Novilase Laser Therapy System, Model LTS-2

K160392 · Novian Health, Inc. · GEX · Feb 26, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160392
• Device Name: Novilase Laser Therapy System, Model LTS-2
• Applicant: Novian Health, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Novilase® Laser Therapy System (LTS-2) is intended for use as a surgical instrument in the excision of external tumors and lesions, complete and partial resection of internal organs, treatment of tumors and lesions, skin incision and tissue dissection and ablation.

Device Story

Novilase LTS-2 is a second-generation laser-based system for minimally-invasive tumor destruction. It uses a GaAIAs laser diode (805 nm, 1-8 watts) to deliver energy via a 600 µm core diameter fiber optic probe. The system includes a thermistor controller, laser source, and PC-based interface. Used in hospitals, surgical centers, and physician offices by physicians/radiologists/surgeons experienced in image-guided biopsy. The physician monitors the procedure via an ultrasound or x-ray imaging system; the LTS-2 provides real-time thermal feedback via embedded thermistors in the thermal probe. The system produces coagulative necrosis in target tissue. Modifications from the predicate include hardware repackaging for improved mobility/aesthetics, a touch-screen interface, and an updated Windows 7 operating system. The device benefits patients by providing a minimally-invasive alternative for fibroadenoma treatment.

Clinical Evidence

No clinical data was acquired for this submission. Substantial equivalence is based on design, technological characteristics, and bench testing (verification and validation) demonstrating performance specifications are met.

Technological Characteristics

GaAIAs laser diode (805 nm, 1-8W, Class IV). Components: 304 stainless steel 14G laser/thermal probes, thermistor controller, PC with touch-screen, power distribution unit. Materials: 304 stainless steel, Loctite 3321 adhesive, Cobalt Polymers U2-110-CLR shrink tubing, quartz fiber. Sterilization: Gamma-sterilized disposable probe kit. Connectivity: USB for data storage. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, ISO 10993, ISO 14971.

Indications for Use

Indicated for treatment of breast fibroadenomas (up to 20 mm) in females ages 15 and older; general surgery procedures including incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues. Contraindications: None.

Regulatory Classification

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.

Predicate Devices

• The Kelsey Interstitial Laser Therapy System (K070353)

Submission Summary (Full Text)

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Public Health Service

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

February 26, 2016

Novian Health, Inc. % John Ziobro Principal Consultant Spectramedex, LLC 117 W. South Street Oconomowoc, Wisconsin 53066

Re: K160392

Trade/Device Name: Novilase Laser Therapy System, Model LTS-2 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: January 28, 2016 Received: February 11, 2016

Dear John Ziobro:

We have reviewed vour 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

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) K160392

Device Name NOVILASE Laser Therapy System, Model LTS-2

Indications for Use (Describe)

The Novilase® Laser Therapy System (LTS-2) is indicated for the treatment of the breast, with tumor sizes up to 20 mm, and for general surgery procedures including incision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div><span style="font-size:10pt">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:10pt">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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### Special 510(k) Summary

- 28 January 2016 1. Summary Date:
- Applicant Name: Novian Health, Inc. 2. 430 W Erie St Ste 500 Chicago, IL 60654 Ph: 312.266.7200 Establishment Registration Number: 3009383334
- 3. Submission Correspondent: On behalf of Novian Health, Inc, the following consultant is assigned the responsibility of submission correspondence: John F. Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc. WI 53066
- 262.719.8922 4. Trade Name: Novilase® Laser Therapy System, Model LTS-2
- న్. Common Name: Laser Therapy System
- 6. Description: The Novilase Laser Therapy System (Model LTS-2) is a second-generation laser-based system that uses laser ablation to destroy tumors via a minimally-invasive procedure
- 7. Manufacturing Site: Biomedical Devices of Kansas (Hardware & Software) 1205 US 24/40 Highway, Suite100 Tonganoxie. Kansas 66086 913.845.3851 Establishment Registration Number: 3007124677
- 8. Sterilization Site: Sterigenics 1003 Lakeside Drive Lakeside, Illinois 60031 847-263-3344 Establishment Registration Number: 1450293
- 9. Classification Regulation, Class & Product Code & Panel: 21 CFR 878.4810 Laser instrument, surgical, powered Class II Product Code: GEX Panel: General & Plastic Surgery
- 10. Reason for Special 510(k): Repackaging of the hardware to decrease size and weight and improve aesthetics, user interface modifications including the introduction of a touch-screen monitor.
- 11. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:

#### Quality, Risk Management & Process related Standards.

CFR 21CFR820: Part 820 - QUALITY SYSTEM REGULATION,

IEC 62304:2006 Medical device software - Software life cycle processes,

- ISO 13485:2012 Medical devices Quality management systems Requirements for regulatory purposes.
- ISO 14971:2012 Medical devices Application of risk management to medical devices,

#### Technical/ Product Specific Standards

| Novilase® Laser Therapy System | VOL_002/003_Special 510(k) Summary_S1.docx | |
|---------------------------------------|--------------------------------------------|---------------|
| Model LTS-2 Special 510(k) Submission | Confidential | Page 002/003- |

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ASTM D 4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems, IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC-60601-1-8:2010 Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, 2nd edition,

IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment,

IEC 60825-1:2005 Safety of laser products - Part 1: Equipment classification and requirements, 2

ISO 11607:2003 Terminally Sterilized Medical Devices Package,

ISO 11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems,

ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes,

21 CFR 1040.10-11: PART 1040 -- PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS,

### Labeling Standards

EN 1041:2008 The system labelling shall comply with BS EN 1041:2008 Information supplied by the manufacturer of medical devices,

EN 556-1:2001 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices,

ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirement,

#### Biocompatibility standards

ISO 10993:2010 The parts of the system that come into contact with humans shall comply with AAM / ANSI / ISO 10993:2010 (Biological evaluation of medical devices),

#### Sterilization standards

ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices,

ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, ISO 11137-3:2006 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects, 12. Intended Use of Device

| PRODUCT REQUIREMENTS DOCUMENT - Novilase Model LTS-2 | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Novilase Laser Therapy System (LTS-2) has an intended use as a surgical instrument in the excision of external tumors and lesions, complete and partial resection of internal organs, treatment of tumors and lesions, skin incision and tissue dissection and ablation. |
| Indication for Use | The Novilase® Laser Therapy System (LTS-2) is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm, and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues. |
| Intended User | The Novilase LTS-2 user profile is a physician, radiologist or surgeon, with demonstrated experience in image-guided biopsy procedures. |
| Intended Use Environment | Medical treatment facilities such as hospitals, surgical centers, breast centers and physician offices with an ultrasound or x-ray imaging system, physical space to accommodate the Novilase LTS-2 unit and a "Laser in Use" sign on the procedure room door that meets laser safety requirements. |
| Targeted Patient Population | Females ages 15 and older with single or multiple fibroadenoma that do not exceed 2.0 cm in diameter and measure at least 0.5 cm away from the skin. |

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| PRODUCT REQUIREMENTS DOCUMENT - Novilase Model LTS-2 | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | None |
| 13. Predicate Device(s): | 510(k) Number: K070353<br>Manufacture: Kelsey, Inc. (Named changed to Novian Health, Inc. in 2007)<br>Trade Name: The Kelsey Interstitial Laser Therapy System (Name changed to the<br>Novilase® Interstitial Laser Therapy System in 2007) |
| | Product Code: GEX<br>Classification: 874.4810 |

#### 14. Comparison to Predicates

The proposed device and the predicate device have the same/equivalent intended user, intended user, intended use environment and targeted patient population. Both devices use the same laser energy and treatment methodologies.

The main differences between Novilase Model LTS-2 Laser Therapy System and the Predicate Kelsey (now Novilase) Model ILT Laser Therapy System are the following:

- Repackaging of the hardware to decrease size and weight and improve aesthetics
- . User interface modifications including the introduction of a touch-screen monitor
- The use of a newer/updated computer operating system. ●

The full Substantial Equivalence Comparison is contained in VOL 003, Section 002 Substantial Equivalence Comparison. The Substantial Equivalence Comparison Table 2-3.1 is included below for reader convenience.

#### 15. Conclusions

Novian Health believes the proposed Novilase Laser Therapy System (Model LTS-2) and its predicate, the Kelsey Interstitial Laser Therapy System (Model ILT) are substantially equivalent in fundamental design and technology characteristics. Based on the predicate device comparison tables for the system under review, and the selected predicate, it is clear that these devices operate in an identical fashion, and there are no major deviations in design or functionality. The major differences in the systems pertain to repackaging the device to improve aesthetics and mobility, and improving the user-interface experience. In all cases, the devices are substantially equivalent and the same or better safety standards are met. In addition, no new issues pertaining to biocompatibility have been raised and therefore no clinical data was acquired.

