(219 days)
Not Found
No
The description focuses on the physical components and optical properties of the laser fiber, with no mention of AI or ML.
Yes
The device is a laser delivery fiber intended for use in surgical specialties, which directly implies its role in delivering energy for therapeutic procedures. Its function is to facilitate surgical interventions, which are therapeutic in nature.
No.
The device description clearly states that the VaporMAX LDD® family of fibers "are fiber optic surgical laser energy delivery devices." Their intended use is to deliver laser energy in surgical specialties. There is no mention of the device performing any diagnostic functions such as detection, monitoring, or analysis of physiological parameters or conditions.
No
The device description clearly outlines physical components such as fiber optic cables, connectors, sleeves, strain relief, a distal tip with a lens and prism, a control knob, and packaging. These are all hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in all surgical specialties in which compatible laser systems... have received regulatory clearance." This describes a device used during surgical procedures to deliver laser energy to tissue.
- Device Description: The description details a fiber optic surgical laser energy delivery device with components like a laser connector, optical fiber, distal tip with a lens and prism, and a control knob for aiming. This is consistent with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
Therefore, the VaporMax LDD family of laser fibers is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, Mega/OULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector or manufacturer specific connectors and adaptors.
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector, SMA 906 connector or manufacturer specific connectors and adaptors.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
VaporMAX LDD® family of fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are fiber optic surgical laser energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905 or Trimedyne OmniPulse™ MAX, an anodized aluminum extension sleeve or polymer overnut for accommodating recessed laser ports, fiber/connector strain relief, and a transmitting optical fiber consisting of a low [OH-], fused silica core fiber with fluorine-doped, fused silica cladding, a fluoropolymer secondary cladding and an ethylene tetrafluorethylene copolymer (ETFE, e.g. DuPont Tefzel 210™) protective jacket. The distal tip is laser polished and is disposed within a fused quartz capsule (cap) containing a beam conditioning lens and a prism for redirecting the output at nearly right angles to the fiber longitudinal axis.
The dimensional difference between the optical fiber and the distal cap is equalized with a Udel tube covering the distal length of fiber that may be tasked to pass a cystoscope bridge working channel, sized to match the cap diameter and upon which is dispose a green visual indicator of the fiber rotational orientation. The proximal end of the diameter matching tube is terminated within a patent pending control knob for ergonomic rotational control (aiming). Some models of the VaporMAX LDD, those with subscripted "e", where e" indicates "ergonomic") exploit severing the connection between the redirection prism from the transmitting fiber by providing for free rotation of the cap about the fiber, vial the control knob, thereby aiming the fiber output without torquing the transmitting fiber.
VaporMAX LDD fibers are packaged as a coil upon a coated fiberboard or dense polymer carrier card that is intended to provide for ease of dispensing within the surgical field while immobilizing the product within the sterile pouch. The working end (distal section) of the fiber is maintained in a straight configuration to avoid "fiber jumping" when rotated in surgery (due to the device's "memory" of being stored in a coil). Carrier cards are sealed within non-woven/impermeable pouches, e.g., Tyvek/paper or Tyvek/Mylar, currently validated by IQ for a three-year shelf life. Sealed sterile pouches are protected by an outer, nonsterile fiberboard carton. Both the sterile pouch and carton are labeled with the product information per FDA labeling requirements. All tissue contacting VaporMAX LDD materials of construction, and any materials in fluidic communication with tissue, are USP Class VI biocompatible and are compatible with ethylene oxide (EO) sterilization.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Briefly, subject fibers were power tested in simulated surgery like the predicate, under saline and in contact with tissue phantoms, at 80 watts average power (4 joules, 20 Hz), using a CTH:YAG laser operating at 2080nm (often incorrectly identified as "holmium lasers at 2100nm") for 320,000 joules delivered, and similarly tested in contact with tissue phantoms at 200 watts using a thulium fiber laser operating at 1940nm for 600,000 joules and 1,000,000 joules (or one megajoule). The subject fibers maintained the original operating characteristics far further into testing than did predicate devices and none of the subject fibers failed even under the most abusive test conditions*, leading to the new product name of "MegaJOULE" (which may or may not be retained as a product identifier).
Beam profiles were obtained for the subject VaporMAX LDD and predicate VaporMAX prior to the accumulation of multiple incremental changes and with each step that has potential for altering the output of the laser fiber and studies were performed to access the reproducibility of key performance variables (as measured by beam profiles and divergence as well as in simulated surgery with tissue phantoms). The subject fibers' construction integrity was then tested with tensile strength measurements of cap retention on the fiber, orientation tube retention within the control knob, and fiber retention within the laser connector, all fibers surpassed design specifications. The subject devices are determined to be as safe and as effective as the lower power capable predicate devices even when used at the maximum power output of modern surgical lasers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
InnovaQuartz LLC Stephen Griffin Chief Innovations Officer 23030 N 15th Avenue Phoenix, Arizona 85027-1315
Re: K233157
Trade/Device Name: VaporMAX LDD; MOJo LDD; MegaJOULE 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: April 2, 2024 Received: April 3, 2024
Dear Stephen Griffin:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Tanisha L. Digitally signed by
Tanisha L. Tanisha L. Hithe -S Hithe -S - Date: 2024.05.03 21:53:12 -04'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K233157
Device Name VaporMAX LDD, MegaJOULE LDD, and MoJo LDD
Indications for Use (Describe)
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, Mega/OULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector or manufacturer specific connectors and adaptors.
