(232 days)
Not Found
No
The summary describes a standard radiofrequency ablation device and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended for "thermal coagulation of soft tissues," which is a therapeutic intervention aimed at treating medical conditions.
No
This device is designed for thermal coagulation of soft tissues, which is a therapeutic intervention, not a diagnostic one. It creates lesions, rather than analyzing or identifying medical conditions.
No
The device description explicitly states it includes physical components (probes and instrument sets) used in conjunction with an RF generator and cable to deliver energy to tissue. This is a hardware-based medical 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." This describes a therapeutic procedure performed on a patient's body, not a test performed on a sample taken from a patient's body.
- Device Description: The description details a system that delivers energy to create lesions in soft tissue within the body. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The INTRACEPT Bi-Polar RF Probe and Instrument Set 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 Relievant INTRACEPT Bi-Polar RF Probe and Instrument Sets are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue and are available in a Standard Length and an Extra Length version.
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)
The INTRACEPT Bi-Polar RF Probe and Instrument Set was tested and compared to predicate devices. In vivo data demonstrated that the INTRACEPT Bi-Polar RF Probe and Instrument Set creates clinically relevant lesions that are equivalent in size to the predicate device. The test data gathered demonstrate that this device is substantially equivalent to the predicate devices. No new safety or effectiveness issues have been raised.
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.
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
OCT 5
2007 K070443 510(k) Summary of Safety and Effectiveness
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- Submitter's Name Relievant MedSystems, Inc. 713 Sandoval Way Hayward, CA 94544
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- Company Contact Mark Smutka Regulatory and Clinical Consultant Telephone - 510-489-1080 Fax - 510-489-1082
- Device Name Trade Name: Common Name: Classification Name:
INTRACEPT Bi-Polar RF Probe and Instrument Set Radiofrequency Probe Radiofrequency Lesion Probe
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- Date Summary Prepared September 27, 2007
- న్. Predicate Devices -Neurotherm Disposable Radiofrequency Cannula (K994344) -InCircle Bi-Polar RF Ablation Device (K070711) -Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442)
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- Description of Device The Relievant INTRACEPT Bi-Polar RF Probe and Instrument Sets are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue and are available in a Standard Length and an Extra Length version.
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- Intended Use The INTRACEPT Bi-Polar RF Probe and Instrument Set is intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
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- Comparison of Technological Characteristics The INTRACEPT Bi-Polar RF Probe and Instrument Set are substantially equivalent in design, materials, function and intended use to the following devices cleared for commercial distribution:
Page 1 of 2
1
K070443
-Neurotherm Disposable Radiofrequency Cannula (K994344) -InCircle Bi-Polar RF Ablation Device (K070711) -Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442)
Page 2 of 2
9. Summary of Performance Data
The INTRACEPT Bi-Polar RF Probe and Instrument Set was tested and compared to predicate devices. In vivo data demonstrated that the INTRACEPT Bi-Polar RF Probe and Instrument Set creates clinically relevant lesions that are equivalent in size to the predicate device. The test data gathered demonstrate that this device is substantially equivalent to the predicate devices. No new safety or effectiveness issues have been raised.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Relievant MedSystems, Inc. % Mr. Mark Smutka Regulatory and Clinical Consultant 713 Sandoval Way Hayward, California 94544
ઘદા ક 2007
Rc: K070443
Trade/Device Name: INTRACEPT Bi-Polar RF Probe and Instrument Set Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2007 Received: September 28, 2007
Dear Mr. Smutka:
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 - Mr. Mark Smutka
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 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 vours.
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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Page 3 – Mr. Mark Smutka
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. f/t:GJM:kxl:10-04-07
OC Numbers:
: 上一篇:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
5
Indications for Use
K070443 510(k) Number (if known): K070443
Device Name: INTRACEPT™ Bi-Polar RF Probe and Instrument Set
Indications For Use:
The INTRACEPT Bi-Polar RF Probe and Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070443
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070443