SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers for surgical incision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and gland) laser assisted lipolysis and the treatment of primary axillary hyperhidrosis.

Device Description

The Cynosure 1440nm Wavelength laser is solid state Nd: YAG laser, having a neodymium rod as a lasing medium. Laser activation is by footswitch. Overall weight of the laser is 220lbs, and the size is 38.6"x16.5"x35.5" (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. SideLaze800™ Laser Beam Delivery Accessory is an optional side-firing fiber optic accessory used with the Cynosure Lasers with 1440nm wavelength. The SideLaze800™ option is intended to offer physicians a convenient accessory.

AI/ML Overview

This document describes the SideLaze800™ Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers, and its application for the treatment of primary axillary hyperhidrosis. Since this is a medical device submission, the "acceptance criteria" discussed are related to demonstrating safety and effectiveness for a new indication for use rather than statistical performance metrics typical of AI/ML devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are implied by the clinical study's objective: demonstrating the device is safe and effective for treating primary axillary hyperhidrosis. The reported device performance focuses on the clinical outcomes observed in the study.

Acceptance Criteria (Implied by Clinical Study Objective)	Reported Device Performance (Clinical Study Findings)
Safe for treating primary axillary hyperhidrosis	No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs) reported.
Effective in treating primary axillary hyperhidrosis	All subjects demonstrated a reduction, ablation, and fragmentation of the sweat glands. Treatment effectiveness assessed through: - Subject-rated Hyperhidrosis Disease Severity Scale (HDSS) scores - Physician Satisfaction Scale (PSS) - Blinded evaluation of pre and post photographs from starch iodine test results

2. Sample Size and Data Provenance

Sample Size (Test Set): 59 subjects
Data Provenance: The study was conducted at 4 study centers. The location of these centers (e.g., country of origin) is not specified. The study appears to be prospective as subjects underwent treatment and were followed up for 12 months.

3. Number of Experts and Qualifications

The document mentions "Physician Satisfaction Scale (PSS)" and "blinded evaluation of pre and post photographs from starch iodine test results." It does not explicitly state the number or specific qualifications of the physicians or experts involved in these evaluations. It can be inferred that these evaluations were performed by qualified medical professionals.

4. Adjudication Method

The document mentions "blinded evaluation of pre and post photographs from starch iodine test results." This implies a form of adjudication for objective assessment, but the specific method (e.g., how disagreements were resolved, 2+1, 3+1) is not detailed. It's only stated that the evaluation was "blinded."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study comparing human readers with and without AI assistance was mentioned. This device is a laser-based medical device, not an AI/ML diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth for effectiveness was established through a combination of:

Clinical outcomes:
- Subject-rated Hyperhidrosis Disease Severity Scale (HDSS) scores.
- Physician Satisfaction Scale (PSS).
- Blinded evaluation of pre and post photographs from starch iodine test results (an objective measure of sweat production).
- Direct observation of "reduction, ablation and fragmentation of the sweat glands" (likely from biopsy or other imaging, though not explicitly stated how this was observed in all subjects).
Safety data: Adverse event reporting.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML system requiring a training set in the conventional sense. The "training" or development of the device likely involved engineering and preclinical testing before the clinical study.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no "training set" for an AI/ML algorithm. The safety and effectiveness for a medical device are established through a combination of engineering design, preclinical testing, and clinical trials. The previous clearance of the SideLaze800™ for other soft tissue applications (K121127) also provided a foundation for its known performance characteristics, with this submission specifically adding the hyperhidrosis indication based on the clinical study.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2015

Cynosure Incorporated Ms. Aastha Kohli Senior Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886

Re: K141511 Trade/Device Name: SideLaze800™ Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers 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: December 18, 2014 Received: December 19, 2014

Dear Ms. Kohli:

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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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141511

Device Name

SideLaze800™Laser BeamDelivery Accessory for Cynosure 1440nmWavelength Lasers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510K Summary

510(k) Summary for SideLaze800™ Laser Beam Delivery Accessory

A. Sponsor

Cynosure, Inc. 5 Carlisle Road Westford, MA 01886

B. Contact

Ms. Aastha Kohli Senior Regulatory Affairs Specialist 781-993-2394 akohli@cynosure.com

C. Device Name

Trade Name:	SideLaze800 TM Laser Beam Delivery Accessory for Cynosure 1440nmWavelength Lasers
Common/usual Name:	Powered Laser Surgical Instrument (Laser for Surgery and Dermatology)
Classification Name:	GEX-Powered laser surgical instrument, General & Plastic Surgery21 CFR 878.4810, Class II

D. Predicate Device

Trade Name:	SideLaze800TM Laser Beam Delivery Accessory for Cynosure 1440nmWavelength Lasers
Common/usual Name:	Powered Laser Surgical Instrument (Laser for Surgery and Dermatology)
Classification Name:	GEX-Powered laser surgical instrument, General & Plastic Surgery21 CFR 878.4810, Class II
Premarket Notification:	Cynosure Inc, K121127 (05/13/2012)
Trade Name:	miraDry System
Common/usual Name:	Microwave And Accessories

Classification Name: NEY-System, Ablation, Microwave and Accessories, General & Plastic Surgery 21 CFR 878.4400, Class II Premarket Notification: Miramar Labs, Inc., K103014 (01/08/2011)

E. Device Description

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F. Intended Use/Indications for Use

SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' for surgical incision, excision, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and gland), laser assisted lipolysis and the treatment of primary axillary hyperhidrosis.

