(84 days)
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The HM-IPL-B8 device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200mm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
The provided text is a 510(k) summary for the "Intense Pulsed Light Treatment System" (Model: HM-IPL-B8) and details its substantial equivalence to a predicate device (Intense Pulsed Light (IPL) Systems, K122995).
Based on the document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with specified thresholds. Instead, it demonstrates "Substantial Equivalence (SE)" to a predicate device by comparing various specifications and performance parameters. The "acceptance criteria" can be inferred as being "substantially equivalent" to the predicate device for each listed characteristic.
| Parameter | Acceptance Criteria (inferred: Substantially Equivalent to Predicate) | Reported Device Performance (Proposed Device) | Comparison Remark |
|---|---|---|---|
| Product Code | ONF | ONF | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Intended Use | Matching predicate's core intended use | Matches predicate's core uses (hair removal, pigmented lesions, vascular lesions) | SE (with slight wording differences) |
| Light Source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 430-1200nm, 530-1200nm, 640-1200nm, Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750 -1200nm | 430-1200nm, 530-1200nm, 640-1200nm, Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750 -1200nm | SE |
| Delivery System | Sapphire | Sapphire | SE |
| Energy Density | 10-60 J/cm² | 10-50 J/cm² | Analysis 1 (slight difference, not negative effect) |
| Pulse Delay | 5-50ms | 5-50ms | SE |
| Pulse Width | 1-20ms | 1-20ms | SE |
| Max. Power | 2000W | 2000W | SE |
| Spot Size (General) | Various sizes (e.g., 15mmX50mm, 12mmX33mm, 15mmX35mm) | 15mm×50mm; 80mm×40mm; | Analysis 2 (difference for treatment area, not negative effect) |
| Permanent Hair Reduction | |||
| Wavelength Range (nm) | 640-1200/690-1200/ 750-1200 | 640-1200/690-1200/ 750-1200 | SE |
| Energy Range (J/cm²) | 10-44 | 10-44 | - |
| Pulse Width (ms) | 3-14 | 3-14 | - |
| Pulse Delay (ms) | 16-32 | 16-32 | - |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 15mm×50mm; 80mm×40mm; | - |
| Pigmented Lesions | |||
| Wavelength Range (nm) | 480-1200/530-1200/560-1200 | 480-1200/530-1200/560-1200 | SE |
| Energy Range (J/cm²) | 12-44 | 12-44 | - |
| Pulse Width (ms) | 3-9 | 3-9 | - |
| Pulse Delay (ms) | 16-32 | 16-32 | - |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 15mm×50mm; 80mm×40mm; | - |
| Vascular Lesions | |||
| Wavelength Range (nm) | 530-1200/560-1200/ 590-1200 | 530-1200/560-1200/ 590-1200 | SE |
| Energy Range (J/cm²) | 10-42 | 10-42 | SE |
| Pulse Width (ms) | 3-8 | 3-8 | - |
| Pulse Delay (ms) | 16-32 | 16-32 | - |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 15mm×50mm; 80mm×40mm; | - |
| Power Supply | $220V \pm 20V \ 50Hz$ or $110V \pm 20V \ 60Hz$ | $110V \pm 10% \ 60Hz$ | SE |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE |
| Patient Contact Material | Handpiece (Sapphire Crystal) | Handpiece (Sapphire Crystal) | SE |
| Biocompatibility (Cytotoxicity) | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Biocompatibility (Irritation) | No irritation (ISO 10993-10) | No irritation (ISO 10993-10) | SE |
| Biocompatibility (Sensitization) | No sensitization (ISO 10993-10) | No sensitization (ISO 10993-10) | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "7. Clinical Test Conclusion: No clinical study is included in this submission."
Therefore, there is no test set, sample size, or data provenance related to clinical performance. The evaluation for substantial equivalence is based on non-clinical engineering tests and comparison of specifications to a previously cleared predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical study was conducted, there are no experts involved in establishing ground truth for a clinical test set. The approval is based on non-clinical engineering and biological safety evaluations.
4. Adjudication Method for the Test Set
As there was no clinical study or test set involving expert assessments, no adjudication method was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done, as no clinical study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an Intense Pulsed Light Treatment System, which is a physical device used for treatment, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance study is not applicable. The performance is related to its physical parameters and biological effects.
7. The Type of Ground Truth Used
For the non-clinical tests conducted (e.g., electrical safety, EMC, biocompatibility), the "ground truth" would be the established standards and regulations (e.g., IEC 60601-1, ISO 10993-5, ISO 10993-10). The device's performance was compared against these standards to demonstrate compliance. For the comparison to the predicate, the "ground truth" is the specifications and intended use of the legally marketed predicate device.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
{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.
December 6, 2019
Shangdong Huamei Technology Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 CN
Re: K192521
Trade/Device Name: Intense Pulsed Light Treatment System 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: ONF Dated: September 11, 2019 Received: September 13, 2019
Dear Ray Wang:
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
{1}------------------------------------------------
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 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 (QS) 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 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-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,
Purva Pandva Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K192521
Device Name Intense Pulsed Light Treatment System
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Paperwork Reduction Act (PRA) Staff
PRAStaff(@fda.hhs.gov
==============================================================================================================================================================================
{3}------------------------------------------------
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192521
-
- Date of Preparation: 11/25/2019
-
- Sponsor Identification
Shangdong Huamei Technology Co., Ltd.
