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510(k) Data Aggregation
(245 days)
Refine USA LLC
The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.
The Rejuvapen is a handheld instrument that contains a Single Use micro needle cartridge containing 12 stainless steel microneedles in a circular arrangement with an adjustable microneedle depth of up to 2.5 mm. The needles create very small punctures in the epidermal and dermal layers of the skin. The device is powered by a medical grade wall plug-in supply. An adjustment is provided for a variable speed motor that controls the frequency of the puncture process with a
Here's an analysis of the acceptance criteria and study findings based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with quantitative thresholds for effectiveness as a primary endpoint. Instead, the effectiveness is demonstrated through a clinical study where improvement in periorbital wrinkles is observed. The acceptance criteria for safety are primarily qualitative observations and adherence to international standards.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Safety - Biocompatibility | ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, USP 40 part 151, ISO 10993-12 | Biocompatibility evaluation performed, indicating compliance with standards. (Implied successful given broader conclusion of substantial equivalence). |
| Safety - Sterilization | ISO11135-1:2007, ISO/TS11135-2:2008, ISO11737-1:2006 | Shelf life (2 years) verified; sterilization validation reports in accordance with standards. |
| Safety - Reprocessing | Cleaning and low-level disinfection validation, use of protective sleeve required. | Cleaning and low-level disinfection validations performed. |
| Safety - Electrical | IEC / ES60601-1, IEC60601-1-2, IEC60601-1-6 | EMC testing and electrical safety testing performed, complying with standards. |
| Performance - Needle Protrusion Accuracy | Maximum needle protrusion setting of 2.5 + 0.25 mm. | Bench testing demonstrated accuracy of needle penetration depth and maximum permissible depth within set tolerance (± 0.25mm) at depths of 0.5mm and 2.5mm. Device maintained functional integrity with aged cartridges and devices. |
| Performance - Puncture Frequency Accuracy | Maximum puncture frequency of 110 Hz + 2%. | Bench testing demonstrated accuracy of puncture rate within set tolerance (± 2%) at frequencies of 80 Hz and 110 Hz. Device maintained functional integrity with aged cartridges and devices. |
| Performance - Cross-Contamination | Safety features to protect against cross-contamination (e.g., fluid ingress protection, safety membrane). | Testing of the safety membrane/seal under worst-case scenario (maximum puncture rate and needle penetration depth) did not result in penetration of viral particles, protein, or hemoglobin markers. |
| Effectiveness (Periorbital Wrinkles) | Not explicitly stated as a quantitative threshold in the provided text, but implied as significant improvement. | Physician Assessment: For 37 subjects with consistent grading, mean improvement in Lemperle scale was 0.57. 19 out of 45 subjects (42%) had at least a one-grade improvement according to both assessors. |
| Subject Assessment: 37/46 (80%) of subjects graded their treatment response as "slight to somewhat noticeable improvement in periorbital wrinkles." | ||
| Adverse Events | Not explicitly stated as a quantitative threshold or maximum allowed percentage, but events should be mild and self-limiting. | 20 adverse events in 12/52 subjects (23%), all judged mild, self-limiting, and requiring no intervention. 14/20 (70%) were bruising, 2/20 (10%) swelling, 1/20 (5%) blotchy skin/bruising, 1/20 (5%) 'watery eyes'/allergic response. |
| Erythema (Physician) | Not explicitly stated as a quantitative threshold; generally expected to be mild/moderate and transient. | Immediately post-treatment: predominantly minor or mild (83-93% across treatments), with 2-10% moderate. No severe erythema was observed. |
| Erythema (Subject) | Not explicitly stated as a quantitative threshold; generally expected to be transient. | Immediately post-treatment: 26% severe, 52% moderate, 22% mild/minor. |
| One day post-treatment: 11% severe. | ||
| By evening Day 3: 96% mild, minor, or absent. | ||
| By Day 8: 96% none, 4% minor, 2% mild. | ||
| Pain/Discomfort (Subject) | Not explicitly stated as a quantitative threshold; generally expected to be low and transient. | Mean pain score during treatment: 2.1 (range 0-7) on a 0-10 scale. |
| Mean discomfort score during treatment: |
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(270 days)
REFINE USA, LLC
The VeinGogh device is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
The VeinGogh instrument is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation. Users could wear a magnification aid to ensure adequate vision of the treatment area. The user could wear a face shield and gloves as indicated by office practices. The user inserts the needle point in a telangiectasia at a right angle to the vein after setting the instrument's control panel setting of time and pulse or using the instrument's Auto-Pulse functionality. Pulses are intended to be created every 2-3 mm along a vein. The user should clean the needle point frequently between vein insertions with a sterile compress.
