(15 days)
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.
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
The provided text is a 510(k) Special Summary for the Novilase Laser Therapy System, Model LTS-2. It primarily focuses on demonstrating substantial equivalence to a predicate device (Kelsey Interstitial Laser Therapy System, Model ILT) rather than presenting a performance study with a test set, ground truth establishment, and detailed acceptance criteria for a new and complex AI/software device.
The document states:
- "In addition, no new issues pertaining to biocompatibility have been raised and therefore no clinical data was acquired." This is a crucial point that indicates the absence of a comprehensive clinical performance study as would be expected for an AI/software device.
- The reason for the Special 510(k) is "Repackaging of the hardware to decrease size and weight and improve aesthetics, user interface modifications including the introduction of a touch-screen monitor." These are primarily physical and user interface changes, not changes to the fundamental operating principle or diagnostic/treatment algorithm.
- The comparison tables (Table 2-3.1) focus on features, specifications, and components, demonstrating that the new device operates in an identical fashion to the predicate device, with minor updates (e.g., operating system, touch screen).
Therefore, based on the provided text, it's not possible to generate the requested information about acceptance criteria, a test set, ground truth, or an MRMC study that would be typical for an AI-powered medical device. The "study" proving the device meets acceptance criteria appears to be a comparison to a predicate device showing substantial equivalence in functionality and safety specifications, rather than a clinical trial or performance evaluation against a defined ground truth for a new algorithm.
Here's an attempt to answer the questions based only on the provided text, acknowledging its limitations for an AI/software context:
Acceptance Criteria and Device Performance (Based only on the provided document's equivalence claim):
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Novilase LTS-2 compared to predicate ILT) |
|---|---|
| Functional Equivalence: Device performs the same intended use. | "Both devices have the same intended use." "Both devices operate in an identical fashion." |
| Indication Equivalence: Device is indicated for the same uses. | "Both devices have the same indications for use statement." |
| User & Environment Equivalence: Same intended user and use environment. | "Both devices have the same intended user profile." "Both devices have the same intended use environments." |
| Patient Population Equivalence: Targets the same patient population. | "Identical patient populations." |
| Performance Specification Equivalence: Core performance parameters (e.g., laser type, wavelength, power, treatment mode) are identical. | "GaAIAs Laser Diode, 805 nm ± 15 nm, 1-8 watts, Continuous operation, Multimode optical output, Internal/automatic ± 20% calibration, 600 µm core diameter." (All identical to predicate). |
| Safety and Effectiveness Equivalence: Changes do not raise new questions of safety or effectiveness. | "The modifications do not raise new questions of safety or effectiveness and the device continues to meet its specifications." "No new issues pertaining to biocompatibility have been raised and therefore no clinical data was acquired." "Same or better safety standards are met." |
| Component Equivalence/Acceptability: Updated components (e.g., OS, display) are suitable and validated to meet specifications. | "PC Environment updated per new standard operating systems; As emulated, identical to predicate." "V&V testing... demonstrates that when used with the specified computer, the device continues to meet its performance specifications." "Increased input functionality by adding touch screen functionality." |
| Physical/Ergonomic Equivalence/Acceptability: Physical changes (size, weight, mobility) do not negatively impact use or safety. | "The new device is slightly taller in its maximal height. This does not have an impact on the use environment." "The new unit is lighter in weight by 70 lbs. Increased mobility. This does not have an impact on the use environment or intended user." "The larger diameter wheels add to the mobility and stability." |
| Environmental Operational Equivalence/Acceptability: Operating and storage environmental specs are met or improved without safety concerns. | "The specifications for the operating environment have been tightened for increased control and environmental consistency... This does not raise new questions of safety or effectiveness." "The storage environment specifications... do not have an impact on device performance and do not raise new questions of safety or effectiveness." |
Study Details (based only on the provided document):
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this 510(k) Special Summary. No distinct "test set" for performance evaluation of a new algorithm is mentioned. The submission relies on substantial equivalence to a legally marketed predicate device.
