Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Description

The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse:

. A Laser Console with a Free Beam Port to which an articulated arm attached.
- Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
. An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
. A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
. A variety of Free Beam Delivery Device and accessories.

The AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597.

The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing handpiece is comprised of the following components:

Handpiece Adapter
Tip (Standard or Fine)
. Limiter ring (Standard or Fine)

This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories:

Observation: The provided text is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific, novel acceptance criteria through a primary clinical study. It details changes from a previous version and outlines various verification and validation activities conducted. Therefore, it does not contain information about a traditional "study that proves the device meets acceptance criteria" in the sense of a standalone clinical trial with pre-defined performance endpoints. Instead, it indicates that the device was evaluated against existing standards and specifications to ensure it performs comparably to the predicate.

Given this context, I will extract relevant information to address your points, acknowledging that some fields might not be directly applicable as they pertain to clinical performance studies, which are not detailed here.

Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily established by the successful demonstration of substantial equivalence to the predicate device and compliance with relevant industry standards for safety and performance. There isn't a table of specific clinical performance criteria (e.g., sensitivity, specificity for a diagnostic device) and reported device performance from a clinical trial in this document.

The document implicitly states that the device performs in accordance with its requirements and specifications similarly to its predicate device. The "reported device performance" is effectively its compliance with the listed standards and its functional equivalence to the cleared predicate.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Compliance with Risk Analysis (ISO 14971)	Risk analysis performed and design verification processes conducted to address any new safety/effectiveness questions from modifications.
Electrical, laser safety, and electromagnetic compatibility (EMC) testing based on:- IEC 60601-1- IEC 60601-1-2- IEC 60825-1- IEC 60601-2-22	Testing performed and results indicated that the new configuration performs in accordance with its requirements and specifications similarly to its predicate device. This implies successful completion and compliance with these standards.
90° Side-firing Handpiece performance (functional)	Testing demonstrated that the accessory (90° Side-firing Handpiece) together with the AcuPulse W system performs in compliance with their specifications and requirements. This includes functional equivalence to existing cleared CO2 delivery devices based on the same technology and principles.
90° Side-firing Handpiece Cleaning Validation (AAMI TIR 30)	Validation activities performed.
90° Side-firing Handpiece Sterilization Validation (ISO 17665-1)	Validation activities performed.
90° Side-firing Handpiece Biocompatibility (ISO 10993)	Biocompatibility testing performed for materials.
Software Validation	The AcuPulse and AcuPulse W systems use the same proprietary software version, which was already validated, verified, and submitted under K180597. The differences are enabled or disabled features via a hardware key. This implies the software continues to meet its previously established performance criteria as the core software remains unchanged.
Substantial Equivalence to Predicate Device (K180597)	The device is deemed substantially equivalent. Test results indicated that the new configuration performs in accordance with its requirements and specifications, similarly to its predicate device, and does not raise new questions of safety and/or effectiveness.

Study Details (as inferable from the 510(k) Summary):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of a clinical test set. The document describes engineering verification and validation activities (testing against standards, functional testing of accessories). For these engineering tests, sample sizes are not explicitly stated, but typically involve representative samples of the device and its components.
- Data Provenance: Not applicable for a clinical test set. The studies are engineering and regulatory compliance tests.
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. This device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for the engineering tests is compliance with established safety and performance standards and the functional specifications of the device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of clinical outcomes or diagnostic interpretations.
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. This device is a laser surgical instrument, not an AI-based diagnostic or assistive system for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm but a physical medical device. Software validation was done, but it pertains to the device's operational control, not a standalone diagnostic algorithm. The software is embedded and controls the laser device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the evaluation documented here is primarily compliance with recognized electrical, laser safety, and biocompatibility standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993, ISO 17665-1, AAMI TIR 30), and the functional specifications set for the device and its accessories, evaluated through engineering tests, rather than clinical outcomes or expert consensus on patient data.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that involves a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.

Summary

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July 16, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Lumenis Ltd. Shlomit Segman Senior Manager RA 6 Hakidma Street PO Box 240 Yokneam, 2069204 Israel

Re: K201663

Trade/Device Name: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories 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: June 15, 2020 Received: June 19, 2020

Dear Shlomit Segman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K201663

Device Name

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories

Indications for Use (Describe)

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)

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K201663

510(k) SUMMARY

The Lumenis AcuPulse W Laser System, Delivery Devices and Accessories

Applicant Name:	Lumenis Ltd.6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599000Fax: +972-4-9599046
Contact Person:	Shlomit Segman Lumenis Ltd.6 Hakidma Street PO Box 240,Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599230Fax: +972-4-9599198Email:Shlomit.Segman@lumenis.com
Date Prepared:	15 June 2020
Trade Name:	The Lumenis AcuPulse W Laser System, Delivery Devices andAccessories
Classification Name:	Powered laser surgical instrument
Product Code:	GEX
Device Class:	Class II
Regulation Number:	21 CFR 878.4810
Panel:	General & Plastic Surgery
Predicate Devices:	AcuPulse Family of CO2Lasers system (K180597)

Intended Use/ Indications for Use:

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

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Device Description:

. A Laser Console with a Free Beam Port to which an articulated arm attached.
- Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
. An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
. A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
. A variety of Free Beam Delivery Device and accessories.

Handpiece Adapter
Tip (Standard or Fine)
. Limiter ring (Standard or Fine)

This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.

Substantial Equivalence

The intended use of the AcuPulse W System is a shortened version of the cleared AcuPulse, with the changes to reflect the reduced options proposed for the AcuPulse W System and to follow the format that we have noted for the reference, competing device DEKA SmartXide2 (K133895) and other cleared CO2 laser systems (see also K101555, K063001, K160312 and K172096).

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In addition, the same technological characteristics and principles of operation apply for all laser systems, Delivery Devices and accessories.

Design verification processes were performed as a result of this risk analysis assessment to verify that no different questions of safety and effectiveness have been raised due to the modifications introduced. The test methods are essentially the same as those used to support to the clearance of the AcuPulse CO2 Laser System, Delivery Devices and Accessories (K082809, K100415, K180597).

The following activities were performed:

. Risk analysis (ISO 14971)
Electrical and laser safety and electromagnetic compatibility testing as required to conform . to performance standards as follows:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for o basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for o basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests
- IEC 60825-1: Safety of laser Products-Part 1: Equipment classification and o requirements
- IEC 60601-2-22: Medical electrical equipment- part 2: particular requirements for o the safety of diagnostic and therapeutic laser equipment.
. 90° Side-firing Handpiece testing demonstrating demonstrate that the accessory together with the AcuPulse W system performs in compliance with their specifications and requirements
90° Side-firing Handpiece Cleaning (AAMI TIR 30) and sterilization validation activities (ISO ● 17665-1)
90° Side-firing Handpiece Biocompatibility of materials (ISO 10993) .

Test results indicated that the new configuration AcuPulse W CO2 Laser System, Delivery Devices and accessories perform in accordance with its requirements and specifications similarly to its predicate device. Consequently, Lumenis Ltd. believes that AcuPulse W CO2 Laser System, Delivery Devices and Accessories is substantially equivalent to the cleared predicate and it does not raise any different questions of safety and/or effectiveness.

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.