(365 days)
Not Found
No
The document describes a physical medical device (cannula) and its intended use in conjunction with other standard medical equipment. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML. The performance studies are limited to bench testing and biocompatibility, with no clinical studies or data analysis metrics typically associated with AI/ML devices.
Yes
The device is intended for "radiofrequency (RF) heat lesion procedures for relief of pain," which is a therapeutic intervention.
No
The device is intended for therapeutic purposes (radiofrequency heat lesion procedures for relief of pain), not for diagnosing conditions.
No
The device description clearly states it is a physical cannula, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiofrequency (RF) heat lesion procedures for relief of pain." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a cannula used in conjunction with an RF generator and probe to deliver heat to tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such tests.
The Vesta RF Cannula is a medical device used for a therapeutic procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GXI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Necrosis of soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Restricted to use by physicians familiar with radio-frequency lesion techniques.
Hospital, Surgical Suite
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:
- 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
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.
- Irritation – Intracutaneous Injection (Pooled Blue/Green Hub): The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. Conclusion: Non-irritant.
- Sensitization – Kligman Maximization (Pooled Blue/Green Hub): The USP 0.9% Sodium Chloride for Injection (NaCl) and Cottonseed Oil (CSO) extracts of the test article, NLT-150-18-10-CS Blue Hub Lot 18121-1 NLT-150-18-10-CS Green Hub lot 18121.1, elicited no reaction at the challenge (0% sensitization), following an induction phase. Conclusion: Non-sensitizer.
- Cytotoxicity – MEM Elution (Blue Hub): Cell monolayers treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic.
- Cytotoxicity – MEM Elution (Green Hub): Cell monolayers treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic.
- 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. Conclusion: 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. Conclusion: 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). Conclusion: EO sterilization is appropriate for the subject device.
- Material Mediated Pyrogen: The material-mediated pyrogenicity risk of the Vesta RF Cannula was assessed and was found to be acceptable. Conclusion: Non-pyrogenic.
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
§ 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).
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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
1
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
2
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 Multitined
Expandable 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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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 Electrosurgical | ||
| Radiofrequency | |||
| Multitined Expandable | |||
| Electrode | Vesta RF Cannula | Substantially | |
| Equivalent or | |||
| Identical to | |||
| Predicate | |||
| 510(k) | |||
| Number | K121773 | K190259 (Pending) | N/A |
| 510(k) | |||
| Submitter | Biomerics | Biomerics | Identical to |
| Predicate | |||
| Trade Name | Nimbus Electrosurgical | ||
| Radiofrequency | |||
| Multitined Expandable | |||
| Electrode | Vesta RF Cannula | Substantially | |
| Equivalent to | |||
| Predicate | |||
| Classification Name | Probe, Radiofrequency | ||
| Lesion | Probe, Radiofrequency | ||
| Lesion | Identical to | ||
| Predicate | |||
| Regulatory | |||
| Class | 2 | 2 | Identical to |
| Predicate | |||
| Classification | |||
| Regulation | 21 CFR 882.4725 | 21 CFR 882.4725 | Identical to |
| Predicate | |||
| Attribute | Predicate Device | Subject Device | Substantially Equivalent or Identical to Predicate |
| Device Name | Nimbus Electrosurgical | ||
| Radiofrequency | |||
| Multitined Expandable | |||
| Electrode | Vesta RF Cannula | Substantially | |
| Equivalent or | |||
| Identical to | |||
| Predicate | |||
| Product Code | GXI | GXI | Identical to |
| Predicate | |||
| Review Panel / | |||
| Division | Neurology | Neurology | Identical to |
| Predicate | |||
| 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 | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| Intended Use | Intended for use in | ||
| radiofrequency (RF) heat | |||
| lesion procedures for | |||
| relief of pain. | Intended for use in | ||
| radiofrequency (RF) heat | |||
| lesion procedures for | |||
| relief of pain. | Identical to | ||
| Predicate (The | |||
| Intended Use has | |||
| not changed as a | |||
| result of the | |||
| Modifications) | |||
| Attribute | Predicate Device | Subject Device | Substantially Equivalent or Identical to Predicate |
