The Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation and division of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instrument.

The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

Device Description

Electrosurgical cutting and coagulation devices (and accessories) are devices intended to remove tissue and control bleeding by use of high-frequency electrical current (see 21 CFR §878.4400). They are classified as Class II (510(k)) devices.

The Laparoscopic FMsealer is a sterile, single-patient use, hand-held surgical instrument intended for ligation and division of vessels. The Laparoscopic FMsealer must be connected to a generator (Domain Surgical's FMwand Generator) by an accessory cable (Domain Surgical's FMwand Power Module). It is capable of blunt dissection, grasping and division of tissue enclosed within its jaws during open or laparoscopic procedures. The outer diameter of the instrument shaft is 5mm, with a working length of 36cm.

The Laparoscopic FMsealer includes a rotation knob, front lever and two actuation buttons. The rotation knob, located at the distal end of the handle, allows for a full 360 degrees of rotation of the jaws to improve visibility of the tissue as well as permit access to tissues on differing planes. The front lever closes the jaws of the device which allows pressure to be applied to the tissue between the jaws. The actuation buttons activate the transfer of current from the generator to the tip of the device which creates the heat necessary for sealing and dividing.

This system creates sealing, cutting and coagulation of heat and compression (from the opposing jaws of the device) to tissue bundles and vessels interposed between the jaws of the instrument.

The Laparoscopic FMsealer has been shown to cut and seal vessels (veins and arteries) up to and including 7mm in diameter.

AI/ML Overview

This document describes the Premarket Notification for the "Laparoscopic FMsealer." The acceptance criteria and the study that proves the device meets them are outlined.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" with quantitative performance metrics for the Laparoscopic FMsealer, such as specific burst pressures for sealed vessels. Instead, it states that the device "passed all bench tests performed" and details the types of tests conducted. The key performance claim is its ability to seal vessels up to and including 7mm. The comparison to predicate devices focuses on technological characteristics and overall safety and effectiveness.

Here's a summary of the implicit acceptance criteria based on the described tests and the reported performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Performance for Vessel Sealing and Division:
Ability to ligate and divide vessels up to and including 7mm and bundles as large as will fit in the jaws.	"The Laparoscopic FMsealer has been shown to cut and seal vessels (veins and arteries) up to and including 7mm in diameter." This was demonstrated through "Ex-Vivo Vessel Sealing Test Results (2mm-7mm Porcine Arteries)" and "In-vivo GLP Chronic Animal Study - Vessel Sealing." The specific quantitative results (e.g., burst pressures, seal integrity) are not provided in this summary but are referenced as being in the full submission.
Demonstrate effective sealing and cutting in both open and laparoscopic surgical procedures for general and gynecologic applications.	"In-vivo GLP Acute Animal Study - Laparoscopic Stress Testing" and "In-vivo GLP Chronic Animal Study - Vessel Sealing" were conducted. The device is intended for "open and laparoscopic surgical procedures."
Thermal Safety: Prevent excessive thermal spread to surrounding tissues.	"Vessel Sealing Tool Thermal Test" was performed, indicating evaluation of thermal characteristics. The ferromagnetic induction method is described as providing "an elevated temperature surface which will cauterize soft tissue as it seals and cuts." The intent is to show safe and controlled thermal management.
Electrical Safety: Comply with relevant electrical safety standards.	"Electrical safety testing was successfully performed on this device according to IEC 60601-1 and IEC 60601-2-2." Furthermore, the device "Meets applicable sections of IEC 60801-2-2" (presumably an error in the document and should be IEC 60601-2-2), and its "Output Type" is "Type CF" (indicating a high degree of patient protection against electric shock).
Biocompatibility: Materials in patient-contacting portions must be safe for human use.	"Materials used in the patient-contacting portions of the Laparoscopic FMsealer are either known to be biocompatible or have passed testing performed according to ISO 10993-5 (Cytotoxicity), 10993-10 (Acute Systemic Toxicity) and 10993-11 (Sensitization and Irritation)."
Sterility: Device must be provided sterile with an appropriate sterility assurance level (SAL).	"Laparoscopic FMsealer is for single-patient use and will be provided sterile. Sterilization method will be Ethylene Oxide: SAL 10⁻⁶."
Mechanical Integrity/Durability: Withstand normal surgical use conditions.	The document states "All applicable bench testing was performed with the Laparoscopic FMsealer to assure that it functions as intended." While not explicitly detailed, this would include mechanical evaluations of the rotation knob, levers, and jaw mechanism.
Substantial Equivalence: Demonstrate that the device is as safe and effective as predicate devices and does not raise new questions of safety and effectiveness, despite technological differences (e.g., heat generation method compared to LigaSure).	The conclusion explicitly states: "The Laparoscopic FMsealer is substantially equivalent to the predicate devices... The information presented in this 510(k), including the bench and animal testing, demonstrates that the Laparoscopic FMsealer is as safe and effective as the predicate devices for its intended use." Differences in technological characteristics (ferromagnetic induction vs. bipolar electrosurgery) were analyzed and determined not to raise new questions of safety and effectiveness.

