(24 days)
No
The device description focuses on hardware components and basic monitoring of electrical parameters, with no mention of AI/ML terms or functionalities like image processing, data analysis for decision making, or learning algorithms.
Yes
The device is indicated for "electrocoagulation and hemostasis" in "dermatologic and general surgical procedures." These are medical procedures aimed at treating or managing a condition, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose is for therapeutic procedures (electrocoagulation and hemostasis) and does not mention any diagnostic capabilities.
No
The device description explicitly lists four principal hardware components (RF Generator, Handpiece Connection Module, RF Cooling Module, RF Handpiece Assembly) and describes physical modifications to the handpiece (heating element, cryogen metering valve). This indicates it is a hardware-based medical device.
Based on the provided information, the ThermaCool IIA System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a system that generates radio frequency (RF) energy for electrocoagulation and hemostasis. This is a physical process applied to tissue, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The ThermaCool IIA System's function is to apply energy to tissue for therapeutic effect.
N/A
Intended Use / Indications for Use
The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes
79GEI
Device Description
Description of the Device consists of the same four principal components as the ThermaCool and The ThemaCool II as reviewed under the referenced earlier premarket notifications. The four principal components are: Se Thermage ThermaCool IIA RF Generator Se Thermage ThermaCool IIA Handpiece Connection Module Ses Thermage ThermaCool IIA RF Cooling Module Se Thermage ThermaCool IIA RF Handpiece Assembly The device generates radio frequency (RF) energy and operates in either monopolar or bipolar mode as selected I ne user. The device continuously monitors output energy, treatment duration, and measured impedance. When used in monopolar mode, a commercially available dispersive patient return electrode is impleance. When used in bipolar mode, a conners viathe handpiece msett tip and no dispersive electrode is needed. The handpiece attaches to the unit via an industry standard BNC type connector. As before, the intended use of the device is for use in dematologic and general surgical procedures for electrocoagulation and hemostasis. The system has been modified and now includes a heating element and a new cryogen metering valve within the handpiece. The effect of the change is improving cryogen flow characteristics in the clinical setting.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT = 4 2001
KO13034
k) Premarket Notification
mmary of Safety and Effectiveness Information
ThermaCool IIA Device Name:
RF Unit, coagulator Common Name(s):
Common Name: Electrosurgical cutting and coagulation device and accessories
Establishment Name & Registration Number:
Thermage Name: Number: 2954746
Classification:
Title 21, Code of Federal Regulations,
$ 878.4400 Electrosurgical cutting and coagulation device and accessories. (a) Identification. An electrosurgical cutting and coagulation device and accessories in a device intended to remove tissue and control bleeding by use of high-frequency electrical current. (b) Classification. Class II.
ProCode: 79GEI
Equivalent Device(s):
Equivalent Device(s):
The modified ThermaCool IIA claims substantial equivalence to the ThermaCool II (K000944 & K003183).
Description of the Device:
Description of the Device consists of the same four principal components as the ThermaCool and The ThemaCool II as reviewed under the referenced earlier premarket notifications. The four principal components are:
Se Thermage ThermaCool IIA RF Generator
Se Thermage ThermaCool IIA Handpiece Connection Module
Ses Thermage ThermaCool IIA RF Cooling Module
Se Thermage ThermaCool IIA RF Handpiece Assembly
The device generates radio frequency (RF) energy and operates in either monopolar or bipolar mode as selected I ne user. The device continuously monitors output energy, treatment duration, and measured impedance. When used in monopolar mode, a commercially available dispersive patient return electrode is impleance. When used in bipolar mode, a conners viathe handpiece msett tip and no dispersive electrode is needed. The handpiece attaches to the unit via an industry standard BNC type connector. As before, the intended use of the device is for use in dematologic and general surgical procedures for electrocoagulation and hemostasis.
The system has been modified and now includes a heating element and a new cryogen metering valve within the handpiece. The effect of the change is improving cryogen flow characteristics in the clinical setting.
Applicant / Sponsor Name / Address:
Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax
1
Contact Person:
Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax
Submission Correspondent:
Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax
Manufacturing Facility:
Manufacturing i actifity .
At the present time, the ThermaCool IIA is contract manufactured according to Thermage specifications.
Performance Standards:
Performance Standards.
There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation I hele and accessories. However, voluntary standards such as in-house Standard Operating Procedures and device and accessories. Trowerer, velazary of and utilized in the production of the device.
2
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a symbol that looks like three stylized lines that resemble a bird in flight.
OCT = 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela Buckman Director, Regulatory and Clinical Affairs Thermage, Inc. 4058 Point Eden Way Hayward, California 94545-3721
Re: K013034
Trade/Device Name: ThermaCool IIA Regulation Number: 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: September 7, 2001 Received: September 10, 2001
Dear Ms. Buckman:
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.
3
Page 2 - Ms. Pamela Buckman
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mankeing your and equivalence of your device to a legally prematicated 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 and If you desire specific au roo for your witto diagnostic devices), please contact the Office of additionally 21 CF N Fat 607.10 for the raily, for questions on the promotion and advertising of Compliance at (301) 597 1009 - 122215 Compliance at (301) 594-4639. Also, please note the your device, picuse commor and seemes to premarket notification" (21CFR Part 807.97). Tegulation chitica, "Misorananing of responsibilities under the Act may be obtained from the Outler general information on your respational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walter, MP
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) NUMBER: K013034
DEVICE NAME : ThermaCool IIA
INDICATIONS FOR USE:
The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) (Division Sigh Oral), Restorative Division of egical Devices
510(k) Number K013034
OR
Over-The-Counter Use (Optional format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
ThermaCool510.doc