(191 days)
Perfectio LED infrared device is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Perfectio LED infrared device is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter. It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use.
This document, an FDA 510(k) Premarket Notification Summary for the "Perfectio LED Infrared Device," does not include specific acceptance criteria for device performance based on a clinical study, nor does it detail a study that proves the device meets such criteria in the way a clinical study typically would. Instead, the submission relies on demonstrating substantially equivalent (SE) to a predicate device through non-clinical testing and shared indications for use.
Here's an analysis based on the provided text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria for clinical performance (e.g., a specific percentage reduction in wrinkles, or a statistical improvement over a control). Instead, it establishes substantial equivalence based on:
- Identical Indications for Use: Both the predicate and proposed device are "indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles."
- Similar Technological Characteristics: Wavelengths, light source (LED), waveform, handheld nature, and materials are the same or very similar.
- Compliance with Safety Standards: The device met several IEC and AAMI/ANSI standards related to electrical safety, electromagnetic disturbances, home healthcare environment, and photobiological safety.
- Biocompatibility: Patient contact materials (ABS and stainless steel 304) were tested and found to meet ISO biocompatibility standards (cytotoxicity, irritation, delayed-type hypersensitivity).
- Usability/Label Comprehension:
- Acceptance Criteria (Implied): A high percentage of participants (stated as 100% for setup/operation, 95% for questionnaire) can correctly perform critical tasks and understand labels.
- Reported Performance:
- 100% of 35 participants correctly self-selected, demonstrated setup, light sensitivity test, operation, and cleaning.
- 95% of 35 participants correctly answered each question on the questionnaire.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Tests (Bench Tests/Standards Compliance): No "test set" in the sense of patient data is mentioned for these. These are typically laboratory-based tests on the device itself.
- Usability/Label Comprehension Study:
- Sample Size: 35 participants.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would generally be considered prospective data collection for a usability study.
- Clinical Data: The document explicitly states: "Clinical data was not included in this submission." This means there was no patient-based performance study to demonstrate efficacy for wrinkle treatment. The reliance is on non-clinical data and equivalence to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable in this Context: Since no clinical data was submitted, there was no clinical "ground truth" to establish for device performance on patients.
- For the usability study, "ground truth" would be the objectively correct way to perform tasks or answers to questions, established by the study design and device manufacturer, not independent experts in the same way clinical data is adjudicated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set requiring expert adjudication was performed.
- For the Usability Study, "adjudication" (e.g., if a participant performed a step correctly) would be determined by the study observers following a predefined protocol, not by independent expert concensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This device is not an AI-assisted diagnostic tool, and no clinical comparative effectiveness study (MRMC or otherwise) involving human readers was mentioned. The device is a direct-treatment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of a software algorithm. The "Perfectio LED Infrared Device" is a hardware device for direct light therapy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for Clinical Efficacy: As clinical data was explicitly excluded, there was no ground truth for "treatment of periorbital wrinkles" established for this submission. The "ground truth" for the non-clinical tests revolved around meeting engineering and safety specifications (e.g., actual vs. required power output, successful completion of usability tasks).
8. The sample size for the training set
- Not Applicable: This device is a hardware device for light therapy, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set for a machine learning model was used.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Omm Imports Inc Dba Zero Gravity % Ms. Susan Anthoney-DeWet Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, IA 52241
Re: K152332
Trade/Device Name: Perfectio LED Infrared Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHS Dated: January 27, 2015 Received: January 27, 2015
Dear Ms. Anthoney-DeWet:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Post-market Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -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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Indications for Use
510(k) Number (if known) K152332
Device Name Perfectio LED infrared Device
Indications for Use (Describe)
Perfectio LED infrared device is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K152332 |
|---|---|
| Date: | Aug 10, 2015 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | OMM IMPORTS INC DBA ZERO GRAVITY;1945 S OCEAN DR APT 509 HALLANDLE BEACH BLVD,FLORIDA33009, US |
| Contact: | Doris Dong (Consultant)Shanghai CV Technology Co., Ltd.Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, 201600 ChinaE-mail: doris_d@126.comTel: 86 21-31261348 |
2. Device Description:
| Proprietary Name: | Perfectio LED infrared device |
|---|---|
| Common Name: | Light Emitting Diode (LED) device |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Product Code: | OHS |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4810 |
| Review Panel: | General & Plastic Surgery |
| Indications for use: | Perfectio LED infrared device is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. |
| Device Description: | Perfectio LED infrared device is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter. It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use. |
3. Predicate Device Identification
510(k) Number: K110301 Clearing date: August 19, 2011 Product Name: Silk'n FX Manufacturer: Home Skinovations Ltd.
