(131 days)
The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:
General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).
Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.
Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).
InnoVoyce VYLO is a solid-state laser device with laser energy generated by internal diodes. The laser output energy of the device is in the blue spectrum at wavelength of 445-465nm.
The system is intended to be used by professional practitioners (specialized physician/ authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environments.
The VYLO's base unit is a console with a graphical touch screen user interface and a footswitch, and single-use, disposable LOFs. The system has four laser emission modes: Continuous Wave (CW), Pulsed Wave (PW), Quasi Pulsed Wave (QPW), and Quasi Continuous Wave (QCW).
The provided text is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the InnoVoyce VYLO laser surgical instrument to a legally marketed predicate device (Greenlight XPS Laser System). It discusses indications for use, device description, electrical safety, electromagnetic compatibility, software, and performance testing.
However, the document does not describe a study that involves human readers, AI assistance, ground truth established by medical experts (other than potentially for the histology review, which is not explicitly detailed), or acceptance criteria related to diagnostic performance metrics for an AI/software device. The performance testing described is a bench test comparing the VYLO device's tissue interaction to the predicate device, not an AI or software performance study.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context, as they relate to the evaluation of an AI/software diagnostic device, which the InnoVoyce VYLO is not.
Based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes "Performance Testing" which is a comparison of tissue effects (Coagulation and Ablation Zones - CAZs) between the subject device (InnoVoyce VYLO) and the predicate device (Greenlight XPS). The acceptance criterion implicitly seems to be "comparable performance" in terms of tissue effects, with a note that smaller CAZs at max power for the subject device indicate a "safer and more controlled way."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Production of clearly detectable Coagulation and Ablation Zones (CAZs) in treated tissues. | The study demonstrated that the treatments produced clearly detectable Coagulation and Ablation Zones (CAZs) in all three treated tissues (liver, kidney, and muscle) at all dose levels for both devices. |
| Consistency of thermal damage profiles across test specimens and parameters. | The obtained data allows one to conclude the VYLO's thermal damage profiles were consistent across all three test specimens for all tested parameters. |
| Comparability of CAZs to the predicate device at similar power levels. | The dimensions of the CAZs produced by the Predicate Device at 30 W were in close proximity to the CAZs produced by the VYLO Device at 30 W. |
| "Worst-case" performance (max power level) of VYLO should be acceptable (implicitly safer). | The dimensions of the CAZs produced by the Predicate Device at its maximum power level (180 W) were larger (deeper and wider) than damage produced by the VYLO Device at its maximum power level (30 W). "Thus, it can be concluded that treatment by the VYLO device at the maximum dose settings will provide a similar clinical effect to the Predicate Device in a safer and more controlled way, because the lesions profiles at worst cases (at max power levels 30 W at CW vs. 180 W at Q-CW) for the VYLO Device is smaller compared to Predicate device." "It can be concluded that treatment by such a device at the appropriate testing settings will possess a desirable clinical treatment effect." |
2. Sample size used for the test set and the data provenance:
- Sample Size: For the histology testing, the document states: "All settings mentioned above were triplicated in all three types of tissues (liver, kidney, and muscle)." This means for VYLO, 3 power/mode settings (30W CW for 300 & 600 µm, 20W CW for 600 µm, 20W Q-CW for 600 µm) x 3 tissues x 3 repetitions = 27 tissue samples. For the Predicate, 2 power levels (30W, 180W) x 3 tissues x 3 repetitions = 18 tissue samples. The total number of tissue samples is 45.
- Data Provenance: The tissues used were liver, kidney, and muscle. The document does not specify the origin (e.g., animal, human, specific country) or whether the study was retrospective or prospective, but it's clearly a bench/pre-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "Histology testing was conducted." While histology implicitly involves expert review (pathologist), the number of experts, their qualifications, or their role in establishing "ground truth" (e.g., measurement of CAZs) is not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable or Not specified. Adjudication methods are typically for human reader studies with multiple interpretations. For histology, it's usually either a single expert or a consensus process which is not detailed here.
5. 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. An MRMC study was not done. This device is a laser surgical instrument, not an AI or software diagnostic tool intended to assist human readers. The clinical evidence section explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is evaluated through its interaction with tissue, not as a standalone diagnostic algorithm.
7. The type of ground truth used:
- The ground truth for evaluating the device's performance was the dimensions of the Coagulation and Ablation Zones (CAZs) in ex vivo tissue samples, as determined by histology. This is primarily a pathology/histology-based ground truth for physical tissue effects.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.
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May 29, 2024
InnoVoyce % Thompson Aubrey Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825
Re: K240159
Trade/Device Name: InnoVoyce VYLO 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 25, 2024 Received: April 25, 2024
Dear Thompson Aubrey:
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
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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" (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 820.30 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-devices/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).
