(103 days)
No! No! Skin is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Not Found
The provided text describes the FDA's decision to deem the "No! No! Skin™" device substantially equivalent for the treatment of mild to moderate acne based on a clinical trial. However, it does not explicitly state acceptance criteria in a quantitative table or the specific reported device performance values. It focuses more on the type of study and its outcome rather than numerical criteria and results.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from FDA's Decision) | Reported Device Performance (Inferred from FDA's Decision) |
|---|---|
| Demonstrate statistically and clinically significant improvement in: | A statistically and clinically significant improvement in the time to improvement and time to resolution of mild to moderate acne. |
| - Time to improvement of mild to moderate acne | Assessed as improved compared to sham treatment. |
| - Time to resolution of mild to moderate acne | Assessed as improved compared to sham treatment. |
- Note: The document does not provide specific numerical thresholds for "statistically and clinically significant improvement" or the exact performance metrics (e.g., mean time to resolution in days). It focuses on the conclusion drawn from the study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "data from a randomized, sham-controlled, double-blinded, clinical trial," but the number of participants is not provided.
- Data Provenance:
- Country of Origin: Radiancy (Israel) LTD. is the applicant, suggesting the study could have been conducted in Israel or elsewhere, but the document does not explicitly state the study's location.
- Retrospective or Prospective: The study was a "randomized, sham-controlled, double-blinded, clinical trial," which by its nature is a prospective study.
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)
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The assessment was carried out by "blinded investigators." Their specific qualifications (e.g., dermatologists, medical professionals) are not detailed, but their role as "investigators" implies medical expertise in evaluating acne.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document mentions "blinded investigators" assessed the improvement and resolution of acne. The specific adjudication method (e.g., consensus, single reader, majority vote) is not specified.
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
- This device is not an AI-assisted diagnostic tool. It is a device for treating acne. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The study described is a clinical trial comparing the device's effectiveness to sham treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical treatment device, not an algorithm. The "performance" in this context refers to its clinical efficacy in treating acne when used by individuals, not an algorithmic assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was established by clinical assessment / outcomes data by blinded investigators. They assessed the "time to improvement and time to resolution of mild to moderate acne." This implies a subjective or semi-objective clinical evaluation of acne severity and progression by trained medical professionals.
8. The sample size for the training set
- The concept of a "training set" is not applicable here as this is a physical medical device undergoing a clinical trial for efficacy, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- As the concept of a "training set" is not applicable, this question is also not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle in flight, rendered in blue. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in a simple, sans-serif font.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2009
Radiancy (Israel) LTD. c/o Boston MedTech Advisors, Inc. Zvi Ladin, PhD, Principal 990 Washington Street. Suite 204 Dedham, MA 02026
Re: K082423 No! No! Skin™ Appeal of Not Substantially Equivalent Decision Dated: December 18, 2008 Received: December 19, 2008
Dear Dr. Ladin:
This letter is in response to your letter of appeal dated December 18, 2008, requesting that the not substantially equivalent (NSE) decision for the above reference premarket notification submission (510(k)) that was issued on December 3, 2008, from Mark N. Melkerson, Director, Division of General, Restorative, and Neurological Devices (DGRND), now the Division of Surgical, Orthopedic, and Restorative Devices (DSORD), Office of Device Evaluation, be reviewed by the next level supervisor. I have reviewed this appeal under our regulations found in Title 21 of the Code of Federal Regulations Part 10.75 Internal agency review of decision, as the next level supervisor.
After reviewing your letter of appeal, including my review of the 510(k), meeting internally on several occasions with DSORD, and discussing your appeal with you and your clients on February 17, 2009, and consulting with my clinical deputy. I have determined that your device has performance that is substantially equivalent to predicate devices cleared for over-the-counter used in the treatment of mild to moderate acne. My decision is based on the fact that your 510(k) contained data from a randomized, shamcontrolled, double-blinded, clinical trial demonstrating that your device provides a statistically and clinically significant improvement in the time to improvement and time to resolution of mild to moderate acne when compared to sham treatment, as assessed by blinded investigators. I have determined that these data are sufficient to provide a reasonable assurance of the safety and effectiveness of your device for the purposes of demonstrating substantial equivalence. Therefore, I am overturning the NSE decision from DSORD and issuing a letter of substantial equivalence (enclosed) for the above referenced device as described in the 510(k).
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Page 2 – Zvi Ladin, Ph.D.,Principal
If you have any questions regarding this letter, please contact Heather S. Rosecrans, Chief, 510(k) Staff at (240) 276- 4021.
Sincerely yours.
De Till Ph.D., M.B.A.
Denna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Radiancy (Israel) LTD. c/o Boston MedTech Advisors, Inc. Zvi Ladin, PhD. Principal 990 Washington Street. Suite 204 Dedham, MA 02026
JUL - 8 2009
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K082423
Trade/Device Name: No! No! SkinTM 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: October 23, 2008 Received: October 24, 2008
Dear Dr. Ladin:
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. Drue, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (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.
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Page 2 - Zvi Ladin, Ph.D.,Principal
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 yours,
Do na-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082423
Device Name: No! No! Skin™
Indications For Use: No! No! Skin is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
The product code is: GEX Regulation number: 21 CFR 878.4810 Regulation name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory class: II
NCeTK
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
§ 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.