(98 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
No
The device is described as a surgical tool for cutting and coagulating soft tissue and for smoke evacuation, which are procedural functions rather than therapeutic ones.
No.
The device is indicated for cutting and coagulation of soft tissue and for removing smoke during surgical procedures, which are therapeutic and supportive functions, not diagnostic.
No
The device description explicitly states it is a "sterile, single-patient use, soft tissue cutting and coagulation device," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery". This describes a surgical tool used directly on the patient's body, not a device used to examine samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its use as a surgical handpiece for soft tissue cutting and coagulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely surgical and smoke evacuation.
N/A
Intended Use / Indications for Use
The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Product codes
GEI
Device Description
The FMwand Handpiece SE is a sterile, single-patient use, soft tissue cutting and coagulation device intended to be used with the FMwand Generator and FMwand Power Module (both previously cleared in 510(k) #K130606) and also with an effective user-supplied smoke evacuation system.
The FMwand Handpiece SE is identical in function to the FMwand Handpiece (K130606) with one exception: the FMwand Handpiece SE has an integrated smoke evacuation function which allows connection of the handpiece to a user-supplied smoke evacuation system. The FMwand Handpiece SE includes a removable shroud that fits on the handpiece tip to permit the device to remove the smoke from the surgical site as it is created. It is a single-patient use device intended to be provided to the user in a sterile state.
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
Not Found
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)
The ability of the FMwand Handpiece SE to effectively remove smoke from the surgical site was shown through bench testing.
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
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
MAY 2 3 2014
510(k) SUMMARY
FMwand Handpiece SE Date of Summary: March 18, 2014
General Provisions
| 510(k) Owner's Name: | Domain Surgical, Inc. |
|---|---|
| Address: | 1370 South 2100 East |
| Salt Lake City, Utah 84108 | |
| Contact Person: | Curtis Jensen, Vice President of Quality and Regulatory Affairs |
| Phone Number: | (801) 924-4958 |
| Fax Number: | (801) 924-4951 |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| §878.4400, Product Code GEI) | |
| Proprietary Name: | FMwand Handpiece SE |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
Name of Predicate Device(s)
- FMwand Ferromagnetic Surgical System, (Product Code GEI, HGI) 510(k) #K130606 ●
- LiNA Medical SafeAir Smoke Pencil (Product Code GEI), 510(k) #K120454 .
Device Description
The FMwand Handpiece SE is a sterile, single-patient use, soft tissue cutting and coagulation device intended to be used with the FMwand Generator and FMwand Power Module (both previously cleared in 510(k) #K130606) and also with an effective user-supplied smoke evacuation system.
Technological Comparison
The FMwand Handpiece SE is identical in function to the FMwand Handpiece (K130606) with one exception: the FMwand Handpiece SE has an integrated smoke evacuation function which allows connection of the handpiece to a user-supplied smoke evacuation system. The FMwand Handpiece SE includes a removable shroud that fits on the handpiece tip to permit the device to remove the smoke from the surgical site as it is created. It is a single-patient use device intended to be provided to the user in a sterile state.
The FMwand Ferromagnetic Surgical System differs from the SafeAir Smoke Pencil because the SafeAir device is a standard monopolar electrosurgical device which uses a high density current through the inductance of soft tissue to create heat, and the FMwand Handpiece SE employs ferromagnetic induction to create the heat necessary to cut and coagulation soft tissue.
1
Device Comparison Table
Note: Shaded Items are identical.