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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,
Digitally signed Tanisha L. by Tanisha L. Hithe -S Hithe -S Date: 2024.05.29 23:22:25 -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
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Indications for Use
Submission Number (if known)
Device Name
InnoVoyce VYLO
Indications for Use (Describe)
The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coaqulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:
General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).
Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaqinal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.
Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Ophthalmology:
Post-vitrectomy endophotocoaqulation of the retina.
Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).
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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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| Applicant | InnoVoyce, LLC |
|---|---|
| Address | One Beacon Street, Floor 15Boston, MA 02108 |
| Sponsor Contact | Stephen MaisStephen.mais@innovoyce.com |
| Regulatory Contact | Aubrey Thompson, Regulatory ConsultantAubreythompson@hoyregulatory.com |
| Preparation Date | May 22, 2024 |
| Device Trade Name | InnoVoyce VYLO |
| K Number | K240159 |
| Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code | GEX |
| Regulatory Class | II |
| Legally Marketed Predicate Device | Greenlight XPS Laser SystemK092735 |
Device Description:
InnoVoyce VYLO is a solid-state laser device with laser energy generated by internal diodes. The laser output energy of the device is in the blue spectrum at wavelength of 445-465nm.
The system is intended to be used by professional practitioners (specialized physician/ authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environments.
Indications for use:
The InnoVoyce VYLO is intended for the surgical incision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:
General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract;
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510(K) Summary InnoVovce VYI ()
esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).
Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.
Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, incision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia/ hypoplasia (BPH).
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Device Comparison – Indications for use and Technical Specifications:
| Specification | Subject Device | Predicate Device - Greenlight XPS Laser | Comparison |
|---|---|---|---|
| K240159 | System (K092735) | ||
| Indications for use | The InnoVoyce VYLO is intended for thesurgical incision/excision,vaporization, ablation, hemostasis andcoagulation of soft tissue. All soft tissueis included, such as skin, cutaneoustissue, subcutaneous tissue, striated andsmooth tissue, muscle, cartilagemeniscus, mucous membrane, lymphvessels and nodes, organs and glands.Suggested applications include:General Surgery: Vaporizing,coagulating, incising, excising, debulking,and ablating of soft tissue as well as inendoscopic (e.g., laparoscopic) or opensurgeries.Gastroenterology: Tissue ablation andhemostasis in the gastrointestinal tract;esophageal neoplastic obstructions,including squamous cell carcinoma andadenocarcinoma; gastrointestinalhemostasis (including varices,espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia,stomal ulcers non-bleeding ulcers | The GreenLight XPS Laser System isintended for the surgical incision/excision,vaporization, ablation, hemostasis andcoagulation of soft tissue. All soft tissue isincluded, such as skin, cutaneous tissue,subcutaneous tissue, striated and smoothtissue, muscle, cartilage meniscus, mucousmembrane, lymph vessels and nodes,organs and glands. Suggested applicationsinclude:General Surgery: Vaporizing, coagulating,incising, excising, debulking, andablating of soft tissue as well as inendoscopic (e.g., laparoscopic) or opensurgeries.Gastroenterology: Tissue ablation andhemostasis in the gastrointestinal tract;esophageal neoplastic obstructions,including squamous cell carcinoma andadenocarcinoma; gastrointestinalhemostasis (including varices, espohagitis,esophageal ulcer, Mallory-Weiss tear,gastric ulcer, angiodysplasia, stomal ulcers, | Same |
| Specification | Subject Device | Predicate Device – Greenlight XPS Laser | Comparison |
| K240159 | System (K092735) | ||
| gastric erosions); gastrointestinal tissueablation (benign and | non-bleeding ulcers, gastric erosions);gastrointestinal tissue ablation (benign and | ||
| malignant neoplasm, angiodysplasia, | malignant neoplasm, angiodysplasia, | ||
| polyps, ulcer, colitis, hemorrhoids). | polyps, ulcer, colitis, hemorrhoids). | ||
| Gynecology: Vaporizing, incising, orcoagulating tissue associated withtreatments of conditions such as:endometriosis; cervical, vulvar, andvaginal intraepithelial neoplasia;condyloma acuminata; uterine septum;intrauterine adhesions; submucosalfibroids. | Gynecology: Vaporizing, incising, orcoagulating tissue associated withtreatments of conditions such as:endometriosis; cervical, vulvar, and vaginalntraepithelialneoplasia; condyloma acuminata; uterineseptum; intrauterine adhesions;submucosal fibroids. | ||
