(191 days)
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 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 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, 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.
The provided text is a 510(k) summary for the CoolSeal™ Trinity electrosurgical device. It outlines the device's indications for use, technological characteristics, and performance data submitted to demonstrate substantial equivalence to predicate devices. However, this document primarily focuses on regulatory submission and does NOT contain information about an AI/ML-based medical device.
Therefore, I cannot extract the acceptance criteria or study details for an AI/ML device from this document as it describes a physical electrosurgical instrument and its testing. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are specific to the evaluation of AI/ML algorithms and are not relevant to the CoolSeal™ Trinity device described here.
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Image /page/0/Picture/0 description: The image shows 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.
May 6, 2021
Bolder Surgical, LLC Nicholas Wong Regulatory Affairs Manager 331 S. 104th Street, Suite 200 Louisville, Colorado 80027
Re: K203183
Trade/Device Name: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 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: March 26, 2021 Received: March 29, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K203183
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 arteries up to and including 6 mm, veins, 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 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 ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/2 description: The image shows the logo for Bolder Surgical. The word "BOLDER" is written in a sans-serif font, with the "O" being a circle with a small black diamond inside. Below "BOLDER" is the word "SURGICAL" in a smaller, thinner sans-serif font. The text is a dark blue color.
CoolSeal™ Trinity Traditional 510(k) Submission K203183
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
DEVICES
Trade Name / Model #:
CoolSeal™ Trinity
- 30 cm / CSL-TR105-30
- 37 cm / CSL-TR105-37 ●
- 44 cm / CSL-TR105-44 0
| 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: CoolSeal™ Trinity 510(k): K202114
Trade Name: JustRight™ Sealer 510(k) K160602
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
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CoolSeal™ Trinity Traditional 510(k) Submission K203183
the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.
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 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 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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203183
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്ലൂറ്റുല്ല e
raditional 510(k) Submission
raditional 510(k) Submission
OMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
ble 1 below presents the comparison of technological characteristics between the swbject device and the
| Description | CoolSeal™ Trinity (Subject Device) | CoolSeal™ Trinity (Predicate/K202114) | JustRight™ Sealer (Predicate/K160602) |
|---|---|---|---|
| Indicationsfor Use | 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 ingeneral surgery procedures includingurologic, vascular, and gynecologic. It isindicated for use in adult and pediatricpopulations (infants, children, andadolescents). | 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 ingeneral surgery procedures includingurologic, vascular, and gynecologic. | The JustRight Surgical® Vessel SealingSystem is intended for use in open andlaparoscopic general surgical procedures toseal blood vessels and vascular bundles up toand including 5 mm in diameter for use inadult and pediatric populations, wherevervessel ligation is required. |
| 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 in ENTprocedures. | |
| Where used(environment) | Operating Room | Operating Room | Operating Room |
| Intended User | Surgeons | Surgeons | Surgeons |
| Description | CoolSeal™ Trinity (Subject Device) | CoolSeal™ Trinity (Predicate/K202114) | JustRight™ Sealer (Predicate/K160602) |
| Anatomical Sites | Vessels, tissue bundles, and lymphatics | Vessels, Tissue bundles | |
| Anatomical Size | Arteries up to and including 6 mm, veins, and vascular bundles up to and including 7 mm in diameter | Up to and including 5 mm diameter | |
| Patient Population | Adult and Pediatric (infants, children, and adolescents) | Not specified | Adult and Pediatric |
