The neoV810 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV980 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

Device Description

The neo V Diode Laser Family are medical grade, solid-state, infrared diode lasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10 and LSV1064-20), and neoV1470, and are designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and 1470mm respectively, at power levels ranging from 8Watts up to 20Watts. The lasers are controlled via a high-resolution color touch screen. The touch screen display includes a user interface allowing selection of continuous, repeat pulse, or single pulse modes of operation as well as repetition rates, aiming beam settings, password key protection, and standby/ready mode selection. The units have an emergency shut off button on the front of the unit.

The Laser System: The laser system consists of an optical block which contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and electronics which include the color touch screen control panel. The unit utilizes an external low voltage power supply, as well as an external wired foot switch for laser activation.

The Delivery System: The delivery system consists of fiber optics and a hand piece. Safety goggles and a safety sign are also provided with the unit.

AI/ML Overview

The provided text is a 510(k) Summary for the neoV Diode Laser Family. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on technical specifications and comparisons, not on a clinical study demonstrating the device's performance against specific acceptance criteria for an AI algorithm.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, are not applicable and not present in this document.

The "acceptance criteria" discussed in this document relate to compliance with regulatory standards and demonstrating substantial equivalence to predicate devices, rather than performance metrics of an AI model against a specific medical task.

Here's a breakdown of what can be extracted from the provided text based on your request, with the understanding that it pertains to the device as a laser surgical instrument, not an AI system:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of numerical thresholds for an AI's performance (e.g., sensitivity, specificity). Instead, it demonstrates compliance with international standards and substantial equivalence to predicate devices as its basis for acceptance. The "reported device performance" is essentially that it meets these standards and is comparable to existing devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Compliance with IEC 60601-2-22: 2007 (Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment)	The neoV Diode Laser family has been tested for compliance to IEC 60601-2-22: 2007 (Third Edition).
Compliance with IEC 60601-1: 2005 (Third Edition) (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)	The neoV Diode Laser family has been tested for compliance with all functional requirements of IEC 60601-1: 2005 (Third Edition).
Compliance with IEC 60825-1:2007 (Safety of Laser Products - Part 1: Equipment classification, requirements and user's guide)	The neoV Diode Laser family has been tested for compliance with all functional requirements of IEC 60825-1:2007.
Compliance with EN 60601-1-2: 2007 (Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests)	The neoV Diode Laser family has been tested for compliance with EN 60601-1-2: 2007.
Substantial Equivalence to Predicate Devices (Quanta Diode Laser Family K100558 and Sheaumann Laser PL-1064 K120938) regarding technical and performance characteristics and intended use.	The neoV Diode Laser Family shares the same technical and performance characteristics and the same intended use as the predicate devices. This is supported by the comparison table of specifications (wavelength, max power, laser media, output mode, etc.).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes a medical device (a laser), not an AI algorithm evaluated on a data set. The "testing" refers to compliance with safety and performance standards for the hardware, not an evaluation of an AI model's performance on a dataset of patient information. No patient data or test sets, in the context of AI, are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" in the AI sense established for this device, as it is not an AI system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set for an AI algorithm is present.

5. 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

Not Applicable. No MRMC study was done, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a standalone medical device (a laser), not a standalone AI algorithm. It operates independently of an AI, though it is used by a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No ground truth in the context of AI evaluation is used. The "ground truth" for this device's acceptance is its adherence to established electrical and laser safety standards, and its technical specifications matching those of already-cleared predicate devices.

8. The sample size for the training set

Not Applicable. This device does not involve a training set for an AI algorithm.

9. How the ground truth for the training set was established

Not Applicable. This device does not involve a training set for an AI algorithm.

Summary

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neoV FDA 510(k) Submission

Section 5 – 510(k) Summary

Ha'Eshel St. 7, 38900, Caesarea ISRAEL	Revision #2
----------------------------------------	-------------

SOP Number:	DHF-001-R-014-5	Effective Date:	15.3.14	Page 10
PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505		Section 5

な
『

510k SUMMARY

K133006

APR 1 7 2014

Title:	neoV Diode Laser Family
Submitter:	G.N.S neoLaser Ltd.Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203
Contact:	Gil Shapira, CEOG.N.S neoLaser Ltd.Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203Phone: +972 52 2246965Fax: +972 4 859 1505Email: shapirag@neo-laser.com
DatePrepared:	August 29, 2013
Device TradeName:	neoV Diode Laser Family
CommonName:	Laser surgical instrument for use in general surgery and dermatology
ClassificationName:	Instrument, surgical, powered laserGEX21 CFR 878.4810
PredicateDevices:	Quanta Diode Laser Family (K100558)Sheaumann Laser PL-1064 (K120938)
DeviceDescription:	The neo V Diode Laser Family are medical grade, solid-state, infrared diodelasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10and LSV1064-20), and neoV1470, and are designed to deliver continuous orpulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and1470mm respectively, at power levels ranging from 8Watts up to 20Watts. Thelasers are controlled via a high-resolution color touch screen. The touch screendisplay includes a user interface allowing selection of continuous, repeat pulse,or single pulse modes of operation as well as repetition rates, aiming beamsettings, password key protection, and standby/ready mode selection. The unitshave an emergency shut off button on the front of the unit.

