(131 days)
Not Found
No
The description focuses on the mechanical function of the microneedling device and does not mention any AI or ML components.
Yes.
The device is intended to be used as a treatment to improve the appearance of facial acne scars.
No
The device is described as a microneedling treatment to improve the appearance of facial acne scars, not to diagnose a condition.
No
The device description explicitly states it is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter, which are all hardware components. The performance studies also focus on hardware-related testing.
Based on the provided information, the 1NEED Pro is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "improve the appearance of facial acne scars in adults aged 22 years or older." This is a therapeutic or cosmetic treatment applied directly to the patient's skin.
- Device Description: The device is a microneedling pen that creates "microscopic punctures in the epidermal and dermal layers of the skin." This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The 1NEED Pro does not perform any such analysis of specimens.
The 1NEED Pro is a medical device used for a dermatological procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The 1NEED Pro is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.
Product codes
QAI
Device Description
The 1NEED Pro is a minimally invasive microneedling device that microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The 1NEED Pro is comprised of a reusable pen body, a sterile, single use microneedling cartridge and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending of the skin being treated. Charging is accomplished by attaching the 1NEED Pro pen body to the power adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
adults aged 22 years or older
Intended User / Care Setting
Prescription Use
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
Bench testing included the following:
- Motor Speed Puncture Rate Testing
- · Needle Penetration Depth and Extension Accuracy Testing
- Needle Bonding Strength Test
- Use Life Testing
- Cartridge Life Testing
- Anti-suction Testing
- Microbial Ingress Testing
Conclusion: Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Controlled Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
March 19, 2025
Campomats S.r.1. % Chiara Violini Consultant White Lab S.r.l. via del Consorzio, 41 Falconara Marittima, AN 60015 Italy
Re: K243472
Trade/Device Name: 1NEED Pro Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling device for aesthetic use Regulatory Class: Class II Product Code: QAI Dated: December 19, 2024 Received: December 19, 2024
Dear Chiara Violini:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Wilmarie Flores -S
Wilmarie Flores Ph.D. Acting Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K243472
Device Name 1NEED Pro
Indications for Use (Describe)
The 1NEED Pro is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.
| 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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510(k) #: K243472
510(k) Summary
Prepared on: 2025-02-11
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | CAMPOMATS S.R.L. |
|---|---|
| Applicant Address | Via Monte Rosa 11 Riccione RN 47838 Italy |
| Applicant Contact Telephone | +393357190018 |
| Applicant Contact | Mr. Mats Erik Andreasson |
| Applicant Contact Email | mats@campomats.it |
| Correspondent Name | White Lab S.r.l. |
| Correspondent Address | via del Consorzio, 41 Falconara Marittima AN 60015 Italy |
| Correspondent Contact Telephone | +390710971877 |
| Correspondent Contact | Mrs. Chiara Violini |
| Correspondent Contact Email | c.violini@endoengineering.it |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | 1NEED Pro |
|---|---|
| Common Name | Powered microneedle device |
| Classification Name | Microneedling device for aesthetic use |
| Regulation Number | 878.4430 |
| Product Code(s) | QAI |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate# | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K230420 | Dr.pen Microneedling System | QAI |
Device Description Summary
21 CFR 807.92(a)(4)
The 1NEED Pro is a minimally invasive microneedling device that microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The 1NEED Pro is comprised of a reusable pen body, a sterile, single use microneedling cartridge and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending of the skin being treated. Charging is accomplished by attaching the 1NEED Pro pen body to the power adapter.
5
Intended Use/Indications for Use
The 1NEED Pro is a microneedling device intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 vears or older.
Indications for Use Comparison
1NEED Pro device has the same intended use of the legally marketed predicate devices. The 1NEED Pro is a microneedling device intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older
Technological Comparison
1NEED Pro has the same technological characteristics and microneedling is the toch the subject and predicate device (K230420).
The 1NEED Pro and the predicate are for identical uses and rely on the same mode of action. The devices include disposable needle cartridges with design features to mitigate the likelinod of cross-contamination between patients and to prevent needle depth greater than 2 mm.
The subject and the predicate have the same technological characteristics including:
- Intended Location of use: Face
- Power source (pen body): Rechargeable Li-ion battery
- Power Source (Battery Charger): AC Powered
- Control mechanism: Microprocessor; embedded software
- Single Speed (RPM): 6300- 7700
- Puncture Rate: 105 -128 stamps/second
- Microneedling Cartridge: Sterile, Single Use
- Number of needles and geometry: 14 (radially arranged)
- Needle Gauge: 34 Ga
- Needle Material: Stainless Steel
- Needle Shape Geometry: Straight, cylindrical body with a conical tapered, sharp point
- Needle spacing: 2 mm spacing/3.96 mm2 per needle
- Penetration depth: 1.5 mm (Recommended)
- Max. needle Depth setting: 2,0 mm
- Penetration Depth Selection: 9 depth settings; 0 mm in 0.25 mm increments
- Sterility: Not sterile device, Sterile cartridges (EO)
- Shelf life: 2 years (cartridge)
- Barrier- Cross/Contamination: Protective Sleeve (Disposable)
- Treatment protocol 3 treatments spaced 4 weeks apart
- Bench tests:
- · Motor Speed Puncture Rate Testing
- · Extension Accuracy Testing
- Needle Bonding Strength Test
- · Use Life Testing
- · Cartridge Life Testing
- · Anti-suction Testing
- · Microbial Ingress Testing
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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Bench testing included the following:
- Motor Speed Puncture Rate Testing
- · Needle Penetration Depth and Extension Accuracy Testing
- Needle Bonding Strength Test
- Use Life Testing
- Cartridge Life Testing
- Anti-suction Testing
- Microbial Ingress Testing
Conclusion
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device.
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