(191 days)
Not Found
No
The summary describes a standard electrosurgical instrument for vessel sealing and division. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on mechanical, electrical, and biological effects, not algorithmic performance.
Yes
The device is described as a bipolar electrosurgical instrument for use in surgical procedures to ligate and divide vessels and tissue. It uses radiofrequency energy to seal tissues and has a blade to divide them, which are therapeutic actions to treat medical conditions.
No.
The device is an electrosurgical instrument designed for sealing and dividing tissue during surgical procedures, not for diagnostic purposes.
No
The device description clearly states it is a physical instrument (Maryland Laparoscopic Sealer, Divider, and Dissector) with a shaft, jaws, and a blade, designed for use with a generator. It is a single-use disposable instrument that applies RF energy and physically divides tissue. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired." This describes a surgical instrument used directly on living tissue within the body.
- Device Description: The description details a "bipolar electrosurgical instrument" that "creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures... interposed between its jaws." This is a description of a surgical tool for manipulating and sealing tissue during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on samples outside the body.
The CoolSeal™ Trinity is a surgical instrument 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 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.
Product codes
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. 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 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Seal Quality: Greater than 3x systolic pressure
Mean thermal spread: Less than 1 mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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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
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
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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
4
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.
5
203183
Page 3 of 7
്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) |
|---|---|---|---|
| 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 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 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. | The JustRight Surgical® Vessel Sealing | ||
| System is intended for use in open and | |||
| laparoscopic general surgical procedures to | |||
| seal blood vessels and vascular bundles up to | |||
| and including 5 mm in diameter for use in | |||
| adult and pediatric populations, wherever | |||
| vessel ligation is required. | |||
| 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. | |||
| 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 mm | ||
| Distal Side Width: 2.3 mm | Proximal Side Width: 3.3 mm | ||
| Distal Side Width: 1.4 mm | |||
| Description | CoolSeal™ Trinity (Subject Device) | ||
| CoolSeal™ Trinity (Predicate/K202114) | JustRight™ Sealer (Predicate/K160602) | ||
| Thermal | |||
| Coating on | |||
| Jaws | Present | Present | |
| Shaft | |||
| Diameter | 5 mm | 3 mm | |
| Shaft Length | 30 cm, 37 cm, 44 cm | 20 cm | |
| Shaft | |||
| Rotation | >360° | 340° | |
| Seal Length | 19 mm | 10.5 mm | |
| Seal Quality | Greater than 3x systolic pressure | Greater than 3x systolic pressure | |
| Seal | |||
| Width/Plate | Seal Plate Width: 1.8 mm throughout | Seal Plate Width: | |
| Proximal: 3.3 mm | |||
| Distal: 1.4 mm | |||
| Mean thermal | |||
| spread | Less than 1 mm | Less than 1 mm | |
| How | |||
| Supplied | Sealer instruments are single use disposable | Sealer instruments are 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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Page 4 of 7
ទ្រប្រពុទ្ធស្នាប់មកមួ
raditional 510(k) Submission
raditional 510(k) Submission
K203183
Page 4 of 7
7
នប្រព័ន្ធបន្តបុគ្គន
Page 5 of 7
CoolSeal™ Trinity
Faditional 510(k) Submission
L
8
| BOLDER
SURGICAL | CoolSeal™ Trinity
Traditional 510(k) Submission
K203183 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| 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. 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 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 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™ Trinity
Traditional 510(k) Submission
K203183 |
| 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. | |
Page 6 of 7
Chronic Animal Study
CoolSeal™ Trinity:
9