(11 days)
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:
- Console .
- A Bipolar RF handpieces (normal and small-tip)
- A Unipolar RF handpieces (normal and unilarge)
- Control panel .
- Footswitch. .
This document is a 510(k) summary for the Alma Lasers Family of Accent™ RF Systems and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or the methodology of an AI-powered system.
However, based on the provided text, I can infer the acceptance criteria and the study done from the perspective of a 510(k) submission, not from a clinical performance study.
Acceptance Criteria and Reported Device Performance (from a 510(k) perspective):
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Same Indications for Use | "The Alma Lasers Accent XL™ RF device shares the same indications for use..." |
| Similar Device Operation | "...device operation..." |
| Similar Technical Capabilities | "...technical and functional capabilities..." |
| Substantially Equivalent to Predicate | "...therefore is substantially equivalent to the predicate Accent™ system." |
Based on the provided document, the following information regarding acceptance criteria and a study to prove device performance is either not applicable (for an AI diagnostic device) or not present:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a traditional medical device (RF system) rather than an AI-powered diagnostic device. The submission focuses on device equivalence, not clinical performance data in this manner.
- 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. Ground truth as typically defined for AI diagnostic performance studies is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 diagnostic tool and does not involve human readers interpreting AI output.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) submission of this nature is primarily the established performance and safety of the predicate device.
- The sample size for the training set: Not applicable. This device does not use a training set as an AI algorithm would.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (from a 510(k) perspective):
The "study" presented here is a 510(k) premarket notification to demonstrate substantial equivalence of the Alma Lasers Family of Accent™ RF Systems (specifically Accent XL) to its predicate device, the Alma Lasers, Ltd. Accent™ (K070004).
- Type of Study: Regulatory submission (510(k) to establish substantial equivalence).
- Methodology: Comparison of the new device (Accent XL) against a legally marketed predicate device (Accent™) based on:
- Indications for Use
- Device Operation
- Technical and Functional Capabilities
- Conclusion: The Accent XL™ RF device was found to be substantially equivalent to the predicate Accent™ system because it shares "the same or similar indications for use, similar design features, and functional features."
In essence, this document is a regulatory filing for a non-AI medical device; therefore, many of the requested details pertaining to AI performance studies are not relevant nor included.
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CONFIDENTIAL
Appendix 7 - 510(k) Summary for the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL]
I. General Information
| Submitter: | Alma Lasers, Ltd.Halamish Street (PO Box 3021), Industrial Park,Caesarea, 38900ISRAEL |
|---|---|
| Contact Person: | Tatiana EpsteinRegulatory Affairs Manager,Alma Lasers, Ltd. |
| Anne Worden |
Regulatory Consultant to Alma Lasers, Ltd.
Summary Preparation Date: September 19, 2007
- II. Names
Device Names:
Alma Lasers Family of Accent™ RF Systems
Primary Classification Names:
Electrosurgical cutting and coagulation device and accessories
III. Predicate Devices
- Alma Lasers, Ltd. Accent™ (K070004) .
IV. Product Description
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:
- Console .
- A Bipolar RF handpieces (normal and small-tip)
- A Unipolar RF handpieces (normal and unilarge)
- Control panel .
- Footswitch. .
V. Indications for Use
The Alma Lasers Family of Accent™ RF Systems is intended for use in dermatologic and general surgical procedures.
The Indications for Use of the Accent™ RF Systems are provided in Appendix 4.
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Image /page/1/Picture/1 description: The image shows the text "Page 2 of 2" in cursive handwriting, with the final "2" circled. Below this, the word "CONFIDENTIAL" is partially visible. The text appears to be part of a document or report, indicating it is the second page of a two-page document.
VI. Rationale for Substantial Equivalence
The Alma Lasers Accent XL™ RF device shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate Accent™ system.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Accent XL™ RF device is substantially equivalent to the predicate Accent™ system.
VIII. Conclusion
The Accent XL™ RF device was found to be substantially equivalent to the predicate Accent™ system.
The Alma Lasers Family of Accent™ RF Devices shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alma Lasers, Ltd. % A. Worden Consulting Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566
0CT 5 * 2007
Re: K072699
Trade/Device Name: Alma Lasers Family of Accent" RF Systems Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 19, 2007 Received: September 24, 2007
Dear Ms. Worden
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 A. 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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cc: HF7-401 DMC HFZ-404 510(k) Staff HFZ-410 (DGRND/GSDB) D.O. f/t:GJM:kxl:10-01-07
OC Numbers:
. . . . . .
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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510(k) Number (if known): ____K072 699
Device Name: The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL]
Indications for Use:
The Alma Lasers Family of Accent™ RF Systems [Accent XL] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
Prescription Use __ > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H Millikin
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
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510(k) Number
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.