| Head and Neck/ Otorhinolaryngology(ENT): Tissue incision, excision, ablation,and vessel hemostasis.Neurosurgery: Incising, excising,coagulating, and vaporizing neurological | Head and Neck/ Otorhinolaryngology(ENT): Tissue incision, excision, ablation,and vessel hemostasis.Neurosurgery: Incising, excising,coagulating, and vaporizing neurological | ||
| tumors of the firm textured type. | tumorsof the firm textured type. | ||
| Ophthalmology: | |||
| Post-vitrectomy endophotocoagulation | Ophthalmology: | ||
| of the retina. | Post-vitrectomy endophotocoagulation ofthe retina. | ||
| Specification | Subject DeviceK240159 | Predicate Device - Greenlight XPS LaserSystem (K092735) | Comparison |
| Plastic Surgery: Vaporizing, coagulating,incising, excising, debulking, and ablatingof soft tissue in endoscopic and openprocedures. | Plastic Surgery: Vaporizing, coagulating,incising, excising, debulking, and ablatingof soft tissue in endoscopic and openprocedures. | ||
| Spinal Surgery: Percutaneous lumbardiskectomy. | Spinal Surgery: Percutaneous lumbardiskectomy. | ||
| Thoracic Surgery: Vaporizing,coagulating, incising, excising, debulking,and ablating of soft tissue, including lungtissue in thoroscopic or openprocedures. | Thoracic Surgery: Vaporizing, coagulating,incising, excising, debulking, and ablating ofsoft tissue, including lung tissue inthoroscopic or open procedures. | ||
| Urology: Cutting, coagulating, orvaporizing urologic soft tissues. Openendoscopic minimally invasive urologicalsurgery (ablation, vaporization, incision,excision and coagulation of soft tissue)including treatment of: bladder, urethral& ureteral tumors; condylomas; lesionsof external genitalia; urethral & penile;hemangioma; urethral strictures;bladder neck obstructions; andvaporization of prostate tissue for mensuffering from benign prostatehyperplasia/ hypoplasia (BPH). | Urology: Cutting, coagulating, or vaporizingurologic soft tissues. Open endoscopicminimally invasive urological surgery(ablation, vaporization, incision, excisionandcoagulation of soft tissue) includingtreatment of: bladder, urethral & ureteraltumors;condylomas; lesions of external genitalia;urethral & penile; hemangioma; urethralstrictures; bladder neck obstructions; andvaporization of prostate tissue for mensuffering from benign prostatehyperplasia/hypoplasia (BPH) | ||
| Specification | Subject DeviceK240159 | Predicate Device – Greenlight XPS LaserSystem (K092735) | Comparison |
| Laser Type | Diode Laser | KTP Laser | Different. |
| Laser Power | Up to 30 W | Up to 180W | Different.Seediscussionbelow. |
| Wavelength | 455nm +/-10nm | 532nm | Different.Absorptionspectra arevery close for532nm and455nm, andperformancetesting showscomparableperformancefor thedesiredindications. |
| Laser Class | 4 | 4 | Same |
| Operation Mode | Continuous Wave, pulsed wave, Quasi-pulsed wave, Quasi-continuous wave | Unknown | Different.Performancetesting wasconductedwith CW andQC-W for theVYLO torepresentworst case. |
| Specification | Subject DeviceK240159 | Predicate Device – Greenlight XPS LaserSystem (K092735) | Comparison |
| PulseLength/Duration | 1ms to 200ms (operation mode dependent) and continuous wave | Unknown | See testingdiscussionbelow. |
| Repetition Rate | Up to 1000 pulses per second (quasi-continuous mode) | Unknown | Different. Seediscussionbelow. |
| Fluence | 300μm: 5,163 – 51,629 J/cm2400μm: 2,867 – 28,671 J/cm2600μm: 1,263 – 12,627 J/cm2 | Unknown | Different. Seetestingdiscussionbelow. |
| Aiming BeamWavelength | 515nm | Unknown | Different.Thoughslightlydifferent inwavelength,both producesimilar visiblelight for theaiming beam |
| Aiming Beam Power | 5mW | 5mW | same |
| Optical Fiber CoreDiameter | 300µm fiber: 272µm core diameter400µm fiber: 365µm core diameter600µm fiber: 550µm core diameter | Unknown | Different.Seediscussionbelow. |
| Cooling | Internal coolant | Unknown | Different |
| Specification | Subject DeviceK240159 | Predicate Device – Greenlight XPS LaserSystem (K092735) | Comparison |
| Display | Touchscreen | Touchscreen | Same |
| Main Power Supply | 100VAC to 240VAC +/- 10%50Hz to 60Hz<5A | Unknown47-63 Hz1.06-0.45 A | Same |
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Discussion
The InnoVovce VYLO is a 30W 455nm Diode surgical laser, and the Greenlight XPS (Predicate Device) is a 180W 532nm potassium-titanyl-phosphate (KTP) surgical laser. Both are intended for the surgical incision/excision, vaporization, ablation, hemostasis, and coagulation of soft tissue. Both devices are comprised of a base unit, an applicator, and handheld laser optical fibers ("LOFs"). In the case of VYLO, LOFs are sterile, single use, disposable devices designed to deliver the laser's energy. VYLO LOFs are available in three different diameters: 300, 400, and 600 microns. The output settings of the laser can be adjusted by the user. The VYLO's base unit is a console with a graphical touch screen user interface and a footswitch, and single-use, disposable LOFs. The system has four laser emission modes: Continuous Wave (CW), Pulsed Wave (PW), Quasi Pulsed Wave (QPW), and Quasi Continuous Wave (QCW). The Greenlight XPS functions on the same principles with some differences.
