(245 days)
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: <1 (range 0-7) on a 0-10 scale. By evening Day 2: mean pain score 0.5; mean discomfort score <1. By Day 4: mean pain score 0. |
2. Sample Size Used for the Test Set and the Data Provenance
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Sample Size for Test Set:
- Clinical Study (Effectiveness & Safety): 52 healthy volunteers recruited.
- Effectiveness Analysis (Physician): 37 subjects for whom both physicians gave the same grade improvement, out of 45 subjects evaluated by both assessors.
- Safety Analysis (Physician & Subject): 52 subjects initially, with 46 subjects completing all treatments and follow-up.
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Data Provenance: The clinical study was conducted at a single center. The document does not specify the country of origin of the data, but the submission is to the U.S. FDA, implying the data was likely collected in the U.S. or recognized by U.S. standards. The study design (recruitment, interventions, follow-up) indicates it was a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: 2 physicians.
- Qualifications of Experts: The document states they were "2 physicians" who used the Lemperle grading scale (periorbital region) and were "blinded evaluators." No further specific qualifications (e.g., years of experience, specialization like dermatology or plastic surgery) are provided.
4. Adjudication Method for the Test Set
- The effectiveness results are reported based on instances where the two blinded evaluators gave the same grade improvement (37 out of 45 subjects). This implies an approach where agreement was prioritized or a subset with agreement was analyzed, rather than a formal adjudication method like 2+1 or 3+1 for resolving disagreements. The document mentions "For the 37 subjects for whom the two physicians gave the same grade improvement the mean improvement was 0.57." This suggests that cases where the physicians disagreed might have been excluded from the primary effectiveness metric presented, or an averaging/adjudication was not explicitly detailed for disparate readings.
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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical trial evaluating the standalone effectiveness and safety of the Rejuvapen NXT device itself on patients, not comparing human reader performance with or without AI assistance. The device is a microneedling device, which is a physical skin treatment, not an AI-powered diagnostic or interpretive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of the Rejuvapen NXT. The Rejuvapen NXT is a physical microneedling device, not an algorithm or software. The "standalone" performance tested was the device's ability to mechanically deliver treatments (e.g., needle penetration, puncture rate accuracy) and its clinical effectiveness when used by a human operator.
7. The Type of Ground Truth Used
- Clinical Study (Effectiveness): The ground truth for effectiveness was established through expert consensus (2 blinded physicians using the Lemperle grading scale) and subject-reported outcomes (grading their own improvement).
- Clinical Study (Safety): The ground truth for safety was based on physician assessments of erythema and adverse events, and subject-reported assessments of erythema, pain, discomfort, and peeling.
- Bench Testing (Performance): The ground truth for mechanical performance (e.g., needle protrusion, puncture rate, fluid ingress) was established through direct measurements and laboratory testing against predefined technical specifications.
8. The Sample Size for the Training Set
- This question is not applicable as the Rejuvapen NXT is a physical medical device, not a machine learning or AI algorithm that requires a training set. The study describes a clinical trial and bench testing for device validation.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as the Rejuvapen NXT is a physical medical device, not a machine learning or AI algorithm that requires a training set.
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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 9, 2020
Refine USA LLC % Wayne Glover President TechniReg, Inc 19404 Pine Valley Drive Odessa, Florida 33556-3955
Re: K192138
Trade/Device Name: Rejuvapen NXT Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling device for aesthetic use Regulatory Class: Class II Product Code: QAI Dated: February 28, 2020 Received: March 6, 2020
Dear Wayne Glover:
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,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K192138
Device Name Rejuvapen NXT
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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a
Image /page/3/Picture/1 description: The image shows the RefineUSA logo on the left and the text "510(k) Summary" on the right. The RefineUSA logo consists of a stylized letter R in blue, with the company name written in gray next to it. The text "510(k) Summary" is written in a bold, sans-serif font. The image is likely a document header or title page for a medical device submission.
