(288 days)
Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Radio Frequency Hand piece The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain.
Laser surgical unit, diode: Specifically, a 1450 nm wavelength laser is absorbed into the skin to be transformed into thermal energy, which then induces incision, destruction and removal of skin tissues. Laser is sent out through the power unit equipped inside the Main Body to oscillate the laser diode, and the user uses the touch LCD in the Main Body to set the output parameters while controlling laser radiation through the foot switch. At this point, a coolant is sprayed from the end of the hand piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
Electrosurgical system, general-purpose: The operating concept of the electrosurgical unit is to let the high frequency (RF) energy flow through the electrodes of the hand piece to use the load or heat generated by contact resistance, resulting in a coagulant activity on the cell tissues.
The provided text is a 510(k) Summary for the A-FIT device, which combines a laser and radiofrequency (RF) handpiece. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and adherence to performance standards, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for specific clinical indications.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted in the way typically found in a clinical trial report. However, I can summarize the information provided about the device's performance data and its regulatory compliance.
Here's a breakdown of what can be gathered from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with numerical performance metrics for the device's clinical efficacy (e.g., success rate for acne treatment). Instead, it states that the device was tested against recognized performance standards for safety and essential performance. The "reported device performance" is essentially its compliance with these standards, indicating it meets safety and basic functional requirements.
| Acceptance Criterion Type | Details Reported in Document |
|---|---|
| Safety | Compliance with: |
| (Laser Products) | 21 CFR 1040.11 (mandatory performance standards for laser products) |
| IEC 60825-1:2014 (Third Edition) (Safety of laser products) | |
| (Electrosurgical) | IEC 60601-2-2:2009 (Fifth Edition) + C1:2014 (Particular Requirements for The Basic Safety and Essential Performance of High-Frequency Surgery Equipment And High Frequency Surgical Accessories) |
| (Laser Equipment) | IEC 60601-2-22:2007 (Third Edition) +A1:2012 (Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment) |
| Essential Performance | Compliance with: |
| (Basic Safety & Essential Performance) | IEC 60601-1:2005 (Third Edition) + CORR, 1:2006 + CORR, 2:2007 + A1:2012 (or IEC 60601-1:2012 reprint) |
| Electromagnetic Compatibility (EMC) | Compliance with: IEC 60601-1-2 Edition 3: 2007-03 |
| Usability | Compliance with: IEC 60601-1-6 Edition 3.1 2013-10; IEC 62366:2007 (Application of usability engineering to medical devices) |
| Risk Management | Compliance with: ISO 14971 |
| Software Validation | Verified and validated based on its moderate level of concern; evaluated according to IEC 62304:2006 (Software life cycle processes) |
| Biocompatibility | Documented referred to ISO 10993-1:2009, ISO 10993-5:2009, and 10993-10:2010 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical test set in terms of patient numbers or demographic data. The "test set" in this context refers to the device itself being subjected to various engineering and safety tests according to the listed consensus standards. Therefore, specific sample sizes for a clinical test set and data provenance (country of origin, retrospective/prospective) are not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided. The "ground truth" for the non-clinical tests described is the established requirements of the referenced industry standards (e.g., IEC, ISO). There is no mention of external human experts establishing a clinical ground truth for device performance in this summary.
4. Adjudication Method for the Test Set:
Not applicable, as this refers to a clinical study methodology. The tests conducted were against technical standards, not adjudicated clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned or described. This document is a 510(k) summary, which generally relies on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety, rather than providing comparative effectiveness data or human reader improvement with AI assistance. The A-FIT is a physical medical device, not an AI-assisted diagnostic tool in the sense of image interpretation.
6. Standalone Performance:
The document describes the performance of the A-FIT device in a standalone manner, meaning the device itself (laser and RF handpiece) was tested against various safety and performance standards. It does not refer to an "algorithm only (without human-in-the-loop performance)" because the A-FIT is a therapeutic device operated by a human, not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth used for the reported performance data is the consensus international and national standards (e.g., IEC 60601-1, IEC 60825-1, ISO 14971, 21 CFR 1040.11) outlining safety, essential performance, EMC, usability, risk management, software validation, and biocompatibility for such medical devices. There is no mention of expert consensus derived from clinical cases, pathology, or outcomes data in this summary.
