(365 days)
The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.
The information provided is about the Biomerics Vesta RF Cannula, cleared under K190259, which is a medical device and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable.
However, I can provide the acceptance criteria and study information that was conducted for this device. The regulatory submission primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance (Not applicable for AI/ML device studies)
The device, the Vesta RF Cannula, is a non-AI medical device. Its performance is demonstrated through meeting various industry standards for physical characteristics, sterilization, and biocompatibility, rather than metrics like sensitivity, specificity, or AUC as would be seen in an AI study.
Table of Acceptance Criteria and Reported Device Performance:
| Standard/Test | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| ISO 6009 (Needle Diameter) | Compliance with ISO 6009 standard | Passed |
| ISO 9626 (Cannula Verification) | Compliance with ISO 9626 standard | Passed |
| ISO 7864 (Needle Tip Inspection) | Compliance with ISO 7864 standard | Passed |
| ISO 80369-7 (Luer Acceptance) | Compliance with ISO 80369-7 standard | Passed |
| ISO 15223-1 (Label Proof Approval) | Compliance with ISO 15223-1 standard | Passed |
| ISO 11135, ISO 10993-7, ISO 11138-2 (Sterilization Assessment) | Compliance with relevant ISO standards for sterilization and residuals | Passed |
| ISO 11607-1 (Stability and Aging Assessment) | Compliance with ISO 11607-1 standard for packaging and shelf-life | Passed |
| Biocompatibility Testing | ||
| Irritation – Intracutaneous (Pooled Blue/Green Hub) | No significantly greater biological reaction than control | Non-irritant |
| Sensitization – Kligman Maximization (Pooled Blue/Green Hub) | No reaction at challenge (0% sensitization) | Non-sensitizer |
| Cytotoxicity – MEM Elution (Blue Hub) | No reactivity (Grade 0) | Non-cytotoxic |
| Cytotoxicity – MEM Elution (Green Hub) | No reactivity (Grade 0) | Non-cytotoxic |
| Systemic Toxicity (Blue Hub) | No clinical signs consistent with toxicity | Non-toxic |
| Systemic Toxicity (Green Hub) | No clinical signs consistent with toxicity | Non-toxic |
| EO Residuals | Below allowable limits established in ISO 10993-7 Section 4.3 for limited exposure device (≤24 hours) | EO sterilization is appropriate |
| Material Mediated Pyrogen | Pyrogenicity risk assessed and found acceptable | Non-pyrogenic |
Since this is a non-AI/ML device, the following points are largely inapplicable or have no information provided in the given document.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable for an AI/ML test set. For bench and biocompatibility testing, the sample sizes are determined by the respective ISO or test standards. These typically involve a small number of samples for physical and chemical tests (e.g., a few units per test).
- Data Provenance: Not applicable. The tests are bench and lab-based studies performed to evaluate device characteristics, not clinical data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable as this is a non-AI/ML device. Ground truth is established by objective measurements against engineering specifications and industry standards for physical and chemical properties.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a non-AI/ML device. Performance is determined by objective measurements and standard compliance.
-
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:
- Not applicable. This device is an RF cannula, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for its safety and effectiveness is established by compliance with recognized international standards (ISO, IEC, ASTM) for material properties, sterilization, physical dimensions, and biocompatibility. This involves objective measurements and qualitative assessments (e.g., "non-irritant," "non-cytotoxic") based on established laboratory protocols.
-
The sample size for the training set:
- Not applicable. This is a non-AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. This is a non-AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2020
Biomerics Jake Wakley Vice President of Quality and Regulatory 6030 West Harold Gatty Drive Salt Lake City, Utah 84116
Re: K190259
Trade/Device Name: Vesta RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: January 3, 2020 Received: January 8, 2020
Dear Jake Wakley:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190259
Device Name Vesta RF Cannula
Indications for Use (Describe)
The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Biomerics. The logo consists of a blue abstract symbol on the left and the word "BIOMERICS" in blue on the right. The abstract symbol is made up of interconnected circles, and the word "BIOMERICS" is written in a bold, sans-serif font.
510(k) Summary (21 CFR 807.92)
SUBMITTER I.