This 510(k) Summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| Summary Date: | April 8, 2020 | ||
|---|---|---|---|
| Manufacturer: | Refine USA LLC | ||
| Telephone: | 866-590-5533 | ||
| EstablishmentRegistration No.: | 3006033709 | ||
| Contact Person: | Mr. Brian SmithPresidentPhone: (904) 629-0100Fax: (888) 842-0395 | ||
| Trade Name: | Rejuvapen™ NXT | ||
| Common Name: | Powered Microneedle Device | ||
| Classification Name: | Microneedling device for aesthetic use (21 CFR 878.4430) | ||
| Product Code: | QAI | ||
| Equivalence /Predicate Device: | Substantial equivalence to the following legally marketed predicate devices isclaimed: | ||
| Device Name: | 510(k) No.: | Date: | |
| SkinPen® Precision System | DEN160029 | 03/01/2018 | |
| Description: | The Rejuvapen is a handheld instrument that contains a Single Use micro needlecartridge containing 12 stainless steel microneedles in a circular arrangementwith an adjustable microneedle depth of up to 2.5 mm. The needles create verysmall punctures in the epidermal and dermal layers of the skin. The device ispowered by a medical grade wall plug-in supply. An adjustment is provided for avariable speed motor that controls the frequency of the puncture process with a |
The Rejuvapen may be used with the operator and/or patient in any position that is comfortable. There are no restrictions for other nearby persons.
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| Caution: Federal law restricts this device to sale by or on the order of a physician. This is a Class II device (USA). | |
|---|---|
| Intended Use: | 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. |
| Predicate Device: | The Rejuvapen NXT characteristics with its included accessories and intended use are compared to the following predicate device: |
| SkinPen® Precision System (DEN160029) manufactured by Bellus Medical, LLC. | |
| Please refer to data in the comparison chart for comparison of the design, materials, chemical composition, packaging, intended use, mechanical performance and other characteristics of the subject device to those of the predicate devices. | |
| Biocompatibility: | The biocompatibility endpoints were evaluated to the following standards: |
| Cytotoxicity - ISO 10993-5 Skin irritation – ISO 10993-10 Skin sensitization - ISO 10993-10 Pyrogenicity - USP <151> Acute Systemic Toxicity - ISO 10993-11 | |
| EMC: | Electromagnetic Compatibility testing was performed on the device and its power supply adapter by an NRTL and complies with IEC 60601-1-2 Medical Electrical Equipment, Electromagnetic Compatibility. |
| Essential Performance: | The Rejuvapen NXT has been tested for electromagnetic immunity and emissions. The basic safety and essential performance of the device is maintained if the user follows the rules, distances and exclusions described in the information and tables that follow. |
| The essential performance of Rejuvapen NXT microneedling device is defined as:a) Needle protrusion: Maximum needle protrusion is a needle protrusion setting of 2.5 + 0.25 mm. | |
| Note: As the dial for the needle protrusion setting is mechanical, this needle protrusion cannot be influenced by EMC, electronic or electric phenomena.b) Puncture frequency: Maximum puncture frequency of 110 Hz + 2 % | |
| Electrical Safety: | Electrical Safety testing was performed on the device and its power adapter byan NRTL and fulfil the requirements of ANSI AAMI ES60601-1:2005/(R)2012 +A1:2012 + C1:2009(R)2012 + A2:2010(R)2012 (Consolidated Text) MedicalElectrical Equipment - Part 1: General Requirements for Basic Safety andEssential Performance (IEC 60601-1:2005, MOD). |
| Shelf Life andSterilizationValidation: | The shelf life of the handheld unit and microneedle cartridge is 2 years and wasverified by testing in accordance with the shelf life and sterilization validationtest report. References include ISO 11607 and FDA guidance document'Submission and Review of Sterility Information in Premarket Notification(510(k)) Submissions for Devices Labeled as Sterile', March 2016. |
| TechnicalSpecifications: | Needle Length: 3.0mm - includes length inside molded housingGeometry: 12 needles in a circular arrangement outer circle of 8, inner circle of 4Maximum Penetration Depth Setting: 2.5mmIt is not recommended to use the device at depths greater than 1.3mmPuncture Rate Frequency: User adjustable in 9 steps from 80 to 110 Hz(4800 to 6600 RPM)Needle Penetration Depth Accuracy: ±0.25mm.Puncture Rate Accuracy: ±2% |
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General controls and mitigation measures
To support substantial equivalence of the Rejuvapen NXT Microneedling device system, it has undergone non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, electrical safety and software.
