(41 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard RF ablation technology and compatibility with existing generators.
Yes
The device is used for thermal coagulation of soft tissues, which is a therapeutic procedure involving the treatment of diseases or disorders.
No
The device is described as an "RF Ablation System" intended for "thermal coagulation of soft tissues" and "coagulate/ablate a region of soft tissue". This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device," indicating it is a physical hardware device.
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 "thermal coagulation of soft tissues" using radiofrequency energy. This is a therapeutic procedure performed in vivo (within the body) on a patient.
- Device Description: The device is described as a "hand-held electrosurgical device" used in "percutaneous, laparoscopic, and intraoperative surgical use procedures." This further confirms its use in surgical interventions on a living patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the RFA Medical InCircle™ Bi-Polar RF Ablation System does not involve the analysis of biological specimens.
Therefore, the RFA Medical InCircle™ Bi-Polar RF Ablation System is a therapeutic medical device used for surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The RFA Medical InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that utilizes opposing sets of Electrodes to coagulate/ablate a region of soft tissue using bi-polar RF energy. The device is designed for in percutaneous, laparoscopic, and intraoperative surgical use procedures. The device is designed for use with standard FDA cleared generators, such as the Boston RF Scientific Corporation (RadioTherapeutics) RF3000 (K000241) and the RITA Medical Systems 1500X (K983214).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Bench testing/functional testing was performed on the RFA Medical InCircle™ Bi-Polar RF Ablation System to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.
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.
K040785, K050361, K060419, K010060
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.
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
RFA Medical, Inc.
070711
Page 1 of
510(k) Notification
InCircle™ Bi-Polar RF Ablation System
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name, Address, Phone and Fax Number of Applicant
APR 2 4 2007
RFA Medical, Inc. 40874 Calido Place Fremont, CA 94539, USA Telephone: (650) 776-4804 Fax: (510) 573-3343
Contact Person Nancy Lincé Regulatory Affairs Consultant Telephone: (650) 759-6186 (510) 885-9935 Fax:
். Date Prepared
B.
February 9, 2007
D. Device Name
Trade Name: InCircle™ Bi-Polar RF Ablation System Classification Name: Electrosurgical cutting and coagulation device and accessories
E. Performance Standards
The RFA Medical InCircle™ Bi-Polar RF Ablation Device has been designed to comply with the applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18:2001 and the International Electrotechnical Commission Standard for Electrosurgical Devices IEC 60601-2-2:2006.
F. Device Description
The RFA Medical InCircle™ Bi-Polar RF Ablation System is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that utilizes opposing sets of Electrodes to coagulate/ablate a region of soft tissue using bi-polar RF energy. The device is designed for in percutaneous, laparoscopic, and intraoperative surgical use procedures. The device is designed for use with standard FDA cleared generators, such as the Boston RF Scientific Corporation (RadioTherapeutics) RF3000 (K000241) and the RITA Medical Systems 1500X (K983214).
1
K O'70711
RFA Medical, Inc.
Page 2 of (2)
InCircle™ Bi-Polar RF Ablation System
G. Intended Use
The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
H. Substantial Equivalence
The RFA Medical InCircle™ Bi-Polar RF Ablation System is substantially equivalent to the Boston Scientific Concerto™ Bipolar Needle Electrode (K040785, K050361, and K060419) and Rita Medical Systems StarBurst™ XII Electrosurgical Device (K010060). The InCircle has a similar intended use, materials of construction, and principles of operation as the predicate Both the subject and predicate devices are designed to devices. coagulate/ablate tissue by delivering RF energy with the use of electrodes.
l. Summary of Data
Bench testing/functional testing was performed on the RFA Medical InCircle™ Bi-Polar RF Ablation System to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RFA Medical, Inc. % KEMA Quality B.V. Ms. Patricia L. Murphy 4377 County Line Road Chalfont, Penssylvania 18914
APR 2 4 2007
Re: K070711
Trade/Device Name: InCircle™ Bi-Polar RF Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 11, 2007 Received: April 12, 2007
Dear Ms. Murphy:
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.
3
Page 2 - Ms. Patricia L. Murphy
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your is one of substantial equivalence of your device to a legally premainted 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
for Pete Rummo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
RFA Medical, Inc.
Indications for Use Statement
510(k) Number (if known): K 070071
Device Name:
InCircle™ Bi-Polar RF Ablation System
Indications for Use:
The RFA Medical InCircle™ Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
Prescription Use * *
OR (per 21 CFR 801.109) Over-The-Counter Use_
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of General, Restorative, |
| and Neurological Devices |
| 510(k) Number | K070711 |
|---|---|
| --------------- | --------- |
Appendix B
Page 1 of 1