |
|---|---|
| பப | C |
| 1 | |
| l | |
| 기 이 | |
| 0- | |
| a o |
| Description | CoolSeal™ Trinity
(Subject Device) | CoolSeal™ Trinity
(Primary Predicate/K203183) | LigaSure Maryland (Secondary
Predicate/K170869) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Intended User | Surgeons | Surgeons | Surgeons |
| Anatomical
Sites | Vessels, tissue bundles, and lymphatics | Vessels, tissue bundles, and lymphatics | Vessels, tissue bundles, and lymphatics |
| Anatomical Size | Arteries, veins, and vascular bundles up
to and including 7 mm in diameter | Arteries up to and including 6 mm,
veins, and vascular bundles up to and
including 7 mm in diameter | Arteries, veins, and vascular bundles up
to and including 7 mm in diameter |
| Patient
Population | Adult and pediatric populations (infants, children, and adolescents). | | Not specified |
| Power Source | Bipolar energy platform | Bipolar energy platform | Bipolar energy platform |
| Primary
Functions | Grasp, Dissect, Seal, Divide | 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 | Hand actuated lever allows user to open
or close |
| Mechanism of
Dissection
(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
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 is created by the application of RF
energy to structures interposed between
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
activated by full compression of the lever
or optional footswitch pedal |
| Knife Activation | Cutting trigger – non-energized | Cutting trigger – non-energized | Cutting trigger – non-energized |
| Automatic
sealing cycle | Yes | Yes | Yes |
| Rated Voltage
(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
(Subject Device) | CoolSeal™ Trinity
(Primary Predicate/K203183) | LigaSure Maryland (Secondary
Predicate/K170869) |
| Shaft Rotation | | >360° | 159°-359° |
| Seal Length | | 19 mm | 20 mm |
| How Supplied | | Single-use disposable | Single-use disposable |
| 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 or laparoscopic | Open or laparoscopic |
| Sterilization | | Ethylene Oxide | Ethylene Oxide |
| Sterility
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.