(228 days)
Not Found
No
The document describes a laser and an accessory for delivering optical energy. There is no mention of AI, ML, or any computational processing that would suggest the use of these technologies. The performance studies focus on clinical outcomes and safety, not on the performance of an AI/ML algorithm.
Yes
The device is described as being used for "surgical incision, vaporization, ablation, and coagulation of soft tissue," "laser assisted lipolysis," and "the treatment of primary axillary hyperhidrosis." These are all therapeutic applications.
No
Explanation: The provided text explicitly states the device's intended use for "surgical incision, vaporization, ablation, and coagulation of soft tissue," "laser assisted lipolysis," and "the treatment of primary axillary hyperhidrosis." These are all therapeutic or surgical procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly outlines a physical laser system (Cynosure 1440nm Wavelength laser) and a physical accessory (SideLaze800™ Laser Beam Delivery Accessory), including details about weight, size, and electrical requirements. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures performed directly on the patient's body (incision, vaporization, ablation, coagulation of soft tissue, laser assisted lipolysis, treatment of primary axillary hyperhidrosis). IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a laser system and an accessory for delivering optical energy. This is consistent with a surgical device, not a device for analyzing biological samples.
- Anatomical Site: The anatomical sites listed are parts of the human body where surgical procedures are performed.
- Performance Studies: The performance studies describe clinical trials where the device was used on human subjects to treat a medical condition (axillary hyperhidrosis) and assess the clinical outcome. This is typical for a therapeutic or surgical device, not an IVD.
In summary, the SideLaze800™ and the Cynosure 1440nm wavelength laser are devices used for surgical and therapeutic procedures performed directly on the patient, which is the defining characteristic of a non-IVD medical device.
N/A
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and gland), primary axillary hyperhidrosis (sweat glands in the underarm area).
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
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
1
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)
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.
| 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 1440nm
Wavelength Lasers |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/usual Name: | Powered Laser Surgical Instrument (Laser for Surgery and Dermatology) |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery
21 CFR 878.4810, Class II |
D. Predicate Device
| Trade Name: | SideLaze800TM Laser Beam Delivery Accessory for Cynosure 1440nm
Wavelength Lasers | | |
|-------------------------|-----------------------------------------------------------------------------------------------|--|--|
| Common/usual Name: | Powered Laser Surgical Instrument (Laser for Surgery and Dermatology) | | |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery
21 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
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.
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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 Accessory | ||
| for Cynosure 1440nm Wavelength Lasers | SideLaze800™, Laser Beam Accessory | ||
| for 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 delivery | ||
| optical energy for Cynosure 1440nm | |||
| wavelength lasers and intended to be used | |||
| with Cynosure 1440nm wavelength | |||
| lasers' cleared indications for use, such as | |||
| the surgical incision, excision, | |||
| vaporization, 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. | SideLaze™ is an accessory to deliver | ||
| optical energy for Cynosure 1440nm | |||
| wavelength lasers and intended to be used | |||
| with Cynosure 1440nm wavelength | |||
| lasers' cleared indications for use, such as | |||
| the surgical incision, excision, | |||
| vaporization, 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 glands) and | |||
| laser assisted lipolysis. SideLaze800™ | |||
| may be used in combination with a | |||
| Cynosure SMA-compatible laser system | |||
| for the same indications | The miraDry System is indicated for use | ||
| in the treatment of primary axillary | |||
| hyperhidrosis. | |||
| Use Principle | Delivers focused laser energy for surgical | ||
| incision, excision, vaporization, ablation, | |||
| and coagulation of soft tissue, which | |||
| includes ablation of sweat glands. | The SideLaze800™ Laser Beam Delivery | ||
| Accessory targets the sweat glands in the | |||
| underarm area and uses focused laser | |||
| energy to ablate their function. | MiraDry utilizes microwave energy, for | ||
| the 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.