(464 days)
Not Found
No
The description focuses on a microprocessor-controlled RF generator and a hand-held instrument for delivering RF energy, with no mention of AI, ML, or image processing.
Yes
The device is indicated for "palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body," which is a therapeutic purpose.
No
The device description clearly states its purpose is for "palliative treatment" by precise energy delivery to ablate tissue, indicating a therapeutic function rather than diagnostic.
No
The device description explicitly details hardware components: a microprocessor-controlled RF generator (Ablation Generator System) and a hand-held, single-use instrument with electrodes (Ablation Instrument). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the palliative treatment of metastatic malignant lesions in a vertebral body by ablation. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is a radiofrequency (RF) generator and an instrument for delivering RF energy to tissue. This is a treatment modality, not a diagnostic test performed on samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device is used to treat a known condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ablation Generator System and Ablation Instrument are indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Ablation Instrument:
The Ablation Instrument is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Ablation Generator System:
The Ablation Generator is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Product codes
GEI
Device Description
Ablation Generator System is a microprocessor controlled radiofrequency (RF) generator designed for use with the hand held, bipolar, sterile, single use Ablation Instrument for percutaneous delivery of low power bi-polar RF energy by the physician to the tissue site in contact with the Electrode of the Ablation Instrument.
The Ablation Instrument is a hand held, bi-polar, sterile, single use device designed specifically for use with the Ablation Generator System. The user connects the Ablation Instrument to the Ablation Generator System using the AE Cable (for delivery of RF energy). The user positions the distal tip of the device containing the active and return electrodes at the tissue site where the specific treatment is to be performed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Results of in-vitro and in-vivo testing (performance, mechanical, electrical, software) demonstrate that the Ablation Generator System and the Ablation Instrument function as intended and the results of tests were as expected.
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
510(K) SUMMARY 3.
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 878.4400.
Date Prepared: 07/19/10
| 510(k) number: | K091310 |
|---|---|
| ---------------- | --------- |
Applicant Information:
DFine Inc. 3047 Orchard Parkway San Jose, CA 95134, USA AUG 1 1 2010
Contact Person:
| Sandeep Saboo | |
|---|---|
| Vice-President, Quality Assurance and Regulatory Affairs | |
| Phone Number: | 408-321-9999 ext 248 |
| Fax Number: | 408-321-9401 |
| e-mail: | sandeeps@dfineinc.com |
Device Information:
| Trade Name: | Ablation Generator System, and Ablation Instrument |
|---|---|
| Classification: | Class II (for both, Ablation Generator System and Ablation Instrument) |
| Classification Name: | Electrosurgical Cutting and Coagulation and Accessories |
| Product Code: | GEI |
| Regulation No.: | 21CFR 888.4400 878.4400 |
Physical Description:
Ablation Generator System is a microprocessor controlled radiofrequency (RF) generator designed for use with the hand held, bipolar, sterile, single use Ablation Instrument for percutaneous delivery of low power bi-polar RF energy by the physician to the tissue site in contact with the Electrode of the Ablation Instrument.
The Ablation Instrument is a hand held, bi-polar, sterile, single use device designed specifically for use with the Ablation Generator System. The user connects the Ablation Instrument to the Ablation Generator System using the AE Cable (for delivery of RF energy). The user positions the distal tip of the device containing the active and return electrodes at the tissue site where the specific treatment is to be performed.
Indications For Use:
The Ablation Generator System and Ablation Instrument are indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
1
Test Results:
Performance
Results of in-vitro and in-vivo testing (performance, mechanical, electrical, software) demonstrate that the Ablation Generator System and the Ablation Instrument function as intended and the results of tests were as expected.
Biocompatibility
The materials used in the Ablation Generator System and Ablation Instrument meet the requirements of ISO 10993-1.
Substantial Equivalence and Summary:
The subject device:
- · Ablation Instrument has the same technological characteristics and principles of operation as its predicate, ArthroCare Cavity SpineWand [K063172, manufactured by ArthroCare Corporation]. The intended use and indications for the Ablation Instrument is a subset of that for its predicate device.
- · Ablation Generator System (used only with the Ablation Instrument) has the same technological characteristics and principles of operation as its predicate, ArthroCare Orthopedic Electrosurgery System [K992581] when used with ArthroCare Cavity SpineWand [K063172, manufactured by ArthroCare Corporation]. The intended use and indications for the Ablation Generator is a subset of that for its predicate device.
The minor technological differences between the subject devices (Ablation Generator System and Ablation Instrument) and their predicate devices (ArthroCare Orthopedic Electrosurgery System and ArthroCare Cavity SpineWand) raise no new issues of safety or effectiveness. Performance data demonstrate that Ablation Generator System and the Ablation Instrument are as safe and effective as the predicate devices for their intended use. Thus, the Ablation Generator System and Ablation Instrument are substantially equivalent to their identified predicate devices.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized emblem that resembles an eagle or a bird in flight, composed of three curved lines above a wavy line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DFine, Inc. % Mr. Sandeep Saboo Vice President, Quality Assurance and Regulatory Affairs 3047 Orchard Parkway San Jose, California 95134
AUG 1 1 2010
Re: K091310
Trade/Device Name: Ablation Instrument and Ablation Generator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 19, 2010 Received: July 20, 2010
Dear Mr. Saboo:
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 indice includions 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, Dr w 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 libility warranties. We remind you; however, that device labeling must be truthful and not misleding,
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.
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Page 2 - Mr. Sandeep Saboo
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/ucm1118809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance Alexanding to note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pred. 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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DFine, Inc.
INDICATIONS FOR USE STATEMENT 2.
AUG 1 1 2010
| 510(k) Number (if known): | K091310 |
|---|---|
| Device Name: | Ablation Instrument and Ablation Generator System |
Indications for Use:
Ablation Instrument:
The Ablation Instrument is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Ablation Generator System:
The Ablation Generator is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K 091310
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