2. Sample Sized Used for the Test Set and the Data Provenance:

The document provides the following information regarding test samples:

Ex-Vivo Vessel Sealing Test Results: 2mm-7mm Porcine Arteries. (The exact number of arteries or samples tested is not specified in this summary. "Porcine" indicates animal origin, not human.)
In-vivo GLP Acute Animal Study - Laparoscopic Stress Testing: Animal study. (The specific species and number of animals are not detailed in this summary.)
In-vivo GLP Chronic Animal Study - Vessel Sealing: Animal study. (The specific species and number of animals are not detailed in this summary.)
Provenance: All animal studies (Ex-vivo and In-vivo) are based on animal tissue/models. The GLP (Good Laboratory Practice) designation indicates a regulatory standard for non-clinical laboratory studies. The studies are prospective in nature as they are specifically conducted to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document does not specify the number of experts or their qualifications for establishing ground truth for the animal studies or ex-vivo tests. In medical device submissions, animal studies are typically overseen by veterinarians and surgical specialists, and their observations and measurements serve as the "ground truth" for success or failure criteria (e.g., successful hemostasis, lack of thermal injury, absence of late complications). However, these details are not provided in this summary.

4. Adjudication Method for the Test Set:

The document does not explicitly state an adjudication method (like 2+1 or 3+1). For the reported tests (Ex-Vivo and In-vivo Animal Studies), results would typically be objectively measured (e.g., burst pressure, direct observation of tissue integrity, histological evaluation) rather than requiring consensus among human experts for interpreting results in the same way clinical image interpretation studies might. Data analysis would follow standard statistical methods for the parameters measured.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this device submission. The Laparoscopic FMsealer is an electrosurgical instrument for vessel sealing, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant. The studies performed were for direct device performance and safety.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable to this device. As an electrosurgical instrument, its performance is inherently human-in-the-loop as it is manipulated by a surgeon. There is no "algorithm only" performance to evaluate in this context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance studies primarily relies on:

Direct observation and measurement: In both ex-vivo and in-vivo animal studies, the success of vessel sealing (e.g., hemostasis, lack of bleeding, integrity of the seal) would be directly observed.
Pathology/Histology: For chronic animal studies, tissue samples would likely be sent for histological examination to assess seal quality, thermal injury, and healing over time.
Functional outcomes: For the animal studies, the functional outcome related to the intended use (ligation and division of vessels) is evaluated.

8. The Sample Size for the Training Set:

This is not applicable. The Laparoscopic FMsealer is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Device development involves engineering design, prototyping, and iterative testing, not explicit data training sets.

9. How the Ground Truth for the Training Set was Established:

This is not applicable as there is no "training set" for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002

May 13, 2015

Domain Surgical Incorporated Mr. Curtis Jensen Vice President of Quality and Regulatory Affairs 1370 South 2100 East Salt Lake City, Utah 84108

Re: K142229

Trade/Device Name: Laparoscopic FMsealer Regulation Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 22, 2014 Received: December 24, 2014

Dear Mr. Jensen:

This letter corrects our substantially equivalent letter of January 2, 2015.

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Curtis Jensen

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Submission: Laparoscopic FMsealer

Indications for Use

510(k) Number (if known): __________

Device Name: Laparoscopic FMsealer

Indications for Use:

The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: __ (21 CFR 801 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Section 4:Indications for Use

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510(k) Summarv

SUBMITTER

Domain Surgical, Inc. 1370 South 2100 East Salt Lake City, Utah 84108 Phone: 801-924-4958 Fax: 801-924-4951

Contact Person: Curtis Jensen Date Prepared: May 16, 2013

DEVICE

Name of Device: Laparoscopic FMsealer Common or Usual Name: Electrosurgical cutting and coagulation device and accessories Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR §878.4400) Requiatory Class: II Product Code: GEI

PREDICATE DEVICES

LigaSure Vessel Sealing System (Product Code GEI) 510(k) #K043273 Open FMsealer (Product Code GEI) 510(k) #K141484

No reference devices were used in this submission.

DEVICE DESCRIPTION

This system creates sealing, cutting and coagulation of heat and compression (from the opposing jaws of the device) to tissue bundles and vessels interposed between the jaws of the instrument.

The Laparoscopic FMsealer has been shown to cut and seal vessels (veins and arteries) up to and including 7mm in diameter.

