(391 days)
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
The CLARO is a portable handheld intense pulse light (IPL) device powered by a rechargeable battery. The CLARO uses a Xenon flash lamp which delivers pulses of light with a wavelength range from 400-1100 nm at Imsec pulse duration and a fluence of 6 J/cm2. The spot size of the CLARO is 1cm2.
Here's a breakdown of the acceptance criteria and study information for the CLARO device, based on the provided text:
CLARO Device Performance Study Summary
1. Acceptance Criteria and Reported Device Performance
The provided document describes studies primarily focused on usability and self-selection for Over-The-Counter (OTC) use, rather than clinical efficacy studies with specific performance metrics like sensitivity or specificity for acne treatment. The acceptance criteria relate to the ability of users to understand labeling and operate the device correctly for OTC use.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Self-Selection | Percentage of participants able to properly self-select themselves using the box labeling | Study 1: 98.3% Study 2: 95% |
| Device Operation | Percentage of participants able to correctly use the device by reading the User's Guide (without assistance) | Study 1 (without final labeling): 86.4% Study 1 (with final labeling): 97.2% Study 2 (with final labeling): 93% Study 3 (with final labeling): 100% |
2. Sample Size and Data Provenance
The provided document outlines the following sample sizes and provenance details:
- Test Set Sample Sizes:
- Self-Selection Study 1: 61 subjects
- Usability Study 1: 59 subjects (from Self-Selection Study 1)
- Self-Selection and Usability Study 2: 165 subjects
- Usability Study 3: 19 subjects
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for OTC clearance, these would most likely be prospective usability and self-selection studies conducted in a controlled environment.
3. Number and Qualifications of Experts for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth for the usability and self-selection studies. For these types of studies, "ground truth" would typically be defined by whether participants followed instructions and operated the device as intended, assessed by study administrators or observers rather than medical experts.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test sets. This is expected given the nature of usability and self-selection studies, where the primary assessment is direct observation of user behavior compared to predefined correct actions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The studies described are usability and self-selection studies for OTC device use, not clinical comparative effectiveness studies involving human readers (e.g., radiologists) and AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The CLARO is a physical device, and the described studies evaluate user interaction and understanding of labeling, not an algorithm's performance in isolation. The device itself is "identical in all technological respects" to a previously cleared prescription device (K080638), suggesting its standalone efficacy was previously established for a similar indication.
7. Type of Ground Truth Used
For the usability and self-selection studies, the "ground truth" was based on:
- Observed user behavior: Whether participants correctly followed instructions for self-selection from labeling.
- Observed device operation: Whether participants correctly operated the device based on the User's Guide.
This is a form of empirical observation and adherence to instructions, rather than expert consensus, pathology, or outcomes data related to an underlying medical condition.
8. Sample Size for the Training Set
The document does not mention a training set in the context of these usability and self-selection studies. These studies were intended to test the device and its labeling, not to train an algorithm or model.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of these studies, this question is not applicable.
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pg 1 of 3
510(k) Summary for the CLARO
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
APR 1 5 2010
1. General Information
نهن منهنجي ته
| Submitter: | CLRS Technology Corporation |
|---|---|
| 3183 A-1 Airway Ave. | |
| Costa Mesa, CA 92626 | |
| Contact Person: | Maureen O'Connell |
| O'Connell Regulatory Consultants, Inc. | |
| 5 Timber Lane | |
| North Reading, MA 01864 |
Summary Preparation Date:
April 14, 2010
-
- Names
Device Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:
- Names
CLARO 21 CFR 878.4810 Laser Instrument, Surgical, Powered Class II OLP
3. Predicate Devices
CLARO (K080638) Zeno Acne Device (K043377) ThermaClear (K060653) Tanda (K080591) Clear-U (K081307)
4. Device Description
The CLARO is a portable handheld intense pulse light (IPL) device powered by a rechargeable battery. The CLARO uses a Xenon flash lamp which delivers pulses of light with a wavelength range from 400-1100 nm at Imsec pulse duration and a fluence of 6 J/cm2. The spot size of the CLARO is 1cm2.
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5. Substantial Equivalence Discussion
The CLARO which is the subject of this 510(k) is identical in all technological respects to the CLARO that was cleared for prescription home use in K080638. This application is for OTC clearance of the same device. The CLARO treats acne using both heat and light in exactly the same way as the CLARO cleared in K080638.
The OTC indication for use was based on the Zeno, ThermaClear, Tanda and Clear-U predicate devices that are cleared for OTC treatment of mild to moderate inflammatory acne.
In conclusion, the CLARO shares identical technological characteristics with the CLARO cleared in K080638 and indications for use with the Zeno, ThermaClear, Tanda and Clear-U and is therefore substantially equivalent to the other identified predicate devices.
6. Indications for Use
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
7. Performance Data
The CLARO is identical in electrical, mechanical and output characteristics to the already cleared CLARO for prescription use and complies with IEC 60601-1-1 and IEC 60601-1-2.
Revisions made to the labeling for OTC use were tested in three usability studies and two self-selection studies. The performance data supplied in this 510(k) demonstrated that the vast majority of study participants were able to properly self-select themselves using the box labeling and that study participants were able to properly use the device by reading the instructions in the User's Guide without any assistance.
The first self-selection study included 61 subjects. 98.3% of participants were able to properly self-select themselves using the box labeling. Fifty nine of these subjects also participated in the usability study which evauated if subjects were able to correctly use the device by reading the instructions in the User's Guide. Results showed that overall, 86.4% of the study participants were able to properly use the device, and that 97.2% with the labeling submitted for clearance were able to correctly use the device.
The second self-selection and usability study was conducted with 165 subjects which tested changes to the labeling. The study demonstrated that 95% of the
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K090744 pg 3 of 3
participants could correctly self-select themselves. Different iterations of the labeling were tested regarding correct device operation and 93% of subjects correctly used the CLARO, based on the final revision of the labeling.
A third usability study was conducted to test additional changes to the labeling. Nineteen subjects participated. 100% of participants correctly operated the CLARO with the final version of the User's Guide.
The nonclinical tests demonstrate that the CLARO is as safe, as effective, and performs at least as safety and effectively as the legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 5 2010
CLRS Technology Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
Re: K090744
Trade/Device Name: Claro 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: OLP
Dated: March 31. 2010 Received: April 01, 2010
Dear Ms. O'Connell:
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
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Page 2 - Ms. Maureen O'Connell
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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 vours.
yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090744 pg 1 of 1
Device Name: CLARO
Indications For Use:
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NifRedl for m-km
Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
§ 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.