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.

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.

AI/ML Overview

The provided 510(k) summary for the INTRACEPT Bi-Polar RF Probe and Instrument Set includes limited information regarding detailed acceptance criteria and a comprehensive study report. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance validation with specific acceptance criteria.

However, based on the available information, here's a breakdown:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance/Findings
Lesion Creation Equivalence	The INTRACEPT system should create clinically relevant lesions that are equivalent in size.	"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."
Substantial Equivalence	The device should be substantially equivalent in design, materials, function, and intended use to listed predicate devices.	"The test data gathered demonstrate that this device is substantially equivalent to the predicate devices.""No new safety or effectiveness issues have been raised."

Note: The 510(k) summary does not specify quantitative acceptance criteria (e.g., a specific percentage deviation for lesion size or specific dimensions). The equivalence is stated qualitatively.

2. Sample Size and Data Provenance for the Test Set

Sample Size: Not explicitly stated. The document only mentions "In vivo data."
Data Provenance: Not explicitly stated. Given it's "In vivo data," it implies animal or human testing. However, the country of origin and whether it was retrospective or prospective is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

Not applicable/Not provided. The study focuses on demonstrating physical equivalence to predicate devices, primarily through lesion size, rather than diagnostic accuracy requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't the primary focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The submission does not describe any study involving human readers or comparative effectiveness with or without AI assistance. The device is a medical instrument for thermal coagulation, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done, but it's for the device's physical function, not an algorithm. The "In vivo data" on lesion creation and the comparison to predicate devices represent the standalone performance of the INTRACEPT system in achieving its intended function (thermal coagulation). This is not an algorithm in the typical AI sense, but rather the device itself performing its designated function.

7. Type of Ground Truth Used

Physical measurement/comparison: The ground truth for the "in vivo data" regarding lesion size would most likely involve direct measurement (e.g., pathology, imaging, or gross examination) of the lesions created by both the INTRACEPT device and the predicate device. The comparison then establishes equivalence.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The development of the device would involve engineering, bench testing, and optimization, but not typically a data training set like AI.

9. How Ground Truth for the Training Set Was Established

Not applicable/Not provided. As stated above, there is no training set for this type of device.

Summary

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OCT 5

2007 K070443 510(k) Summary of Safety and Effectiveness

1. Submitter's Name Relievant MedSystems, Inc. 713 Sandoval Way Hayward, CA 94544
1. 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

1. 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)
1. 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.
1. 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.
1. 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:

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K070443

-Neurotherm Disposable Radiofrequency Cannula (K994344) -InCircle Bi-Polar RF Ablation Device (K070711) -Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442)

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.