| Power Source | Bipolar energy platform | Bipolar energy platform | |
| Primary Functions | Grasp, Dissect, Seal, Divide | Grasp, Dissect, Seal | |
| Mechanism of Grasping | Hand actuated lever allows user to open or close | Hand actuated lever allows user to open or close | |
| Mechanism of Dissection (Separation) | Bilateral jaw allows user to separate planes of tissue | Bilateral jaw allows user to separate planes of tissue | |
| Mechanism of Action (Sealing) | Seal is created by application of RF energy to structures interposed between the jaws of the instrument. | Seal is created by application of RF energy to structures interposed between the jaws of the instrument. | |
| Seal Activation | Button on the sealer instrument handle activated by thumb | Button on the sealer instrument handle activated by user | |
| Knife Activation | Cutting trigger – non-energized | No cutting functionality. | |
| Automatic Sealing cycle | Yes | Yes | |
| Rated Voltage (Vpeak) | 190 Vpeak | 190 Vpeak | |
| Maximum Output Power | 35 Watts | 25 Watts | |
| Jaw Dimensions – Side Width | Proximal Side Width: 4.5 mmDistal Side Width: 2.3 mm | Proximal Side Width: 3.3 mmDistal Side Width: 1.4 mm | |
| Description | CoolSeal™ Trinity (Subject Device)CoolSeal™ Trinity (Predicate/K202114) | JustRight™ Sealer (Predicate/K160602) | |
| ThermalCoating onJaws | Present | Present | |
| ShaftDiameter | 5 mm | 3 mm | |
| Shaft Length | 30 cm, 37 cm, 44 cm | 20 cm | |
| ShaftRotation | >360° | 340° | |
| Seal Length | 19 mm | 10.5 mm | |
| Seal Quality | Greater than 3x systolic pressure | Greater than 3x systolic pressure | |
| SealWidth/Plate | Seal Plate Width: 1.8 mm throughout | Seal Plate Width:Proximal: 3.3 mmDistal: 1.4 mm | |
| Mean thermalspread | Less than 1 mm | Less than 1 mm | |
| HowSupplied | Sealer instruments are single use disposable | Sealer instruments are single use disposable | |
| TissueContactMaterials | Stainless steel, titanium, polymers, silicone, polymer adhesives, and insulating coatings | Stainless steel, titanium, polymers, silicone, polymer adhesives, and insulating coatings | |
| SurgicalApproach | Open or laparoscopic | Open or laparoscopic | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | |
| SterilityAssuranceLevel | 10-6 | 10-6 |
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ទ្រប្រពុទ្ធស្នាប់មកមួ
raditional 510(k) Submission
raditional 510(k) Submission
K203183
Page 4 of 7
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នប្រព័ន្ធបន្តបុគ្គន
Page 5 of 7
CoolSeal™ Trinity
Faditional 510(k) Submission
L
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| BOLDERSURGICAL | CoolSeal™ TrinityTraditional 510(k) SubmissionK203183 |
|---|---|
| PERFORMANCE DATAThe following performance data were provided in support of the substantial equivalence determination. | |
| Biocompatibility TestingCoolSeal™ Trinity:The biocompatibility evaluation for the CoolSeal™ Trinity was conducted in accordance with ISO 10993-1, Biological evaluation ofmedical 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 TestingMechanical, electrical, and functional testing was carried out to verify that the proposed device performed as expected. | |
| Ex-vivo and In-vivo Vessel Burst PressureCoolSeal™ 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. Additionally, in-vivo burst pressure testing of lymphatics was conducted on the subject device to demonstrate effective bipolar electrosurgical vessel sealing performance. | |
| In-vivo Thermal Spread ComparisonCoolSeal™ 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 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. | |
| CoolSeal™ TrinityTraditional 510(k) SubmissionK203183 | |
| A chronic study was conducted to assess safety and performance of bipolar vessel sealing with the subject device over the course of 28 days. All animals survived 28 days post-op without any complications. All vessel sealing effects on tissue maintained chronic hemostasis and healed as anticipated. | |
| Clinical Data | |
| A literature review, including meta-analysis, was conducted to evaluate complication rates noted for vessel sealers in pediatric populations compared to adult populations. This information supports a device indication for use in both adult and pediatric populations. | |
| 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. |
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Chronic Animal Study
CoolSeal™ Trinity:
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§ 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.