No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205
Contact Person: Xu QingHua Position: General Manager Tel: +86-536-2110001 Fax: +86-536-2109823 Email: xuqh@yeah.net
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
{4}------------------------------------------------
4. Identification of Proposed Device
Trade Name: Intense Pulsed Light Treatment System Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): HM-IPL-B8
Regulatory Information:
Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Classification: II; Product Code: ONF; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Indication For Use Statement:
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description:
The HM-IPL-B8 device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200mm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
-
- Identification of Predicate Device(s)
510(k) Number: K122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology Technology Co., Ltd.
- Identification of Predicate Device(s)
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
{5}------------------------------------------------
a) IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
b) IEC 60601-1:2005/A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
c) IEC60601-2-57:2011, Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
d) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
e) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
{6}------------------------------------------------
Substantially Equivalent (SE) Comparison 8.
| Table 7-1 General Comparison | |||
|---|---|---|---|
| ITEM | Proposed Device | Predicate Device | Remark |
| Product Code | ONF | ONF | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Intended Use | The Intense Pulsed Light TreatmentSystem (Model: HM-IPL-B8) areindicated for use in surgical andaesthetic applications in permanenthair removal, reduction of benignpigmented lesions and benignvascular lesions.Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowingwhen measured at 6, 9, and 12months after the completion of atreatment regimen. | Intense Pulsed Light (IPL) Systems (inclusive of the handpiece usedto deliver pulsed-light energy) areindicated for use in surgical,aesthetic and cosmetic applicationsin permanent hair removal,reduction of pigmented lesions,acne therapy, freckles, vascularlesions and facial blemish. | SE |
Table 7-1 General Comparison
{7}------------------------------------------------
| ITEM | Proposed Device | Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995) | Remark |
|---|---|---|---|
| Light source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 430-1200nm, 530-1200nm,640-1200nm,Optional: 480-1200nm,560-1200nm, 590-1200nm,690-1200nm, 750 -1200nm | 430-1200nm, 530-1200nm,640-1200nm,Optional: 480-1200nm,560-1200nm, 590-1200nm,690-1200nm, 750 -1200nm | SE |
| Deliver system | Sapphire | Sapphire | SE |
| Energy density | 10-50J/cm² | 10-60J/cm² | Analysis 1 |
| Pulse Delay | 5-50ms | 5 - 50ms | SE |
| Pulse Width | 1-20ms | 1-20ms | SE |
| Max. Power | 2000W | 2000 W | SE |
| Spot size | 15mm×50mm; 80mm×40mm; | MED-210: 15mmX50mm(optional: 12mmX33mm,15mmX35mm )MED-230:A: 12mm X33mm;B: 15mmX50mm (optional:15mmX35mm) | Analysis 2 |
| Table 7-2 Performance Comparison |
|---|
| ---------------------------------- |
| ITEM | Proposed Device | Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995) | Remark |
|---|---|---|---|
| permanent hair reduction | |||
| Wavelength Range(nm) | 640-1200/690-1200/ 750-1200 | 640-1200/690-1200/ 750-1200 | SE |
| Energy Range(J/cm2) | 10-44 | 10-44 | |
| Pulse Width (ms) | 3-14 | 3-14 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 12mm X33mm; 15mmX50mm15mmX35mm | |
| pigmented lesions | |||
| Wavelength Range(nm) | 480-1200/530-1200/560-1200 | 480-1200/530-1200/560-1200 | SE |
| Energy Range(J/cm2) | 12-44 | 12-44 | |
| Pulse Width (ms) | 3-9 | 3-9 |
Table 7-3 Setting Comparison of Specified Indication for Use
{8}------------------------------------------------
| Pulse Delay (ms) | 16-32 | 16-32 | |
|---|---|---|---|
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 12mm X33mm; 15mmX50mm15mmX35mm | |
| vascular lesions | |||
| Wavelength Range(nm) | 530-1200/560-1200/590-1200 | 530-1200/560-1200/590-1200 | |
| Energy Range(J/cm2) | 10-42 | 10-42 | SE |
| Pulse Width (ms) | 3-8 | 3-8 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 12mm X33mm; 15mmX50mm15mmX35mm |
Analysis 1:
The energy density range of the proposed device is within the energy density range of the predicate for the indications for use, and the slight difference does not result in a negative effect on safety and effectiveness.
Therefore, the slight difference is considered to have no negative effect on effectiveness and safety.
The spot size of the proposed device is different from that of predicate device, but the difference of the spot size is only for different treatment area, and it does not negatively affect the output parameter for treatment. Therefore, the slight difference is considered to have no negative effect on effectiveness and safety.
{9}------------------------------------------------
| Table 7-4 Safety Comparison | |||
|---|---|---|---|
| ITEM | Proposed DeviceHM-IPL-B8 | Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995) | Remark |
| Power supply | $110V \pm 10% \ 60Hz$ | $220V \pm 20V \ 50Hz$ or$110V \pm 20V \ 60Hz$ | SE |
| ElectricalSafety | The proposed devices were testedto demonstrated to comply withIEC 60601-1 | The proposed devices were testedto demonstrated to comply withIEC 60601-1 | SE |
| EMC | The proposed devices were testedto demonstrated to comply withIEC 60601-1-2 | The proposed devices were testedto demonstrated to comply withIEC 60601-1-2 | SE |
| Patient ContactMaterial | Handpiece (Sapphire Crystal) | Handpiece (Sapphire Crystal) | SE |
| Biocompatibility | |||
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not induceirritation to skin. (ISO 10993 -10) | Applied sample did not induceirritation to skin. (ISO 10993 -10) | SE |
| Sensitization | The test article showed nosignification evidence of causingskin sensitization in the guineapig .(ISO 10993-10) | The test article showed nosignification evidence of causingskin sensitization in the guineapig .(ISO 10993-10) | SE |
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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.