(87 days)
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.
The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 380-680 mbar. Suction can be delivered through its handpiece. which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.
This device, the Candela-Inolase Serenity Pro PSF™ System, is an accessory for laser/IPL hair removal systems. Its primary claim is to reduce pain during treatment and lessen associated erythema.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not explicitly define "acceptance criteria" with specific numerical thresholds (e.g., "pain reduction must be >X%"). Instead, it states the objectives of the clinical study and presents the findings as confirmation that these objectives were met.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Primary Objective: Reduce laser therapy-associated pain. | The Candela - Inolase Serenity PSF™ System (PSF) significantly reduces the pain associated with laser hair removal when compared to treated sites without PSF. |
| Secondary Objective: Decrease erythema associated with laser therapy. | The side effect of erythema was lessened with PSF vs. without PSF standard laser treatment. Clinical investigators rated erythema immediately and 20 minutes post-treatment, showing a decrease with PSF. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the number of subjects (test set sample size) used in the clinical study. It only mentions that the study "involved normal laser treatment parameters which were typically expected to be painful."
- Data Provenance: The document does not specify the country of origin. The study was a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the submitted documents. The pain assessment was "recorded utilizing a modified McGill Pain questionnaire," which is a self-reported patient outcome. Erythema was "rated by clinical investigators," but their number and qualifications are not specified.
4. Adjudication Method
The document does not mention any adjudication method specifically. For pain, it was self-reported by subjects. For erythema, clinical investigators rated it (implying subjective assessment, but no details on consensus or single rater).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focused on the effectiveness of the Serenity PSF™ system itself on objective patient outcomes (pain and erythema), not on comparing human readers' diagnostic accuracy with and without AI assistance. The device is a physical accessory to a laser, not an imaging or diagnostic AI tool.
6. Standalone (Algorithm Only) Performance
Not applicable. The Serenity Pro PSF™ System is a physical accessory (a handpiece producing negative pressure) that works in conjunction with a laser or IPL system and a human operator. It is not a standalone algorithm.
7. Type of Ground Truth Used
- Pain Reduction: Patient-reported outcomes using a modified McGill Pain questionnaire.
- Erythema Reduction: Clinical investigator ratings immediately and 20 minutes post-treatment.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical/physical accessory, not an AI or machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/ML algorithm, there is no training set or ground truth establishment relevant to an algorithm.
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K07-2925
Pg 1 of 2
510(k) Summar
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
Somerset, MA 02726
-
- (a) Submitter's George J. Hattub Address: MedicSense, USA 291 Hillside Avenue
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- (b) Manufacturer Inolase, Ltd. 13 Giborei Israel St., PO Box 8497 Address: Netanya (New Industrial Area) Israel, 42504 JAN 1 0 2008
Mfg. Phone: 972-9-865-6750
Date:
Contact Person: Raphi Shavit, CEO
Revised- December 26, 2007 (revisions bolded)
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- Device & Laser Handpiece Accessory System (Class 2), Product Code GEX, Classification Name: 21 CFR 878.4810 - Tradename of device: Serenity Pro PSF™ System Inolase Serenity PSF™ (Pneumatic Skin Flattening) Systems (K071469), (K071943) Predicate Devices: 3. & (K062589) 4. Description: The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 380-680 mbar. Suction can be delivered through its handpiece. which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.
- The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: 5. Intended Use: As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.
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- Comparison of Technological With respect to technology, the Serenity Pro PSF™ is substantially Characteristics: equivalent to its predicate device. No changes have been made to the technology. The purpose of the 510(k) was to expand its indications for use for the device.
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K07 2925 P.2 01-2
510(k) Summary
7. Performance Data: The basis for substantial equivalence for this device (K072925) relies upon the clinical data which was submitted in K071469. K071469 was determined to be substantially equivalent by FDA on 8/15/2007.
This data was obtained in a clinical study. The primary objective of the study was to confirm the assumption that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (PSF) reduces laser therapy associated pain. This study involved normal laser treatment parameters which were typically expected to be painful. Evaluation consisted of pain experienced in treated sites with PSF compared with treated sites without PSF. The measurement of immediate post treatment subject pain was recorded utilizing a modified McGill Pain questionnaire, which is commonly used in pain evaluation.
A secondary objective of this clinical study was to confirm that the use of PSF decreased the erythema associated with current laser therapy. The clinical investigators rated erythema immediately and 20 minutes post treatment for standard laser treatment laser vs. laser with PSF.
The results of the clinical data indicated that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (PSF) significantly reduces the pain associated with laser hair removal and that the side effect of erythema was lessened with PSF vs. without PSF standard laser treatment.
In terms of fundamental technology and intended use, the device (K071469), which was utilized in the clinical study, is essentially the same as the device (K072925), which is subject of this 510(k) submission. Therefore, this clinical study is relevant to this 510(k) submission and, Candela - Inolase has concluded that no new safety or efficacy issues have been raised.
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K072925 Pd lotl
Indications for Use
510(k) Number (if known):
Device Name: Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System
Indications For Use:
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses:
As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2008
Inolase, Ltd. % MedicSense, USA Mr. George J. Hattub. RAC & COE Senior Staff Consultant 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K072925
Trade/Device Name: Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System 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: GEX Dated: October 9, 2007 Received: October 24, 2007
Dear Mr. Hattub:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 -- Mr. George J. Hattub
CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K072925 pg 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System
Indications For Use:
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses:
As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it.
Reduction of pain during Laser or Intense Pulse Light System treatment.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
Page
and Neurological
Page 1 of 1
510(k) Number |
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§ 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.