The Noveon™ (Model LS1100-01-0968) delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue.

Device Description

The Noveon™ (Model LS1100-01-0968) is a Class IV Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology. The device consists of the following components and accessories:

Laser Source and Control Unit: Two Class IV laser diodes, each providing continuous-wave laser light, one at the 870 mm and one at 930 nm wavelength. The power output of each laser is selectable from 1W to 8W in 0.1 W increments. There are two touch sensitive screens to control the optical power output of each laser and a separate emergency on/off button.
Foot Pedal Switch: turns the lasers on/off when the lasers are enabled.
Flexible Optical Fiber and End Piece: designed to be lightweight for holding the distal end of the fiber comfortably in the hand to perform procedures.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Nomir Noveon™ (Model LS1100-01-0968)

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel clinical effectiveness or setting specific numerical performance targets for sensitivity, specificity, or similar metrics. The acceptance criteria are therefore largely based on compliance with regulatory standards and comparable performance to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Regulatory Compliance (Performance Standards)	21 CFR 1040.10 and 21 CFR 1040.11: Applicable performance standards for light-emitting products.	The Noveon™ (Model LS1100-01-0968) complies with applicable performance standards as outlined in 21 CFR 1040.10 and 21 CFR 1040.11.
Regulatory Compliance (Electrical/Electromagnetic)	47 CFR Part 15, Subpart B Unintentional Radiator Class A: Conformance for electromagnetic compatibility. IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2: Applicable voluntary electrical equipment standards.	The device has been tested and verified by Intertek ETI Semko as conforming to 47 CFR Part 15, Subpart B Unintentional Radiator Class A. "Prior to introduction into the US market, the device will be tested and verified to conform to the applicable voluntary electrical equipment standards..." (This indicates a commitment, not necessarily completed at the time of submission for the latter set).
Biocompatibility	ISO 10993-5 (Cytoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Irritation): Standards for biocompatibility.	The device conforms to the standards for biocompatibility as given by Cytoxicity: ISO 10993-5, Sensitization: ISO 10993-10, and Irritation: ISO 10993-10.
Functional Performance (Surgical Procedures)	Capability to perform incision, contact coagulation, non-contact coagulation, debridement, curettage, and excision satisfactorily. No adverse events.	A surgical study with a live Yorkshire pig demonstrated the device satisfactorily performed these procedures when used by a medical professional. No adverse events were noted. The study involved 130 passes (127 in contact mode) across various procedures.
Substantial Equivalence (Tissue Effect)	Tissue effect (zone of ablation, coagulation, total destruction) comparable to a 940 nm predicate device, with any differences not of clinical significance.	Testing on porcine skin, muscle, and liver with various wavelengths (940 nm, 930 nm, 870 nm, and combinations) showed that "the difference in tissue effect was comparable to the 940 nm predicate device and any differences were not of clinical significance."
Safety and Effectiveness	Device is safe and effective for indicated medical procedures, consistent with predicate devices that have demonstrated clinical effectiveness.	The device "is designed in accordance with both mandatory and voluntary Standards ensuring it is both safe and effective for the medical procedures indicated above." "No new clinical indications are to be provided by the introduction of the device as compared to the predicate devices, identified above, which have previously demonstrated clinical effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Animal Study: A single "live Yorkshire pig" was used for the surgical capability test. This is an animal model.
Tissue Sample Study: Porcine skin, muscle, and liver tissue samples were used for the in-vitro tissue effect comparison. The exact number of individual samples is not specified, but it states "individual samples" and "testing was performed in triplicate." This is also an animal model / ex-vivo study.
Provenance: All data appears to be from prospective studies specifically conducted for this submission, utilizing animal models (Yorkshire pig, porcine tissue). There is no mention of human data, retrospective data, or country of origin beyond "porcine."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The text does not explicitly state the "number of experts" or their specific "qualifications" involved in establishing ground truth in the manner typically seen for diagnostic devices (e.g., radiologists interpreting images).

Surgical Study: The "medical professional" who performed the procedures on the Yorkshire pig implicitly established the ground truth for "satisfactorily performed." No specific qualifications for this individual are provided.
Tissue Sample Study: The process of recording "the width and depth of the zone of ablation, the zone of coagulation (necrosis) and the zone of total destruction" would have been performed by technical staff or researchers, likely under the supervision of experts, but no details are given. The interpretation that differences were "not of clinical significance" would have been made by medical or scientific experts involved in the study. No specific number or qualifications are given for these experts.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth regarding the device's performance in either the animal surgical study or the tissue sample study.

For the surgical study, the assessment of "satisfactorily performed" and "no adverse events" appears to be based on the observations of the performing medical professional and other study personnel.
For the tissue sample study, the measurements of ablation/coagulation zones were recorded, and the conclusion about clinical significance appears to be an overall assessment based on those measurements and comparison to the predicate, rather than a formal adjudication process between multiple independent readers.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The Noveon™ is a surgical laser, and its evaluation focuses on its direct functional performance, safety, and equivalence to existing surgical lasers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Noveon™ is a physical surgical laser device, not an algorithm or AI system that operates in a standalone capacity. Its performance is its "standalone" performance, but always with a human operator. The performance testing described (surgical study, tissue sample study) inherently reflects the device's capabilities when operated by a user.

7. Type of Ground Truth Used

Animal Surgical Study: The ground truth for satisfactory performance and absence of adverse events was based on direct observation and clinical assessment by a medical professional during the live animal procedure.
Tissue Sample Study: The ground truth for tissue effects (ablation, coagulation, destruction zones) was based on direct physical measurement and histological assessment of the treated porcine tissue samples. The comparison to the predicate device for clinical significance also falls under expert interpretation of these measurements.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (laser), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and engineering of the laser are based on established physics and prior medical device development knowledge, not on a data training set.

