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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FMwand Handpiece SE, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance; instead, it establishes substantial equivalence to predicate devices primarily through design and functional similarity, coupled with bench testing to confirm the added smoke evacuation feature. The performance is reported implicitly by comparing its features and functions to the predicate devices and confirming the smoke evacuation functionality.

Performance Feature / Acceptance Criteria (Implied)	Reported Device Performance
Smoke Evacuation Effectiveness	Shown through bench testing.
Cutting and Coagulation of Soft Tissue	Performed using ferromagnetic induction heating, similar to K130606 predicate.
Biocompatibility	Complies with ISO 10993-1 and 510(k) Memorandum G95-1 (materials chosen based on common use or results of accredited testing).
Electrical Safety	Complies with IEC 60601-1 and IEC 60601-2-2.
Sterility	Provided to user in a sterile state (Ethylene Oxide - SAL 10-6).
Single-use	Designed for single-patient use.
Compatibility with Generator	Compatible with FMwand Generator (K130606).

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical or performance data. The primary performance assertion for the new feature (smoke evacuation) was demonstrated through bench testing. Therefore:

Sample Size for Test Set: Not applicable/not specified in terms of clinical or "case" samples. Performance was demonstrated via bench testing.
Data Provenance: Bench testing data. The document does not provide details on country of origin or if it was retrospective/prospective, as it's laboratory-based testing.

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

This information is not provided in the document. Given that the primary performance evaluation for the new feature was bench testing for smoke evacuation effectiveness, the concept of "ground truth established by experts" as seen in clinical studies (e.g., for diagnostic AI) does not directly apply in the same way. The efficacy would be measured against objective physical criteria during bench testing.

4. Adjudication Method for the Test Set

This information is not provided nor is it applicable, as the evaluation type was bench testing for smoke evacuation, not a reader-based clinical study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not reported or performed. The device is an electrosurgical handpiece, and its improvements are mechanical/functional (integrated smoke evacuation), not related to AI-assisted interpretation or diagnostic accuracy in human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in the sense of bench testing. The document states that "The ability of the FMwand Handpiece SE to effectively remove smoke from the surgical site was shown through bench testing." This constitutes a standalone (algorithm-only if thinking broadly about the device's function) evaluation of the new smoke evacuation feature, without human intervention in the smoke removal process itself (beyond activating the device). The device's electrosurgical cutting and coagulation function is also evaluated intrinsically.

7. The Type of Ground Truth Used

For the new smoke evacuation feature, the ground truth was based on objective measurements during bench testing to demonstrate the effectiveness of smoke removal. For the core electrosurgical functions (cutting and coagulation), the ground truth is established by the device's design and mechanism (ferromagnetic induction heating) being substantially equivalent to the cleared predicate device (K130606), which itself would have demonstrated its intended functionality during its own clearance process.

8. The Sample Size for the Training Set

This information is not applicable as the device is a medical instrument and not an AI/ML algorithm that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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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:	(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

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.

PerformanceFeature	FMwand Handpiece SE	FMwand FerromagneticSurgical System Handpiece	LINA Medical SafeAir SmokePencil
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
ClassificationRegulation	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
Basis Intended Use	Cutting and coagulation of softtissue and removal of surgicallygenerated smoke	Cutting and coagulation of softtissue	Cutting and coagulation of softtissue and removal of surgicallygenerated smoke
Indications for Use	The FMwand Handpiece SE isindicated for cutting andcoagulation of soft tissue duringsurgical procedures, and forremoving smoke generated byelectrosurgery when used inconjunction with an effective smokeevacuation system.	The FMwand FerromagneticSurgical System is indicated forcutting and coagulation of softtissue during surgical procedures,including Gynecologic procedures(open transabdominal only	The SafeAir Smoke Pencil isdesigned for general electrosurgicalapplications, including cutting andcoagulation, and for removingsmoke generated by electrosurgerywhen used in conjunction with aneffective smoke evacuation system
Operation FunctionSwitches	Two actuation buttonscorresponding to dual user-selectedhigh/low power levels.	Two actuation buttonscorresponding to dual user-selected high/low power levels.	button labelled yellow andproximal to electrode; button labelled blue and distal toelectrode
Power Supply	FMwand Generator (K130606)supplied by user	FMwand Generator (K130606)supplied by user	Monopolar generator supplied byuser
Heat GenerationMethod	Ferromagnetic induction heatingprovides an elevated temperatureblade which will cauterize tissue asit cuts	Ferromagnetic induction heatingprovides an elevated temperatureblade which will cauterize tissue asit cuts	Application of a high-frequencycurrent to soft tissue creates heatnecessary to cut and/or cauterize.
Removable SuctionSleeve	Yes	No	Yes
Tip Lengths	75mm, 100mm, 125mm and150mm	75mm, 100mm, 125mm and150mm	Four different lengths available.Actual measurements unknown.
Complies with ISO10993	Yes	Yes	Yes
Complies with IEC60601-1	Yes	Yes	Yes
Complies with IEC60601-2-2	Yes	Yes	Yes
Provided to the Userin a Sterile State	Yes	Yes	Yes
Single-patient Use	Yes	Yes	Yes
Method ofSterilization	Ethylene Oxide - SAL 10-6	Ethylene Oxide - SAL 10-6	Ethylene Oxide - SAL 10-6

Table 5-1: Device Comparison Table

Indications for Use

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 (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

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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

Page 4-1

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.