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### Table 2-3.1 is a duplicate of Table 3-2.1 from VOL_003, Section_002 Substantial Equivalison document; it has been copied here for reader convenience. The table details the specifications of the device under review and compares it to the predicate device.

| | Novilase® Laser Therapy System<br>Model LTS-2<br>(Novilase System Under Review) | Kelsey Interstitial Laser Therapy System<br>Model ILT<br>(Cleared under K070353) | |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | Substantial Equivalence Comments |
| | | COMPARISON OF USES/INDICATIONS | |
| Intended Use | The Novilase® Laser Therapy System (LTS-2) is intended for<br>use as a surgical instrument in the excision of external tumors<br>and lesions, complete and partial resection of internal organs,<br>treatment of tumors and lesions, skin incision and tissue<br>dissection and ablation. | The Kelsey Interstitial Laser Therapy it is intended for use<br>as a surgical instrument in the excision of external tumors<br>and lesions, complete and partial resection of internal<br>organs, treatment of tumors and lesions, skin incision and<br>tissue dissection and ablation. | Both devices have the same intended use. Only<br>the device name is updated.<br>Therefore, Substantially Equivalent |
| Indication for Use Statement | The Novilase® Laser Therapy System (LTS-2) is indicated for<br>the treatment of fibroadenomas of the breast, with tumor sizes<br>up to 20 mm, and for general surgery procedures including<br>incision, excision and ablation of soft tissues; and coagulative | The Kelsey Interstitial Laser Therapy System is indicated for<br>the treatment of fibroadenomas of the breast, with tumor<br>sizes up to 20 mm, and for general surgery procedures<br>including incision, excision and ablation of soft tissues; and | Both devices have the same indications for use<br>statement. Only the device name is updated.<br>Therefore, Substantially Equivalent<br>Note: the ongoing clinical study (NCT01478438, |
| | necrosis and interstitial laser coagulation of soft tissues. | coagulative necrosis and interstitial laser coagulation of soft<br>tissues. | A Multicenter "Ablate and Resect" Study of<br>Novilase® Interstitial Laser Therapy for the<br>Ablation of Small Breast Cancers) is seeking to<br>establish the use of the device on malignant<br>tumors. This potential new indication for use is<br>outside the scope of this submission. The<br>subject device is indicated for the same uses as<br>the predicate device. |
| Intended User | The Novilase® Laser Therapy System (LTS-2) user profile is a<br>physician with experience in image-guided biopsy procedures. | The Kelsey Interstitial Laser Therapy user profile is a<br>physician with experience in image-guided biopsy<br>procedures. | Both devices have the same intended user profile.<br>Therefore, Substantially Equivalent |
| Intended Use Environment | Medical treatment facilities such as hospitals, surgical centers,<br>breast centers and physician offices with an ultrasound or x-ray<br>imaging system, physical space to accommodate the Novilase<br>LTS-2 unit and a "Laser in Use" sign on the procedure room<br>door that meets laser safety requirements. | Medical treatment facilities such as hospitals, surgical<br>centers, breast centers and physician offices with an<br>ultrasound or x-ray imaging system, physical space to<br>accommodate the device and a "Laser in Use" sign on the<br>procedure room door that meets laser safety requirements. | Both devices have the same intended use<br>environments.<br>Therefore, Substantially Equivalent |
| Target Patient Population | Females ages 15 and older with single or multiple fibroadenoma<br>that do not exceed 2.0 cm in diameter and measure at least 0.5<br>cm away from the skin. | Females ages 15 and older with single or multiple<br>fibroadenoma that do not exceed 2.0 cm in diameter and<br>measure at least 0.5 cm away from the skin. | Identical patient populations.<br>Therefore, Substantially Equivalent |
| Contraindications | None. | The predicate submission did not contain any<br>contraindications | Neither the predicate nor the proposed device<br>have any contraindications.<br>Therefore, Substantially Equivalent |
| | | COMPARISON OF SYSTEM CONFIGURATIONS | |
