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 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.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a medical device called the "TD-Wand," an electrosurgical cutting and coagulation device. The document summarizes the device, its indications for use, and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not describe acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, or AUC) or a study proving the device meets such criteria related to AI/algorithm performance.

The testing described is primarily focused on mechanical integrity, electrical safety, thermal injury analysis, and biocompatibility, which are standard for electrosurgical devices but do not involve AI or algorithms that would have performance metrics like sensitivity, specificity, or human-in-the-loop improvements.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI performance) are not applicable or cannot be extracted from this document, as the device is not an AI-powered diagnostic tool.

Below is an attempt to address the relevant points based on the available information:

Acceptance Criteria and Study for TD-Wand (Electrosurgical Device)

The document describes engineering and biocompatibility testing for the TD-Wand, an electrosurgical device, to demonstrate its substantial equivalence to a predicate device, rather than performance criteria for an AI or diagnostic algorithm. Therefore, the requested information regarding AI-specific performance metrics, ground truth establishment, and expert involvement for diagnostic assessment is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Substantially equivalent mechanical integrity to predicate device.	- Static Cantilever Bending results were evaluated. - Static Axial Compression results were evaluated. - Dynamic Compression Bending results were evaluated. Conclusion: TD-Wand is substantially equivalent to the predicate device in mechanical integrity.
Electrical Safety	Compliance with specified IEC/EN/ANSI/AAMI standards.	- Complies 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). - Tested to IEC 60601-2-2: 2009.
Thermal Injury	Thermal zones are substantially the same as or less substantial than those generated by the predicate and traditional paddle electrode.	Conclusion: Thermal zones of the TD-Wand were substantially the same and in many cases not as substantial as those generated by the predicate Epitome electrode and/or the traditional paddle electrode, regardless of tissue type or power setting.
Biocompatibility	Compliance with ISO 10993 for various tests.	- Cytotoxicity (ISO 10993-5): Cell culture treated with test sample exhibited no reactivity (Grade 0). - Sensitization (ISO 10993-10): Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0). - Intracutaneous Irritation Reactivity (ISO 10993-10): 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. Conclusion: Fully biocompatible in compliance with ISO 10993.

Regarding AI-Specific Information:

Since this document describes an electrosurgical device and its safety/performance, not an AI or diagnostic algorithm, the following points are not applicable and cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable, as this is not an AI diagnostic study. The testing refers to physical and biological tests, not data sets for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI diagnostics (e.g., expert consensus on medical images) is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a surgical tool, not an AI assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI performance. The "ground truth" for the device's testing relates to established engineering standards, biological responses, and comparison to a predicate device's physical attributes.
The sample size for the training set: Not applicable, as this is not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K150824

Device Name TD-Wand

Indications for Use (Describe)

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)

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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 SummaryPrepared	March 26, 2015
Sponsor510(k) Contact	TDM SurgiTech, Inc.Michael Weber4626 Ayron TerracePalm Harbor, FL 34685 USA813-263-5669 (direct)727-255-5036 (fax)MWeber@TDMSurgiTech.comSecure BioMed EvaluationsLinda Braddon, Ph.D.CEO / President
	7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (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 dissectionwith electrosection and electrocoagulation at its ceramic tip. The ceramic tip's bulbsprovide blunt dissection capabilities between tissue planes similar to a cannula,bulbous scissors, or other blunt instrument. As such, initiation of the dissection pathmay be facilitated with the use of traditional surgical instruments. The deviceemploys two types of recessed stainless steel electrodes that distributeelectrosurgical current:(1) For cutting, the Cutting Electrode is comprised of 3 segments protectivelyrecessed between four ceramic bulbs at the axial tip. When activated, the CuttingElectrode, along its 3 recessed segments, distributes a cut or blended cut/coagwaveform yielding a cutting effect that may also have a hemostatic effect dependingupon the "blended" waveform chosen.(2) For coagulation, the Coagulation Electrode, via the 7 termini protectivelyrecessed atop the ceramic domes in the chevron shape, distributes coagulationwaveforms 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.

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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.

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Biocompatibility

Biocompatibility testing in compliance with ISO 10993 showed TDM SurgiTech TD-Wand is fully biocompatible.

Biocompatibility Tests	Results
ISO Cytotoxicity MEM ElutionAccording to ISO 10993-5 Biological evaluation of medical devices:Part 5 Tests for In vitro Cytotoxicity	Cell culture treated with test sampleexhibited no reactivity (Grade 0)
Guinea Pig Maximization - SensitizationAccording to ISO 10993-10 Biological evaluation of medical devices:Part 10 Tests for irritation and delayed hypersensitivity	Albino guinea pigs treated with testsample did not elicit a sensitizationresponse (Grade 0)
Intracutaneous Irritation ReactivityAccording to ISO 10993-10 Biological evaluation of medical devices:Part 10 Tests for irritation and delayed hypersensitivity	Rabbits treated with test samples werenon-irritating (Less than 1.0 differencebetween test and control)
PyrogenicityMaterials Mediated Rabbit Pyrogen Test	Albino rabbits treated with testsamples 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.

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.