(83 days)
The SmartLipo Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.
The SmartLipo Laser is a Nd: YAG laser system. It emits a 1064nm wavelength. Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 65" x 23" x 68" (LxWxH). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
This response is based on the provided 510(k) Summary for the Cynosure SmartLipo Nd: YAG Laser system (K062321).
Observations from the Provided Document:
The provided 510(k) Summary explicitly states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
This means the submission for the SmartLipo Laser did not include any studies or data pertaining to device performance against acceptance criteria in a clinical or non-clinical setting. The filing relies on comparison to a predicate device to establish substantial equivalence.
Therefore, for the specific questions requested, many of them cannot be answered from the provided document as no such studies were conducted or reported.
Detailed Breakdown based on Document (K062321):
Given the information provided, the device's acceptance criteria and the study proving it meets those criteria are not described in a manner typical for performance studies as no clinical or nonclinical performance data was submitted. The submission relies on "substantial equivalence" to a predicate device.
Here's how the questions relate to the information in K062321:
-
A table of acceptance criteria and the reported device performance
- Not applicable / No data provided. The document states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." Therefore, no specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcomes) or reported device performance against such criteria are 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 / No data provided. Since no nonclinical or clinical performance studies were conducted or submitted, there is no test set, sample size, or data provenance to report.
-
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 / No data provided. Without a test set and associated performance studies, there is no ground truth, expert panel, or their qualifications to report.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / No data provided. No test set means no adjudication method was used or reported.
-
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
- No, an MRMC study was not done. This device is a laser system, not an AI-assisted diagnostic tool for human readers. No such study would be applicable or expected for this type of device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / No data provided. This device is a laser system which is a physical surgical tool; it is not an algorithm, so a standalone algorithm performance study is irrelevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / No data provided. As no performance studies were submitted, no ground truth was established for this purpose.
-
The sample size for the training set
- Not applicable / No data provided. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established
- Not applicable / No data provided. As this is not an AI/ML device, there is no training set or ground truth for it.
Summary based on Substantial Equivalence:
The provided 510(k) relied on demonstrating substantial equivalence to a predicate device (Laserscope Lyra Series Nd: YAG Laser system), rather than providing new performance studies. The core argument for acceptance was:
- Same indication for use: Surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, plus laser-assisted lipolysis.
- Same principle of operation: Nd: YAG laser system.
- Essentially the same wavelength and pulse energy range as the predicate device.
The "conclusion" stated in the summary is: "The SmartLipo laser is a safe and effective device for the indicated uses," which is a regulatory conclusion based on the substantial equivalence argument, not on new clinical or nonclinical performance data submitted within this particular 510(k).
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1-062321
510(K) Summary
Submitter:
Contact:
Contact:
Date Summary Prepared:
Common Name:
Device Trade Name:
Classification Name:
Equivalent Device:
Device Description:
Intended Use:
Comparison:
Nonclinical Performance Data: Clinical Performance Data: Conclusion:
Additional Information:
Cynosure, Inc. 5 Carlisle Road Westford, MA 01886
OCT 3 1 2006
George Cho Senior Vice President of Medical Technology
August 8, 2006
SmartLipo Nd: YAG Laser system
Nd: YAG laser
Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810
Laserscope Lyra Series Nd: Y AG Laser system
The SmartLipo Laser is a Nd: YAG laser system. It emits a 1064nm wavelength.
Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 65" x 23" x 68" (LxWxH).
Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
The SmartLipo laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.
The SmartLipo laser system has the same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy range as the predicate device.
none
none
The SmartLipo laser is a safe and effective device for the indicated uses.
none
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Image /page/1/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three curved lines representing the head, torso, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH". The text is arranged vertically, with the letters stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2006
Cynosure, Inc. % Mr. George Cho Senior Vice President 5 Carlisle Road Westford, Massachusetts 01886
Re: K062321
Trade/Device Name: Cynosure SmartLipo Laser 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 2, 2006 Received: October 3, 2006
Dear Mr. Cho:
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 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 - Mr. George Cho
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 vours
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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510(k) Number (if known):
R 062321
Device Name: Cynosure SmartLipo Laser
Indications For Use:
The SmartLipo Laser is intended for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous. tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.
Prescriptive Use OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 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)
Division of General, Restorative, and Neurological Devices
7100 Number Kd(232)
§ 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.