(145 days)
Not Found
Not Found
No
The provided text describes a surgical device for tissue manipulation and coagulation and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for "resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints", which are therapeutic applications.
No
The device is described as an "Ablator and Coagulator" intended for "resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue". These are therapeutic actions, not diagnostic ones.
No
The intended use describes a device for resection, ablation, excision, hemostasis, and coagulation of soft tissue, which are physical actions typically performed by hardware devices, not software alone. The summary does not mention any software-specific functions or components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery on a patient's joints for procedures like resection, ablation, excision, hemostasis, and coagulation of soft tissue. This is an in vivo (within a living organism) application.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device does not fit that description.
The device is a surgical tool used directly on the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joints including, but not limited to, the knee, shoulder, wrist and hip.
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA." Inside the circle is a stylized image of an eagle, with its wings forming a shape reminiscent of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
OrthoDynamix, LLC % Mr. Brian S. Zimovan Engineering Manager 10302 Deerwood Park Boulevard, Suite 209 Jacksonville, Florida 32256
FEB 2 8 2010
Re: K093086
Trade Name: Arthrosteer Ablator & Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 15, 2010 Received: February 17, 2010
Dear Mr. Zimovan:
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
1
Page 2 - Mr. Brian Zimovan
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 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 vours.
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
APPENDIX E
Indications for Use
510(k) Number : K093086
Device Name: ArthroSteer Ablator & Coagulator, Models: Ref 1070 & 1080
Indications For Use:
The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M.MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093086
Page 1 of _