Aurolase Therapy, Laser Delivery Device (LDD)

K202953 · Nanospectra Biosciences, Inc. · GEX · Oct 3, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K202953
• Device Name: Aurolase Therapy, Laser Delivery Device (LDD)
• Applicant: Nanospectra Biosciences, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Aurolase Therapy Laser Delivery Device (LDD) functions as an accessory to 810nm surgical lasers; transmits laser energy to target tissue. System comprises three components: Laser Catheter Assembly (LCA), Optical Fiber Diffuser (OFD), and Coolant Supply Set (CSS). LCA/OFD deliver near-infrared light radially via 18mm diffuser; CSS provides active cooling to tissue and LCA via peristaltic pump and coolant recovery bag. Used in clinical settings by physicians for laser-based procedures. Device is single-use, disposable, and sterilized via ethylene oxide. Benefits include precise energy delivery and thermal management of adjacent tissue during laser procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance supported by physical/environmental use studies, sterility testing, and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Dual lumen Laser Catheter Assembly (LCA); glass/silica Optical Fiber Diffuser (OFD) with 18mm radial emission; Coolant Supply Set (CSS) with peristaltic pump compatibility. Energy source: 810nm (+/- 10nm) laser. Max output power: 5W. Sterilization: Ethylene Oxide. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for use as a fiber-optical laser delivery device in conjunction with a compatible 810nm laser for procedures cleared for that laser system.

Regulatory Classification

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.

Predicate Devices

• Visualase Cooled Laser Application System, Laser Diffusing Fiber, Cooling Catheter System, Bare Tip Fiber (K053087)

Reference Devices

• Terumo Surflo I.V. Catheter 14G x 2 (K133280)
• LightForce LTS Model 2500 (K173067)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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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: 06/30/2023

See PRA Statement below.

510(k) Number (if known) K202953

Device Name Aurolase Therapy Laser Delivery Device

Indications for Use (Describe)

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.

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)

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FORM FDA 3881 (6/20)

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#### 510(k) Summary - K202953

Sponsor: Nanospectra Biosciences Inc. Address: 8285 El Rio St # 150, Houston, TX 77054 Phone Number: [phone] Email address: [e-mail]

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:

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.

#### Indications for Use:

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.

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.

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# 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.

| Technological<br>Characteristic | Subject Device<br>Aurolase Therapy LDD | Predicate Device<br>VCLAS | Comparison |
|----------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------|
| Product Code | GEX | GEX | Same |
| Regulation | 21 CFR §878.4810 | 21 CFR §878.4810 | Same |
| Classification | 2 | 2 | Same |
| Device Type | Accessory to powered<br>surgical laser<br>instrument | Accessory to powered<br>surgical laser<br>instrument | Same |
| Composition | Three-part system for<br>delivering laser energy | Three-part system for<br>delivering laser energy | Same |
| Biocompatible per ISO<br>10993-1 | Biocompatible<br>materials | Biocompatible<br>materials | Same |
| Mode of Action | Delivery of laser energy<br>to achieve the desired<br>effect of the intended<br>use | Delivery of laser energy<br>to achieve the desired<br>effect of the intended<br>use | Same |
| Compatible output power | Up to 5 W | Not disclosed | |
| Compatible<br>wavelength(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.

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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