8. Sample Size for the Training Set:
This information is not applicable and not provided. The A-FIT is not an AI/machine learning model whose performance is dependent on a 'training set'. Its design and functionality are based on established engineering principles and its manufacturing processes adhere to quality systems.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set in the context of this device.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
September 14, 2018
HIRONIC Co., Ltd. % Mina Joo Assistant Manager BT Solutions, Inc. Unit 502, 148 Yeoksam-ro Seoul, 06249 Kr
Re: K173676 Trade/Device Name: A-fit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: August 9, 2018 Received: August 15, 2018
Dear Mina Joo:
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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) NOXANING K173676
Device Name A-FIT
Indications for Use (Describe)
Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Radio Frequency Hand piece
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Hironic Co., Ltd. |
|---|---|
| Address: | 19F, 767, Sinsu-Ro, Suji-GuYongin-Si, Gyeonggi-do, 16827Republic of KoreaTel) +82-31-525-7400Fax) +82-505-360-4201 |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul,Republic of KoreaTel) +82.2.538.9140Email) smanager@btsolutions.co.kr |
| Preparation Date: | September – 13 – 2018 |
2. Device Name and Code
| Device Trade Name: | A-FIT |
|---|---|
| Common Name: | Laser Surgical Unit |
| Classification Name: | Laser surgical instrument for use in general and plasticsurgery and in dermatologyElectrosurgical cutting and coagulation device andaccessories |
| Product Code: | GEX, PBX |
| Regulation Number: | 878.4810878.4400 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |
3. Technical Characteristics in Comparison to Predicate Devices
A-FIT is substantially equivalent to the following legally marketed predicate devices. We identified two predicate devices under product code GEX for Laser hand piece and PBX for RF hand piece respectively.
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1) Predicate device for Laser – K041242
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K041242 | N/A |
| Manufacturer | CANDELA CORP. | Hironic Co., Ltd. |
| Device Name | CANDELA SMOOTHBEAM LASERSYSTEM | A-FIT |
| Clearance Date: | April 23, 2004 | N/A |
| Classification /Regulation | Class II / (21 CFR § 878.4810 LaserSurgical Instrument for use in Generaland Plastic Surgery and in Dermatology) | Class II / (21 CFR § 878.4810 LaserSurgical Instrument for use in Generaland Plastic Surgery and in Dermatology) |
| Product Code | GEX | GEX |
| Light Source | Diode Laser | Diode Laser |
| Wavelength -Beam radiation | 1450 nm | 1450 nm ± 10% |
| Wavelength -Beam pointing | Unknown | 635 nm ± 10 % |
| Indications forUse / IntendedUse | For use in dermatology: incision,excision, ablation, and vaporization withhemostasis of soft tissue,Treatment of back acneTreatment of atrophic acne scarsTreatment of facial wrinklesTreatment of mild to moderate acnevulgarisTreatment of Sebaceous Hyperplasia | For use in dermatology: incision,excision, ablation, and vaporization withhemostasis of soft tissue,Treatment of back acneTreatment of atrophic acne scarsTreatment of facial wrinklesTreatment of mild to moderate acnevulgarisTreatment of Sebaceous Hyperplasia |
| Intended for | Prescription Use | Prescription Use |
| Maximum PulseDuration (PulseWidth) | 210 ms | Total 250 ms (62.5 ms X 4) ± 10%Total 250 ms (4.17 ms X 60) ± 10% |
| Maximum laseroutput (J/cm²) | 8-25 J/cm² | 4 J/cm² - 13 J/cm² ± 20%(Soft and Normal modes) |
| Maximum laseroutput - Beampointing | Unknown | < 5 Mw |
| Laser radiationrange - Beamradiation | 4mm, 6mm | 6mm ± 20% |
| Laser radiationrange - Beampointing | Unknown | 6mm ± 20% |
| Pulse RepetitionRate (Hz) | 1 Hz | Normal Mode: 4 Hz (62.5ms x 4 pulse)Soft Mode: 60 Hz (4.17ms x 60 pulse) |
| Interface | Touch Screen | Touch Screen |
| Beam DeliverySystem | Handpiece | Handpiece |
| Lasertransmissionmethod | Diode | Optical Fiber |
| Activation | Via Foot switch | Via Footswitch |
| Cooling System | Integrated-Spray Duration Control /Canister Counter | Cryogen Cooling Device |
| ElectricalRequirements | 115/230 VAC 50/60 Hz | 110 V 60 Hz / 2-1A, 600 VA |
| Weight | 40 lbs (18 kg) | 21.8 lbs (48 kg) |
| Dimension | 17" H x 22" W x 20" D (431.8 x 558.8 x 508 mm) | 350 x 500 x 857 mm |
| Operation time | 10 minutes | 10 minutes |
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A-FIT 510(k) Summary
2) Predicate device for RF – K133739
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K133739 | N/A |
| Manufacturer | Cutera, Inc. | Hironic Co., Ltd. |
| Device Name | truSculpt | A-FIT |