The following non-clinical performance data is provided in support of the substantial equivalence determination
| Identified Risk to Health | Mitigation Measures | Substantiation |
|---|---|---|
| Safety profile | Biocompatibilityevaluation | ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, USP 40 part 151, andISO 10993-12 |
| Labeling | ISO 15223-1:2012, EN 1041:2008,IEC 82079-1:2012, IEC 62366:2007 | |
| Cross contaminationand infection | Sterilization validation | ISO11135-1:2007ISO/TS11135-2:2008ISO11737-1:2006 |
| Reprocessing validation | A cleaning validation and a low-leveldisinfection validation was performed(Reprocessing Medical Devices in HealthCare Settings: Validation Methods andLabeling). In addition, the use of aprotective sleeve is required. | |
| Non-clinical performancetesting | Non-clinical performance datademonstrates that the device performs asintended under anticipated conditions ofuse.The following performance characteristicswere tested:i. Accuracy of needle penetration depthand puncture rate in pig skinii. Safety features built into the device toprotect against cross-contamination,including fluid ingress protection due to asafety membrane; andiii. Identification of the maximum needlepenetration depth for the device in pigskin | |
| Shelf life testing | Performance data supports the shelf lifeof the device by demonstrating continuedsterility, package integrity, and devicefunctionality over the intended shelf lifeaccording to ISO 11607-1, ISO11607-2and ISO 11737-2 | |
| Labeling | ISO 15223-1EN 1041IEC 82079-1IEC62366 | |
| Electrical shock orElectromagneticinterference with otherdevices | EMC testing and electricalsafety testing | IEC / ES60601-1IEC60601-1-2IEC60601-1-6 |
| Labeling | ISO 15223-1EN 1041IEC 82079-1IEC62366 | |
| Non-clinical performancetesting | Non-clinical performance datademonstrates that the device performs asintended under anticipated conditions ofuse.The following performance characteristicswere tested:i. Accuracy of needle penetration depthand puncture rate in pig skinii. Safety features built into the device toprotect against cross-contamination,including fluid ingress protection due to asafety membrane; andiii. Identification of the maximum safeneedle penetration depth for the device inpig skin | |
| Exceeding safe penetrationdepthMechanical failureSoftware malfunction | Technologicalcharacteristics | Non-clinical performance datademonstrates that the device performs asintended under anticipated conditions ofuse.The manufacturer has set tolerances formaximum needle depth penetration andpuncture rate and has performed benchtesting to demonstrate the efficacy offluid ingress protection.The following performance characteristicsare tested:i. Accuracy of needle penetration depth,maximum needle depth penetration andpuncture rate was tested in a clinicallysuitable substrate porcine skin. Twopenetration depths of 0.5mm and 2.5mmwere tested at frequencies (puncturerate) of 80 and 110Hz using agedcartridges and aged devices to verify theaccuracy of the penetration depth,maximum permissible depth and puncturerate.A tolerance was set of ± 0.25mm forneedle penetration and a 2% tolerance ofpuncture rate. In all tests and in allvariations the accuracy of needlepenetration depth and puncture rate werewithin the expected tolerances. Themaximum needle depth penetration of the |
| exceed the tolerances set by themanufacturer.ii. Safety features built into the device toprotect against cross-contamination,including fluid ingress protection. Themicro needling cartridge contains a safetymembrane (seal) that was tested underlaboratory conditions. Testing of the sealunder a worst-case scenario (maximumpuncture rate and needle penetrationdepth) did not result in the penetration ofviral particles, protein or hemoglobinmarkers through the seal to the chamberof the device.iii. Identification of the maximum needlepenetration depth for the device in pigskin. | ||
| Shelf life testing | ISO 11607-1ISO 11607-2 | |
