(25 days)
The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
The Relievant INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The device is a modification to the Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set incorporating upgraded access and deployment instrumentation. 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.
The provided text describes a Special 510(k) Premarket Notification for the Relievant INTRACEPT Flexible RF Probe and Easy Access Instrument Set. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a comprehensive study that proves the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance:
The document states: "The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set were tested and compared to the predicate device. Ex vivo and in vitro data demonstrated that the INTRACEPT Easy Access Instrument Set achieves RF Probe placements with less procedural complexity and improved ergonomics, which may result in reduced overall procedure time and more efficient instrument exchange. The test data gathered demonstrate that this device is substantially equivalent to the predicate device. No new safety or effectiveness issues have been raised."
Therefore, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device (Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set) in terms of:
- Design
- Materials
- Function
- Intended Use
- Safety
- Effectiveness
The reported device performance indicates that the new instrument set offers:
- Less procedural complexity
- Improved ergonomics
- Potential for reduced overall procedure time
- More efficient instrument exchange
Table of Acceptance Criteria and Reported Device Performance (based on available information):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated) |
|---|---|---|
| Substantial Equivalence | Equivalent in Design to Predicate Device | "substantially equivalent in design" |
| Equivalent in Materials to Predicate Device | "substantially equivalent in materials" | |
| Equivalent in Function to Predicate Device | "substantially equivalent in function" | |
| Equivalent in Intended Use to Predicate Device | "substantially equivalent... and intended use" | |
| Safety | No new safety issues compared to Predicate Device | "No new safety or effectiveness issues have been raised." |
| Effectiveness | No new effectiveness issues compared to Predicate Device | "No new safety or effectiveness issues have been raised." |
| Procedural Efficiency | Improved or equivalent procedural complexity | "achieves RF Probe placements with less procedural complexity" |
| Ergonomics | Improved or equivalent ergonomics | "improved ergonomics" |
| Procedure Time | Potential for reduced or equivalent overall procedure time | "may result in reduced overall procedure time" |
| Instrument Exchange | Improved or equivalent instrument exchange efficiency | "more efficient instrument exchange" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states "Ex vivo and in vitro data". This indicates laboratory testing, not clinical studies involving human patients. It does not specify sample sizes, country of origin, or whether the ex vivo data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given that the testing was ex vivo and in vitro, "ground truth" would likely be established through engineering specifications, physical measurements, and comparison to the predicate device's measured performance in controlled settings, rather than expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an RF probe and instrument set for thermal coagulation of soft tissues, not an AI or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is not an algorithm. Performance was assessed on the physical device and its components, primarily through ex vivo and in vitro testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the device and the specified testing (ex vivo, in vitro), the ground truth for this type of submission would typically be based on:
- Engineering specifications and measurements: Performance metrics like power output, lesion size, temperature control, mechanical strength, and material biocompatibility.
- Comparison to predicate device performance: Direct comparative measurements against the established predicate device in controlled laboratory settings.
- Functional testing: Demonstrating the device performs its intended mechanical and electrical functions as designed.
8. The sample size for the training set:
This refers to a training set for machine learning models, which is not applicable to a physical medical device like an RF probe.
9. How the ground truth for the training set was established:
Not applicable, as this is not a device based on machine learning.
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Relievant Medsystems, Inc.
Special 510(k) Premarket Notification
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March 4, 2010 INTRACEPT Flexible RF Probe and Easy Access Instrument Set
K i 00641
Page 1 of 2
MAR 8 0 2010
510(k) Summary of Safety and Effectiveness
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- Submitter's Name Relievant MedSystems, Inc. 2688 Middlefield Rd, Suite A Redwood City, CA 94063
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- Company Contact Adam Savakus Executive Vice President Telephone: 650 368-1000 Fax: 650 298-9205
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- Device Name Trade Name:
Common Name: Classification Name: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set Radiofrequency Probe Electrosurgical, cutting & coagulation & accessories
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- Date Summary Prepared March 3, 2010
- ર. Predicate Device Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set
6. Description of Device
The Relievant INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The device is a modification to the Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set incorporating upgraded access and deployment instrumentation. 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.
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- Intended Use
The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
- Intended Use
-4.
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Relievant Medsystems, Inc. and
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- Comparison of Technological Characteristics The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution: Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set
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- Summary of Performance Data
1
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The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set were tested and compared to the predicate device. Ex vivo and in vitro data demonstrated that the INTRACEPT Easy Access Instrument Set achieves RF Probe placements with less procedural complexity and improved ergonomics, which may result in reduced overall procedure time and more efficient instrument exchange. The test data gathered demonstrate that this device is substantially equivalent to the predicate device. No new safety or effectiveness issues have been raised.
2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird, indicating the department's name and the country it represents.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Relievant Medsystems, Inc. % Mr. Adam Savakus Executive Vice President 2688 Middlefield Road, Suite A Redwood City, California 94063
MAR 3 0 2010
Re: K100641
Trade/Device Name: INTRACEPT Flexible RF Probe and Easy Access Instrument Set Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 04, 2010 Received: March 05, 2010
Dear Mr. Savakus:
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
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Page 2 - Mr. Adam Savakus
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 yours,
Sincerely yours,
Mark N. Milkeran
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Prescription Use _X (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle for men
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100641
Confidential
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§ 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.