(76 days)
No
The summary describes a standard RF generator for electrocoagulation and hemostasis, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is used for electrocoagulation and hemostasis during surgical procedures, which are interventional actions rather than therapeutic in the sense of treating a disease or condition therapeutically. Its function is to assist in the surgical procedure itself.
No
The "Intended Use / Indications for Use" states the device is for "electrocoagulation and hemostasis" in General Surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of a "RF generator and accessories, including disposable treatment electrodes," which are hardware components.
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 General Surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is described as an "RF generator and accessories, including disposable treatment electrodes." This aligns with a surgical device that delivers energy for treatment, not a device used 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 diagnostic information about a patient's health status
Therefore, the AT2™ System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AT2™ System is indicated for use in General Surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
The AT2™ System consists of a RF generator and accessories, including disposable 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)
Biocompatibility, EMC, safety testing, and software tests have been completed.
The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT2 System is safe and effective and is substantially equivalent to the legally marketed predicate devices.
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 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.
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Image /page/0/Picture/0 description: The image shows the text "alpha orthopaedics" in a simple, sans-serif font. The word "alpha" is preceded by a stylized symbol resembling a lowercase "a" or a curved checkmark. The text is horizontally aligned and appears to be part of a logo or heading.
510(k) Summary
| Company Information: | Alpha Orthopaedics, Inc.
23575 Cabot Blvd., Ste. 210
Hayward, CA 94545 | DEC 1 8 2008 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------|
| Contact Information: | Gina To
Vice President, Regulatory/Quality
Phone: (510) 783-5888
Fax: (510) 783-5889 | |
| Date Summary Prepared: | November 5, 2008 | |
| Trade Name: | Alpha Orthopaedics AT2 System | |
| Common Name: | Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Product Code GEI, Class II, CFR §878.4400 | |
| Predicate Devices (Legally
Marketed Device): | • K013639 Thermage ThermaCool TC System
• K043402 Thermage ThermaCool System Treatment Tip | |
DEVICE DESCRIPTION
The AT2™ System consists of a RF generator and accessories, including disposable treatment electrodes.
INTENDED USE
The AT2 System is indicated for use in General Surgical procedures for electrocoagulation and hemostasis.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the AT2 System are same as the Thermage ThermaCool TC System.
SUBSTANTIAL EQUIVALENCE
The AT2 System that is the subject of this notification is substantially equivalent to the predicate legally marketed devices listed above.
SUMMARY OF PERFORMANCE TESTING
Biocompatibility, EMC, safety testing, and software tests have been completed.
CONCLUSION
The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT2 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 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 white, and the text is in a simple, sans-serif font. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alpha Orthopaedics, Inc. % TÜV SÜD America, Inc. Ms. Dawn Tibodeau 1775 Old Highway 8 NW / Suite 104 New Brighton, MN 55112-1891
DEC 1 8 2008
Re: K082956
Trade/Device Name: Alpha Orthopaedics AT2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: November 26, 2008 Received: December 3, 2008
Dear Ms. Tibodeau:
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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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 Center for Devices and Radiological Health's (CDRII's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
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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Indications for Use
510(k) Number (if known): K082956
Device Name: Alpha Orthopaedics AT2 System
Indications for Use:
The AT2™ System is indicated for use in General Surgical procedures for electrocoagulation and hemostasis.
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)
Mark A. Millhuser
(Division Sign-Ciral, Restorative, Division of G and 510(k) Number
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