FMWAND HANDPIECE SE

K140384 · Domain Surgical, Inc. · GEI · May 23, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140384
• Device Name: FMWAND HANDPIECE SE
• Applicant: Domain Surgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

FMwand Handpiece SE is a sterile, single-patient use electrosurgical device; used with FMwand Generator and Power Module (K130606) and user-supplied smoke evacuation system. Device employs ferromagnetic induction to heat a blade for soft tissue cutting and coagulation; integrated removable suction shroud captures surgical smoke. Operated by surgeons in clinical settings. Output is thermal energy for tissue effect and vacuum-assisted smoke removal. Benefits include effective tissue management and smoke evacuation during surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Bench testing demonstrated the device's ability to effectively remove smoke from the surgical site.

Technological Characteristics

Ferromagnetic induction heating; sterile, single-patient use; ethylene oxide sterilization (SAL 10^-6); includes removable suction shroud; compatible with FMwand Generator; complies with ISO 10993, IEC 60601-1, and IEC 60601-2-2.

Indications for Use

Indicated for cutting and coagulation of soft tissue during surgical procedures and removal of electrosurgical smoke when used with an effective smoke evacuation system. No specific patient population or contraindications defined.

Regulatory Classification

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.

Predicate Devices

• FMwand Ferromagnetic Surgical System (K130606)
• LiNA Medical SafeAir Smoke Pencil (K120454)

Submission Summary (Full Text)

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# 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: | [phone] |
| Fax Number: | [phone] |
| 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.

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# Device Comparison Table

Note: Shaded Items are identical.

| Performance<br>Feature | FMwand Handpiece SE | FMwand Ferromagnetic<br>Surgical System Handpiece | LINA Medical SafeAir Smoke<br>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<br>Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Basis Intended Use | Cutting and coagulation of soft<br>tissue and removal of surgically<br>generated smoke | Cutting and coagulation of soft<br>tissue | Cutting and coagulation of soft<br>tissue and removal of surgically<br>generated smoke |
| Indications for Use | The FMwand Handpiece SE is<br>indicated for cutting and<br>coagulation of soft tissue during<br>surgical procedures, and for<br>removing smoke generated by<br>electrosurgery when used in<br>conjunction with an effective smoke<br>evacuation system. | The FMwand Ferromagnetic<br>Surgical System is indicated for<br>cutting and coagulation of soft<br>tissue during surgical procedures,<br>including Gynecologic procedures<br>(open transabdominal only | The SafeAir Smoke Pencil is<br>designed for general electrosurgical<br>applications, including cutting and<br>coagulation, and for removing<br>smoke generated by electrosurgery<br>when used in conjunction with an<br>effective smoke evacuation system |
| Operation Function<br>Switches | Two actuation buttons<br>corresponding to dual user-selected<br>high/low power levels. | Two actuation buttons<br>corresponding to dual user-<br>selected high/low power levels. | <CUT> button labelled yellow and<br>proximal to electrode; <COAG><br>button labelled blue and distal to<br>electrode |
| Power Supply | FMwand Generator (K130606)<br>supplied by user | FMwand Generator (K130606)<br>supplied by user | Monopolar generator supplied by<br>user |
| Heat Generation<br>Method | Ferromagnetic induction heating<br>provides an elevated temperature<br>blade which will cauterize tissue as<br>it cuts | Ferromagnetic induction heating<br>provides an elevated temperature<br>blade which will cauterize tissue as<br>it cuts | Application of a high-frequency<br>current to soft tissue creates heat<br>necessary to cut and/or cauterize. |
| Removable Suction<br>Sleeve | Yes | No | Yes |
| Tip Lengths | 75mm, 100mm, 125mm and<br>150mm | 75mm, 100mm, 125mm and<br>150mm | Four different lengths available.<br>Actual measurements unknown. |
| Complies with ISO<br>10993 | Yes | Yes | Yes |
| Complies with IEC<br>60601-1 | Yes | Yes | Yes |
| Complies with IEC<br>60601-2-2 | Yes | Yes | Yes |
| Provided to the User<br>in a Sterile State | Yes | Yes | Yes |
| Single-patient Use | Yes | Yes | Yes |
| Method of<br>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

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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.

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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

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