Dr. pen Microneedling System

• K Number: K230420
• Device Name: Dr. pen Microneedling System
• Manufacturer: Guangzhou Ekai Electronic Technology Co., Ltd.
• Date Cleared: 2023-08-11 ( 176 days)
• Product Code: QAI , OAI
• Regulation Number: 878.4430
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K203144

Intended Use

The Dr.pen Microneedling System 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 and older.

Device Description

The Dr.pen Microneedling System is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The Dr. pen Microneedling System is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a power adapter, and a disposible protective sleeve. 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 on the condition of the skin being treated. Charging is accomplished by attaching the Dr.pen pen body to the power adapter.

AI/ML Overview

The provided document is a 510(k) premarket notification for a microneedling device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving de novo performance criteria for a novel device. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance against those criteria (especially regarding AI/human reader studies, ground truth, and sample sizes for training/test sets) is not present in this document.

The document primarily discusses bench testing to show that the device meets safety and performance standards equivalent to the predicate device, not a clinical study to prove efficacy in improving acne scars based on image analysis or similar AI-assisted diagnostics.

Here's a breakdown of what can be extracted and what information is missing based on your request:

Information Present in the Document:

1. Acceptance Criteria and Device Performance (in a limited sense related to substantial equivalence):
   The document focuses on comparing technological characteristics to a predicate device and demonstrating equivalence through bench testing. It does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) because it's a microneedling device for aesthetic use, not an AI diagnostic tool.

   The "acceptance criteria" here are implied by the standards and bench tests performed to show equivalence in physical and electrical characteristics and safety.

   Acceptance Criteria (Implied by Bench Testing & Predicate Equivalence)	Reported Device Performance (Dr.pen Microneedling System)
   Motor Speed Puncture Rate: Match predicate range (6300-7700 RPM, 105-128 stamps/sec)	Reported as "Same" as predicate (6300-7700 RPM, 105-128 stamps/second)
   Needle Penetration Depth and Extension Accuracy: Accurate to selected depth settings and within acceptable tolerances	Bench testing performed; results supported substantial equivalence. Specific accuracy values not listed.
   Needle Bonding Strength: Sufficient for intended use	Bench testing performed; results supported substantial equivalence. Specific strength values not listed.
   Use Life Testing: Device maintains function over expected lifespan	Bench testing performed; results supported substantial equivalence. Specific lifespan not listed.
   Cartridge Life Testing: Cartridge maintains function over expected lifespan	Bench testing performed; results supported substantial equivalence. Specific lifespan not listed.
   Anti-suction Testing: Prevent suction/tissue damage	Bench testing performed; results supported substantial equivalence.
   Microbial Ingress Testing: Prevent microbial contamination	Bench testing performed; results supported substantial equivalence.
   Cleaning and Disinfection Validation: Effective cleaning and disinfection	Passed ISO 11737-1, AAMI TIR-30, AAMI TIR-12.
   Sterilization and Shelf Life: Maintain sterility and integrity for specified shelf life	Passed ISO 11135-2014, ISO 11737-1:2018, ISO 11737-2:2009, ISO 10993-7:2008, ASTM F1980-16, ASTM F1886/F1886M-16, ASTM F1929-2015, ASTM F88/F88M-2015, ASTM D3078-02(2013), ASTM F1140-2013, DIN 58953-6:2016, ISO 11737-2:2019.
   Biocompatibility: Non-toxic, non-sensitizing, non-irritating, non-pyrogenic	Passed Cytotoxicity (ISO 10993-5:2009), Sensitization/Irritation/Intracutaneous Reactivity (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test). "Demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity."
   Electrical Safety and EMC: Compliance with medical electrical safety standards	Passed IEC 60601-1:2005 + A1:2012 and EN/IEC 60601-1-2:2015 /IEC 60601-1-2:2014.

2. Sample Size used for the test set and data provenance:

   • Sample Size: Not applicable in the context of human clinical data for a "test set" as understood for AI performance. The "testing" here refers to bench testing of the device's physical/electrical properties. No patient data or image data test sets are mentioned.
   • Data Provenance: Not applicable. The testing is bench-based, not clinical or image-based.

3. Number of experts used to establish ground truth for the test set and qualifications:

   • Not applicable. This device is not an AI diagnostic tool that requires expert ground truth establishment for a test set.

4. Adjudication method for the test set:

   • Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is typically done for diagnostic imaging AI devices to compare human performance with and without AI assistance. This document is for a physical microneedling device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device does not have a standalone "algorithm only" performance that would be evaluated in this manner.

7. The type of ground truth used:

   • Not applicable. For the bench testing, the "ground truth" would be the established engineering/materials standards and specifications.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established:

   • Not applicable.

Summary Conclusion:

The provided FDA 510(k) clearance letter and summary for the "Dr.pen Microneedling System" is for a physical medical device (a microneedling device). It is not for an AI-powered diagnostic or assistive tool. As such, the information requested regarding AI acceptance criteria, clinical test sets, expert ground truth, MRMC studies, training data, etc., is not relevant or present in this type of regulatory submission. The regulatory pathway followed here relies on demonstrating substantial equivalence to an existing predicate device through bench testing for safety and performance characteristics, not through clinical efficacy studies involving AI performance metrics.

Regulation Number and Section

§ 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.