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OMM IMPORTS INC DBA ZERO GRAVITY; 1945 S OCEAN DR APT 509 HALLANDLE BEACH BLVD,FLORIDA 33009
4. Non-Clinical Test Conclusion
Bench 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 conforms with the following standards:
-
AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
-
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests. * IEC 60601-1-11:2010, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 62471:2006, Photobiological Safety of Lamps and Lamp Systems
The patient contact materials in Perfectio LED infrared device are the body housing material of ABS and the head housing material of Stainless steel 304. Both the two materials were tested and found to meet the biocompatibility standards of:
-
ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, and * ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and
delayed-type hypersensitivity
A Usability/Label Comprehension Study was conducted with 35 participants.
The results of the study showed that (100%) were able to:
-Correctly self-select as being an appropriate user of the device.
-Correctly demonstrate how to set up the device, perform the Light Sensitivity Test, operate the device (apply Tx), and clean the device.
And that (95%) of participants were able to correctly answer each question for the Questionnaire portion of the Study.
5. Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not included in this submission.
| New Device | Predicate Device | |
|---|---|---|
| 510(k) Number: | K152332 | K110301 |
| Product Code: | OHS | OHS |
| Proprietary Name: | Perfectio LED infrared device | Silk'n FX |
| Manufacturer: | OMM IMPORTS INC DBA ZEROGRAVITY | Home Skinovations Ltd. |
| Indications for use: | Perfectio LED infrared device is an overthe counter device indicated to emit energyin the red and IR region of the spectrum foruse in dermatology for the treatment of | Silkn FX is an over the counter deviceindicated to emit energy in the red and IRregion of the spectrum for use indermatology for the treatment of |
6. Substantially Equivalent Comparison Conclusion
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OMM IMPORTS INC DBA ZERO GRAVITY; 1945 S OCEAN DR APT 509 HALLANDLE BEACH BLVD,FLORIDA 33009
| periorbital wrinkles. | periorbital wrinkles. | |
|---|---|---|
| Handheld | Yes | Yes |
| Materials | ABS and stainless steel | ABS and stainless steel |
| Wavelengths | 633 ±5nm, 830 ±5nm | 633 ±5nm, 830 ±5nm |
| Light source | Light emitting diode(LED) | Light emitting diode(LED) |
| Waveform | Constant | Constant |
| Energy Source | 25 LEDs over 17cm² | 24 LEDs over 12 cm² |
| Power supply | Adaptor:100~240V AC 50/60Hz 0.2A | Adaptor:100~240V AC 50/60Hz 0.4A |
| Lithium battery: 2x3.7V, 900 mAh | Lithium battery: 2x3.7V, 750±50mAh | |
| Initial treatment course | For the first month (4 weeks), treatment | For the first month (4 weeks), treatment |
| should be performed 3 times a week for | should be performed 3 times a week for | |
| 15-20 minutes each time.(5-7 minutes on | 15-20 minutes each time.(5-7 minutes on | |
| each treatment zone). | each treatment zone). | |
| Maintenance regime | Once a week for 15-20 minutes | Once a week for 15-20 minutes |
| Target Population | Individuals with periorbital lines and | Individuals with periorbital lines and |
| wrinkles | wrinkles | |
| Location for use | OTC | OTC |
| Standard meet | IEC60601-1 | IEC60601-1 |
| IEC60601-1-2 | IEC60601-1-2 | |
| IEC60601-1-11 | IEC62471 | |
| IEC62471 |
The Conclusions:
Taking into consideration the table for substantial equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the proposed device raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.
§ 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.