TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

K093079 · Hobbs Medical, Inc. · KNS · Aug 2, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093079
• Device Name: TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
• Applicant: Hobbs Medical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Aug 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TouchSoft™ Coagulator is used to provide therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

Device Story

TouchSoft™ Coagulator is an electrosurgical accessory used during gastrointestinal endoscopic procedures. Device facilitates therapeutic hemostasis and tissue ablation. Operated by trained physicians or clinicians in clinical settings. Device functions as an electrosurgical tool delivered through a flexible endoscope to target tissue. Output is the application of electrical energy to achieve coagulation or ablation. Benefits include effective management of GI bleeding and tissue removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical accessory for use with flexible endoscopes. Operates as part of an electrosurgical unit system. Materials and design consistent with standard endoscopic electrosurgical accessories. No software or complex algorithms involved.

Indications for Use

Indicated for therapeutic hemostasis and tissue ablation in the gastrointestinal tract via flexible endoscope for patients requiring such procedures, performed by trained physicians or clinicians.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Mr. Edmund Bednarz Director of Quality Assurance Hobbs Medical, Inc. 8 Spring Street STAFFORD SPRINGS CT 06076

AUG 0 2 2010

Re: K093079 Trade/Device Name: TouchSoft™ Coagulator

Regulation Number: 21 CFR §876.4300

Regulation Name: Endoscope electrosurgical unit and accessories

Regulatory Class: II Product Code: KNS Dated: July 28, 2010 Received: July 29, 2010

Dear Mr. Bednarz:

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 v 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. 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 of medical device-related

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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/CDRH/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Levin MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 'AUG 0-2 2019

#### Intended Use Statement 8.2

## 510k INDICATION FOR USE STATEMENT

510(k) Number (if known): K093079

TouchSoft™ Coagulator Device Name: Applicant Name: Hobbs Medical, Inc.

Indication for Use:

The TouchSoft™ Coagulator is used to provide therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

PRESCRIPTION USE: Yes

OVER-THE-COUNTER USE: No AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number