| Labeling | ISO 15223-1EN 1041 | |
| Software verification,validation and hazardanalysis | IEC 62304 | |
Summary of Risk and mitigation measures
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Technological Characteristics
| Property: | Rejuvapen NXT | SkinPen® PrecisionSystem | Significant differences |
|---|---|---|---|
| DeviceManufacturer | Refine USA, LLC340 3rd Avenue SouthSuite CJacksonville Beach, FL32250 | Bellus Medical, LLC4505 Excel ParkwaySuite 100Addison, TX 75001 | Not Applicable |
| Device Tradename | Rejuvapen NXT | SkinPen® PrecisionSystem | Not Applicable |
| 510(k) Number | K192138 | DEN160029 | Not Applicable |
| DeviceClassificationName | Microneedling devicefor aesthetic use | Microneedling device foraesthetic use | Identical |
| DeviceProduct Code | QAI | QAI | Identical |
| DeviceClassification | Class II | Class II | Identical |
| Regulation Number | 21CFR 878.4430 | 21CFR 878.4430 | Identical |
| Use | Prescription Only | Prescription Only | Identical |
| Intended Locationof Use | Face | Face | Identical |
| Indications for Useand Intended Use | The Rejuvapen NXT isa microneedling deviceand accessoriesintended to be used asa treatment to improvethe appearance ofperiorbital wrinkles inFitzpatrick skin types I-IV. The RejuvapenNXT is intended for useon adults at least 22years of age. | SkinPen® PrecisionSystem is a microneedlingdevice and accessoriesintended to be used as atreatment to improve theappearance of facial acnescars in adults aged 22years or older | Dissimilar - clinical data wasprovided to support theindication |
| Geometry | 12 needles in a circulararrangement:outer circle of 8, innercircle of 4 | 14 needles in a circulararrangement:outer circle of 7, innercircle of 6, middle has 1 | Dissimilar - Non clinicalperformance testing using pigskin demonstrates that theneedle geometry of theproposed device is uniformand does not raise anydifferent questions in relationto safety, compared to thepredicate device. |
| Property: | Rejuvapen NXT | SkinPen® Precision System | Significant differences |
| Needle protrusion settings | 0 – 2.5mm | 0 – 2.5mm | Identical |
| Max. Penetration Depth | 2.5mm | 2.5mm | Identical |
| Puncture Rate Frequency | 80Hz to 110Hz user adjustable, 9 regulated speeds | 105Hz to 136Hz unregulated | Dissimilar - Proposed device does not exceed the frequency of the predicate device. Bench testing was provided to support the difference in technology. |
| Treatment Protocol | 4 treatments spaced 4 weeks apart | 3 treatments spaced 4 weeks apart | Identical |
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Substantial Equivalency and Comparison of Technological Similarities and Differences:
Key Similarities:
-
- The device classification (generic description) and basic technologies are equivalent in that both devices are micro needling devices containing more than 1 needle that mechanically punctures and injures the skin for aesthetic use.
-
- Both devices are by prescription use only.
-
- Both use a circular arrangement for the micro-needles.
- Both have a maximum penetration depth of 2.5mm. 4.
-
- Both use treatment tips that are disposable and for single use only.
Differences:
Althouqh the devices share the basic generic description and technologies they do differ in several areas.
- a. Indication
- b. Geometry and needle count
- c. Puncture rate frequency
These differences have been addressed by the manufacturer through the applicable safety standards, general controls, non-clinical, and clinical testing.
Clinical performance testing
A clinical study was conducted to support the safe and effective use of the Rejuvapen NXT Microneedling device for the treatment of Periorbital wrinkles.
The study was conducted at a single center. 52 healthy volunteers with facial ageing were recruited. After informed consent, subjects underwent 4 micro needling sessions 4 weeks apart. Subjects were assessed at baseline and 30 days after the last treatment, on Day 120.
