PINPOINTE FOOTLASER

{0}------------------------------------------------ K130413 MAR 2 1 2013 # Section 8 – Special 510(k) Summary I. General Information Submitter: Nuvolase, Inc. Contact Person: Steve Duddy 530-809-1970 ext. 207 sduddy@nuvolase.com Summary Preparation Date: February 11, 2013 II. Names Device Name(s): PinPointe FootLaser Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories #### III. Predicate Devices - K093547 PinPointe FootLaser and Accessories . {1}------------------------------------------------ #### IV. Product Description The PinPointe™ FootLaser™ is comprised of the following main components: - Main console containing the major electrical components, including: t - Control/ Display Panel with the: . - . Keyswitch (that controls authorized access to the laser system); - . emergency Laser Stop button; - Displays (laser emission indicator, average power, pulse energy, . - . repetition rate) - LCD screen user interface permitting selection of treatment ● - . emission when the footswitch is depressed and a fiber optic is properly - attached); . - 1064 nm treatment laser (solid state Nd:Y AG laser rod) with flashlamp and associated light ● regulation components and electronics; - 630 -680 nm (red) aiming beam diode laser; ● - . Delivery device fiber-optic connector port; - . Remote interlock connector (External door interlock connector); - Connector ports for the footswitch and power cord; � - . Accessory holder (attached to the rear of the main console); - Footswitch; - Medical grade power cord; . - Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue: . - Guide Tip No Standoff: Reusable, cleanable, tip is provided for noncontactuse to direct and . control the placement of the laser beam (free beam) at the treatment location. The Guide tipattaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip; - . Guide Tip - With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip; - Delivery Devices for Contact with Breached Surfaces: . - . Optical Fibers - Reusable, cleanable, sterilizable optical fibers (range of 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave). - . Handpieces - Reusable, cleanable, sterilizable handpieces (large and small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap; - · Handpiece Tips Disposable single-use tips are provided in straight and curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment location. The handpiece tips attach to the end of the handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip; - Accessories: � - Safety Glasses � - Tools: . - Optical Fiber Striper; {2}------------------------------------------------ - Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the . optical fibers). #### V. Indications for Use #### Indications for Use (same as K093547): The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology IENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery. ### Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy . - Periungual and subungual warts . - . Plantar warts - . Radical nail excision - Neuromas . The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). #### Dermatology and Plastic Surgery Dermatology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including: - Lesions of skin and subcutaneous tissue . - . Telangiectasia - . Port wine lesions - . Spider veins - . Hemangiomas - . Plantar warts - . Periungual and subungual warts - . Removal of tattoos - Debridement of decubitus ulcer ◆ - Treatment of keloids . {3}------------------------------------------------ ### Oropharangeal/ Dental Surgery Indicated for: - Abscess incision and drainage . - . Aphthous ulcers treatment - Biopsies, excisional and incisional . - . Crown lengthening - Exposure of unerupted I partially erupted teeth . - . Fibroma removal - Frenectomy . - . Frenotomy - . Gingival incision and excision - . Gingivectomy - Gingivoplasty . - Hemostasis . - Implant removal . - Lesion (tumor) removal . - . Leukoplakia - . Operculectomy - . Oral papillectomy - . Pulpotomy - . Pulpotomy as adjunct to root canal therapy - Removal of filling material such as gutta percha or resin as adjunct treatment . during root canal re-treatment - Selective ablation of enamel (first degree) caries removal . - . Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility - . Tissue retraction for impressions - . Vestibuloplasty ## General Surgery Indicated for: Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue) including: - . Cholecystectomy - . Lymphadenectomy - . Mastectomy - Partial nephrectomy ● - . Hepatectomy - . Pilonidal cystectomy - . Pancreatectomy - Resection of lipoma Splenectomy - . Pelvic adhesiolysis - . Hemorrhoidectomy - Removal of lesions . - Thyroidectomy . - Removal of polyps ● - . Parathyroidectomy {4}------------------------------------------------ - . Removal of tumors - . Herniorrhaphy - . Tumor biopsy - Tonsillectomy . - . Debridement of decubitus ulcers - . Appendectomy ## Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including: - Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues l - . Tonsillectomy - . Adenoidectomy No clinical data was needed for these indications. They are identical to those on K093547. #### VI. Summary of Technological Characteristics The technological characteristics of the PinPointe Footlaser are substantially equivalent to those of the predicate device. | | | K093547 | |-----------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------| | Characteristic | PinPointe FootLaser | PinPointe FootLaser | | Product Code | General & Plastic Surgery | General & Plastic Surgery | | Regulation | • GEX, 21 CFR 878.4810 | • GEX, 21 CFR 878.4810 | | Intended Use | Intended for use in dermatologic and<br>general surgical procedures | Intended for use in<br>dermatologic and general<br>surgical procedures | | Indications for<br>Use | Exactly the same as K093547 | See K093547 | | Wavelength | 1064nm | 1064nm | | Aiming beam | 630-680 nm (< 2.5 mW) | 630-680 nm (< 2.5 