| 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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4
Image /page/4/Picture/0 description: The image shows the logo for IQ LLC InnovaQuartz. The letters "IQ" are in a large, bold, blue font, with a red swoosh design wrapping around the top and bottom of the letters. To the right of "IQ" is the text "LLC" in a smaller, blue font. Below the letters is the word "InnovaQuartz" in a smaller, gray font.
23030 North Fifteenth Avenue Phoenix, Arizona 85027-1315 623-434-1895 innovaquartz.com
510(K) Summary K233157
Date Submitted: May 2, 2024
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Sponsor/Owner/Holder:
InnovaQuartz, LLC 23030 N 15th Ave Phoenix, AZ 85027-1315 623-434-1895
Company Contact:
Stephen Griffin, CIO 623-434-1895 (main) x101 623-229-5174 (mobile) steveg@innovaquartz.com
Registration Number: 3010933841
Subject Device Name:
| Trade Name: | VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD |
|---|---|
| Common Name: | Laser Fiber |
| Classification: | Laser Instrument, Surgical, Powered Laser surgical instrument for use in general |
| and plastic surgery and in dermatology | |
| Product Code: | GEX |
| Regulatory Class: | Class II |
| Panel: | General and Plastic Surgery |
Predicate Devices:
| Trade Name: | VaporMAX™ |
|---|---|
| Common Name: | Laser Fiber |
| Classification: | Laser Instrument, Surgical, Powered Laser surgical instrument for use in general |
| and plastic surgery and in dermatology | |
| Product Code: | GEX |
| Regulatory Class: | Class II |
| Panel: | General and Plastic Surgery |
| 510(k) Number: | K053457 issued to Trimedyne, Inc., 15091 Bake Parkway, Irvine, CA 92618 |
| Trade Name: | Multiwavelength Lateral Emitting Laser Fiber |
| Common Name: | Laser Fiber |
| Classification: | Laser Instrument, Surgical, Powered Laser surgical instrument for use in general |
| and plastic surgery and in dermatology | |
| Product Code: | GEX |
| Regulatory Class: | Class II |
| Panel: | General and Plastic Surgery |
| 510(k) Number: | K170366 issued to Laser Peripherals, LLC 13355 10th Ave, Ste 110, Plymouth, |
| MN 55441 |
5
This statement is based on the similarity of the subject device to the predicate devices in the intended use and optical principles.
Device Description:
VaporMAX LDD® family of fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are fiber optic surgical laser energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905 or Trimedyne OmniPulse™ MAX, an anodized aluminum extension sleeve or polymer overnut for accommodating recessed laser ports, fiber/connector strain relief, and a transmitting optical fiber consisting of a low [OH-], fused silica core fiber with fluorine-doped, fused silica cladding, a fluoropolymer secondary cladding and an ethylene tetrafluorethylene copolymer (ETFE, e.g. DuPont Tefzel 210™) protective jacket. The distal tip is laser polished and is disposed within a fused quartz capsule (cap) containing a beam conditioning lens and a prism for redirecting the output at nearly right angles to the fiber longitudinal axis.
The dimensional difference between the optical fiber and the distal cap is equalized with a Udel tube covering the distal length of fiber that may be tasked to pass a cystoscope bridge working channel, sized to match the cap diameter and upon which is dispose a green visual indicator of the fiber rotational orientation. The proximal end of the diameter matching tube is terminated within a patent pending control knob for ergonomic rotational control (aiming). Some models of the VaporMAX LDD, those with subscripted "e", where e" indicates "ergonomic") exploit severing the connection between the redirection prism from the transmitting fiber by providing for free rotation of the cap about the fiber, vial the control knob, thereby aiming the fiber output without torquing the transmitting fiber.
VaporMAX LDD fibers are packaged as a coil upon a coated fiberboard or dense polymer carrier card that is intended to provide for ease of dispensing within the surgical field while immobilizing the product within the sterile pouch. The working end (distal section) of the fiber is maintained in a straight configuration to avoid "fiber jumping" when rotated in surgery (due to the device's "memory" of being stored in a coil). Carrier cards are sealed within non-woven/impermeable pouches, e.g., Tyvek/paper or Tyvek/Mylar, currently validated by IQ for a three-year shelf life. Sealed sterile pouches are protected by an outer, nonsterile fiberboard carton. Both the sterile pouch and carton are labeled with the product information per FDA labeling requirements. All tissue contacting VaporMAX LDD materials of construction, and any materials in fluidic communication with tissue, are USP Class VI biocompatible and are compatible with ethylene oxide (EO) sterilization.