- Data Provenance: Not applicable as no clinical data or performance data from a specific test set is presented. The document states "no clinical data was acquired."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment is described as there was no test set for clinical performance evaluation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
-
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, and this device is not described as involving AI assistance for human readers. It is a laser therapy system.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser therapy system, not an algorithm, and its performance relies on the device's physical and functional specifications.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established for a performance study. The "truth" in this submission relies on the established safety and effectiveness of the predicate device and the demonstration that the new device is fundamentally the same despite minor modifications.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for Novian Health. The logo features a stylized figure in light blue, followed by the word "NOVIAN" in dark blue, and the word "HEALTH" in light blue below it. The figure appears to be a person in motion, with a circular head and flowing lines representing the body.
VOLUME 2
SECTION 3
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
-
- 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
-
- 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
-
- Manufacturing Site: Biomedical Devices of Kansas (Hardware & Software) 1205 US 24/40 Highway, Suite100 Tonganoxie. Kansas 66086 913.845.3851 Establishment Registration Number: 3007124677
-
- Sterilization Site: Sterigenics 1003 Lakeside Drive Lakeside, Illinois 60031 847-263-3344 Establishment Registration Number: 1450293
-
- Classification Regulation, Class & Product Code & Panel: 21 CFR 878.4810 Laser instrument, surgical, powered Class II Product Code: GEX Panel: General & Plastic Surgery
-
- 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.
-
- 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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VOLUME 2
SECTION 3
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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VOLUME 2
SECTION 3
| PRODUCT REQUIREMENTS DOCUMENT - Novilase Model LTS-2 | |
|---|---|
| Contraindications | None |
| 13. Predicate Device(s): | 510(k) Number: K070353Manufacture: Kelsey, Inc. (Named changed to Novian Health, Inc. in 2007)Trade Name: The Kelsey Interstitial Laser Therapy System (Name changed to theNovilase® Interstitial Laser Therapy System in 2007) |
| Product Code: GEXClassification: 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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VOLUME 2
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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 SystemModel LTS-2(Novilase System Under Review) | Kelsey Interstitial Laser Therapy SystemModel ILT(Cleared under K070353) | ||
|---|---|---|---|
| Feature | Substantial Equivalence Comments | ||
| COMPARISON OF USES/INDICATIONS | |||
| Intended Use | The Novilase® Laser Therapy System (LTS-2) is intended foruse as a surgical instrument in the excision of external tumorsand lesions, complete and partial resection of internal organs,treatment of tumors and lesions, skin incision and tissuedissection and ablation. | The Kelsey Interstitial Laser Therapy it is intended for useas a surgical instrument in the excision of external tumorsand lesions, complete and partial resection of internalorgans, treatment of tumors and lesions, skin incision andtissue dissection and ablation. | Both devices have the same intended use. Onlythe device name is updated.Therefore, Substantially Equivalent |
| Indication for Use Statement | The Novilase® Laser Therapy System (LTS-2) is indicated forthe treatment of fibroadenomas of the breast, with tumor sizesup to 20 mm, and for general surgery procedures includingincision, excision and ablation of soft tissues; and coagulative | The Kelsey Interstitial Laser Therapy System is indicated forthe treatment of fibroadenomas of the breast, with tumorsizes up to 20 mm, and for general surgery proceduresincluding incision, excision and ablation of soft tissues; and | Both devices have the same indications for usestatement. Only the device name is updated.Therefore, Substantially EquivalentNote: the ongoing clinical study (NCT01478438, |
| necrosis and interstitial laser coagulation of soft tissues. | coagulative necrosis and interstitial laser coagulation of softtissues. | A Multicenter "Ablate and Resect" Study ofNovilase® Interstitial Laser Therapy for theAblation of Small Breast Cancers) is seeking toestablish the use of the device on malignanttumors. This potential new indication for use isoutside the scope of this submission. Thesubject device is indicated for the same uses asthe predicate device. | |
