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.

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.

AI/ML Overview

This document (K211579) describes a 510(k) premarket notification for the CoolSeal™ Trinity, a bipolar electrosurgical instrument. The information provided heavily focuses on the device's technical specifications, indications for use, and a comparison to predicate devices, along with general statements about safety and performance testing. However, it does not contain the specific details regarding acceptance criteria and the comprehensive study that proves the device meets those criteria, especially in the context of an AI/ML-based device.

The document confirms that mechanical, electrical, and functional testing was carried out, along with ex-vivo and in-vivo vessel burst pressure studies, in-vivo thermal spread comparison, and chronic animal studies. While these are performance studies, they are geared towards demonstrating the safety and effectiveness of a physical electrosurgical medical device and not an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device's performance from this document. The document primarily addresses the substantial equivalence of a surgical instrument to its predicates.

To answer your request, the document would need to contain information about:

A specific algorithm or AI component.
Performance metrics like sensitivity, specificity, AUC, or accuracy (for classification tasks).
Details on test datasets (sample size, provenance, ground truth establishment, adjudication).
Details on training datasets.
MRMC study results, if applicable.

Since this information is not present, I must state that the document does not provide the necessary data to answer the request in the context of an AI/ML device.

Summary

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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)

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:

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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(Subject Device)	CoolSeal™ Trinity(Primary Predicate/K203183)	LigaSure Maryland (Secondary Predicate/K170869)
Indications forUse	The CoolSeal™ Trinity is a bipolarelectrosurgical instrument intended foruse in minimally invasive or opensurgical procedures where ligation anddivision of vessels, tissue bundles, andlymphatics is desired. The CoolSeal™Trinity can be used on vessels (arteries,veins, and vascular bundles) up to andincluding 7 mm in diameter. It isindicated for use in general surgeryprocedures including urologic, vascular,and gynecologic. It is indicated for use inadult and pediatric populations (infants,children, and adolescents). Proceduresmay include, but are not limited to,Nissen fundoplication, colectomy,cholecystectomy, adhesiolysis,hysterectomy, oophorectomy, etc.	The CoolSeal™ Trinity is a bipolarelectrosurgical instrument intended foruse in minimally invasive or opensurgical procedures where ligation anddivision of vessels, tissue bundles, andlymphatics is desired. The CoolSeal™Trinity can be used on arteries up to andincluding 6 mm, veins, and vascularbundles up to and including 7 mm indiameter. It is indicated for use in generalsurgery procedures including urologic,vascular, and gynecologic. It is indicatedfor use in adult and pediatric populations(infants, children, and adolescents).	The LigaSure Sealer/Divider is a bipolarelectrosurgical instrument intended foruse in minimally invasive or opensurgical procedures where ligation anddivision of vessels, tissue bundles, andlymphatics is desired. The LigaSureSealer/ Divider can be used on vessels(arteries, veins, and vascular bundles) upto and including 7 mm in diameter. It isindicated for use in general surgeryprocedures and such surgical specialtiesas urologic, vascular, thoracic, andgynecologic. Procedures may include, butare not limited to, Nissen fundoplication,colectomy, cholecystectomy,adhesiolysis, hysterectomy,oophorectomy, etc.
	The CoolSeal™ Trinity has not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures. Do not use theCoolSeal™ Trinity for these procedures.The device is contraindicated for use inENT procedures.	The CoolSeal™ Trinity has not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures. Do not use theCoolSeal™ Trinity for these procedures.The device is contraindicated for use inENT procedures.	The LigaSure system has not been shownto be effective for tubal sterilization ortubal coagulation for sterilizationprocedures. Do not use the LigaSuresystem for these procedures.
Where used(environment)	Operating Room		Operating Room

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Description	CoolSeal™ Trinity(Subject Device)	CoolSeal™ Trinity(Primary Predicate/K203183)	LigaSure Maryland (SecondaryPredicate/K170869)
Intended User	Surgeons	Surgeons	Surgeons
AnatomicalSites	Vessels, tissue bundles, and lymphatics	Vessels, tissue bundles, and lymphatics	Vessels, tissue bundles, and lymphatics
Anatomical Size	Arteries, veins, and vascular bundles upto and including 7 mm in diameter	Arteries up to and including 6 mm,veins, and vascular bundles up to andincluding 7 mm in diameter	Arteries, veins, and vascular bundles upto and including 7 mm in diameter
PatientPopulation	Adult and pediatric populations (infants, children, and adolescents).		Not specified
Power Source	Bipolar energy platform	Bipolar energy platform	Bipolar energy platform
PrimaryFunctions	Grasp, Dissect, Seal, Divide	Grasp, Dissect, Seal, Divide	Grasp, Dissect, Seal, Divide
Mechanism ofGrasping	Hand actuated lever allows user to open or close	Hand actuated lever allows user to open or close	Hand actuated lever allows user to openor close
Mechanism ofDissection(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 separateplanes of tissue
Mechanism ofAction (Sealing)	Seal is created by application of RF energy to structures interposed between the jawsof the instrument.	Seal is created by application of RF energy to structures interposed between the jawsof the instrument.	Seal is created by the application of RFenergy to structures interposed betweenthe 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 handleactivated by full compression of the leveror optional footswitch pedal
Knife Activation	Cutting trigger – non-energized	Cutting trigger – non-energized	Cutting trigger – non-energized
Automaticsealing 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 (SecondaryPredicate/K170869)
Shaft Rotation		>360°	159°-359°
Seal Length		19 mm	20 mm
How Supplied		Single-use disposable	Single-use disposable
Tissue ContactMaterials		Stainless steel, titanium, polymers, silicone, polymer adhesives, and insulatingcoatings	Stainless steel, titanium, polymers,silicone, polymer adhesives, andinsulating coatings
SurgicalApproach		Open or laparoscopic	Open or laparoscopic
Sterilization		Ethylene Oxide	Ethylene Oxide
SterilityAssurance 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.

Regulation Number and Section

§ 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.