(117 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on radiofrequency energy and cooling, with no mention of data analysis or learning algorithms.
Yes
The device is indicated for "electrocoagulation and hemostasis" and uses radiofrequency energy to "induce tissue changes," which are therapeutic actions.
No
The device description states its purpose is for "electrocoagulation and hemostasis" and to "induce tissue changes," which are treatment functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including an RF generator, cooling module, handpiece, electrodes, and accessories like a return pad and coolant canister. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis" in "Dermatologic and General Surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient's body.
- Device Description: The description details a system that applies radiofrequency energy to tissue for coagulation and tissue changes. This is a physical interaction with the body, not an analysis of samples taken from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such specimen analysis.
Therefore, the AT2 System is a therapeutic/surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².
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)
Biocompatibility, EMC, safety, and bench tests have been completed. The technological characteristics demonstrate that the Alpha Orthopaedics AT2 System is as safe, as effective, and performs as well as the legally marketed predicate device.
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.
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
alpha orthopaedics
JUN 1 8 2012
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. General Information
Date Summary Prepared: May 31, 2012
| Submitted by: | Alpha Orthopaedics, Inc.
7700 Edgewater Drive, Suite #405
Oakland, CA 94621
Phone: (510) 969-7323
Fax: (510) 969-7203 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact name: | Gina To
Vice President, Regulatory/Quality |
2. Name of Device
| Trade Name: | Alpha Orthopaedics AT2 System |
|---|---|
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Product code GEI, Class II, CFR §878.4400 |
3. Legally Marketed Predicate Devices for Claimed Equivalence
- K031046 Thermage ThermaCool TC System: primary predicate device for . substantial equivalence claim
- K082956 Alpha Orthopaedics AT2 System: predicate device for substantial . equivalence claim
4. Device Description
The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².
5. Intended Use
The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
1
Image /page/1/Picture/0 description: The image shows the text "K120527" on the top line. The second line of text says "PAGE 2 OF 2". The text is written in a handwritten style.
Image /page/1/Picture/1 description: The image shows the logo for Alpha Orthopaedics. The logo consists of a stylized letter "a" followed by the words "alpha orthopaedics" in a simple, sans-serif font. The logo is black and white.
6. Technological Characteristics
The technological characteristics of the AT2 System, including treatment electrodes, are identical to the Thermage ThermaCool TC System, as follows:
| Operational principle: | The system delivers RF energy while cooling the surface of the tissue in contact with the treatment electrode |
|---|---|
| Modes: | Monopolar/Bipolar |
| Capacitive vs. Inductive: | Capacitive |
| Operating Frequency: | 6 MHz |
| Treatment Electrodes: | Sterile, disposable, single patient use |
| Tuning | Tuning function built into RF Generator and automated Process is software controlled. |
· 7. Substantial Equivalence
The AT2 System with the addition of 0.25cm² and 1.50cm² treatment electrodes has the same intended use and the same technological characteristics as the legally marketed predicate device cleared under K031046 and K082956.
8. Summary of Performance Testing
Biocompatibility, EMC, safety, and bench tests have been completed. The technological characteristics demonstrate that the Alpha Orthopaedics AT2 System is as safe, as effective, and performs as well as the legally marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alpha Orthopaedics, Incorporated % Ms. Gina To 7700 Edgewater Drive Suite 405 Oakland, California 94621
Re: K120527
Trade/Device Name: Alpha Orthopaedics AT2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 31, 2012 Received: June 5, 2012
JUN 1 8 2012
Dear Ms. To:
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
3
Page 2 - Ms. Gina To
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ely yours,
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120527
Device Name: Alpha Orthopaedics AT2 System
Indications for Use:
The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Prescription Use × (Part 21 CFR 801 Subpart D) 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)
Signature of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
K120527 510(k) Number .