| Intended User | The Novilase® Laser Therapy System (LTS-2) user profile is aphysician with experience in image-guided biopsy procedures. | The Kelsey Interstitial Laser Therapy user profile is aphysician with experience in image-guided biopsyprocedures. | Both devices have the same intended user profile.Therefore, Substantially Equivalent |
| Intended Use Environment | Medical treatment facilities such as hospitals, surgical centers,breast centers and physician offices with an ultrasound or x-rayimaging system, physical space to accommodate the NovilaseLTS-2 unit and a "Laser in Use" sign on the procedure roomdoor that meets laser safety requirements. | Medical treatment facilities such as hospitals, surgicalcenters, breast centers and physician offices with anultrasound or x-ray imaging system, physical space toaccommodate the device and a "Laser in Use" sign on theprocedure room door that meets laser safety requirements. | Both devices have the same intended useenvironments.Therefore, Substantially Equivalent |
| Target Patient Population | Females ages 15 and older with single or multiple fibroadenomathat do not exceed 2.0 cm in diameter and measure at least 0.5cm away from the skin. | Females ages 15 and older with single or multiplefibroadenoma that do not exceed 2.0 cm in diameter andmeasure at least 0.5 cm away from the skin. | Identical patient populations.Therefore, Substantially Equivalent |
| Contraindications | None. | The predicate submission did not contain anycontraindications | Neither the predicate nor the proposed devicehave any contraindications.Therefore, Substantially Equivalent |
| COMPARISON OF SYSTEM CONFIGURATIONS | |||
| System-Level Components | LTS System consisting of:• Thermistor controller and associated hardware.• Laser diode source, 1-8 watts, 805 nominal nanometerwavelength.• Personal computer running Windows 7, or better, includingmonitor, keyboard, touch-screen display) and mouse.• Power distribution unit with user accessible master power | ILT System consisting of:• Thermistor controller and associated hardware.• Laser diode source, 1-8 watts, 805 nominal nanometerwavelength.• Personal computer running Windows XP with ServicePack 2 or better, including monitor, keyboard and mouse.• Power distribution unit with user accessible master power | The differences between the subject device andthe predicate device are discussed in further detailin Table 3-2.2 below. Some components wereupdated to reflect differences in the operatingsystem (Windows 7), ergonomics (touch screen),and dimensions (cart). The predicate device has auninterruptible power supply (UPS) while the |
| Novilase® Laser Therapy SystemVOL 002/003_Special 510(k) Summary_S1.docx | |||
| Feature | Novilase® Laser Therapy SystemModel LTS-2(Novilase System Under Review) | Kelsey Interstitial Laser Therapy SystemModel ILT(Cleared under K070353) | Substantial Equivalence Comments |
| switch.• Isolation transformer.• Thermal temperature to digital converter.• Lightweight storage cart. | switch.• Uninterruptible power supply (UPS).• Isolation transformer.• Thermal temperature to digital converter.• 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.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.Therefore, Substantially Equivalent |
| Reusable Accessories (included with unit; may be available for sale separately) | • Connector box• Umbilical cable, (contains the wires and optical fiber running between the connector box and the LTS cart).• Laser glasses• USB thumb drive (for data storage)• One color-coded adaptor for the laser probe• One color-coded adapter for the thermal probe | • Connector box• Umbilical cable, (contains the wires and optical fiber running between the connector box and the ILT cart).• Laser glasses (These are included with shipments, but were not described in the original submission.• 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.Therefore, Substantially Equivalent |
| Disposable Accessories | A Gamma-sterilized Laser Probe Kit, consisting of:• One disposable laser probe, hollow 14 gauge 304 stainless steel with one attached thermistor.• One disposable thermal probe, solid 14 gauge 304 stainless steel with five embedded thermistors• One probe holder• One hemostasis valve | A Gamma-sterilized Laser Probe Kit, consisting of:• One disposable laser probe, hollow 14 gauge 304 stainless steel with one attached thermistor.• One disposable thermal probe, solid 14 gauge 304 stainless steel with five embedded thermistors• One probe holder• One hemostasis valve | The operating principles, materials and sterilization processes used for the proposed kit are identical to the predicate.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.Therefore, Substantially Equivalent |
| COMPARISON OF OUTPUT ENERGY (Principle of Operation) & PERFORMANCE SPECIFICATIONS | |||