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The subject's face was cleansed with cleanser to remove all traces of make-up. A topical anesthetic (Numbmaster; 5% Lidocaine) was applied to the periorbital region for 30 minutes, as per the manufacturer's instructions. After 30 minutes the topical anesthetic was removed.
A standard microneedle cartridge containing 12 stainless steel microneedles (maximum 2.5 mm length, 32 gauge) was used to achieve pinpoint bleeding over the periorbital treatment area. The operator was instructed to start at a needle protrusion setting of 0.5 mm and gradually increase the depth until pinpoint bleeding was observed, with a maximum depth of 1.3 mm. After treatment the skin was cleansed with warm water and sterile gauze. A physical sunblock cream with SPF 40 was applied to the subject's skin.
Forty-six subjects (88%) completed all treatment visits and attended follow up. One subject was withdrawn as they had commenced Apixiban, an anticoagulant, two withdrew for no reason and did not return the research staff calls, one withdrew to undergo additional aesthetic treatments, one withdrew for personal reasons and one subject withdrew because they 'did not like the treatments'.
The mean age of the subject was 57 years (range 37-72 vears). Six males, 46 females, Fitzpatrick phototypes (FP) ranged from 1-4. Six of the subjects identified as Hispanic the remainder were white Caucasian. Five of the subjects were smokers (see table 1).
Table 1 Subject demographics at baseline
| N | Mean age | Age range | M:F | Hispanic | FP I | FP II | FP III | FP IV | FP V | FP VI |
|---|---|---|---|---|---|---|---|---|---|---|
| 52 | 57 | 37-72 | 6:46 | 6 | 3 | 20 | 22 | 7 | - | - |
MEASUREMENT OF SAFETY
Physician measurement of safety
Immediately after each micro needling procedure the research staff graded the amount of visible erythema in the treatment area. Grading was carried out using a 5-point grading scale; whereby none was equivalent to "No erythema or redness. Skin is normal color" to Severe; "Bright or dark red color to the skin. Skin is severely red."
Subjects measurement of safety
Subjects also graded erythema, pain and discomfort experienced during the treatment. A descriptive grading scale was used for subjects to evaluate their erythema with the addition of photography. This scale was also used for subjects to record their erythema at home. Pain and discomfort were recorded using a visual analoque scale (0-10) where 0 was equivalent to "no discomfort" to 10, "most intense pain ever" and "most discomfort ever". This grading structure was also used to record changes to pain and discomfort at home. In addition, skin peeling was assessed by the subject from day 3 to day 8 using a visual analogue scale.
From commencement of the study to study close out adverse events were recorded and monitored by the research staff.
MEASUREMENT OF EFFECTIVENESS
Physician measurement of effectiveness
At each visit digital photographs (VISIA) were taken of the subject's face. At the end of the study the digital images of the subject's face were masked and randomized independently by 2
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physicians using the Lemperle grading scale (periorbital region). *Lemperle G, Holmes RE, Lemperle SS. A Classification of Facial Wrinkles. Plastic and reconstructive surgery. 2001 Nov 1;108(6):1735-50.
Subject measurement of effectiveness
Subjects were asked to grade their skin at baseline in respect to periorbital lines and wrinkles, and pigmentation. Thirty days after the last treatment, subjects were asked to grade their treatment response.
RESULTS
Physician Measurements of safety
There were 20 adverse events during the study, that occurred in 12/52 subjects (23%) The adverse events were judged to be mild by the principle investigator.
Fourteen (14/20, 70%) of the 20 AEs were reports of bruising in the treatment area lasting between 1-7 days. Only one event (1/20, 5%) reported bruising under both eyes and the remainder were singular occurrences, either left or right eye areas. Swelling in the treatment area was reported in two (2/20, 10%) of subjects and blotchy skin and bruising were reported in one subject (1/20(5%)). One subject (1/20(5%)) reported 'watery eyes' and a post-treatment allergic response after three treatment visits. There were no unrelated adverse events.