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

Not applicable. As explained in point 8, there is no "training set" for this device.

Summary

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Nomir Noveon™ (Model LS1100-01-0968)- 510(k) Summary

K071815

510(k) Summary

Noveon™ (Model LS1100-01-0968) Dual Wavelength Laser Instrument

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November 19, 2007

Submittal information:

Post-approval contact: Richard Burtt Chief Executive Officer Nomir Medical Technologies 275 Grove Street, Suite 2-400 Newton, MA 02466 Phone: 617-901-6637 Fax: 617-663-4801

NOV 2 8 2007

Device name and classification

510(k) Number: K071815 Proprietary Name: Noveon™ (Model LS1100-01-0968) Common Name: Medical Diode Laser Classification Name: Class IV Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Classification Panel: General and Plastic Surgery Devices CFR Section: 21 CFR 870.4810 Class: II Product Code: GEX

Predicate Devices

Ceralas D 810 Diode Laser System, K032864, by Biolitec, Inc .
LaserPro 810, 940, and 980 Dioxide Laser Systems, K040294, by Photomedex, Inc .
. Vectra Laser System, K060114, by Xintec Corporation
. BWF-5 Medical Laser Series, K062363, by B&W Tek Inc
PhoTex15 Diode Laser Series: 980, 810, 940, K060304, by BioTex Inc .
Q YAG 5 Nd: YAG Laser System, K061436, by Palomar Medical Technologies, Inc .
. Medlite C3 Q Switched Nd: YAG Laser, K011677, by Continuum Electro-Optics, Inc (now Hoya ConBio, Inc)

Device Description

The Noveon™ (Model LS1100-01-0968) is a Class IV Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology. The device consists of the following components and accessories:

1. Laser Source and Control Unit: Two Class IV laser diodes, each providing continuous-wave laser light, one at the 870 mm and one at 930 nm wavelength. The power output of each laser is selectable from 1W to 8W in 0.1 W increments. There are two touch sensitive screens to control the optical power output of each laser and a separate emergency on/off button.
1. Foot Pedal Switch: turns the lasers on/off when the lasers are enabled.

Confidential and Proprietary to Nomir Medical Technologies

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1. Flexible Optical Fiber and End Piece: designed to be lightweight for holding the distal end of the fiber comfortably in the hand to perform procedures.

Intended Use

Performance Data

Performance Standards

The Noveon™ (Model LS1100-01-0968) complies with applicable performance standards . for light emitting products as outlined in 21 CFR 1040.10 and 21 CFR 1040.11.
. The device has been tested and verified by Intertek ETI Semko as conforming to 47 CFR Part 15, Subpart B Unintentional Radiator Class A. Prior to introduction into the US market, the device will be tested and verified to conform to the applicable voluntary electrical equipment standards; IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2.
The device also conforms to the standards for biocompatibility as given by Cytoxicity: ISO ● 10993-5, Sensitization: ISO 10993-10, and Irritation: ISO 10993-10.

Performance Testing

A surgical study with a live Yorkshire pig was conducted to test the capability of the Noveon™ (Model LS1100-01-0968) to perform incision, contact coagulation, non-contact coagulation, debridement, curettage and excision. Results from this study demonstrate the device satisfactorily performed these procedures when used by a medical professional. Importantly, there were no adverse events that were noted during the performance of any of these demonstrations. Altogether there were 130 passes of the laser made during this demonstration, of which 127 were made in the contact mode: incision (5), contact coagulation (4), debridement (19), curettage (31), and excision (68).

Using tissue samples of porcine skin, muscle, and liver we tested individual samples with exposures to 940 nm, 930 nm, and 870 nm. In addition, we tested samples with 870 nm and 930 nm in three different optical power combinations. The testing included both contact and noncontact (free beam) mode. The testing was performed in triplicate. For each test the width and depth of the zone of ablation, the zone of coagulation (necrosis) and the zone of total destruction were recorded. These data substantiate that the difference in tissue effect was comparable to the 940 nm predicate device and any differences were not of clinical significance.

Substantial Equivalence

The Noveon™ (Model LS1100-01-0968) share the same indications for use, similar laser and electronics design features, safety and functional features, and therefore are substantially equivalent to the predicate devices listed above.

Safety and Effectiveness

The Noveon™ (Model LS1100-01-0968) is designed in accordance with both mandatory and voluntary Standards ensuring it is both safe and effective for the medical procedures indicated above. No new clinical indications are to be provided by the introduction of the device as compared to the predicate devices, identified above, which have previously demonstrated clinical effectiveness.

Confidential and Proprietary to Nomir Medical Technologies

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2007

Nomir Medical Technologies, Inc % Richard Burtt Chief Executive Officer 275 Grove Street, Suite 2-400 Newton, Massachusetts 02466

Re: K071815

Trade/Device Name: Noveon™ Model LS1100-01-0968 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: November 19, 2007 Received: November 20, 2007

Dear Mr.Burtt:

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 such 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); 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.

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Page 2 -- Mr. Richard Burtt

This letter will allow you to begin marketing your device as described in your Section 510(k) r ms leter witification. The FDA finding of substantial equivalence of your device to a legally premaince noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to ( premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Mark N Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement L1

510(k) Number (if known): K071815

Device Name: Noveon™ (Model LS1100-01-0968)

Indications For Use:

Rih
(Division Sig-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number: 2601818

Prescription Use X AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.