K Number

Device Name

FMWAND FERROMAGNETIC SURGICAL SYSTEM

Manufacturer

DOMAIN SURGICAL, INC.

Date Cleared

2014-01-03

(302 days)

Product Code

HGI

Regulation Number

884.4120

Intended Use

The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

Device Description

The FMwand Ferromagnetic Surgical System is a soft tissue cutting and coagulation device that consists of the FMwand Generator that is electrically connected to the sterile, single-use FMwand Handpiece by the FMwand Power Module (a resterilizable, reusable accessory cable) and a single-use, sterile air line. Like the predicate device, the handpiece includes actuation buttons that can be used to activate the handpiece tip. Also like the predicate device, an optional footpedal can be used to activate the handpiece. The connectors at both ends of the FMwand Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The FMwand Power Module is provided non-sterile. It is intended to be cleaned and sterilized prior to the initial use and before each subsequent reuse.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K121881

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a surgical device for cutting and coagulation of soft tissue using ferromagnetic technology, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
Explanation: The device is indicated for cutting and coagulation of soft tissue during surgical procedures, which are interventional actions rather than therapeutic ones aimed at treating a disease or condition.

Diagnostic

No
The device is described as a surgical system for cutting and coagulation of soft tissue, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly details multiple hardware components: a generator, handpiece, power module (cable), air line, and optional footpedal. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "cutting and coagulation of soft tissue during surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
Device Description: The description details a surgical system with a generator, handpiece, and accessories used for cutting and coagulation. This aligns with a surgical device, not a device used to test samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions based on in vitro testing.

Therefore, the FMwand Ferromagnetic Surgical System is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

Product codes (comma separated list FDA assigned to the subject device)

GEI, HGI

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

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)

All applicable bench testing was performed with the FMwand Ferromagnetic Surgical System to assure that it functions as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece and tip corresponded to the target values.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121881

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).

Summary

JAN - 3 2014

K130606 pg 1 of 4

510(k) SUMMARY

FMwand Ferromagnetic Surgical System Date of Summary: March 6, 2013

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, HGI)
Proprietary Name:	FMwand Ferromagnetic Surgical System
Common Name:	Electrosurgical cutting and coagulation device and accessories

Name of Predicate Device(s)

Domain Surgical System, (Product Code GEI, HGI) 510(k) #K121881 .

Device Description

Technological Comparison

Both the FMwand Ferromagnetic Surgical System and the Domain Surgical System employ ferromannetic induction to generate heat in the handpiece tip for the purpose of cutting and coagulation of soft tissue. Both devices offer active cooling of the handpiece by circulating air through the handpiece and air line.

The FMwand Ferromagnetic Surgical System handpiece consists of a disposable, single-patient use portion (the FMwand Handpiece) and a reusable, user-resterilizable connection cable (FMwand Power Module), whereas the Domain Surgical System Handpiece is a one piece disposable accessory.

The FMwand Ferromagnetic Surgical System differs from the predicate device in that it offers a second button on the handpiece as well as a second footpedal to allow the ability to quickly switch two user-selected power levels when desired.

