(142 days)
No
The description focuses on the electrosurgical mechanism and mechanical features of the device, with no mention of AI or ML.
Yes
A therapeutic device is used in treating or managing a specific medical condition. This device is used for the ligation and division of vessels and tissue during surgery, which directly contributes to the treatment of a patient.
No
The Laparoscopic FMsealer is an electrosurgical instrument used for cutting, sealing, and coagulating tissue and vessels during surgical procedures; it does not diagnose medical conditions.
No
The device is a physical, hand-held surgical instrument with mechanical components (rotation knob, lever, buttons) and requires connection to a generator for electrical current, clearly indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Laparoscopic FMsealer Function: The description clearly states that the Laparoscopic FMsealer is an electrosurgical instrument used during surgical procedures (open and laparoscopic) to ligate and divide vessels and tissue within the body. It directly interacts with and modifies tissue inside the patient.
The intended use, device description, and performance studies all focus on the device's function as a surgical tool for tissue manipulation and sealing in vivo, not for analyzing samples in vitro.
N/A
Intended Use / 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 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use / Open and laparoscopic surgical procedures
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
Bench Testing: The Laparoscopic FMsealer passed all bench tests performed.
Study types 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. Electrical safety testing was successfully performed on this device according to IEC 60601-1 and IEC 60601-2-2. Biocompatibility testing was performed according to ISO 10993-5 (Cytotoxicity), 10993-10 (Acute Systemic Toxicity) and 10993-11 (Sensitization and Irritation).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
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
1
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
2
Premarket Submission: Laparoscopic FMsealer
Indications for Use
510(k) Number (if known): __________
Device Name: Laparoscopic FMsealer
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 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.
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
3
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
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.
Error! Reference source not found. Error! Reference source not found.
4
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).
| Performance
Feature | 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 |
| Classification
Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Basis Intended
Use | Sealing, cutting and coagulation of
soft tissue | Sealing, cutting and coagulation of
soft tissue | Sealing, cutting and coagulation of
soft tissue |
| Heat Generation
Method | Ferromagnetic induction provides
an elevated temperature surface
which will cauterize soft tissue as
it seals and cuts. | Ferromagnetic induction provides an
elevated temperature surface which
will cauterize soft tissue as it seals
and cuts. | Application of bipolar electrosurgical
energy to tissue interposed between
the jaws of the instrument. |
| Shaft Diameter | 5mm | N/A - The Open FMsealer for open
procedures only. | 5mm |
| Operational
Control Method | Controlled power delivered to tip
of connected accessory | Controlled power delivered to tip of
connected accessory | Controlled power delivered to tip of
connected accessory |
| Mode of
Operation | Intermittent Operation | Intermittent Operation | Intermittent Operation |
| Output Type | Type CF | Type CF | Unknown |
| Bench Testing | The Laparoscopic FMsealer
passed all bench tests performed.
Details are found in this
submission. | The FMwand System (Handpiece)
passed all bench tests performed.
Details are found in the original 510(k)
submission #K141484. | Unknown |
| Meets applicable
sections of IEC
60801-2-2 | Yes. Details are found this
submission. | Yes. Details are found in 510(k)
#K141484. | Unknown |
| Biocompatibility
Testing | 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). | Materials used in the patient-
contacting portions of the Open
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). Details
are found in the original 510(k)
submission, K141484. | Unknown |
| Sterilization
Method | Laparoscopic FMsealer is for
single-patient use and will be
provided sterile. Sterilization
method will be Ethylene Oxide:
SAL 10⁻⁶. | Open FMsealer is for single-patient
use and provided sterile. Sterilization
method is Ethylene Oxide: SAL 10⁻⁶. | Unknown |
Device Comparison Table
Error! Reference source not found. Error! Reference source not found.
5
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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