Submitter Name: Address:
Telephone: Fax:
Biomerics 6030 West Harold Gatty Drive Salt Lake City, UT 84116 801-355-2705 801-355-3045
Contact Person: Email of Contact: Date Prepared:
Jake Wakley jwakley@biomerics.com 01/24/2020
II. DEVICE
Device Name: Common/Usual Name: Classification Name: Classification Panel: Regulation Device Name: Regulation Number: Regulatory Class: Product Code:
Vesta RF Cannula Cannula, Radiofrequency Lesion Radiofrequency Lesion Probe Neurology Radiofrequency Lesion Probe 21 CFR 882.4725 2 GXI
III. PREDICATE DEVICE
| Predicate Name: | Nimbus Electrosurgical Radiofrequency MultitinedExpandable Electrode |
|---|---|
| Common/Usual Name: | Probe, Radiofrequency Lesion |
| Classification Name: | GXI – Radiofrequency Lesion Probe |
| Premarket Notification: | K121773 |
| Manufacturer: | Biomerics |
Per the FDA Medical Device Recalls Database, this predicate has not been subject to a design related recall.
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Image /page/4/Picture/1 description: The image shows the logo for BIOMERICS. The logo consists of a blue abstract symbol on the left and the word "BIOMERICS" in blue on the right. The abstract symbol is made up of interconnected circles, and the word "BIOMERICS" is written in a bold, sans-serif font.
IV. DEVICE DESCRIPTION
The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.
INDICATIONS FOR USE V.
The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Vesta RF Cannula device is substantially equivalent to the predicate device, the Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode. Both the subject and the predicate device consist of an insulated cannula with an active tip that directs RF energy into target tissues. Both are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. Both have the same intended use, indications for use, similar design, similar sizes, similar or the same materials and similar properties. See comparison table below.
| Attribute | Predicate Device | Subject Device | |
|---|---|---|---|
| Device Name | Nimbus ElectrosurgicalRadiofrequencyMultitined ExpandableElectrode | Vesta RF Cannula | SubstantiallyEquivalent orIdentical toPredicate |
| 510(k)Number | K121773 | K190259 (Pending) | N/A |
| 510(k)Submitter | Biomerics | Biomerics | Identical toPredicate |
| Trade Name | Nimbus ElectrosurgicalRadiofrequencyMultitined ExpandableElectrode | Vesta RF Cannula | SubstantiallyEquivalent toPredicate |
| Classification Name | Probe, RadiofrequencyLesion | Probe, RadiofrequencyLesion | Identical toPredicate |
| RegulatoryClass | 2 | 2 | Identical toPredicate |
| ClassificationRegulation | 21 CFR 882.4725 | 21 CFR 882.4725 | Identical toPredicate |
| Attribute | Predicate Device | Subject Device | Substantially Equivalent or Identical to Predicate |
| Device Name | Nimbus ElectrosurgicalRadiofrequencyMultitined ExpandableElectrode | Vesta RF Cannula | SubstantiallyEquivalent orIdentical toPredicate |
| Product Code | GXI | GXI | Identical toPredicate |
| Review Panel /Division | Neurology | Neurology | Identical toPredicate |
| Variants | • NIM-050-10BB• NIM-100-10BB• NIM-150-10BB• NIM-100-10BB-CS | • NLT-100-22-10-BB• NLT-100-22-05-BB• NLT-100-22-10-CS• NLT-150-22-10-BB• NLT-150-22-10-CS• NLT-50-22-10-BB• NLT-100-20-10-BB• NLT-100-20-10-CS• NLT-100-20-10-CH• NLT-150-20-10-BB• NLT-150-20-10-CS• NLT-100-18-10-BB• NLT-100-18-10-CS• NLT-150-18-10-BB• NLT-150-18-10-CS• NLT-100-18-10-CH• NLT-150-20-10-CH• NLT-150-18-10-CH• NLT-100-22-10-CH• NLT-150-22-10-CH | SubstantiallyEquivalent toPredicate |
| Intended Use | Intended for use inradiofrequency (RF) heatlesion procedures forrelief of pain. | Intended for use inradiofrequency (RF) heatlesion procedures forrelief of pain. | Identical toPredicate (TheIntended Use hasnot changed as aresult of theModifications) |
| Attribute | Predicate Device | Subject Device | Substantially Equivalent or Identical to Predicate |
