The Aurolase Therapy, Laser Delivery Device is a fiber-optical laser delivery device to be used with a compatible 810nm laser device for laser-based applications and procedures that are cleared for the compatible laser.

Device Description

Laser light generated by the Laser Module is delivery Device (LDD) Assembly, that is comprised of three components: the Laser Catheter Assembly (LCA), the Optical Fiber Diffuser (OFD), and the Coolant Supply Set (CSS). The LCA and OFD transmit laser energy to the tissue situated at their distal regions, to achieve the desired effect of the intended use. The use of coolant provides cooling for the surfaces of the CSS in contact with both the tissue and the LCA.

AI/ML Overview

The provided text is a 510(k) summary for the Aurolase Therapy, Laser Delivery Device (LDD). It discusses the device's classification, intended use, technological characteristics, and a comparison to a predicate device. However, this document does not contain information about acceptance criteria, detailed study designs, performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies, which are typically found in a clinical study report or a more detailed section of a 510(k) submission regarding performance data.

The document states: "The results of testing, including rigorous physical and environmental use studies, sterility, and biocompatibility tests, support a conclusion that the Aurolase Therapy LDD satisfies the requirements of performance to achieve its intended effect within its indication for use, and have not produced any additional risks of hazard leading to harm of the user and/or the patient within its intended use." This broadly refers to non-clinical performance data, but does not provide specific metrics or acceptance criteria for device performance in a clinical context (e.g., related to an AI/ML algorithm's diagnostic or predictive capabilities).

Therefore, I cannot fully answer your request based on the provided text. The questions you posed, particularly those related to acceptance criteria, diagnostic performance studies (like MRMC, standalone), ground truth, and sample sizes for training/test sets, typically apply to devices that involve AI/ML algorithms or interpretative functions. The Aurolase Therapy LDD, as described, appears to be a delivery device for laser energy, rather than a diagnostic device or one that incorporates AI/ML for analysis or interpretation. Its "performance" would likely be evaluated on optical, mechanical, and safety specifications, not on diagnostic accuracy metrics.

Here's a breakdown of why the information is not present and what types of information would typically be provided for the type of study you're asking about:

Acceptance Criteria & Reported Device Performance Table: This would typically apply to a diagnostic device or an AI algorithm. For a laser delivery device, acceptance criteria would be for things like power output accuracy, wavelength, fiber integrity, cooling efficiency, etc. These are not detailed in the provided summary.
Sample size and Data Provenance: Not applicable in the context of clinical performance evaluation for this type of device based on the provided document.
Number of Experts & Qualifications / Adjudication Method / MRMC / Standalone performance / Type of Ground Truth: These are all highly relevant for AI/ML-based diagnostic devices where human readers or algorithms interpret medical images or data. They are not relevant for a passive laser delivery device like the Aurolase LDD as described in this 510(k) summary. The "ground truth" for this device would be its physical and optical characteristics meeting specifications, not clinical outcomes related to diagnosis or prediction.
Training Set Sample Size & Ground Truth for Training: Applicable to AI/ML devices. Not relevant for this device.

In summary, the provided document for the Aurolase Therapy, Laser Delivery Device (LDD) does not contain the type of clinical performance study data (e.g., diagnostic accuracy, reader studies, AI/ML algorithm performance) that your questions refer to. The 510(k) largely focuses on the device's physical characteristics, its role as an accessory, and its substantial equivalence to a predicate device based on non-clinical testing (sterility, biocompatibility, physical performance).

Summary

{0}------------------------------------------------

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

October 3, 2022

Nanospectra Biosciences, Inc. % Shepard Bentley Consultant Bentley Biomedical Consulting, LLC. 28241 Crown Valley Parkway Suite 510(K) Laguna Niguel, California 92677

Re: K202953

Trade/Device Name: Aurolase Therapy, Laser Delivery Device (LDD) 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: August 31, 2022 Received: August 31, 2022

Dear Shepard Bentley:

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.

