(148 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing for decision-making.
Yes
The device is intended for use as a treatment to improve the appearance of facial acne scars and surgical or traumatic hypertrophic scars, which are therapeutic indications.
No
The device is described as a treatment to improve the appearance of scars, creating channels and microinjuries in the skin, rather than for the purpose of identifying or characterizing a medical condition or disease.
No
The device description clearly outlines a physical, handheld device with a motor, needles, power source, and disposable cartridges, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of facial acne scars and surgical/traumatic hypertrophic scars. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a mechanical system for creating microinjuries in the skin. This is a physical intervention, not a method for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting biomarkers or performing any kind of in vitro test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Product codes
QAI
Device Description
The SER Pen Carain MicroSystem (MP1209SP) is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a DC motor drive system that rapidly reciprocates an array of 12 needles and 36 needles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, and a disposable, single use cartridge containing an array of needles.
The power source consists of a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.
The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.
The SER Pen Carain MicroSystem's disposable cartridge is designed in two configurations, a 12-needle array and a 36-needle array. The needle array is housed in a specially designed cartridge housing with a silicon spring that prevents liquids from entering the motor body via the inside lumen of the cartridge.
The SER Pen Carain MicroSystem biolock sleeve is a one end elastic opening PE bag to protect the whole system from cross contamination from the outside during the operation procedure.
The SER Pen Carain MicroSystem microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-5, 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11 (Method A) (C/S Analyzer) was also completed and is attached.
Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy. Certifications on file with the Sponsor and available for review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Facial acne scars, surgical or traumatic hypertrophic scars on the abdomen
Indicated Patient Age Range
Adults aged 22 years or older.
Intended User / Care Setting
Not Found
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)
The Sponsor intends to rely on the same performance data submitted in Collagen P.I.N. (K222199) and SkinStylus (K200044 and K231073) devices and not include any clinical data. Specifically, the Sponsor intends to rely on the following performance data reports:
Biocompatibility tests: Cytotoxity - ISO 10993-5:2009, Sensitization -ISO 10993-10:2010, Irritation - Intracutaneous Injection Test GLP -ISO 10993-10:2010, Systemic Toxicity – Systemic Injection GLP -ISO 10993-11:2017, Pyrogenicity ISO 10993, Metallurgical Analysis – GLP - ASTM E1019-11(Method A)(C/S Analyzer).
Sterilization Validation: Sterilization of Health Care Products – Moist heat ISO 17665-1:2006, Sterilization of Medical Devices ISO 11737-1:2006, Sterilization of Medical Devices ISO 11737-2: 2009, Sterility and Bacteriostasis/Fungistasis Tests ISO 11737-2: 2009 and USP 71.
Reprocessing Validation: ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMI TIR-12:2004).
Fluid Ingress Validation.
Shelf-life Testing: Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F88/F88M-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ASTM F1929-15.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 9, 2024
Su-Ko Technologies LLC % Marc Sanchez, Esq. Regulatory Counsel Contract In-House Counsel and Consultants, LLC d/b/a FDA Atty 1717 Pennsylvania Ave NW Suite 1025 Washington, District of Columbia 20006
Re: K241355
Trade/Device Name: SER Pen Carain MicroSystem (MP1209SP) Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: September 11, 2024 Received: September 11, 2024
Dear Marc Sanchez, Esq.:
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.