| Performance
Feature | FMwand Handpiece SE | FMwand Ferromagnetic
Surgical System Handpiece | LINA Medical SafeAir Smoke
Pencil |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Domain Surgical Inc. | Domain Surgical Inc. | LINA Medical ApS |
| 510(k) Number | To be assigned | K130606 | K120454 |
| Prescription/ OTC | Prescription Only | Prescription Only | Prescription Only |
| Product Code | GEI | GEI, HGI | GEI |
| Classification
Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Basis Intended Use | Cutting and coagulation of soft
tissue and removal of surgically
generated smoke | Cutting and coagulation of soft
tissue | Cutting and coagulation of soft
tissue and removal of surgically
generated smoke |
| Indications for Use | The FMwand Handpiece SE is
indicated for cutting and
coagulation of soft tissue during
surgical procedures, and for
removing smoke generated by
electrosurgery when used in
conjunction with an effective smoke
evacuation system. | The FMwand Ferromagnetic
Surgical System is indicated for
cutting and coagulation of soft
tissue during surgical procedures,
including Gynecologic procedures
(open transabdominal only | The SafeAir Smoke Pencil is
designed for general electrosurgical
applications, including cutting and
coagulation, and for removing
smoke generated by electrosurgery
when used in conjunction with an
effective smoke evacuation system |
| Operation Function
Switches | Two actuation buttons
corresponding to dual user-selected
high/low power levels. | Two actuation buttons
corresponding to dual user-
selected high/low power levels. | button labelled yellow and
proximal to electrode;
button labelled blue and distal to
electrode |
| Power Supply | FMwand Generator (K130606)
supplied by user | FMwand Generator (K130606)
supplied by user | Monopolar generator supplied by
user |
| Heat Generation
Method | Ferromagnetic induction heating
provides an elevated temperature
blade which will cauterize tissue as
it cuts | Ferromagnetic induction heating
provides an elevated temperature
blade which will cauterize tissue as
it cuts | Application of a high-frequency
current to soft tissue creates heat
necessary to cut and/or cauterize. |
| Removable Suction
Sleeve | Yes | No | Yes |
| Tip Lengths | 75mm, 100mm, 125mm and
150mm | 75mm, 100mm, 125mm and
150mm | Four different lengths available.
Actual measurements unknown. |
| Complies with ISO
10993 | Yes | Yes | Yes |
| Complies with IEC
60601-1 | Yes | Yes | Yes |
| Complies with IEC
60601-2-2 | Yes | Yes | Yes |
| Provided to the User
in a Sterile State | Yes | Yes | Yes |
| Single-patient Use | Yes | Yes | Yes |
| Method of
Sterilization | Ethylene Oxide - SAL 10-6 | Ethylene Oxide - SAL 10-6 | Ethylene Oxide - SAL 10-6 |
Table 5-1: Device Comparison Table
Indications for Use
The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Performance Testing Data Summary
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. The ability of the FMwand Handpiece SE to effectively remove smoke from the surgical site was shown through bench testing.
Safety and Biocompatibility Summary
The patient contacting materials used in the FMwand Handpiece SE were chosen for their biocompatibility, function and suitability for the intended use of this device. The materials and
Section 5:510(k) Summary
2
colorants chosen are either in common use for medical devices or have been tested by accredited independent testing laboratories according to ISO 10993-1 and 510(k) Memorandum G95-1.
Conclusion
The FMwand Handpiece SE is substantially equivalent to the FMwand Ferromagnetic Surgical System Handpiece (K130606) with the addition of integrated smoke evacuation capabilities. The intended use of the FMwand Handpiece SE is the same as the FMwand Ferromagnetic Surgical System Handpiece with the addition of an indication for its smoke evacuation function. Both the FMwand Handpiece SE and the FMwand Ferromagnetic Surgical System Handpiece employ ferromagnetic induction to create the heat necessary to perform the electrosurgical function of cutting and coagulation of soft tissue.
The FMwand Handpiece SE differs from the SafeAir Smoke Pencil in the method used to cut and coagulate soft tissue. The SafeAir device is a monopolar electrosurgical pencil which uses a high density current through the inductance of soft tissue to create heat, and the FMwand Handpiece SE employs ferromagnetic induction to create the heat necessary to cut and coagulate soft tissue. Both the FMwand Handpiece SE and the SafeAir Smoke Pencil have similar smoke evacuation methods which include a vacuum orifice on the handpiece body and a removable suction sleeve which can be attached to the distal end of the handpieces include a connection to a user-supplied smoke evacuation system.
The FMwand Handbiece SE has similarities and differences from both predicate devices; however the differences do not raise different types of questions of safety and effectiveness. The information presented in this premarket submission, including the bench testing, demonstrates that the FMwand Handpiece SE is as safe and effective as the predicate devices for its intended use.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2014
Domain Surgical Incorporated Mr. Curtis Jensen Vice President, Quality and Regulatory Affairs 1370 South 2100 East Salt Lake City. Utah 84108
Rc: K140384
Trade/Device Name: FMwand Handpiece SE Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 18, 2014 Received: March 19, 2014
Dear Mr. Jensen:
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 ecommored proof conney 2003 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 rou may more on ovisions 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 If your device is elabilitied (boutions). Existing major regulations affecting your device can be may be sabyer to additions, 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I cation station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Mr. Curtis Jensen
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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Submission: FMwand Handpiece SE
Indications for Use
K140384 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: FMwand Handpiece SE
Indications for Use: The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
_ AND/OR Prescription Use _ × -(Part 21 CFR 801 Subpart D) ·
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)
Joshua C. Nipper -S
Section 4:Indications for Use
Page 4-1