{1}------------------------------------------------

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); 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 (QS) 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,

Jianting Wang 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023

See PRA Statement below.

510(k) Number (if known) K202953

Device Name Aurolase Therapy Laser Delivery Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over -The-Counter Use (Part 21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies on to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the Time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency many not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

{3}------------------------------------------------

510(k) Summary - K202953

Sponsor: Nanospectra Biosciences Inc. Address: 8285 El Rio St # 150, Houston, TX 77054 Phone Number: (713) 842-2720 Email address: info@nanospectra.com

Contact Person: Shepard G. Bentley

Trade name: Aurolase Therapy, Laser Delivery Device (LDD) Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product Code: GEX Regulation: 21 CFR 878.4810

Predicate Device: Visualase Cooled Laser Application System, Laser Diffusing Fiber, Cooling Catheter System, Bare Tip Fiber (K053087)

Description of Device:

Indications for Use:

Technological Characteristics:

. A transparent, dual lumen Laser Catheter Assembly (LCA) for percutaneous delivery of the optical fiber into, or adjacent to, the target tissue and to provide a means for actively cooling tissue immediately adjacent to the LCA.
. A Coolant Supply Set (CSS) that provides the source of cooling liquid to the LCA. The tubing set is terminated in a standard spike and consists of a length of tubing to permit the placement of a peristaltic pump anywhere along its length and the coolant recovery bag for collecting the cooling liquid after a single transit of the LCA.
A glass/silica Optical Fiber Diffuser (OFD) assembly for delivering near infrared light to the target tissue. The optical fiber is terminated in an 18mm long diffuser that emits light radially from the fiber.

{4}------------------------------------------------

Shelf Life:

The shelf life of the Aurolase Therapy Laser Delivery Device is six months from the date of sterilization.

Supporting Technology:

The Nanospectra Biosciences Aurolase Therapy Laser Delivery Device (LDD) may be used with any appropriate commercially available introducer (e.g., Terumo® Surflo® I.V. Catheter 14G x 2″, cleared under K133280), and should be used with the compatible laser system; LightForce® LTS Model 2500 cleared under K173067, and Langer Instruments BT100-1L peristaltic pump.

TechnologicalCharacteristic	Subject DeviceAurolase Therapy LDD	Predicate DeviceVCLAS	Comparison
Product Code	GEX	GEX	Same
Regulation	21 CFR §878.4810	21 CFR §878.4810	Same
Classification	2	2	Same
Device Type	Accessory to poweredsurgical laserinstrument	Accessory to poweredsurgical laserinstrument	Same
Composition	Three-part system fordelivering laser energy	Three-part system fordelivering laser energy	Same
Biocompatible per ISO10993-1	Biocompatiblematerials	Biocompatiblematerials	Same
Mode of Action	Delivery of laser energyto achieve the desiredeffect of the intendeduse	Delivery of laser energyto achieve the desiredeffect of the intendeduse	Same
Compatible output power	Up to 5 W	Not disclosed
Compatiblewavelength(s)	810nm, +/- 10nm	800nm – 1064nm	Similar
Method of Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Number of Uses	Single Use, disposable	Single Use, disposable	Same

Comparison with the predicate device:

Non-Clinical Performance Data:

The results of testing, including rigorous physical and environmental use studies, sterility, and biocompatibility tests, support a conclusion that the Aurolase Therapy LDD satisfies the requirements of performance to achieve its intended effect within its indication for use, and have not produced any additional risks of hazard leading to harm of the user and/or the patient within its intended use.

{5}------------------------------------------------

Conclusion:

On the basis of the comparison with the predicate device and on the non-clinical performance data, we conclude that Aurolase Therapy, Laser Delivery Device (LDD) does not introduce any new questions of safety or effectiveness, and is substantially equivalent to the predicate.

End of 510(k) Summary

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.