| System-Level Components | LTS System consisting of:<br>• Thermistor controller and associated hardware.<br>• Laser diode source, 1-8 watts, 805 nominal nanometer<br>wavelength.<br>• Personal computer running Windows 7, or better, including<br>monitor, keyboard, touch-screen display) and mouse.<br>• Power distribution unit with user accessible master power | ILT System consisting of:<br>• Thermistor controller and associated hardware.<br>• Laser diode source, 1-8 watts, 805 nominal nanometer<br>wavelength.<br>• Personal computer running Windows XP with Service<br>Pack 2 or better, including monitor, keyboard and mouse.<br>• Power distribution unit with user accessible master power | The differences between the subject device and<br>the predicate device are discussed in further detail<br>in Table 3-2.2 below. Some components were<br>updated to reflect differences in the operating<br>system (Windows 7), ergonomics (touch screen),<br>and dimensions (cart). The predicate device has a<br>uninterruptible power supply (UPS) while the |
| Novilase® Laser Therapy System<br>VOL 002/003_Special 510(k) Summary_S1.docx | | | |
| Feature | Novilase® Laser Therapy System<br>Model LTS-2<br>(Novilase System Under Review) | Kelsey Interstitial Laser Therapy System<br>Model ILT<br>(Cleared under K070353) | Substantial Equivalence Comments |
| | switch.<br>• Isolation transformer.<br>• Thermal temperature to digital converter.<br>• Lightweight storage cart. | switch.<br>• Uninterruptible power supply (UPS).<br>• Isolation transformer.<br>• Thermal temperature to digital converter.<br>• Storage cart. | proposed device does not. A technical comparison of the components, combined with the verification and validation testing described in Volume 4, Section 1 demonstrate that the modifications do not raise new questions of safety or effectiveness and the device continues to meet its specifications.<br>Therefore, Substantially Equivalent |
| Additional Required Components | Infusion pump capable of accurately dispensing 60 cc syringes of saline at variable flow rates to 1 cc per minute, continuously adjustable, including bolus function. | Infusion pump capable of accurately dispensing 60 cc syringes of saline at variable flow rates to 1 cc per minute, continuously adjustable, including bolus function. | Both devices use the same infusion pump.<br>Therefore, Substantially Equivalent |
| Reusable Accessories (included with unit; may be available for sale separately) | • Connector box<br>• Umbilical cable, (contains the wires and optical fiber running between the connector box and the LTS cart).<br>• Laser glasses<br>• USB thumb drive (for data storage)<br>• One color-coded adaptor for the laser probe<br>• One color-coded adapter for the thermal probe | • Connector box<br>• Umbilical cable, (contains the wires and optical fiber running between the connector box and the ILT cart).<br>• Laser glasses (These are included with shipments, but were not described in the original submission.<br>• USB thumb drive (This is included with shipments, but it was described in the original submission.) | Both devices use the same reusable accessories. Two color-coded and independently non-sterile adaptors (called "patch cords" by the Company) are provided by the company and shipped separately from the main kit. Their purpose is to help the end-user better differentiate the probes when connecting them to the main unit and to serve as receptacle adapters to accommodate predicate probe connector plugs. For additional information, please refer to table 3-2.2 below.<br>Therefore, Substantially Equivalent |
| Disposable Accessories | A Gamma-sterilized Laser Probe Kit, consisting of:<br>• One disposable laser probe, hollow 14 gauge 304 stainless steel with one attached thermistor.<br>• One disposable thermal probe, solid 14 gauge 304 stainless steel with five embedded thermistors<br>• One probe holder<br>• One hemostasis valve | A Gamma-sterilized Laser Probe Kit, consisting of:<br>• One disposable laser probe, hollow 14 gauge 304 stainless steel with one attached thermistor.<br>• One disposable thermal probe, solid 14 gauge 304 stainless steel with five embedded thermistors<br>• One probe holder<br>• One hemostasis valve | The operating principles, materials and sterilization processes used for the proposed kit are identical to the predicate.<br>Therefore, Substantially Equivalent |
| COMPARISON OF INPUT ENERGY | | | |
| Power Source | Single phase 110/220 VAC, 2A 50 or 60 Hz | Single phase 110/220 VAC, 2A 50 or 60 Hz | Identical specifications.<br>Therefore, Substantially Equivalent |
| COMPARISON OF OUTPUT ENERGY (Principle of Operation) & PERFORMANCE SPECIFICATIONS | | | |
| Device Type | GaAIAs Laser Diode | GaAIAs Laser Diode | Identical specifications.<br>Therefore, Substantially Equivalent |
| Laser Safety Class | IV | IV | |
| Wavelength | $805 nm \pm 15 nm$ | $805 nm \pm 15 nm$ | |
| Power at Tissue | 1 – 8 watts | 1 – 8 watts | |
| Treatment Mode | Continuous operation | Continuous operation | |
| Optical Output | Multimode | Multimode | |
| Calibration | Internal, automatic, ± 20% | Internal, automatic, ± 20% | |
| Delivery System | 600 µm core diameter | 600 µm core diameter | |