All the incidents were self-limiting and required no intervention from study staff.
Erythema immediately after treatment was graded by the physician as predominantly minor or mild (see table 2) in subjects (with the remainder of subjects graded as moderate. No subjects were graded as severe.
| Physician Erythema grading - Immediately post treatment | ||||||
|---|---|---|---|---|---|---|
| None | Minor | Mild | Moderate | Severe | Number ofsubjects | |
| Treatment 1 | 0 | 25 (48%) | 22 (42%) | 5 (10%) | 0 | 52 |
| Treatment 2 | 0 | 30 (61%) | 17 (35%) | 2 (4%) | 0 | 49 |
| Treatment 3 | 0 | 29 (63%) | 15 (33%) | 2 (4%) | 0 | 46 |
| Treatment 4 | 0 | 32 (70%) | 13 (28%) | 1 (2%) | 0 | 46 |
| Table 2 Physician Erythema grading - Immediately post treatment | |||
|---|---|---|---|
| ----------------------------------------------------------------- | -- | -- | -- |
Subject evaluation of pain and discomfort during treatment indicated a mean pain score of 2.1 over the four treatments (based on a 0-10 scale) with a range from 0-7, and a mean discomfort score of <1, with a range from 0-7 (based on a 0-10 scale).
Subject measurement of safety
Immediately after treatment, 12/46 (26%) of subjects recorded their erythema as severe ('bright or dark red color to the skin; skin is severely red') 24/46 (52%) of subjects recorded their erythema as moderate ('skin has a very definite redness to it'), and 10/46 (22%) recorded their erythema as mild or minor.
{13}------------------------------------------------
One day after the treatment the number of subjects recording their erythema as severe was 5/46 (11%). By the evening of Day 3 the number of subjects reporting their erythema to be mild, minor or absent was 44/46 (96% of subjects). By Day 8 only one subject 1/46 (2%) graded their erythema as mild, the remainder recording erythema as either minor (2/46; 4%) or none ( 44/46; 96%).
Subjects reported gradual cessation of pain after the treatment. By the evening of Day 2 (on a scale of 0 to 10) the mean pain score was 0.5 and by Day 4 the mean pain score was zero.
Subjects reported gradual cessation of discomfort over the procedure, with a mean discomfort score of <1 (on a scale of 0 to 10) recorded on the evening of Day 2.
Physician measurement of effectiveness
A statistical summary of the evaluation of periorbital wrinkle grading is given in Table 3, showing mean values, numbers/percentages of improvements and 95% confidence intervals (Cls).
Two blinded evaluators graded images at baseline and final follow up (Day 120).
For the 37 subjects for whom the two physicians gave the same grade improvement the mean improvement was 0.57. Nineteen out of 45 subjects, 42% had at least a one grade improvement according to both assessors
Table 3: Combined Assessment of periorbital wrinkles at baseline and Day 120 (95% Cls in brackets)
| Physician | n | Meanbaselinegrade | MeanDay-120grade | Meanimprovement | Number; % of subjectsimproved by ≥ 1 grade |
|---|---|---|---|---|---|
| Combined | 37 | 2.68 | 2.11 | 0.57 (0.37, 0.76) | 19; 42% (35.2%, 67.5%) |
3 Mean baseline grade = 2.67 for all 52 recruited subjects.
Subject measurement of effectiveness
On average, subjects graded their skin at baseline as slight/shallow lines and wrinkles that are noticeably visible, isolated reqions of skin roughness and slight pigmentation and sunspots. Thirty days after the last treatment 37/46 (80%) of subjects graded their treatment responses as "slight to somewhat noticeable improvement in periorbital wrinkles" and 23/46 (50%) "slight improvement in pigmentation"
Five of the 46 subjects (5/46(11%)) reported no improvement in any of the efficacy parameters.
- The Rejuvapen NXT is substantially equivalent to the predicate device. Conclusions: There are no different questions regarding safety or effectiveness.
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.