1
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
2
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. 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
3
Indications for Use
510(k) Number (if known) K241355
Device Name SER Pen Carain MicroSystem (MP1209SP)
Indications for Use (Describe)
The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
| 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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4
510(K) Summary
The following information is provided as required by 21 CFR 807.92 for the Carain MicroSystem 510(k) premarket notification.
| Sponsor: | Su-Ko Technologies, LLC
Attention: Yuan Yuan Korrodi
700 Smith Street, #61070
Houston, TX 77002 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | GUANGZHOU CARAIN BEAUTY EQUIPMENT
501, No. 3 of Xin Liu Mu Road, Zhong
Cun Street
Guangzhou Guangdong, CHINA 511495
Establishment Registration: 3011568699 |
| Contact: | Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717
Pennsylvania Ave NW Suite 1025 Washington D.C. 20006
Ph: 202.765.4491
E-mail: msanchez@fdaatty.com |
| Date of Submission: | October 8, 2024 |
| Proprietary Name: | SER Pen Carain MicroSystem (MP1209SP) |
| Common Name: | Powered Microneedle Device |
| Regulation Number: | 21 CFR 882.4810 |
| Regulatory Class: | Class II |
Product Code: QAI
Predicate Device: Collagen P.I.N. (Percutaneous Induction Microneedling) System (K222199).
Secondary Predicate Device: SkinStylus SteriLock® MicroSystem (K200044).
Device Description:
The SER Pen Carain MicroSystem (MP1209SP) is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a DC motor drive system that rapidly reciprocates an
5
SuKo Technologies, LLC
array of 12 needles and 36 needles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, and a disposable, single use cartridge containing an array of needles.
The power source consists of a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.
The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.
The SER Pen Carain MicroSystem's disposable cartridge is designed in two configurations, a 12-needle array and a 36-needle array. The needle array is housed in a specially designed cartridge housing with a silicon spring that prevents liquids from entering the motor body via the inside lumen of the cartridge.
The SER Pen Carain MicroSystem biolock sleeve is a one end elastic opening PE bag to protect the whole system from cross contamination from the outside during the operation procedure.
The SER Pen Carain MicroSystem microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-5, 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached.
Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy. Certifications on file with the Sponsor and available for review.
Indications for Use:
The SER Pen Carain MicroSystem is intended to be used as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, and to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years and older.
6
Traditional 510k Submission Carain MicroSystem
Summary of Non-Clinical Test Reports
The Sponsor intends to rely on the same performance data submitted in Collagen P.I.N. (K222199) and SkinStylus (K200044 and K231073) devices and not include any clinical data. Specifically, the Sponsor intends to rely on the following performance data reports.
| Test Completed | Standard |
|---|---|
| Biocompatibility | Cytotoxity - ISO 10993-5:2009 |
| Sensitization -ISO 10993-10:2010 | |
| Irritation - Intracutaneous Injection Test GLP - | |
| ISO 10993-10:2010 | |
| Systemic Toxicity – Systemic Injection GLP - | |
| ISO 10993-11:2017 | |
| Pyrogenicity ISO 10993 | |
| Metallurgical Analysis – GLP - ASTM E1019- | |
| 11(Method A)(C/S Analyzer) | |
| Sterilization Validation | Sterilization of Health Care Products – Moist |
| heat ISO 17665-1:2006 | |
| Sterilization of Medical Devices ISO 11737-1: | |
| 2006 Sterilization of Medical Devices ISO | |
| 11737-2: 2009 Sterility and Bacteriostasis/ | |
| Fungistasis Tests ISO | |
| 11737-2: 2009 and USP 71 | |
| Reprocessing Validation | ISO 11737-1: 2018 (AAMI TIR-30; 2011; |
| AAMI TIR-12:2004) | |
| Fluid Ingress Validation | |
| Shelf-life Testing | |
| Standard Test Method for Seal Strength of Flexible | |
| Barrier Materials ASTM F88/F88M-15 | |
| Standard Test Method for Detecting Seal Leaks in | |
| Porous Medical Packaging by Dye Penetration | |
| ASTM F1929-15 |
7
Summary of Substantial Equivalence
The SER Pen Carain MicroSystem and the predicate are for similar uses and rely on the same mode of action. Both devices include disposable needle cartridges with design features to mitigate the likelihood of cross-contamination between patients and to prevent needle depth greater than 2.5mm. Both devices also include a redundant safety feature to ensure no fluid enters the motor or housing.
