(98 days)
Not Found
No
The document describes a radiofrequency energy delivery system with vibration and cooling, focusing on electrocoagulation, hemostasis, and pain relief. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.
Yes
The device is indicated for "Relief of minor muscle aches and pain", "Relief of muscle spasms", and "Temporary improvement of local circulation," which are therapeutic applications.
No
The device is indicated for therapeutic purposes like electrocoagulation, hemostasis, relief of muscle aches/spasms, and temporary improvement of circulation, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a handpiece, return pad, footswitch, cryogen canister, coupling fluid, skin marking paper, and treatment electrodes, indicating it is a hardware-based system with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures for electrocoagulation and hemostasis, as well as relief of muscle aches, spasms, and temporary improvement of local circulation. These are all therapeutic or surgical applications performed directly on the patient's body.
- Device Description: The device description details components for delivering radiofrequency energy and vibration to the patient's tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information. IVDs are designed to diagnose diseases or conditions based on the analysis of such samples.
Therefore, the Alpha Orthopaedics AT3 System is a therapeutic and surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.
The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:
- General surgical procedures for electrocoagulation and hemostasis .
- . Relief of minor muscle aches and pain
- . Relief of muscle spasms
- Temporary improvement of local circulation (i.e., blood circulation) .
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The AT3™ System delivers RF energy while cooling tissue by conduction. Components and accessories include the handpiece with vibration, return pad, electronic footswitch (optional), cryogen canister, coupling fluid, skin marking paper, and treatment electrodes.
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)
Performance, EMC, safety, and software testing have been completed.
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.
K090580, K072849, K052778, K051710, K013639
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
Koguyull
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Image /page/0/Picture/1 description: The image shows the logo for Alpha Orthopaedics. The logo features a stylized letter "A" followed by the words "alpha orthopaedics" in a simple, sans-serif font. The text is all in lowercase letters. The logo is black and white.
APR - 7 2010
510(k) Summary
| Company Information: | Alpha Orthopaedics, Inc.
23575 Cabot Blvd., Ste. 210, Hayward, CA 94545 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Gina To
Vice President, Regulatory/Quality
Phone: (510) 783-5888; Fax: (510) 783-5889 |
| Date Summary Prepared: | April 6, 2010 |
| Trade Name: | Alpha Orthopaedics AT3™ System |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Product Code GEI, Class II, CFR §878.4400 |
| Predicate Devices (Legally
Marketed Device): | • K090580 Thermage ThermaCool NXT System
• K072849 Modification to Thermage ThermaCool System
• K052778 Thermage ThermaCool Skin Marking Paper
• K051710 Thermage ThermaCool Coupling Fluid |
- K013639 Thermage ThermaCool TC System .
DEVICE DESCRIPTION
The AT3™ System delivers RF energy while cooling tissue by conduction. Components and accessories include the handpiece with vibration, return pad, electronic footswitch (optional), cryogen canister, coupling fluid, skin marking paper, and treatment electrodes.
INTENDED USE
The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.
The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:
- . General surgical procedures for electrocoagulation and hemostasis
- . Relief of minor muscle aches and pain
- . Relief of muscle spasms
- . Temporary improvement of local circulation (i.e., blood circulation)
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the AT3 System are same as the Thermage ThermaCool NXT System.
SUBSTANTIAL EQUIVALENCE
The AT3 System that is the subject of this notification is substantially equivalent to the predicate legally marketed devices listed above.
SUMMARY OF PERFORMANCE TESTING
Performance, EMC, safety, and software testing have been completed.
CONCLUSION
The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT3 System is safe and effective and is substantially equivalent to the legally marketed predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 7 2010
Alpha Orthopaedics, Inc. % Ms. Gina To 23575 Cabot Boulevard, Suite 210 Hayward - CA-94545 -----------
· Re: K094041
Trade/Device Name: Alpha Orthopaedics AT3TM System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Class: II Product Code: GEI Dated: April 6, 2010 Received: April 7, 2010
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 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
2
Page 2- Ms. Gina To
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K094041
Device Name: Alpha Orthopaedics AT3™ System
Indications for Use:
The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.
The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:
- General surgical procedures for electrocoagulation and hemostasis .
- . Relief of minor muscle aches and pain
- . Relief of muscle spasms
- Temporary improvement of local circulation (i.e., blood circulation) .
Prescription Use _ X _ (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
(Division (Division of Surgical, Orthopedic, Divisionative Devices
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510(k) Number K094041