(224 days)
The MicroSurgeon Microwave Soft Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue.
The MicroSurgeon Microwave Soft Tissue Ablation device model MTAD-100 is intended to be used by the physician for the ablation of soft tissue by the induction of thermal necrosis in the targeted tissue. The ablation occurs by direct application of microwave energy to the targeted tissue by use of a sterile hand held Disposable Patient Probe (DPP). Lesion sizes ablated by the system are determined by preset values within the system algorithm. The MTAD-100 allows the physician to use a minimally invasive procedure that is an alternative to surgical removal of solid tissue anomalies. It is to be used in conjunction with the clinician's knowledge of the patient as well as the results of a physical examination along with clinical findings as deemed pertinent. The MTAD-100 system is not to be used by untrained and unqualified users in a manner other than that for which it is labeled. The systems Microwave Generator Subsystem (MWGS) generates the RF 2,45GHz signal which is delivered to the DPP via related controlled electronics. It has an RF port for connecting an insulated coaxial cable from the DPP, a port for connecting a temperature measuring interface data cable from the DPP, and an RS232 port for connecting the system Control Processing Subsystem (CPS). Additionally the MWGS provides for required patient galvanic isolation, and is mounted to a Portable Transport Console with a caster base for easy transport in the hospital environment, The MWGS component of the MTAD-100 was designed for exclusive use of, and to generate microwave energy to the patient disposable probe cited above. The one time use sterile DPP Hand-piece incorporates a Tip that is inserted directly into the tissue for localized energy delivery, and acts as a microwave radiator in a bipolar mode; thus near-field radiated energy is contained within a limited field with no currents flowing into the patient (as opposed to uni-polar RF Radiators in which current flows thru the patient's body). Two independent Thermo-sensors (provided for further redundancy of the system) located at the tip of the DPP are used to provide for localized temperature measurement during the ablation process. The CPS utilizes these temperature measurements to control the delivery of energy in order to achieve the desired ablation. The CPS, running a Microsoft Windows Operating System, provides for procedure profile programming onto a patient data file; provides user interface and controls the MWGS unit based on predetermined settings. All MWGS functionality and temperature measurements are processed and displayed by this unit, and utilized to achieve a desired ablation. Additionally, it stores all relevant patient information and measured parameters for the procedure.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroSurgeon Microwave Soft Tissue Ablation System:
Based on the provided document, the device approval is primarily based on non-clinical testing and substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria directly tied to human outcome measures or a specific device performance metric.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., specific ablation lesion size, success rate of ablation). Instead, it refers to:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Safety Standards Adherence | Device completed testing to applicable standards including IEC 60601-1 (2003), UL 60601-1 (2003), IEC 60601-1-1 (2001), IEC 60601-1-2 (2004), ISO 10993-1 (1998), and ANSI/AAMI/ISO 11135-1994, with acceptable results. |
| Performance, Functionality & Reliability | Followed established test procedures and a quality design system; demonstrated substantial equivalence to predicate devices. |
| Ablation Performance Data | "Ablation performance data between the MicroSurgeon MTAD-100 system, and the predicate devices listed in item #5 above shows nearly identical data." (No specific numerical data provided in this summary) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the determination of substantial equivalence was primarily supported by "bench testing" and "non-clinical testing."
- Sample Size for Test Set: Not applicable in the context of human data. The "test set" would refer to the materials and conditions used in the bench and non-clinical tests, for which specific sample sizes (e.g., number of devices tested, number of in-vitro tissue samples, etc.) are not provided in this summary.
- Data Provenance: The data is primarily from non-clinical lab/bench testing. No human clinical data (retrospective or prospective, or country of origin) is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as there was no human-centric "test set" requiring expert ground truth for medical imaging or diagnosis. The ground truth for the non-clinical tests would have been established by engineering specifications, calibration standards, and established laboratory protocols.
4. Adjudication Method for the Test Set
Not applicable. There was no human "test set" requiring adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The approval pathway detailed in this document relies on non-clinical testing and substantial equivalence to predicate devices, not on assessing human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device's control system ("CPS") utilizes an algorithm to achieve desired ablation based on temperature measurements, this is an integral part of the device's operational functionality, not a standalone AI algorithm in the diagnostic or image interpretation sense. The document does not describe a standalone performance study of this algorithm detached from the physical device's operation.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be based on:
- Engineering specifications and design requirements: For functionality, safety, and performance parameters (e.g., power output, temperature control accuracy, lesion creation capabilities in non-biological models).
- Established test standards: Adherence to standards like IEC 60601-1, ISO 10993-1, etc., which have their own defined ground truths for testing specific device characteristics (e.g., electrical safety, biocompatibility, sterilization efficacy).
- Comparison to predicate device performance data: The "nearly identical data" claim suggests the predicate devices' established performance metrics served as a comparative "ground truth."
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI models being developed for diagnostic purposes. The device's algorithm controls energy delivery based on pre-determined settings and real-time temperature feedback; it's not a learning algorithm that would typically require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning "training set" is described for this device.