8
| Technological Characteristics | |||
|---|---|---|---|
| Device Name/Model | SER Pen Carain | ||
| MicroSystem | |||
| (MP1209SP) | Collagen P.I.N. | ||
| (Percutaneous | |||
| Induction | |||
| Microneedling) | |||
| System | SkinStylus | ||
| SteriLock® | |||
| MicroSystem | |||
| 510(k) Number | t/b/d | K222199 | K200044 |
| Indication for Use | The SER Pen Carain | ||
| MicroSystem is | |||
| intended to be used | |||
| as a treatment to | |||
| improve the | |||
| appearance of facial | |||
| acne scars in adults | |||
| with Fitzpatrick Skin | |||
| Types I - III, and to | |||
| improve the | |||
| appearance of | |||
| surgical or traumatic | |||
| hypertrophic scars | |||
| on the abdomen in | |||
| adults aged 22 years | |||
| and older. | for use as a | ||
| treatment to | |||
| improve the | |||
| appearance of facial | |||
| acne scars in adults | |||
| with Fitzpatrick | |||
| Skin Types I - III, | |||
| aged 22 years and | |||
| older. | The SkinStylus | ||
| SteriLock® | |||
| MicroSystem is | |||
| intended to be used | |||
| as a treatment to | |||
| improve the | |||
| appearance of | |||
| surgical or | |||
| traumatic | |||
| hypertrophic scars | |||
| on the abdomen in | |||
| adults aged 22 | |||
| years or older. | |||
| Mode of Action | Identical | Microneedling (using | |
| one or more needles | |||
| to mechanically | |||
| puncture and injure | |||
| skin tissue for | |||
| aesthetic use) | Microneedling (using | ||
| one or more needles | |||
| to mechanically | |||
| puncture and injure | |||
| skin tissue for | |||
| aesthetic use) | |||
| Power Source | Same 5Volt | ||
| DC/ 1 amp | |||
| rechargeable | |||
| lithium-ion | |||
| battery | 5 Volt DC/ 1 amp | ||
| rechargeable lithium- | |||
| ion battery | 5 Volt DC/1 amp | ||
| rechargeable lithium- | |||
| ion battery | |||
| Length/Width/shape/ | |||
| weight of both | |||
| handpiece and | |||
| cartridge | Identical | Identical | Identical |
| Range of Needle | |||
| Length | 0.0-2.5mm | 0.0mm-3.0mm | 0.0-2.5mm |
| Maximum | |||
| Penetration | 2.5mm | 3.0mm | 2.5mm |
| Needle Geometry | Identical, 12 or 36 | ||
| solid needles | 36 solid needles | 12 solid needle | |
| Speed | Identical , | ||
| 6200RPM-900 | |||
| 0 RPM | 7000RPM-9000 | ||
| RPM | 6200RPM-9000 | ||
| RPM | |||
| Sterility and | |||
| Cleaning | Same. Disposable | ||
| cartridge Gamma | |||
| Ray Sterilized prior | |||
| to packaging | Disposable | ||
| cartridge Ethylene | |||
| Oxide | Disposable | ||
| cartridge Gamma | |||
| Ray Sterilized prior | |||
| to packaging | |||
| Cross Contamination | |||
| Feature | Identical:Cartridge | ||
| design with a | |||
| sealing spring | |||
| inside the cartridge | |||
| housing, and a | |||
| biolock sleeve to | |||
| cover from the | |||
| cartridge outshell | |||
| and the whole | |||
| handpiece to stop | |||
| cross | |||
| contamination. | Same | Cartridge | |
| design and | |||
| intermediate | |||
| disinfected | |||
| handpiece and | |||
| nosecone with | |||
| optional | |||
| reprocessed | |||
| (autoclave | |||
| sterilized) | |||
| nosecone; |
Table 2 Technological Characteristics
9
10
Traditional 510k Submission Carain MicroSystem
Conclusion:
Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the SER Pen Carain MicroSystem raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.