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Image: neoLaser logo	neoV FDA 510(k) SubmissionSection 5 – 510(k) Summary	Revision #2
Ha'Eshel St. 7, 38900, Caesarea ISRAEL		SOP Number:DHF-001-R-014-5	EffectiveDate:15.3.14	Page 11
PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505				Section 5

The Delivery System: The delivery system consists of fiber optics and a hand piece. Safety goggles and a safety sign are also provided with the unit.

Intended Use:

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Image: neoLaser logo	neoV FDA 510(k) SubmissionSection 5 – 510(k) Summary			Revision #2
	Ha'Eshel St. 7, 38900, Caesarea ISRAEL	SOP Number:	EffectiveDate:	Page 12
	PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505	DHF-001-R-014-5	15.3.14	Section 5

Comparison: The neoV Diode Laser Family share the same technical and performance characteristics of the Quanta System OUANTA Diode Laser Family, and the Sheaumann PL-1064 systemn. Below is a table summarizing the comparison of the devices:

Specification	neoV Diode Laser Family	QUANTA Diode Laser Family	Sheaumann Laser PL-1064
Ref 510(k)	K133006	K100558	K120938
Wavelength [nm]	810, 980, 1064, 1470	808, 980, 1064, 1470	1064
Max Power [W]	8 - 810nm	30 - 808nm	10 - 1064nm
	20 - 980nm	30 - 980nm
	10 - 1064nm (LSV1064-10)	30 - 1064nm
	20 - 1064nm (LSV1064-20)	15 - 1470nm
	10 - 1470nm
Laser media	Diode	Diode	Diode
Output mode	CW, Pulsed, Single Pulse	CW, Pulsed, Single Pulse	CW, Pulsed, Single Pulse
Spot Size	0.7mm, 1mm, 1.5mm	0.6mm, 0.8mm, 1.2mm, 1.8mm, 2.4mm	0.7mm, 1.5mm, 3mm, 5mm, 7mm
Pulse Duration	100 $ \mu $ sec - 30 sec adjustable	3 msec - 2.5 sec adjustable	200 $ \mu $ sec - 30 sec adjustable
Aiming Beam	Green 532nm (<5mW)	Red 650nm (<5mW)	Red 635-650nm (<1mW)
Power Source	100 - 240 V, 47-63 Hz	100-240V, 50-60Hz	100-240V, 47-63Hz
User Interface	Color touch screen	Color touch screen	LCD touch screen
Laser Beam Delivery	Fiber	Fiber	Fiber
Dimensions [cm] and	22(L) X22(W) X10(H)	39(L) X33(W)X25(H)	22 X 25 X 12
Weight [Kg]	3.5Kg	8Kg	3Kg

Summary: From a design and clinical perspective, the predicates and candidate laser devices, have the same technological characteristics and share the same intended use. Accordingly, the safety and effectiveness of the neoV Diode Laser Family is based upon a determination of the substantial equivalence to the predicate devices.

Non clinical

Performance

Data:

The neo V Diode Laser family has been tested for compliance to IEC 60601-2-22: 2007 (Third Edition), Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment, IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1: General requirements for basic safety and essential performance and tested for compliance with all functional requirements, IEC 60825-1:2007 Safety of Laser Products - Part 1: Equipment classification, requirements and user's guide, EN 60601-1-2: 2007, Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.

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neoLaser	neoV FDA 510(k) SubmissionSection 5 – 510(k) Summary			Revision #2
Ha'Eshel St. 7, 38900, Caesarea ISRAEL		SOP Number:DHF-001-R-014-5	EffectiveDate:15.3.14	Page 13
PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505				Section 5

Clinical
Performance None Data:

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 17, 2014

G.N.S neoLaser Ltd. Mr. Gil Shapira Chief Executive Officer P. O. Box 3203 7 Ha'Eshel Street Caesarea, 38900 ISRAEL

Re: K133006

Trade/Device Name: neo Diode Laser Family 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: March 16, 2014 Received: March 25, 2014

Dear Mr. Shapira:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr mas intacted and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Gil Shapira

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on fast page.

510/k) Number (if known) K133006

Device Name

neoV Diode Laser Family

Indications for Use (Describe)

The neo V810 diode laser is indical for use in surgications requiring the vaporization, incision, ablation, cutting and hemosasis, or coagulation of soft tissue in conjunction with endescopic equipment for medical specialist including: Unlogy, Thoracic Surgery, Plastic Surgery and Dermatology, Central Surgery, Ophthalmology, Orthopedics, Podiatry, Arthrosopy, Spinal Surgery, Gyzecology, Pulmonary Surgery, Gastrocaterology, Headinedogy, Oral Surgery, Oral Surgery and Denal procedures.

The neoV980 diode laser is indications requiring the vaporization, incision, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Unlogy, Thoracic Surgery, Plastic Surgery and Dermatology, Central Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Gstroenterology, HeadineskENT and Radiology, Oral Sugery and Dental procedures.

The no V 1064 diode laser is in surgical applications requiring the vaporization, incision, ablation, coding and hemostasis, or coagulation of soft tissue in conjunction with endical specialist including: Unlogy, Thoracic Surgery, Plastic Surgery and Dermatology, Ophthalmology, Orthopedics, Podiaty, Arthrosopy, Spinal Surgery, Gyneology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Headined/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV1470 diode laser is indicated for use in surgical application, incision, incision, excision, abisting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Artirosopy, Spiral Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Headneck/BNT and Radiology, Oral Surgery and Dental, procedures.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.04.16 11:46:28 -04'00'

FORM FDA 3881 (1/14)

PSC Publishing Services (917) 443-6748

For BSA

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.