K130606

	Device Comparison Table
Performance
Feature	FMwand Ferromagnetic
Surgical System	Domain Surgical System	Discussion
Manufacturer	Domain Surgical Inc.	Domain Surgical Inc.	Identical
510(k) Number	To be assigned	K121881	N/A
Prescription/ OTC	Prescription Only	Prescription Only	Identical
Product Code	GELIGI	GELIGI	Identical
Classification	21 CFR 878.4400	21 CFR 878.4400	Identical
Regulation
Basis Intended
Use	Cutting and coagulation of soft
tissue	Cutting and coagulation of soft
tissue	Identical
Indications for
Use	The FMwand Ferromagnetic
Surgical System is indicated for
cutting and coagulation of soft
tissue during surgical
procedures, including
Gynecologio procedures (opeл
transabdominal only).	The Domain Surgical System is
indicated for cutting and
coagulation of soft tissue during
surgical procedures including
Gynecologic procedures (open
transabdominal only).	Identical
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.	Identical
Power
Requirements	100-240 VAC, 50-60 Hz	100-240 VAC, 50-60 Hz	Identical
Generator Size	Approximately 4" x 14" x 11"	Approximately 4" x 14" x 11"	Identical
Generator Weight	Approximately 10 lbs. (4.5 kg)	Approximately 10 lbs. (4.5 kg)	Identical
Maximum Output
Energy	5 to 60 W
155 Volts maximum	5 to 60 W
166 Volts maximum	Identical
Maximum
Operational
Temperature	450°C	450°C	Identical
Operational
Control Method	Controlled power delivered to the
handpiece tip	Controlled power delivered to
the handpiece tip	Identical
Mode of
Operation	Intermittent Operation	Intermittent Operation	Identical
Active Cooling	Air cooled handpiece	Air cooled handpiece	Identical
Output Type	Type CF	Type BF minimum	Leakage current restrictions for a
Type CF rating are more
stringent than for a Type BF
rating.
Operating
Frequency	Pure Sinusoidal Waveform
(40.68 MHz)	Pure Sinusoidal Waveform
(40.68 MHz)	Identical
Delivery system
configuration
Length
Diameter	Tips of various lengths.	Tips of various lengths.	Identical
Handpiece
Configuration	Handpiece consists of a
disposable, single-patient use
handpiece section connected to
a reusable cable (FMwand
Power Module) section.	Handpiece consists of a
disposable, single-patient use
handle with a disposable,
single-patient use tip.	The internal circuitry as well as
the tip function is equivalent in
these two configurations. The
change is to the form of the
handpiece and to the sterilization
methods.
Handpiece
Actuation Button
Configuration	Two actuation buttons
corresponding to dual user-
selected high/low power levels.	One actuation button
corresponding to a single user-
selected power level.	Having two power settings
available for actuation at the
handpiece is for user
convenience. Single button
handpiece is still supported.
Tip configurations	Various handpiece tip shapes.	Various handpiece tip shapes.	Identical
Footpedal
Configuration	Two actuation pedals
corresponding to dual user-
selected high/low power levels.	One actuation pedal
corresponding to a single user-
selected power level.	With two power levels available,
a dual footpedal is available for
those users who prefer footpedal
actuation of the device. The
interface still supports a single
footpedal if desired.
Performance
Feature	FMwand Ferromagnetic
Surgical System	Domain Surgical System	Discussion
Generator User
Interface	User interface has added
capability to support the dual
user-selected power levels.	User interface can only support
a single user-selected power
level.	With two power levels available, the generator needs the ability to
allow the user to select a low and high power setting
(FMmin/FMmax). The interface still supports single-button
handpieces and single
footswitches.
Treatment
Modality	Cutting and/or coagulation using
conducted heat from an elevated
temperature handpiece tip.	Cutting and/or coagulation using
conducted heat from an
elevated temperature handpiece
tip.	Identical
Bench Testing	The FMwand Ferromagnetic
Surgical System passed all
bench tests performed. Details
are found in Section 15: of this
submission.	The Domain Surgical System
passed all bench tests
performed. Details are found in
the original 510(k) submission,
K121881	Identical
Meets applicable
portions of
IEC 60601-2-2	Yes, Details are found in Section
14: of this submission.	Yes, Details are found in the
original 510(k) submission,
K121881	Identical
Biocompatibility
Tests	Materials used in the patient-
contacting portions of the
FMwand Ferromagnetic Surgical
System 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 Section 12:
of this submission.	Materials used in the patient-
contacting portions of the
Domain Surgical System 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, K121881	Identical
Generator
Sterilization
Method	Generator is not intended to be
provided sterile and is not
intended to be sterilized by the
user.	Generator is not intended to be
provided sterile and is not
intended to be sterilized by the
user.	Identical
Handpiece/Tip
Sterilization	Handpiece/Tip are single-patient
use and provided sterile.
Sterilization method is Ethylene
Oxide: SAL 10-6.
Connection cable is not provided
sterile and is intended to be
cleaned and sterilized by the
user prior to initial use and each
subsequent use up to a
maximum of 100 uses.	Handpiece/Tip, including cable
and connector are single-patient
use and provided sterile.
Sterilization method is Ethylene
Oxide: SAL 10-6.	The sterilization method of the
predicate device has been
validated to an SAL of 10-6. The
subject device cleaning and
sterilization methods will be
validated to an SAL of 10-6.
These are equivalent.

K130606

pg 3 of 4

Figure 5-1: Device Comparison Table

Indications for Use

Indications for Use: The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

The indications statement for the FMwand Ferromagnetic Surgical System is the identical to that of the predicate device.

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. All applicable bench testing was performed with the FMwand Ferromagnetic Surgical System to assure that it functions as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece and tip corresponded to the target values.

K130606 pg 4 of 4

Safety and Biocompatibility Summary

The patient contacting materials used in the FMwand Reusable Power Module were chosen for their biocompatibility, function and suitability for the intended use of this device. All necessary biocompatibility testing of applicable parts of the system was successfully completed by accredited independent testing laboratories according to ISO 10993-1 and 510(k) Memorandum G95-1.

It was also tested by an accredited independent testing laboratory to assure that it complies with the applicable electrical safety standards for medical electrosurgical devices, including the applicable sections of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.

Conclusion

The FMwand Ferromagnetic System is substantially equivalent to the Domain Surgical System (510(k)# K121881). The intended use of the FMwand Ferromagnetic Surgical System is the same as the predicate device. The FMwand Ferromagnetic Surgical System differs from the predicate device; 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 Ferromagnetic System is as safe and effective as the predicate device for its intended use and functions as well as or better than the predicate device.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

January 3, 2014

DOMAINTM Surgical Curtis Jensen Vice President of Quality and Regulatory Affairs 1370 South 2100 East Salt Lake City, UT 84108

Re: K130606

Trade/Device Name: FMwand Ferromagnetic Surgical System Regulation Number: 21 CFR§ 884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: HGI Dated: December 3, 2013 Received: December 4, 2013

Dear Curtis 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 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, 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 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.

Page 2 - Curtis Jensen

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Image /page/5/Picture/6 description: The image shows the text "Benjamin Fisher -S". The text is in a bold, sans-serif font. The word "Benjamin" is on the left, followed by "Fisher" and then "-S". The letters "FDA" are superimposed over the word "Benjamin".

Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K130606

Device Name: FMwand Ferromagnetic Surgical System

ﺮ

ﻌ ﻴﺔ

ﺮ ﺩ

Prescription Use __ × AND/OR (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)

Benjamin R. Fisher -S 2014.01.03 13:19:31 -05'00'

Section 4:- Indications for Use Statement

Page 4-1