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Appendix G
AUG 15 2007
510(k) Summary of Safety and Effectiveness for MicroSurgeon, Inc Microwave Soft Tissue Ablation System
December 30, 2006 1. DATE SUMMARY PREPARED:
2. SUBMITTER'S NAME AND ADDRESS:
MicroSurgeon, Inc 8489 West 3RD Street Suite 1044 Los Angeles, CA 90048
3. CONTACT PERSON:
Mr. Dudley Harris Quality & Regulatory Director Telephone:(323) 801-2209 Facsimile: (310) 423-1008
4. DEVICE NAME:
| Proprietary (trade) Name: | MicroSurgeon Soft Tissue Ablation Device |
|---|---|
| Common Name: | Microwave ablation device |
| Classification Name: | System, ablation, microwave and accessories, CFR 878.4400 |
| Product Code: | NEY |
| Class: | II |
| Panel: | General & Plastic Surgery |
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MicroSurgeon, Inc
Appendix G
5. PREDICATE DEVICE:
The legally marketed device/s to which equivalence is being claimed is:
Afx, Inc 47929 Fremont Blvd Fremont, CA 94538 K003978: Microwave Ablation System & Accessories K013946: Flex 10 Accessory for the Microwave Ablation System
Vivant Medical, Inc 1916-A Old Middlefield Way Mountain View, CA 94043 K011676: Microwave Ablation System & Accessories
6. Device Description
The MicroSurgeon Microwave Soft Tissue Ablation device model MTAD-100 is intended to be used by the physician for the ablation of soft tissue by the induction of thermal necrosis in the targeted tissue. The ablation occurs by direct application of microwave energy to the targeted tissue by use of a sterile hand held Disposable Patient Probe (DPP). Lesion sizes ablated by the system are determined by preset values within the system algorithm.
The MTAD-100 allows the physician to use a minimally invasive procedure that is an alternative to surgical removal of solid tissue anomalies. It is to be used in conjunction with the clinician's knowledge of the patient as well as the results of a physical examination along with clinical findings as deemed pertinent. The MTAD-100 system is not to be used by untrained and unqualified users in a manner other than that for which it is labeled.
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MicroSurgeon, Inc
Appendix G
The systems Microwave Generator Subsystem (MWGS) generates the RF 2,45GHz signal which is delivered to the DPP via related controlled electronics. It has an RF port for connecting an insulated coaxial cable from the DPP, a port for connecting a temperature measuring interface data cable from the DPP, and an RS232 port for connecting the system Control Processing Subsystem (CPS). Additionally the MWGS provides for required patient galvanic isolation, and is mounted to a Portable Transport Console with a caster base for easy transport in the hospital environment, The MWGS component of the MTAD-100 was designed for exclusive use of, and to generate microwave energy to the patient disposable probe cited above.
The one time use sterile DPP Hand-piece incorporates a Tip that is inserted directly into the tissue for localized energy delivery, and acts as a microwave radiator in a bipolar mode; thus near-field radiated energy is contained within a limited field with no currents flowing into the patient (as opposed to uni-polar RF Radiators in which current flows thru the patient's body). Two independent Thermo-sensors (provided for further redundancy of the system) located at the tip of the DPP are used to provide for localized temperature measurement during the ablation process. The CPS utilizes these temperature measurements to control the delivery of energy in order to achieve the desired ablation.
The CPS, running a Microsoft Windows Operating System, provides for procedure profile programming onto a patient data file; provides user interface and controls the MWGS unit based on predetermined settings. All MWGS functionality and temperature measurements are processed and displayed by this unit, and utilized to achieve a desired ablation. Additionally, it stores all relevant patient information and measured parameters for the procedure.
Keyboard Functions
The MTAD-100 contains a full-function keyboard that can be used for input of patient data and for controlling specific system functions such as testing.
7. INDICATIONS FOR USE
The MicroSurgeon Microwave Soft Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue. The system is designed to ablate tissue by the induction of thermal necrosis in targeted tissues.
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Appendix G
8. Clinical Testing In Support Of Substantial Equivalence Determination
The results of bench testing support the above indications for use as well as the claim of Substantial Equivalence to the predicate devices listed in item #5 above.
9. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The substantial equivalence of the Microwave ablation system is also demonstrated by the following non-clinical testing to the following applicable standards: IEC 60601-1: 2003; UL 60601-1: 2003; IEC 60601-1-1:2001; IEC 60601-1-2: 2004; ISO 10993-1:1998; and ANSI/AAMI/ISO 11135-1994.
The performance, functionality, and reliability characteristics of the device followed established test procedures, and a quality design system.
10. CONCLUSIONS FROM NON-CLINICAL TESTING
The MicroSurgeon Microwave Soft Tissue Ablation device (MTAD-100) has completed the testing listed above with acceptable results, demonstrating substantial equivalence.
11. SUBSTANTIAL EQUIVALENCE CONCLUSION
In summary, Indications for Use, safety standards tested to, and the ablation performance data between the MicroSurgeon MTAD-100 system, and the predicate devices listed in item #5 above shows nearly identical data. There are no new questions of safety or efficacy raised by the MTAD-100 system; therefore, the system supports a claim of Substantial Equivalence.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a series of curved lines that form a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
MicroSurgeon, Incorporated % Mr. Dudley Harris Quality & Regulatory Consultant 20662 East Tulip Circle Montrose, Colorado 81401
Re: K070023
Trade/Device Name: MicroSurgeon Microwave Soft Tissue Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: August 1, 2007 Received: August 1, 2007
Dear Mr. Harris:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Dudley Harris
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerso
Mark N kerson Me Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix E
Indications for Use Statement
510(k) Number (if known): 関連項
Device Name: MicroSurgeon Microwave Soft Tissue Ablation Device
Model: MTAD-100
Indications for Use: The MicroSurgeon Microwave Soft Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue.
| Prescription Use(Part 21 CFR 801 Subpart D) | X | AND/OR | 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | L070023 |
|---|---|
| --------------- | --------- |
1
§ 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.