(44 days)
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
The ThermoMed Model 1.8 is a battery-operated device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue.
Here's an analysis of the provided text regarding the ThermoMed Model 1.8 device, focusing on acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Low occurrence of adverse events. | Treatment related side effects were low: two reports of mild infection at the treatment site, one report of pain after treatment, and one report of lightheadedness. |
| Efficacy (Basal Cell Carcinoma): A significant percentage of patients show no evidence of tumor cells. | Eighty-five (85) percent of patients showed no evidence of tumor cells upon histological examination 3 months after a single treatment. |
| Patient Satisfaction (Comfort): High patient rating for comfort. | Average patient rating for treatment comfort was 8.35 (on a 1-10 scale with 10 being most favorable). |
| Patient Satisfaction (Convenience): High patient rating for convenience. | Average patient rating for treatment convenience was 8.97 (on a 1-10 scale with 10 being most favorable). |
| Patient Satisfaction (Side Effects): High patient rating regarding side effects. | Average patient rating for side effects was 9.02 (on a 1-10 scale with 10 being most favorable). |
Note: The document does not explicitly state "acceptance criteria" with numerical thresholds. The "reported device performance" are the results presented from the clinical trial, which implicitly serve as demonstration of acceptable performance for the device's intended use, particularly for basal cell carcinoma. The study concludes that the data "shows safety and effectiveness of the device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 60 patients.
- Data Provenance: The study was a "single center study." The document does not specify the country of origin, but given the 510(k) submission to the FDA (United States), it is highly probable the study was conducted in the USA.
- Retrospective or Prospective: The phrasing "A single center study... was conducted to evaluate the safety and efficacy" indicates a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that efficacy was determined by "histological examination 3 months after a single treatment." This implies that a pathologist or a team of pathologists established the ground truth for the presence or absence of tumor cells. However, the document does not specify the number of experts used or their specific qualifications (e.g., years of experience).
4. Adjudication Method for the Test Set
The document does not provide details about an adjudication method (such as 2+1 or 3+1 consensus) for establishing the ground truth from histological examinations. It's common practice for pathological assessments to be performed by a single pathologist, or for challenging cases to be reviewed by multiple pathologists for consensus, but this specific detail is not mentioned in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The described study evaluates the device's performance in treating basal cell carcinoma directly, not by comparing human reader performance with and without AI assistance. The ThermoMed Model 1.8 is a therapeutic device, not a diagnostic AI system for image interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This question is not applicable. The ThermoMed Model 1.8 is a physical medical device (localized current field radio frequency instrument) that is applied by a healthcare professional to treat conditions. It is not an algorithm or an AI system that operates in a "standalone" or "human-in-the-loop" fashion for diagnostic interpretation.
7. The Type of Ground Truth Used
The primary ground truth for efficacy in the basal cell carcinoma study was histology (pathology), specifically "no evidence of tumor cells upon histological examination." Patient satisfaction data was self-reported by patients.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" because the study described is a clinical trial to evaluate the safety and efficacy of a therapeutic device, not to train or validate a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set for an AI/ML algorithm. The clinical trial described focuses on the direct physiological effect of the device on patients.
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Image /page/0/Picture/0 description: The image shows the logo for Thermosurgery Technologies, Inc. The logo consists of a stylized wave-like graphic on the left, followed by the company name in a bold, sans-serif font. The word "THERMOSURGERY" is on the top line, and "TECHNOLOGIES, INC." is on the bottom line.
Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
| 5. 510(k) Summary | K063748 | Page 1 of 2 |
|---|---|---|
| Submission Date | December 7, 2006 | FEB - 1 2007 |
| Submitter's Nameand Address | Thermosurgery Technologies Inc.2901 W. Indian School RdPhoenix, AZ 82017 | |
| Contact Person | Gene R. HedinPhone: 602-264-7300Fax: 602-248-3809Email: generhedin@thermosurgery.com | |
| Name of MedicalDevice | Trade Name: ThermoMed Model 1.8Common Name: localized current field radio frequencyinstrumentClassification Name: Device, Electrosurgical, Cutting andCoagulation Accessories, Class IIProduct Code: GEI / 878.4000/Class II | |
| SubstantialEquivalence | ThermoMed Model 1.8 (K021117)Thermosurgery (K894166)ConMed Hyfrecator 2000 (K970493)Birtcher (K800617) | |
| DeviceClassification | Class II | |
| Device Description | The ThermoMed Model 1.8 is a battery-operated devicethat delivers precisely controlled localized current field radiofrequency heat to selectively destroy certain diseasedtissue. | |
| Indications for Use | The device is intended to treat benign superficialdermatological indications that includes; warts, molluscumcontagiosm, angioma, fibroma, seborrheic keratoses,acrochordon, syringoma, hydrocystoma, calvus, actinickeratoses, keloids, epidermoid cysts, cystic acne,cutaneous leishmaniasis, atypical mycobacteria, anddermatophytosis. In addition, it is intended to treat basalcell carcinoma. | |
| Summarypredicate deviceSE | The ThermoMed Model 1.8 for this submission is the sameinstrument as the ThermoMed 1.8 (K02117) currentlycleared for marketing in the United States and substantiallyequivalent to the Thermosurgery (K894166), ConMed | |
| (K970493) and the Bircher (K800617). This submission iffor indications statement changes. A summary of theclinical trial performed under IDE G020145 has beenincluded in this submission. | ||
| Safety | The device is the same as the predicate device (K02117).Clinical trial performed under IDE G020145 submitted datashows safety and effectiveness of the device. | |
| Clinical trialsummary | A single center study of 60 patients was conducted toevaluate the safety and efficacy of the ThermoMed™ Model1.8 device in the treatment of basal cell carcinoma. Eightyfive (85) percent of patients showed no evidence of tumorcells upon histological examination 3 months after a singletreatment with the ThermoMed™ device. Treatment relatedside effects were low, with two reports of mild infection atthe treatment site, one report of pain after treatment, andone report of light headedness. Patient satisfaction washigh, with average patient ratings as follows: treatmentcomfort at 8.35, treatment convenience at 8.97, and sideeffects at 9.02, on a 1-10 scale with 10 being mostfavorable. |
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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
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and the comments of the comments of
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermosurgery Technologies, Inc. % Mr. Gene R. Hedin CEO 2901 W. Indian School Road Phoenix, Arizona 85017
FEB - 1 2007
Re: K063748 Trade/Device Name: ThermoMed Model 1.8 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 7, 2006 Received: December 19, 2006
Dear Mr. Hedin:
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. Gene R. Hedin
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 ye
Ka Dio Pm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
KO63748
- Indications for Use Statement
Indications for Use
510 (k) Number:
Device Name:
ThermoMed Model 1.8
Indications for Use:
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Olohe
(Division Sign-Off Division of General, Restorative, and Neurological Devices
5100 Number 11063748 Page 1 of 1
4-1
§ 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.