Electrical Safety, Electromagnetic Compatibility, and Software
The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards.
- IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-22 Edition 3.1 2012-10, Medical electrical equipment part 2-22: Particular ● requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment
- . IEC 60825-1 Edition 2.0 2007-03, Safety of Laser Products – Part 1: Equipment classification and requirements
- . IEC 62304:2006+A1:2015; Medical Device – Software Life Cycle Processes Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
- . EN ISO 14971:2019+A11:2021; Medical Devices – Application of Risk Management To Medical Devices
- IEC TR 60601-4-2 Edition 1.0 2016-05; Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Performance Testing
Performance testing was conducted to verify the pulse width, power output, and repetition rate. Histology testing was conducted side by side with the predicate device to demonstrate in a worst case scenario. Testing was conducted using the cleared laser fiber.
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Performance Testing Summary
For the VYLO device, 300 and 600 microns LOFs were tested at 30 W in CW mode ~ 2 mm distance and 3 mm/sec translation speed to mimic the worst case. For the 600 microns LOFs, testing at 20 W at CW and Q-CW was also performed. All settings mentioned above were triplicated in all three types of tissues (liver, kidney, and muscle) as recommended by FDA guidance for Industry for Premarket Notification.
The predicate device was assessed side-by-side to the VYLO at Q-CW emission mode at two power levels 30 and 180 W. 30 W mimics the max power level of the VYLO device, and 180 W is maximum power level the Predicate is cleared for. The Predicate was also tested on all three types of test tissues and each setting was triplicated. All other treatment parameters were also identical (at 37C, 2 mm distance from the surface, and 3 mm/sec translation speed).
The study demonstrated that the treatments produced clearly detectable Coagulation and Ablation Zones (CAZs) in all three treated tissues at all dose levels for both devices. Dimensions of the CAZs were not significantly different when 300- and 600- microns tips were used. Increasing the power level from 20- to 30 W did not significantly influence the thermally damage profiles produced by the VYLO Device. Relatively shallower CAZ's were observed for the VYLO Device when treatment was performed on Q-CW vs CW at the same power level. The dimensions of the CAZs produced by the Predicate Device at 30 W were in close proximity to the CAZs produced by the VYLO Device at 30 W. However, the dimensions of the CAZs produced by the Predicate Device at its maximum power level (180 W) were larger (deeper and wider) than damage produced by the VYLO Device at its maximum power level. These data are consistent across all three types of test tissue specimens.
The obtained data allows one to conclude the VYLO's thermal damage profiles were consistent across all three test specimens for all tested parameters. The study also demonstrated the ability of the VYLO to deliver consistent thermal damage profiles comparable to the profiles produced by the Predicate Device at the similar power level. The dimensions of CAZs of the VYLO Device at the worst cases (max power level) are relatively smaller than the dimensions of the Predicate Device. Thus, it can be concluded that treatment by the VYLO device at the maximum dose settings will provide a similar clinical effect to the Predicate Device in a safer and more controlled way, because the lesions profiles at worst cases (at max power levels 30 W at CW vs. 180 W at Q-CW) for the VYLO Device is smaller compared to Predicate device. It can be concluded that treatment by such a device at the appropriate testing settings will possess a desirable clinical treatment effect.
Conclusion
The safety and effectiveness determination between the subject and the predicate devices is supported by the performance data provided in the submission. The electrical and EMC testing, the software verification and validation testing and the non-clinical bench tests demonstrate that the InnoVoyce VYLO performs comparably to the predicate device that is currently marketed for the same intended use. Based on the performance testing of the two devices, it can be determined that they are substantially equivalent.
§ 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.