(57 days)
Not Found
No
The description focuses on the mechanical and electrical properties of the device and its interaction with an electrosurgical unit, with no mention of AI or ML.
Yes
Explanation: The device is intended for use in surgical procedures requiring precise cuts and hemostasis, which are therapeutic interventions. Its functions of electrosection and electrocoagulation are directly aimed at treating or modifying biological tissue for medical purposes.
No
The device is an electrosurgical tool designed for precise cuts and coagulation, which are therapeutic rather than diagnostic actions. Its intended use is to perform surgical procedures, not to diagnose conditions.
No
The device description clearly states it is a sterile, single-use, disposable, monopolar device with a ceramic tip and recessed stainless steel electrodes, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical device used for cutting and coagulation of tissue during procedures. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a surgical instrument with a ceramic tip and electrodes for electrosurgery. This is consistent with a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TDM SurgiTech TD-Wand is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Biocompatibility
Biocompatibility testing in compliance with ISO 10993 showed TDM SurgiTech TD-Wand is fully biocompatible.
- ISO Cytotoxicity MEM Elution: Cell culture treated with test sample exhibited no reactivity (Grade 0)
- Guinea Pig Maximization - Sensitization: Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0)
- Intracutaneous Irritation Reactivity: Rabbits treated with test samples were non-irritating (Less than 1.0 difference between test and control)
- Pyrogenicity: Albino rabbits treated with test samples exhibited a negative response (Max Temperature Increase: 0.1°C) Non-pyrogenic
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.
K960255 Utah Medical Products Inc. Ceramic Blade Electrode
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
§ 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.
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) |
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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.