| Device Name | Nimbus Electrosurgical | ||
| Radiofrequency | |||
| Multitined Expandable | |||
| Electrode | Vesta RF Cannula | Substantially | |
| Equivalent or | |||
| Identical to | |||
| Predicate | |||
| Indications for | |||
| Use | The Nimbus | ||
| Electrosurgical | |||
| Radiofrequency | |||
| Multitined Expandable | |||
| Electrode, 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, in | ||
| combination with an RF | |||
| generator and probe, are | |||
| intended for use in | |||
| radiofrequency (RF) heat | |||
| lesion procedures for | |||
| relief of pain. | Identical to | ||
| Predicate | |||
| Clinical | |||
| Mechanism of | |||
| Action | Insulated cannula with an | ||
| active tip that directs RF | |||
| energy into target tissue. | Insulated cannula with an | ||
| active tip that directs RF | |||
| energy into target tissue. | Identical to | ||
| Predicate | |||
| Anatomical | |||
| Sites | Necrosis of soft tissues | Necrosis of soft tissues | Identical to |
| Predicate | |||
| Where Used | Hospital, Surgical Suite | Hospital, Surgical Suite | Identical to |
| Predicate | |||
| Active Tip | Deployable tines to | ||
| modify the shape of the | |||
| lesion. | Multiple active tip lengths | ||
| available. | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| Specific Drug | |||
| Use | None | None | Identical to |
| Predicate | |||
| Human | |||
| Factors | Restricted to use by | ||
| physicians familiar with | |||
| radio-frequency lesion | |||
| techniques. | Restricted to use by | ||
| physicians familiar with | |||
| radio-frequency lesion | |||
| techniques. | Identical to | ||
| Predicate | |||
| 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 | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| Attribute | Predicate Device | Subject Device | |
| Device Name | Nimbus Electrosurgical | ||
| Radiofrequency | |||
| Multitined Expandable | |||
| Electrode | Vesta RF Cannula | Substantially | |
| Equivalent or | |||
| Identical to | |||
| Predicate | |||
| • ISO 11607-2 | |||
| • ISO 13485 | |||
| • ISO 14971 | |||
| • ISO 80369-7 | • ISO 15223-1 | ||
| • ISO 80369-7 | |||
| • ISTA 2A | |||
| Physical | |||
| Description | |||
| (Diameter, | |||
| Length, etc.) | Diameter: 17G | ||
| Length: ≤15cm | |||
| Active Length: 4-10mm | Diameter: 18-22G | ||
| Length: ≤15cm | |||
| Active Length: 5-10mm | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| Components / | |||
| Materials | Hubs: | ||
| Thermoplastics | |||
| Cannula/Needle: | |||
| Stainless steel with | |||
| polymer insulation | |||
| Tines: | |||
| Stainless Steel | Hubs: | ||
| Thermoplastics | |||
| Cannula/Needle: | |||
| Stainless steel with | |||
| polymer insulation | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| General | |||
| Materials | Biocompatible | ||
| (Polyethylene, | |||
| Polycarbonate, Stainless | |||
| Steel, Nylon, Silicone | |||
| and Polyethylene | |||
| Terephthalate (PET), | |||
| Biocompatible Colorants) | Biocompatible | ||
| (Polycarbonate, Stainless | |||
| Steel, and Polyethylene | |||
| Terephthalate (PET), & | |||
| Biocompatible Colorants) | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| Insulation | IEC 60601 compliant | ||
| PET to protect user and | |||
| patient from errant | |||
| electrical discharge. | IEC 60601 compliant | ||
| PET to protect user and | |||
| patient from errant | |||
| electrical discharge. | Substantially | ||
| Equivalent to | |||
| Predicate | |||
| Electrical | |||
| Safety | Conforms to IEC 60601- | ||
| 2-2 | Conforms to IEC 60601- | ||
| 2-2 | Identical to | ||
| Predicate | |||
| Single-Use | Yes | Yes | Identical to |
| Predicate | |||
| Sterilization | EtO | EtO | Identical to |
| Predicate |
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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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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 – | ||
| Intracutaneous | ||
| Injection (Pooled | ||
| Blue/Green Hub) | The test article sites did not show a | |
| significantly greater biological reaction | ||
| than the sites injected with the control | ||
| article. | Non-irritant | |
| Sensitization – | ||
| Kligman | ||
| Maximization (Pooled | ||
| Blue/Green Hub) | The USP 0.9% Sodium Chloride for | |
| Injection (NaCl) and Cottonseed Oil | ||
| (CSO) extracts of the test article, NLT- | ||
| 150-18-10-CS Blue Hub Lot 18121-1 | ||
| NLT-150-18-10-CS Green Hub lot | ||
| 18121.1, elicited no reaction at the | ||
| challenge (0% sensitization), following | ||
| an induction phase. | Non-sensitizer | |
| Cytotoxicity – MEM | ||
| Elution (Blue Hub) | Cell monolayers treated with test sample | |
| exhibited no reactivity (Grade 0). | Non-cytotoxic | |
| Cytotoxicity – MEM | ||
| Elution (Green Hub) | Cell monolayers treated with test sample | |
| exhibited 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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| 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 Mediated | ||
| Pyrogen | 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.