The instrument's regulated, small, high frequency current is delivered to the vessel, in a process called "Ohmic Thermolysis," during which the electrical resistivity selectively thermocoagulates small blood vessels using microbursts of high-frequency electrical energy delivered into the vessel. This Microburst Technology™ of fixed amplitude energy within the vessel is converted to heat instantly, coagulating the blood and collapsing the vessel wall. The pulse train encompasses sharp, precise peaks to minimize the risk of damage and deliver consistent results.
The high frequency current is delivered into each vessel through the sterile needle as positioned and inserted by the medical professional. Trained medical professionals can deliver fast, immediate results, which are consistent and repeatable, with little or no discomfort to the patient.
Experienced medical professionals can treat vessels up to 0.3 mm throughout the body. Typically, only a single treatment is required. Multiple spider veins or telangiectasias are treated subepidermally along each veins length, typically every 2-3 mm.
The instrument has a foot switch that is used to cause the instrument to send one pulse with each pressing of the switch. The instrument also has a Ballet Needle holder and uses single use Ballet K3 and K2 stainless steel and gold needles, which are not intended for reuse. The instrument is designed to accommodate needle holders and needles which are equivalent to Ballet Needle Holders and Needles, specifically, those products having the same or similar labeling and listed by their manufacturer under the same regulation and product code.
The instrument has firmware that interacts with the Control Panel push buttons to provide the professional user with operational controls. The firmware cannot be edited or changed by the user.
No bandage or other treatment of the thermocoagulated area is required. Typical treatment times are under 20 minutes and the treatment area (40-50 cm) may receive 300 to 600 impulses during a treatment.
The instrument is not designed to treat feeder vessels or larger vessels deep beneath the skin's surface.
The instrument's dimensions, 16.1 in wide x 13 inches deep x 5.9 inches high and weight, 5.7 pound, allow the device to be used in small or large medical offices on any convenient flat surface. The instrument is intended to be moved in a safe and effective manner, such as movement from one room to another in a medical office or clinic environment.
The instrument is powered by a grounded 120 Volt power source from a wall or floor electrical receptacle. The electrical components are intended to be safe and effective and easily accessed by a qualified technician for any appropriate replacement or repair.
The VeinGogh instrument has a 4MHz frequency wave output, and a maximum voltage output of 205Vpp +/-10%.
Microburst Technology is a Trade Mark of Refine USA, LLC, Jacksonville Beach, FL
The provided text describes a 510(k) premarket notification for the VeinGogh™ instrument. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical trial to establish new safety and effectiveness. Therefore, the document does not present "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical efficacy testing.
Instead, the submission aims to show that the VeinGogh™ instrument is as safe and effective as its predicate device (Veinwave/TC3000) by demonstrating identical intended use and largely similar technological characteristics, and addressing any differences through non-clinical testing.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" for performance are primarily based on demonstrating equivalence to the predicate device's characteristics and meeting relevant safety standards. The performance is reported through a comparative table and non-clinical testing summaries.
