Who is the manufacturer of FMWAND FERROMAGNETIC SURGICAL SYSTEM?

Domain Surgical, Inc. filed the 510(k) submission for FMWAND FERROMAGNETIC SURGICAL SYSTEM (K130606).

What is the FDA product code for FMWAND FERROMAGNETIC SURGICAL SYSTEM?

HGI. It is classified under 21 CFR 884.4120 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for FMWAND FERROMAGNETIC SURGICAL SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FMWAND FERROMAGNETIC SURGICAL SYSTEM?

Domain Surgical System (K121881).

Who can help prepare an FDA 510(k) submission like FMWAND FERROMAGNETIC SURGICAL SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FMWAND FERROMAGNETIC SURGICAL SYSTEM

K130606 · Domain Surgical, Inc. · HGI · Jan 3, 2014 · Obstetrics/Gynecology

Device Facts

Record ID	K130606
Device Name	FMWAND FERROMAGNETIC SURGICAL SYSTEM
Applicant	Domain Surgical, Inc.
Product Code	HGI · Obstetrics/Gynecology
Decision Date	Jan 3, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.4120
Device Class	Class 2
Attributes	Therapeutic

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).

Device Story

FMwand Ferromagnetic Surgical System is a soft tissue cutting and coagulation device. System components: FMwand Generator, sterile single-use FMwand Handpiece, resterilizable FMwand Power Module (connection cable), and sterile air line. Principle of operation: ferromagnetic induction generates heat in handpiece tip to cauterize tissue during cutting; active cooling provided by circulating air. Used in surgical settings by clinicians. Features dual actuation buttons and dual footpedals for switching between two user-selected power levels. Output: controlled thermal energy at handpiece tip. Benefits: provides precise cutting and coagulation for soft tissue management.

Clinical Evidence

Bench testing only. Testing verified generator output specifications, thermal output of handpiece/tip, and compliance with electrical safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2). Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-11.

Technological Characteristics

Ferromagnetic induction heating; 40.68 MHz pure sinusoidal waveform; 5-60 W output; 450°C max temperature. Air-cooled handpiece. Materials biocompatible per ISO 10993. System includes generator, reusable power module, and sterile single-use handpiece/tip. Sterilization: Ethylene Oxide (SAL 10^-6) for disposable components; user-sterilization for power module. Electrical safety per IEC 60601-2-2.

Indications for Use

Indicated for cutting and coagulation of soft tissue during surgical procedures, including open transabdominal gynecologic procedures.

Regulatory Classification

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.

Predicate Devices

Domain Surgical System (K121881)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 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. # 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. {1}------------------------------------------------ # K130606 | | Device Comparison Table | | | pg 2 of 4 | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | 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. | | ---- {2}------------------------------------------------ ## 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. {3}------------------------------------------------ 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K130606 Device Name: FMwand Ferromagnetic Surgical System ﺮ ﻌ ﻴﺔ ﺮ ﺩ 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). 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

FMWAND FERROMAGNETIC SURGICAL SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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FMWAND FERROMAGNETIC SURGICAL SYSTEM

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Device Story

Clinical Evidence

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Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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