(219 days)
Not Found
No
The 510(k) summary describes a standard electrosurgical instrument for sealing and dividing tissue using RF energy. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of such capabilities. The performance studies focus on electrical, thermal, and burst pressure testing, which are typical for this type of device.
Yes
The device is intended for use in surgical procedures to ligate and divide vessels and tissue, which is a therapeutic action.
No
The device is an electrosurgical instrument used for various surgical procedures involving the ligation and division of vessels and tissue, not for diagnosing conditions. Its function is to treat or manipulate tissue, not to evaluate or identify diseases.
No
The device description clearly states it is a bipolar electrosurgical instrument with a physical shaft, jaws, and a 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 that the device is a bipolar electrosurgical instrument used in surgical procedures for ligation and division of vessels, tissue bundles, and lymphatics. This is a surgical tool used on the patient during a procedure.
- Device Description: The description details a surgical instrument with jaws, a blade, and a shaft, designed to apply RF energy and divide tissue. This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to perform tests on samples taken from a patient. The CoolSeal™ Trinity is used directly on the patient during surgery.
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, 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.
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 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
Arteries, veins, and vascular bundles up to and including 7 mm in diameter
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)
Electrical and Thermal Testing: verified that the proposed subject device performed as expected when connected to the E-200 generator.
Ex-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 that is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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.
November 15, 2023
Bolder Surgical, LLC Nicholas Wong Sr. Manager, Regulatory Affairs 331 S. 104th Street Suite 200 Louisville, Colorado 80027
Re: K231012
Trade/Device Name: CoolSeal Trinity Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 20, 2023 Received: October 24, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.11.15
13:42:02-05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
See PRA Statement below.
510(k) Number (if known)
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, adhesioly, 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
SUBMITTER
Bolder Surgical, LLC. (now part of Hologic, Inc.) 331 S. 104th Street, Suite 200 Louisville, CO 80027
Phone: 720-287-7130 Fax: 720-287-7135
Contact Person: Nick Wong Sr. Manager, Regulatory Affairs
Date Prepared: April 5th, 2023
DEVICES
Trade Name / Model #:
CoolSealTM Trinity
- . 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 DEVICE
Trade Name: CoolSeal™ Trinity 510(k): K211579
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 shaft lengths: 30 cm, 37 cm, and 44 cm.
INDICATIONS FOR USE
CoolSeal™ Trinity:
5
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Table 1 below compares technological characteristics between the subject and predicate devices. As Table 1 illustrates, all characteristics are the same, with the only difference being the identification of a new compatible electrosurgical generator.
| Description | CoolSeal™ Trinity
(Subject Device) | CoolSeal™ Trinity
(Predicate - K211579) |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 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 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 | |
| Intended User | Surgeons | |
| Anatomical Sites | Vessels, tissue bundles, and lymphatics | |
| Anatomical Size | Arteries, veins, and vascular bundles up to and including 7 mm in diameter | |
| Patient Population | Adult and pediatric populations (infants, children, and adolescents). | |
| Power Source | Bipolar energy platform | |
| Compatible
Electrosurgical
Generator | CoolSeal Generator
Da Vinci E-200 | CoolSeal Generator |
| Primary Functions | Grasp, Dissect, Seal, Divide | |
Table 1. Presents the subject device compared to the predicate device.
6
| Description | CoolSeal™ Trinity
(Subject Device) | CoolSeal™ Trinity
(Predicate - K211579) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Mechanism of
Grasping | Hand actuated lever allows user to open or close | |
| Mechanism of
Dissection
(Separation) | Bilateral 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 Activation | Button on the sealer instrument handle activated by thumb | |
| Knife Activation | Cutting trigger – non-energized | |
| Automatic sealing
cycle | Yes | |
| Rated Voltage
(Vpeak) | 190 Vpeak | |
| Shaft Diameter | 5 mm | |
| Shaft Length | 30 cm, 37 cm, 44 cm | |
| Shaft Rotation | >360° | |
| Seal Length | 19 mm | |
| How Supplied | Single-use disposable | |
| Tissue Contact
Materials | Stainless steel, titanium, polymers, silicone, polymer adhesives, and insulating
coatings | |
| Surgical Approach | Open or laparoscopic | |
| Sterilization | Ethylene Oxide | |
| Sterility Assurance
Level | 10-6 | |
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electrical and Thermal Testing
Electrical and thermal testing verified that the proposed subject device performed as expected when connected to the E-200 generator.
Ex-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 that is equivalent to the predicate device.
CONCLUSIONS
Based on a review of performance data, comparison of the device classification, intended use, operating principles, and technological characteristics, the subject device is safe, as effective, and performs as well as the legally marketed predicate device.