mW) | | Power Watts | 6W, 30W, 100W | 6W, 30W, 100W | | Pulse<br>Duration<br>(usec) | 100-700 (6W), 350-3000(30W), 350-<br>3000 (100W) | 100-700 (6W), 350-<br>3000(30W), 350-3000<br>(100W) | {5}------------------------------------------------ | | | K093547 | |--------------------------------------|------------------------------------------------|------------------------------------------------| | Characteristic | PinPointe FootLaser | PinPointe FootLaser | | Energy per<br>pulse (mJ) | 20-200 (6W), 20-1000 (6W), 20-3500 (100W) | 20-200 (6W), 20-1000 (6W), 20-3500 (100W) | | Output Mode | Pulsed, multi mode | Pulsed, multi mode | | Repetition<br>rate | 5-100Hz | 5-100Hz | | Laser media | Flashlamp pumped, solid state laser<br>rod | Flashlamp pumped, solid<br>state laser rod | | User interface | LCD screen | Push button panel | | Laser<br>activation | footswitch | footswitch | | Delivery<br>devices, how<br>supplied | Non-sterile, reusable, cleanable, sterilizable | Non-sterile, reusable, cleanable, sterilizable | | Electrical<br>requirements | 90-130 VAC, 50/60 Hz<br>200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz<br>200-240 VAC, 50/60 Hz | #### VII. Safety and Effectiveness Information The review of the indications for use and technical characteristics provided demonstrates that the PinPointe FootLaser is substantially equivalent to the predicate device and is safe and effective for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis. ## VIII. Conclusion The PinPointerm FootLaser was found to be substantially equivalent to the predicate device. The PinPointe FootLaser shares identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate device. {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with a double-stranded snake winding around a staff. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 21, 2013 Nuvolase, Incorporated % Al Voss Associates Ms. Kathy Maynor Regulatory. Consultant 26 Rebecca Court Homosassa, Florida 34446 Re: K130413 Trade/Device Name: PinPointe FootLaser' 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: February 11, 2013 Received: February 19, 2013 Dear Ms. Maynor: 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {7}------------------------------------------------ Page 2 – Ms. Kathy Maynor 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, FOR # Peter DiRumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### Indications for Use Statement 510(k) Number (if known): K130413 Device Name: PinPointe FootLaser ## Indications for Use (same as K093547): The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology IENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery. #### Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy . - Periungual and subungual warts . - . Plantar warts - . Radical nail excision - Neuromas • The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden 2013.03.20 14:23:36 404 00 (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number Page 1 of 4 {9}------------------------------------------------ ## Indications for Use Statement (continued) 510(k) Number (if known): K130413 Device Name: PinPointe FootLaser #### Dermatology and Plastic Surgery Dermatology and plastic surgery (ablation, vaporization, incision, and coagulation of soft tissue) including: - Lesions of skin and subcutaneous tissue . - Telangiectasia - Port wine lesions . - Spider veins . - Hemangiomas . - . Plantar warts - . Periungual and subungual warts - Removal of tattoos - ◆ Debridement of decubitus ulcer - Treatment of keloids ### Oropharangeal/ Dental Surgery Indicated for: - Abscess incision and drainage � - Aphthous ulcers treatment . - Biopsies, excisional and incisional . - Crown lengthening . - Exposure of unerupted / partially erupted teeth . - Fibromfl removal . - Frenectomy . - Frenotomy • - Gingival incision and excision - Gingivectomy . - Gingivoplasty . Prescription Use V (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogdens 2013.03.20 14:24:18 04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number __ K130413 Page 2 of 4 {10}------------------------------------------------ # Indications for Use Statement (continued) # 51O(k) Number (if known): K130413 # Device Name: PinPointe Fo o tL ase rTM Oropharangeal/ Dental Surgery- Continued Indicated for: - . Hemostasis - . Implant removal - Lesion (tumor) removal . - . Leukoplakia - Operculectomy - . Oral papillectomy - Pulpotomy . - . Pulpotomy as adjunct to root canal therapy - Removal of filling material such as gutta percha or resin as adjunct treatment during root . canal re-treatment - . Selective ablation of enamel (first degree) caries removal - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal . pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility - Tissue retraction for impressions . - Vestibuloplasty . ## General Surgery Indicated for: Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Cholecystectomy Lymphadenectom y Mastectomy Partial nephrectomy Hepatectomy Prescription Use V (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 OF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden Ag 2013.03.20 14:25:07 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Page 3 of 4 {11}------------------------------------------------ 510(k) Number (if known): K130413 Device Name: PinPointe FootLaser Indications for Use- Continued: - General Surgery- Continued Indicated for: Pilonidal cystectomy Pancreatectomy Resection oflipoma Splenectomy - Pelvic adhesiolysis Hemorrhoidectomy Removal of lesions Thyroidectomy Removal of polyps Parathyroidectomy Removal of tumors Herniorrhaphy Tumor biopsy Tonsillectomy Debridement of decubitus ulcers Appendectomy Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - . Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues - Tonsillectomy . - Adenoidectomy . く 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden 2013.03.20 14:25:42 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130413 Page 4_of_4