Intended Use:
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector, SMA 906 connector or manufacturer specific connectors and adaptors.
6
Technological Characteristics Comparison:
The VaporMAX LDD laser fiber is produced as described in US Patents Nos. 9,323,005, 9,488,782 and patents pending. The subject fibers are technologically equivalent to the predicate devices and the intended end use for the subject fibers is the same as the intended use of the predicate devices. All the predicate devices and VaporMAX LDD operate upon the same optical principles, although somewhat refined. The VaporMAX LDD uses similar materials of construction as the predicate devices and has equivalent or better performance than the predicate devices. Table 4-6 illustrated in the comparison between VaporMAX LDD and the two predicate devices in the traditional 510(k) submission.
| Feature | VaporMAX™
Predicate | VaporMAX LDD®
Subject | LP Side Fire
Predicate |
|---------------------|------------------------------|------------------------------|-------------------------------|
| Theory of Operation | Total Internal
Reflection | Total Internal
Reflection | Total Internal
Reflection |
| Fiber total length | 3 meters | 3 meters | 3 meters |
| Fiber core (um) | 430, 550 and 600 | 365, 550 and 660 | 365 and 550 |
| Fiber core material | Low [OH] fused silica | Low [OH] fused silica | Low [OH] fused silica |
| Fiber CCDR | 1.05 and 1.1 | 1.1 | 1.1 |
| Fiber cladding | F-doped fused silica | F-doped fused silica | F-doped fused silica |
| Fiber buffer | Fluoroacrylate | Fluoroacrylate | Fluoroacrylate |
| Fiber jacketing | ETFE | ETFE | ETFE |
| Working length | 35 cm to 41 cm | 36 cm & 38 cm | Variable |
| Control device | Fixed polymer | Fixed polymer | Movable metal |
| Laser connector | SMA 905 + TMED | SMA 905 + TMED | SMA 905, 906 &
Proprietary |
| Output angle | 78° to 82° | 82° to 88° | UNKNOWN |
| Divergence | 12.7°max | 12.7° max | UNKNOWN |
| Cap diameter (max) | 2.2 mm | 2.14 mm | UNKNOWN |
| Output area | >0.8 mm² | >1.2 mm² | UNKNOWN |
| OD | 7.5 French | 7.5 French | UNKNOWN |
| Max energy | 4.0 joules | 4.0 joules | UNKNOWN |
| Max power | 100 watts | 200 watts | UNKNOWN |
| Minimum lifetime | 320,000 J | 600,000 J | UNKNOWN |
Figure 1: Table 4-6 Comparison Table
7
Performance Testing (Bench and User Evaluation):
Briefly, subject fibers were power tested in simulated surgery like the predicate, under saline and in contact with tissue phantoms, at 80 watts average power (4 joules, 20 Hz), using a CTH:YAG laser operating at 2080nm (often incorrectly identified as "holmium lasers at 2100nm") for 320,000 joules delivered, and similarly tested in contact with tissue phantoms at 200 watts using a thulium fiber laser operating at 1940nm for 600,000 joules and 1,000,000 joules (or one megajoule). The subject fibers maintained the original operating characteristics far further into testing than did predicate devices and none of the subject fibers failed even under the most abusive test conditions*, leading to the new product name of "MegaJOULE" (which may or may not be retained as a product identifier).
Beam profiles were obtained for the subject VaporMAX LDD and predicate VaporMAX prior to the accumulation of multiple incremental changes and with each step that has potential for altering the output of the laser fiber and studies were performed to access the reproducibility of key performance variables (as measured by beam profiles and divergence as well as in simulated surgery with tissue phantoms). The subject fibers' construction integrity was then tested with tensile strength measurements of cap retention on the fiber, orientation tube retention within the control knob, and fiber retention within the laser connector, all fibers surpassed design specifications. The subject devices are determined to be as safe and as effective as the lower power capable predicate devices even when used at the maximum power output of modern surgical lasers.
- To test caps retention and erosion under extreme conditions, abusive tests were performed, e.g., cutting a tissue phantom in half, e.g., a London broil steak, at 100 watts with less than 10,000 joules).
Manufacturing, Packaging and Sterilization Facility:
Subject devices are designed, manufactured, packaging and sterilized within the InnovaQuartz manufacturing facility located in Phoenix, Arizona. All manufacturing equipment has been validated as appropriate for the intended functions and the product sterilization is compliant with ISO 11135:2014 standards. Shelf life is three years when stored as directed.
Conclusion:
A direct comparison of key characteristics demonstrates that subject devices are substantially equivalent to the predicate device in terms of materials of construction, intended uses, technological considerations, & performance. The subject devices are as safe, as effective, and perform as well as the predicate devices.