| Characteristic/Function | Acceptance Criteria (Predicate) | Reported Device Performance (VeinGogh™) |
|---|---|---|
| Intended Use | Thermocoagulation for lower limb spider vein or telangiectasia | Thermocoagulation for lower limb spider vein or telangiectasia (Identical) |
| Design Specifications | Similar to submitted device | Similar to predicate device (Equivalent) |
| Classification Name, Number & Product Code | Same as submitted device | Same as predicate device (Identical) |
| Operational Environment | Same as submitted device | Same as predicate device (Identical) |
| Electrical Safety (Certification) | Not referenced in 510(k) Summary for predicate | Certified to IEC 60601-2-2, 5th Ed., 2009-02 (Claimed improvement over predicate) |
| Flammability Testing | No claim made | Passed UL 94 Flammability testing (Claimed improvement over predicate) |
| Power Supply | In-house designed - 100V Output | OTS Medical Rated Astrodyne MKK 40D-24 (24V Output) (Claimed as safe or safer) |
| Isolation Capacitor in Series with Treatment Connection | Yes | Yes (Identical) |
| High Voltage Rated "Y" Type Capacitor | Yes, Y-Type | Yes, Y-Type (Identical) |
| Number of Capacitors | Single | Dual (Claimed greater failure protection) |
| Capacitor Used | 22nF (~20x leakage) | 1.1nF |
| Typical Maximum Output Voltage | 500 V Maximum | 205 V Maximum (+/-10%) (Claimed greater safety) |
| Output Waveform Frequency | 4MHz | 4MHz (Identical) |
| High Voltage Pulse Generator | Yes | Yes (Identical) |
| Type of Generating Circuit | Fly-back Type | Fly-back Type (Identical) |
| Range of Peak to Peak Pulse Amplitude | 80Vpp to 502Vpp | 98Vpp to 205Vpp (+/-10%) (Claimed greater safety) |
| Output Voltage Increases at Low Settings | Yes (with noticeable dip) | No (Output voltage increases throughout useful range) |
| Number of Power Settings | 3 | 14 (Claimed more sophisticated range) |
| Auto-Pulse Functionality | No auto-pulse functionality | User activated software with adjustable delay (New feature, claimed more efficient) |
| Other operational controls (e.g., pulse duration, display, reset functions) | Generally "Yes" for predicate | Generally "Yes" for VeinGogh™ (Stated as identical or very similar) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that no animal or clinical testing was deemed necessary because "both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions." Therefore, there is no "test set" in the sense of patient data.
The "testing" mentioned is non-clinical performance data testing and review, which includes:
- Bench testing of major electronic components.
- Verification testing of firmware modules.
- Validation testing of the finished instrument's intended use, requirements, and hazard mitigation.
- Electrical safety testing (conformance to IEC and EN standards).
- Plastic flammability testing (conformance to UL 94).
The data provenance is therefore from laboratory bench testing and technical conformance assessments. There is no mention of country of origin for such data, as it's typically internal product development and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the absence of patient data or clinical studies, there's no "ground truth" derived from expert clinical assessment of patient outcomes in this submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-2-2, EN 60601-1-2, UL 94) and the design specifications of the device. The experts involved would be the engineers and technicians performing the tests and verifying compliance with these standards, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document states, "The submitter believes that both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions, which negates a requirement for the submission of animal or clinical testing." This indicates that efficacy was assumed based on equivalence to the predicate, and no human reader/clinician study was performed to assess comparative effectiveness or improvement with AI assistance (as no AI is described).
6. Standalone (Algorithm Only) Performance Study
Not applicable. The VeinGogh™ instrument is a physical electrosurgical device, not an algorithm, and the submission does not describe any AI component.
7. Type of Ground Truth Used
The "ground truth" for this submission are:
- Predicate Device Equivalence: The performance and safety profile of the legally marketed Veinwave/TC3000 device.
- Engineering and Safety Standards: Conformance to electrical safety standards (IEC 60601-2-2, EN 60601-1-2), EMC standards (EN 55011/CISPR 11), and flammability standards (UL 94).
- Device Design Specifications: The stated requirements and design specifications established during the device's development.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and no software "training set" is mentioned. The firmware is proprietary and developed by a contract supplier, with verification testing performed on its modules.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
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