| Device Name | Nimbus ElectrosurgicalRadiofrequencyMultitined ExpandableElectrode | Vesta RF Cannula | SubstantiallyEquivalent orIdentical toPredicate |
| Indications forUse | The NimbusElectrosurgicalRadiofrequencyMultitined ExpandableElectrode, in combinationwith an RF generator andprobe, are intended foruse in radiofrequency(RF) heat lesionprocedures for relief ofpain. | The Vesta RF Cannula, incombination with an RFgenerator and probe, areintended for use inradiofrequency (RF) heatlesion procedures forrelief of pain. | Identical toPredicate |
| ClinicalMechanism ofAction | Insulated cannula with anactive tip that directs RFenergy into target tissue. | Insulated cannula with anactive tip that directs RFenergy into target tissue. | Identical toPredicate |
| AnatomicalSites | Necrosis of soft tissues | Necrosis of soft tissues | Identical toPredicate |
| Where Used | Hospital, Surgical Suite | Hospital, Surgical Suite | Identical toPredicate |
| Active Tip | Deployable tines tomodify the shape of thelesion. | Multiple active tip lengthsavailable. | SubstantiallyEquivalent toPredicate |
| Specific DrugUse | None | None | Identical toPredicate |
| HumanFactors | Restricted to use byphysicians familiar withradio-frequency lesiontechniques. | Restricted to use byphysicians familiar withradio-frequency lesiontechniques. | Identical toPredicate |
| Standards Met | • ASTM D4169-16• AAMI TIR28• BS EN 15223-1• IEC 60601-2-2• ISO 7864• ISO 10993-1• ISO 10993-5• ISO 10993-7• ISO 10993-10• ISO 11135• ISO 11607-1 | • IEC 60601-2-2• ISO 7864• ISO 9626• ISO 10993-1• ISO 10993-5• ISO 10993-7• ISO 10993-10• ISO 11135• ISO 11607-1• ISO 13485• ISO 14971 | SubstantiallyEquivalent toPredicate |
| Attribute | Predicate Device | Subject Device | |
| Device Name | Nimbus ElectrosurgicalRadiofrequencyMultitined ExpandableElectrode | Vesta RF Cannula | SubstantiallyEquivalent orIdentical toPredicate |
| • ISO 11607-2• ISO 13485• ISO 14971• ISO 80369-7 | • ISO 15223-1• ISO 80369-7• ISTA 2A | ||
| PhysicalDescription(Diameter,Length, etc.) | Diameter: 17GLength: ≤15cmActive Length: 4-10mm | Diameter: 18-22GLength: ≤15cmActive Length: 5-10mm | SubstantiallyEquivalent toPredicate |
| Components /Materials | Hubs:ThermoplasticsCannula/Needle:Stainless steel withpolymer insulationTines:Stainless Steel | Hubs:ThermoplasticsCannula/Needle:Stainless steel withpolymer insulation | SubstantiallyEquivalent toPredicate |
| GeneralMaterials | Biocompatible(Polyethylene,Polycarbonate, StainlessSteel, Nylon, Siliconeand PolyethyleneTerephthalate (PET),Biocompatible Colorants) | Biocompatible(Polycarbonate, StainlessSteel, and PolyethyleneTerephthalate (PET), &Biocompatible Colorants) | SubstantiallyEquivalent toPredicate |
| Insulation | IEC 60601 compliantPET to protect user andpatient from errantelectrical discharge. | IEC 60601 compliantPET to protect user andpatient from errantelectrical discharge. | SubstantiallyEquivalent toPredicate |
| ElectricalSafety | Conforms to IEC 60601-2-2 | Conforms to IEC 60601-2-2 | Identical toPredicate |
| Single-Use | Yes | Yes | Identical toPredicate |
| Sterilization | EtO | EtO | Identical toPredicate |
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Image /page/5/Picture/1 description: The image shows the logo for Biomerics. The logo consists of a blue abstract symbol on the left and the word "BIOMERICS" in blue on the right. The abstract symbol is made up of interconnected circles, and the word "BIOMERICS" is written in a bold, sans-serif font.
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Image /page/6/Picture/1 description: The image shows the logo for Biomerics. The logo consists of a blue abstract symbol on the left and the word "BIOMERICS" in blue on the right. The abstract symbol is made up of interconnected circles, and the word "BIOMERICS" is written in a bold, sans-serif font.
