(733 days)
No
The summary describes a laser delivery device and its components, focusing on the physical transmission of laser energy and cooling. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis.
Yes
Explanation: The device is described as a "laser delivery device" that is used for "laser-based applications and procedures" to "transmit laser energy to the tissue situated at their distal regions, to achieve the desired effect of the intended use." This indicates its direct involvement in providing a therapeutic intervention. The predicate device listed is also a "Cooled Laser Application System."
No
This device is a fiber-optic laser delivery system used for therapeutic laser applications and procedures, not for diagnosing conditions.
No
The device description clearly outlines hardware components (Laser Catheter Assembly, Optical Fiber Diffuser, Coolant Supply Set) and describes the physical delivery of laser energy and coolant, indicating it is a hardware device with potentially embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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." This describes a device used in vivo (within the body) for therapeutic or surgical procedures, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details components that transmit laser energy to tissue and provide cooling, consistent with a device used directly on or within a patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Aurolase Therapy, Laser Delivery Device is a medical device used for therapeutic or surgical purposes, not an IVD.
N/A
Intended Use / 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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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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 (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
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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: (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:
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.
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.
| Technological
Characteristic | Subject Device
Aurolase Therapy LDD | Predicate Device
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
surgical laser
instrument | Accessory to powered
surgical laser
instrument | Same |
| Composition | Three-part system for
delivering laser energy | Three-part system for
delivering laser energy | Same |
| Biocompatible per ISO
10993-1 | Biocompatible
materials | Biocompatible
materials | Same |
| Mode of Action | Delivery of laser energy
to achieve the desired
effect of the intended
use | Delivery of laser energy
to achieve the desired
effect of the intended
use | Same |
| Compatible output power | Up to 5 W | Not disclosed | |
| Compatible
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.
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