Model LTS-2 Special 510(k) Submission

Page 002/003-4 Confidential

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SECTION 3

| Novilase® Laser Therapy System<br>Model LTS-2 Special 510(k) Submission | Confidential | VOL_002/003_Special 510(k) Summary_S1.doc<br>Page 002/003 |
|-------------------------------------------------------------------------|--------------|-----------------------------------------------------------|
|-------------------------------------------------------------------------|--------------|-----------------------------------------------------------|

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| | Novilase® Laser Therapy System | Kelsey Interstitial Laser Therapy System | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Model LTS-2 | Model ILT | |
| Feature | (Novilase System Under Review) | (Cleared under K070353) | Substantial Equivalence Comments |
| Cooling System | Ambient Air | Ambient Air | |
| Temperature sensing range | 0°C - 105°C | 0°C - 105°C | |
| COMPARISON OF PATIENT CONTACT MECHANISMS & MATERIALS | | | |
| Patient Contact/Interface<br>Materials | 14 gauge, 0.010" thick wall, 304 stainless steel pointed, closed-<br>end trocar laser and thermal probes with Loctite 3321 adhesive<br>and Cobalt Polymers U2-110-CLR shrink tubing and quartz<br>fiber | 14 gauge, 0.010" thick wall, 304 stainless steel pointed,<br>closed-end trocar laser and thermal probes with Loctite 3321<br>adhesive and Cobalt Polymers U2-110-CLR shrink tubing<br>and quartz fiber | There have been no changes to the patient<br>contacting materials or method of manufacture<br>since previous clearance.<br>Therefore, Substantially Equivalent |
| Fiber optic length | 2.3m umbilical fiber | 0.25 m internal fiber + 4.0 m umbilical fiber | Overall fiber optic length was reduced. Testing<br>shows no effect on performance, safety or<br>efficacy For additional information, please refer<br>to Table 3-2.2 below.<br>Therefore, Substantially Equivalent |
| Fiber optic length (patient<br>contact) | 1.0 m | 1.0 m | Identical fiber optic length making patient<br>contact.<br>Therefore, Substantially Equivalent |
| | COMPARISON OF COMPUTER INTERFACE & ERGONOMICS/HUMAN FACTORS | | |
| Computer Specifications | The unit has the following minimum required input/output<br>ports: 1x USB 2.0: 1x Serial; Integrated audio and<br>speakers; video display<br>Input power of 100V-240V AC<br>4GB of memory<br>Integrated graphics card.<br>10 GB HDD or greater<br>Intel compatible CPU rated for use compatibility with<br>Windows XP or better | Not specified | Both proposed and predicate device require the<br>use of a computer. The specifications for the<br>proposed device are provided. The specifications<br>for the predicate device's computer were not<br>included in the previous submission. The V&V<br>testing described in VOL_4/SEC_1demonstrates<br>that when used with the specified computer, the<br>device continues to meet its performance<br>specifications.<br>Therefore, Substantially Equivalent |
| Operating System | Windows 7 | Windows XP with service pack 2 or better | PC Environment updated per new standard<br>operating systems; As emulated, identical to<br>predicate.<br>Therefore, Substantially Equivalent |
| User Input Mechanism | Touch Screen and/or mouse & keyboard | Keyboard | Increased input functionality by adding touch<br>screen functionality.<br>Therefore, Substantially Equivalent |
| Display | 15" display size monitor | 15" display size monitor | Identical specification.<br>Therefore, Substantially Equivalent |
| External Media Storage | USB | USB | Identical specification.<br>Therefore, Substantially Equivalent |
| Alarms | Software prompts, warnings and audible alarm indications | Software prompts, warnings and audible alarm indications | The software provides and operates with the same<br>set of alarms and warnings. No new alarms or<br>alerts have been added.<br>Therefore, Substantially Equivalent |
| | Novilase® Laser Therapy System | Kelsey Interstitial Laser Therapy System | |
| Feature | Model LTS-2<br>(Novilase System Under Review) | Model ILT<br>(Cleared under K070353) | Substantial Equivalence Comments |
| Dimensions | 21D x 18W x 61H (inches). Height is adjustable | 32D x 24W x 51H (inches) | The new device is slightly taller in its maximal<br>height. This does not have an impact on the use<br>environment.<br>Therefore, Substantially Equivalent |
| Weight | 180 lbs | 250 lbs | The new unit is lighter in weight by 70 lbs.<br>Increased mobility. This does not have an impact<br>on the use environment or intended user.<br>Therefore, Substantially Equivalent |
| Caster Diameter | 4 inches…