← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K150824 # TD-Wand (K150824) _Tdm Surgitech, Inc. · GEI · May 28, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K150824 ## Device Facts - **Applicant:** Tdm Surgitech, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** May 28, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes. ## Device Story TD-Wand is a sterile, single-use, disposable, monopolar electrosurgical blade; used with IEC 60601-1 certified electrosurgical units (ESUs) via 3-pinned connector. Device features ceramic tip with bulbs for blunt dissection; recessed stainless steel electrodes distribute current. Cutting electrode (3 segments) provides cut or blended waveforms; coagulation electrode (7 termini in chevron shape) provides surface coagulation. Operated by surgeons in clinical settings. Device facilitates tissue plane separation; provides precise cutting or hemostasis based on ESU mode selection. Benefits include combined blunt dissection and electrosurgical functionality in one instrument. ## Clinical Evidence Bench testing only. No clinical data. Testing included mechanical integrity (static cantilever bending, static axial compression, dynamic compression bending), electrical safety (IEC 60601-1, IEC 60601-2-2), thermal injury analysis compared to predicate and paddle electrodes, and biocompatibility (ISO 10993: cytotoxicity, sensitization, intracutaneous irritation, pyrogenicity). ## Technological Characteristics Monopolar electrosurgical blade; ceramic tip with integrated stainless steel electrodes; 3-pinned connector for ESU interface. Dimensions/form factor: ceramic bulbs for blunt dissection. Energy source: external ESU (high-frequency surgical current). Sterilization: sterile, single-use. Biocompatibility: ISO 10993 compliant. Electrical safety: IEC 60601-1, IEC 60601-2-2. ## Regulatory 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 - Utah Medical Products Inc. Ceramic Blade Electrode ([K960255](/device/K960255.md)) ## Reference Devices - Epitome electrode - Traditional paddle electrode ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 28, 2015 TDM SurgiTech Incorporated % Dr. Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K150824 Trade/Device Name: TD-Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 24, 2015 Received: March 27, 2015 Dear Dr. Braddon: 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. 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 {1}------------------------------------------------ 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150824 Device Name TD-Wand Indications for Use (Describe) The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| |
☑ Prescription Use (Part 21 CFR 801 Subpart D)
|
□ Over-The-Counter Use (21 CFR 801 Subpart C)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the TDM SurgiTech TD-Wand is provided below. | 510(k) | K150824 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Summary
Prepared | March 26, 2015 | | Sponsor
510(k) Contact | TDM SurgiTech, Inc.
Michael Weber
4626 Ayron Terrace
Palm Harbor, FL 34685 USA
813-263-5669 (direct)
727-255-5036 (fax)
MWeber@TDMSurgiTech.com
Secure BioMed Evaluations
Linda Braddon, Ph.D.
CEO / President | | | 7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681 (direct)
855-MED-DEV1 (office)
LGB@SecureBME.com | | Trade Name | TD-Wand | | Common Name | Electrosurgical blade | | Code -Classification | GEI 21 CFR 878.4400: Class II | | Predicate Devices | K960255 Utah Medical Products Inc. Ceramic Blade Electrode | | Device Description | TDM SurgiTech, Inc. ("TDMi")'s TD-Wand is a sterile, single use, disposable,
monopolar device for use only with IEC 60601-1 certified electrosurgical units
("ESUs") that accept 3-pinned connectors. The TD-Wand combines blunt dissection
with electrosection and electrocoagulation at its ceramic tip. The ceramic tip's bulbs
provide blunt dissection capabilities between tissue planes similar to a cannula,
bulbous scissors, or other blunt instrument. As such, initiation of the dissection path
may be facilitated with the use of traditional surgical instruments. The device
employs two types of recessed stainless steel electrodes that distribute
electrosurgical current:
(1) For cutting, the Cutting Electrode is comprised of 3 segments protectively
recessed between four ceramic bulbs at the axial tip. When activated, the Cutting
Electrode, along its 3 recessed segments, distributes a cut or blended cut/coag
waveform yielding a cutting effect that may also have a hemostatic effect depending
upon the "blended" waveform chosen.
(2) For coagulation, the Coagulation Electrode, via the 7 termini protectively
recessed atop the ceramic domes in the chevron shape, distributes coagulation
waveforms producing a disbursed surface coagulation effect. | | Indications for Use | The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes. | {4}------------------------------------------------ #### Mechanical Testing The TD-Wand was tested to determine the performance characteristics of the system. The following tests were performed: - Static Cantilever Bending - Static Axial Compression - Dynamic Compression Bending The mechanical integrity testing showed the TD-Wand is substantially equivalent to the predicate device. #### Electrical Safety Testing Electrical safety testing was performed on the TDM SurgiTech TD-Wand. Specifically, the following testing was performed to confirm the electrical safety characteristics of the device. - . Medical electrical equipment complies with and was tested with respect to electric shock, fire, electromagnetic compatibility, mechanical and other specified hazards, in accordance with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + A2 - Tested to IEC/EN 60601-1-2 Third Edition (2007-03) - IEC 60601-2-2: 2009 Particular Requirements for the Basic Safety and Essential Performance of High frequency surgical equipment and high frequency surgical accessories #### Thermal Injury Analysis A comparative analysis of thermal injury created by the TD-Wand versus the predicate Epitome and the ubiquitous paddle electrode was performed. A direct comparison of TD-Wand with other predicate devices showed the thermal zones of the TD-Wand were substantially the same and in many cases not as substantial as those generated by both the Epitome electrode and/or the traditional paddle electrode regardless of tissue type or power setting. {5}------------------------------------------------ ### Biocompatibility Biocompatibility testing in compliance with ISO 10993 showed TDM SurgiTech TD-Wand is fully biocompatible. | Biocompatibility Tests | Results | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | ISO Cytotoxicity MEM Elution
According to ISO 10993-5 Biological evaluation of medical devices:
Part 5 Tests for In vitro Cytotoxicity | Cell culture treated with test sample
exhibited no reactivity (Grade 0) | | Guinea Pig Maximization - Sensitization
According to ISO 10993-10 Biological evaluation of medical devices:
Part 10 Tests for irritation and delayed hypersensitivity | Albino guinea pigs treated with test
sample did not elicit a sensitization
response (Grade 0) | | Intracutaneous Irritation Reactivity
According to ISO 10993-10 Biological evaluation of medical devices:
Part 10 Tests for irritation and delayed hypersensitivity | Rabbits treated with test samples were
non-irritating (Less than 1.0 difference
between test and control) | | Pyrogenicity
Materials Mediated Rabbit Pyrogen Test | Albino rabbits treated with test
samples exhibited a negative response
(Max Temperature Increase: 0.1°C)
Non-pyrogenic | #### Conclusions Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject TDM SurgiTech TD-Wand has been shown to be substantially equivalent to the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K150824](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K150824) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com