| Device Type | GaAIAs Laser Diode | GaAIAs Laser Diode | Identical specifications.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 SystemModel LTS-2 Special 510(k) Submission | Confidential | VOL_002/003_Special 510(k) Summary_S1.docPage 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/InterfaceMaterials | 14 gauge, 0.010" thick wall, 304 stainless steel pointed, closed-end trocar laser and thermal probes with Loctite 3321 adhesiveand Cobalt Polymers U2-110-CLR shrink tubing and quartzfiber | 14 gauge, 0.010" thick wall, 304 stainless steel pointed,closed-end trocar laser and thermal probes with Loctite 3321adhesive and Cobalt Polymers U2-110-CLR shrink tubingand quartz fiber | There have been no changes to the patientcontacting materials or method of manufacturesince previous clearance.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. Testingshows no effect on performance, safety orefficacy For additional information, please referto Table 3-2.2 below.Therefore, Substantially Equivalent |
| Fiber optic length (patientcontact) | 1.0 m | 1.0 m | Identical fiber optic length making patientcontact.Therefore, Substantially Equivalent |
| COMPARISON OF COMPUTER INTERFACE & ERGONOMICS/HUMAN FACTORS | |||
| Computer Specifications | The unit has the following minimum required input/outputports: 1x USB 2.0: 1x Serial; Integrated audio andspeakers; video displayInput power of 100V-240V AC4GB of memoryIntegrated graphics card.10 GB HDD or greaterIntel compatible CPU rated for use compatibility withWindows XP or better | Not specified | Both proposed and predicate device require theuse of a computer. The specifications for theproposed device are provided. The specificationsfor the predicate device's computer were notincluded in the previous submission. The V&Vtesting described in VOL_4/SEC_1demonstratesthat when used with the specified computer, thedevice continues to meet its performancespecifications.Therefore, Substantially Equivalent |
| Operating System | Windows 7 | Windows XP with service pack 2 or better | PC Environment updated per new standardoperating systems; As emulated, identical topredicate.Therefore, Substantially Equivalent |
| User Input Mechanism | Touch Screen and/or mouse & keyboard | Keyboard | Increased input functionality by adding touchscreen functionality.Therefore, Substantially Equivalent |
| Display | 15" display size monitor | 15" display size monitor | Identical specification.Therefore, Substantially Equivalent |
| External Media Storage | USB | USB | Identical specification.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 sameset of alarms and warnings. No new alarms oralerts have been added.Therefore, Substantially Equivalent |
| Novilase® Laser Therapy System | Kelsey Interstitial Laser Therapy System | ||
| Feature | Model LTS-2(Novilase System Under Review) | Model ILT(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 maximalheight. This does not have an impact on the useenvironment.Therefore, Substantially Equivalent |
| Weight | 180 lbs | 250 lbs | The new unit is lighter in weight by 70 lbs.Increased mobility. This does not have an impacton the use environment or intended user.Therefore, Substantially Equivalent |
| Caster Diameter | 4 inches | 3 inches | The larger diameter wheels add to the mobilityand stability of the device. This does not have animpact on the use environment or intended user.Therefore, Substantially Equivalent |
| COMPARISON OF ENVIRONMENT SPECIFICATIONS | |||
| Operating Environment | Operating temperature range: 15°C to 30°COperating humidity: 10-90% non-condensing humidityOperating pressure: Sea-level to 2,000m | 10° - 40° C, 0 - 80% RH, decreasing linearly to 50% RH at40° C, sea level to 2,000 meters(no protection against ingress of moisture)Drip-proof | The specifications for the operating environmenthave been tightened for increased control andenvironmental consistency. The V&V testingdescribed in VOL_4/SEC_1 demonstrates that thedevice meets its performance specifications whenused in these operating environmentspecifications. This does not raise new questionsof safety or effectiveness.Therefore, Substantially Equivalent |
| Storage Environment | Transportation and storage temperature range: -10°C to 40°CTransportation and storage humidity range: Non-condensinghumidityTransportation and storage pressure: Sea-level to 2,000m | Not specified | The storage environment specifications were notdescribed in the predicate submission. However,they do not have an impact on deviceperformance and do not raise new questions ofsafety or effectiveness.Therefore, Substantially Equivalent |
Novilase® Laser Therapy System Model LTS-2 Special 510(k) Submission
VOL_002/003_Special 510(k) Summary_S1.docx Confidential Page 002/003-6
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SECTION 3
Table 2-3.1 Substantial Equivalence Comparison Table
§ 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.