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INDICATIONS FOR USE

The Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICEs

The Laparoscopic FMsealer employs ferromagnetic induction to generate heat at the tip. This method of heat generation is the same as for the Open FMsealer (K141484), and differs from the LigaSure System which uses the resistance of the target tissue and electrical current to produce the heat necessary for cutting and sealing (bipolar electrosurgery).

PerformanceFeature	Laparoscopic FMsealer	Open FMsealer (K141484)	LigaSure Vessel Sealing System(K043273)
Manufacturer	Domain Surgical, Inc.	Domain Surgical, Inc.	ValleyLab
510(k) Number	To be assigned	K141484	K043273
Prescription/OTC	Prescription Only	Prescription Only	Prescription Only
Product Code	GEI	GEI	GEI
ClassificationRegulation	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
Basis IntendedUse	Sealing, cutting and coagulation ofsoft tissue	Sealing, cutting and coagulation ofsoft tissue	Sealing, cutting and coagulation ofsoft tissue
Heat GenerationMethod	Ferromagnetic induction providesan elevated temperature surfacewhich will cauterize soft tissue asit seals and cuts.	Ferromagnetic induction provides anelevated temperature surface whichwill cauterize soft tissue as it sealsand cuts.	Application of bipolar electrosurgicalenergy to tissue interposed betweenthe jaws of the instrument.
Shaft Diameter	5mm	N/A - The Open FMsealer for openprocedures only.	5mm
OperationalControl Method	Controlled power delivered to tipof connected accessory	Controlled power delivered to tip ofconnected accessory	Controlled power delivered to tip ofconnected accessory
Mode ofOperation	Intermittent Operation	Intermittent Operation	Intermittent Operation
Output Type	Type CF	Type CF	Unknown
Bench Testing	The Laparoscopic FMsealerpassed all bench tests performed.Details are found in thissubmission.	The FMwand System (Handpiece)passed all bench tests performed.Details are found in the original 510(k)submission #K141484.	Unknown
Meets applicablesections of IEC60801-2-2	Yes. Details are found thissubmission.	Yes. Details are found in 510(k)#K141484.	Unknown
BiocompatibilityTesting	Materials used in the patient-contacting portions of theLaparoscopic FMsealer are eitherknown to be biocompatible orhave passed testing performedaccording to ISO 10993-5(Cytotoxicity), 10993-10 (AcuteSystemic Toxicity) and 10993-11(Sensitization and Irritation).	Materials used in the patient-contacting portions of the OpenFMsealer are either known to bebiocompatible or have passed testingperformed according to ISO 10993-5(Cytotoxicity), 10993-10 (AcuteSystemic Toxicity) and 10993-11(Sensitization and Irritation). Detailsare found in the original 510(k)submission, K141484.	Unknown
SterilizationMethod	Laparoscopic FMsealer is forsingle-patient use and will beprovided sterile. Sterilizationmethod will be Ethylene Oxide:SAL 10⁻⁶.	Open FMsealer is for single-patientuse and provided sterile. Sterilizationmethod is Ethylene Oxide: SAL 10⁻⁶.	Unknown

Device Comparison Table

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The differences between the Laparoscopic FMsealer and the predicate devices are discussed and analyzed in detail in the appropriate section of this submission. None of the differences raise new questions of safety and effectiveness.

PERFORMANCE DATA

Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other similar devices on the market. All applicable bench testing was performed with the Laparoscopic FMsealer to assure that it functions as intended. Testing included:

Vessel Sealing Tool Thermal Test

Ex-Vivo Vessel Sealing Test Results (2mm-7mm Porcine Arteries)

In-vivo GLP Acute Animal Study - Laparoscopic Stress Testing

In-vivo GLP Chronic Animal Study - Vessel Sealing

Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other similar devices on the market. Electrical safety testing was successfully performed on this device according to IEC 60601-1 and IEC 60601-2-2.

The patient-contacting materials used in the Laparoscopic FMsealer were chosen for their biocompatibility, function and suitability for the intended use of this device. The materials have been tested to assure that they comply with the ISO 10993 standards and 510(k) Memorandum G95-1.

CONCLUSIONS

The Laparoscopic FMsealer is substantially equivalent to the predicate devices. The intended use of the Laparoscopic FMsealer is the same as the predicate devices with the addition of use in laparoscopic procedures. This minor difference has no effect on safety or effectiveness. The Laparoscopic FMsealer differs from the LigaSure device in technological characteristics; however the differences do not raise different types of questions of safety and effectiveness. The information presented in this 510(k), including the bench and animal testing, demonstrates that the Laparoscopic FMsealer is as safe and effective as the predicate devices for its intended use.

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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.