G. Technological Characteristics

The SideLaze800™ option contains equivalent components and patient-contacting materials as previously cleared SideLaze800 Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers (K121127). There is no change in device design or performance characteristics compared to previously cleared device. This proposed SideLaze800™ Fiber will have an additional indication for use for the treatment of primary axillary hyperhidrosis.

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510K Summary

	Proposed Device	Predicate Device	Predicate Device
510(k)#	K141511	K121127	K103014
Manufacturer	Cynosure, Inc.	Cynosure, Inc.	Miramar Labs, Inc.
Device Name	SideLaze800™™, Laser Beam Accessoryfor Cynosure 1440nm Wavelength Lasers	SideLaze800™, Laser Beam Accessoryfor Cynosure 1440nm Wavelength Lasers	miraDry System
Clearance Date	TBD	May 13, 2012	January 8, 2011
Classification/ Regulation	Class II/21 CFR 878.4810	Class II/21 CFR 878.4810	Class II/21 CFR 878.4400
Indications for Use	SideLaze800™™ is an accessory to deliveryoptical energy for Cynosure 1440nmwavelength lasers and intended to be usedwith Cynosure 1440nm wavelengthlasers' cleared indications for use, such asthe surgical incision, excision,vaporization, ablation, and coagulation ofsoft tissue (including skin, cutaneoustissue, subcutaneous tissue, striated andsmooth tissue, muscle, cartilage,meniscus, mucous membrane, lymphvessels and nodes, organs and gland) laserassisted lipolysis and the treatment ofprimary axillary hyperhidrosis.	SideLaze™ is an accessory to deliveroptical energy for Cynosure 1440nmwavelength lasers and intended to be usedwith Cynosure 1440nm wavelengthlasers' cleared indications for use, such asthe surgical incision, excision,vaporization, ablation, and coagulation ofsoft tissue (including skin, cutaneoustissue, subcutaneous tissue, striated andsmooth tissue, muscle, cartilagemeniscus, mucous membrane, lymphvessels and nodes, organs and glands) andlaser assisted lipolysis. SideLaze800™may be used in combination with aCynosure SMA-compatible laser systemfor the same indications	The miraDry System is indicated for usein the treatment of primary axillaryhyperhidrosis.
Use Principle	Delivers focused laser energy for surgicalincision, excision, vaporization, ablation,and coagulation of soft tissue, whichincludes ablation of sweat glands.	The SideLaze800™ Laser Beam DeliveryAccessory targets the sweat glands in theunderarm area and uses focused laserenergy to ablate their function.	MiraDry utilizes microwave energy, forthe reduction or removal of sweat glands.
Wavelength	1440 nm	1440 nm
Pulse Characteristics:
Maximum Delivered Energy Limit	300 J/cm²	300 J/cm²
Fiber Optic Characteristics:
Diameter	800 µm	800 µm
Length	3 meters	3 meters
Aimino Ream	632.8 nm (wavelength)	632.8 nm (wavelength)

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510K Summary

H. Clinical Information

Clinical testing showed that the device provides a safe and effective means to treat axillary hyperhidrosis using the SideLaze800™ Laser Beam Delivery Accessory. There were 59 subjects enrolled at 4 study centers, all subjects underwent single treatment and were followed up till 12 months. Treatment effectiveness was assessed through subject rated Hyperhidrosis Disease Severity Scale (HDSS) scores at each follow up visit, Physician Satisfaction Scale (PSS), blinded evaluation of pre and post photographs from starch iodine test results obtained at each follow up visit and recording of adverse events. Ninety Eight percent subjects returned for the three month follow up visit, Ninety six percent returned for the six month follow-up visit, eighty six percent returned for the nine month and twelve month follow up. All subjects demonstrated a reduction, ablation and fragmentation of the sweat glands. There were no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in these studies.

I. Substantial Equivalence

There is no change in the SideLaze800™ accessory's design, principle of operation, material of construction and intended use compared to the previously cleared accessories for the Cynosure Lasers with 1440nm wavelength. The proposed indication for use "Primary axillary hyperhidrosis" is supported with clinical evidence demonstrating SideLaze800™ safety and effectiveness.

Regulation Number and Section

§ 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.