| Clearance Date: | September 5, 2014 | N/A |
| Classification /Regulation | Class II / (21 CFR § 878.4400Electrosurgical Cutting and CoagulationDevice and Accessories) | Class II / (21 CFR § 878.4400Electrosurgical Cutting and CoagulationDevice and Accessories) |
| Product Code | PBX | PBX |
| Indications forUse / IntendedUse | The truSculpt RF energy is intended toprovide topical heating for the purpose ofelevating tissue temperature for thetreatment of selected medical conditionssuch as relief of pain, muscle spasms,and increase in local circulation.*The truSculpt massage device isintended to provide a temporaryreduction in the appearanceof cellulite. | The RF Hand piece energy is intended toprovide topical heating for the purpose ofelevating tissue temperature for thetreatment of selected medical conditionssuch as relief of pain, muscle spasms,and increase in local circulation. |
| Intended for | Prescription Use | Prescription Use |
| Massage | Yes – as a separate handpiece | N/A |
| Treatmentactivation | Via Finger switch | Via Footswitch |
| Electrode shape | Square or Rectangular | Circle |
| RF frequency | 300 kHz – 50 MHz | 550 kHz, 700 kHz, 1000 kHz |
| RF type | Bipolar/Monopolar | Bipolar |
| Max RF power | Max 300 W | 12 Watt (240 mA, 48.0 Vrms, 200 Ω,RET) |
*A-FIT does not include the massaging device. However, the A-FIT's RF hand piece share the same intended use of the predicate device (truSculpt's RF energy).
4. Device Description
A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain.
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A-FIT
510(k) Summary
Laser surgical unit, diode: Specifically, a 1450 nm wavelength laser is absorbed into the skin to be transformed into thermal energy, which then induces incision, destruction and removal of skin tissues. Laser is sent out through the power unit equipped inside the Main Body to oscillate the laser diode, and the user uses the touch LCD in the Main Body to set the output parameters while controlling laser radiation through the foot switch. At this point, a coolant is sprayed from the end of the hand piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
Electrosurgical system, general-purpose: The operating concept of the electrosurgical unit is to let the high frequency (RF) energy flow through the electrodes of the hand piece to use the load or heat generated by contact resistance, resulting in a coagulant activity on the cell tissues.
5. Indications / Intended Use
Main Hand piece
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,
Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Radio Frequency Hand piece
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
6. Performance Data
Non-clinical tests: Testing conducted on the A-FIT shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following consensus standards:
- Basic safety and essential performance of the A-FIT was tested and evaluated according to -IEC 60601-1:2005 (Third Edition) + CORR, 1:2006 + CORR, 2:2007 + A1:2012 (or IEC 60601-1:2012 reprint).
- -Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1-2 Edition 3: 2007-03.
- -Safety of laser products is evaluated according to IEC 60825-1:2014 (Third Edition).
- General Requirements For Basic Safety And Essential Performance Collateral Standard: -Usability was tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1-6 Edition 3.1 2013-10.
- Particular Requirements for The Basic Safety and Essential Performance of High -Frequency Surgery Equipment And High Frequency Surgical Accessories was tested and evaluated according to IEC 60601-2-2:2009 (Fifth Edition) + C1:2014.
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A-FIT
510(k) Summary
- Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, -Therapeutic And Diagnostic Laser Equipment was tested and evaluated according to IEC 60601-2-22:2007 (Third Edition) +A1:2012.
- Risk management was recorded by referring to ISO 14971. -
- -The software for A-FIT has been verified and validated based on its moderate level of concern. Software life cycle processes was evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
- -Application of usability engineering to medical devices was tested and evaluated according to IEC 62366:2007.
- Biocompatibility of A-FIT was documented referred to ISO 10993-1:2009, ISO 10993--5:2009, and 10993-10:2010.
7. Substantial Equivalence
The intended use of the A-FIT is within the scope of the predicate devices. A-FIT, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the A-FIT, Hironic Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between A-FIT and the cited predicate device.
8. Conclusions
On the basis of the information provided in this Summary, A-FIT believes that A-FIT is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.