6030 West Harold Gatty Drive, • Salt Lake City, UT 84116 • Telephone: 801-355-2705 • Fax: 801-355-3045 • Website: www.biomerics.com
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Image /page/7/Picture/1 description: The image shows the logo for Biomerics. The logo consists of a blue abstract symbol on the left and the word "BIOMERICS" in blue on the right. The abstract symbol is made up of interconnected circles, and the word "BIOMERICS" is written in a bold, sans-serif font.
Table 1: Technological Characteristics with the Predicate Device
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Image /page/8/Picture/1 description: The image shows the logo for Biomerics. The logo consists of a blue abstract symbol on the left and the word "BIOMERICS" in blue capital letters on the right. The abstract symbol is made up of interconnected circles, and the word "BIOMERICS" is written in a bold, sans-serif font.
VII. PERFORMANCE DATA
Bench Testing
Bench tests are listed below in Table 2.
| Standard | Test Name | Result |
|---|---|---|
| ISO 6009 | Needle Diameter | Passed |
| ISO 9626 | Cannula Verification | Passed |
| ISO 7864 | Needle Tip Inspection | Passed |
| ISO 80369-7 | Luer Acceptance | Passed |
| ISO 15223-1 | Label Proof Approval | Passed |
| ISO 11135, ISO 10993-7, ISO 11138-2 | Sterilization Assessment | Passed |
| ISO 11607-1 | Stability and Aging Assessment | Passed |
Table 2: Vesta RF Cannula Bench Testing
Clinical Testing
No clinical testing was performed.
Biocompatibility
All Vesta RF Cannula subject devices tested for biocompatibility were the same configuration: 150mm length, 18G diameter, 10mm active tip, with both green and blue hub variants either pooled or tested separately. The subject device was evaluated per ISO 10993 as a limited contact device (≤24 hours), and was found to be biocompatible for its intended use. The subject device is therefore equivalent to the predicate device.
| Test | Result | Conclusions |
|---|---|---|
| Irritation –IntracutaneousInjection (PooledBlue/Green Hub) | The test article sites did not show asignificantly greater biological reactionthan the sites injected with the controlarticle. | Non-irritant |
| Sensitization –KligmanMaximization (PooledBlue/Green Hub) | The USP 0.9% Sodium Chloride forInjection (NaCl) and Cottonseed Oil(CSO) extracts of the test article, NLT-150-18-10-CS Blue Hub Lot 18121-1NLT-150-18-10-CS Green Hub lot18121.1, elicited no reaction at thechallenge (0% sensitization), followingan induction phase. | Non-sensitizer |
| Cytotoxicity – MEMElution (Blue Hub) | Cell monolayers treated with test sampleexhibited no reactivity (Grade 0). | Non-cytotoxic |
| Cytotoxicity – MEMElution (Green Hub) | Cell monolayers treated with test sampleexhibited no reactivity (Grade 0). | Non-cytotoxic |
6030 West Harold Gatty Drive, • Salt Lake City, UT 84116 • Telephone: 801-355-2705 • Fax: 801-355-3045 • Website: www.biomerics.com
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Image /page/9/Picture/1 description: The image shows the logo for Biomerics. The logo consists of a blue abstract graphic to the left of the word "BIOMERICS" in a dark blue, sans-serif font. The graphic is made up of interconnected circles and lines, creating a network-like design.
| Test | Result | Conclusions |
|---|---|---|
| Systemic Toxicity(Blue Hub) | None of the test article treated animals were observed with clinical signs consistent with toxicity at any of the observation periods. | Non-toxic |
| Systemic Toxicity(Green Hub) | None of the test article treated animals were observed with clinical signs consistent with toxicity at any of the observation periods. | Non-toxic |
| EO Residuals | EO and ECH residuals were tested per ISO 10993-7 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals and were below allowable limits established in Section 4.3 for a limited exposure device (≤24 hours). | EO sterilization is appropriate for the subject device |
| Material MediatedPyrogen | The material-mediated pyrogenicity risk of the Vesta RF Cannula was assessed and was found to be acceptable | Non-pyrogenic |
Table 3: Vesta RF Cannula Biocompatibility Testing
VIII. CONCLUSION
Through performance bench testing results, it has been demonstrated that the subject device is substantially equivalent to the predicate device, Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode, K121773.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).