(366 days)
Soft tissue treatments and lithotripsy in the field of urology: In CW mode the indications for use are: Enucleation of the prostate Vaporization of the prostate Opening of ureter and urethral strictures Bladder neck incisions Bladder tumor resections Ureter and kidney tumor ablation Condyloma and penile tumor excision In PULSED mode the indications for use are: Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting
The RevoLix HTL is a surgical diode-pumped solid-state laser (DPSS). The laser radiation is generated by the excitation of a solid-state Tm-YAG laser crystal using a QCW laser diode. The laser radiation is cw (continuous wave) or delivered in pulses. The emitted laser radiation has a wavelength of 2.013 nm, which is invisible infrared. RevoLix HTL is a floor standing mobile device. The device is operated by using an operating console equipped with a touch screen and control elements. The laser emission is triggered by a foot switch. The RevoLix HTL operating console enables the user selecting the desired treatment parameters such as laser power and laser energy delivery modes: continuous or pulsed. The GUI is also used to display to the user all operational settings and operational states. The laser is activated by a foot switch. The system design and software ensure that the energy output is delivered as intended by the user. The laser radiation is focused by a fiber coupler into a flexible silica laser fiber which delivers the laser radiation to the surgical site.
This document describes the premarket notification (510(k)) for the RevoLix HTL surgical laser. It establishes substantial equivalence to predicate devices, thus clinical data was not required. Therefore, the information provided focuses on non-clinical performance testing and technical comparisons rather than clinical studies or human reader performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics with PASS/FAIL thresholds. Instead, it demonstrates compliance through:
- Comparison to Predicate Devices: The primary method for proving the RevoLix HTL meets "acceptance criteria" (i.e., is safe and effective) is by showing its substantial equivalence to already cleared predicate devices. The tables on pages 5-10 compare the RevoLix HTL's technical characteristics and intended use/indications for use with its primary and secondary predicate devices (Sphinx jr. Holmium Laser K132975, RevoLix 200 K110941) and reference devices (Lumenis Pulse 120H K140388, Quanta Cyber Ho 150W K201455).
- Compliance with Standards: The "Summary of Performance Testing" section on page 12 states that validation and verification testing was conducted to confirm the device performance meets specifications and assures safety and effectiveness. It lists various IEC standards (e.g., IEC 60601-1-2, IEC 60601-1, IEC 62304, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1) that the device conforms to. These standards implicitly define acceptance criteria for safety and performance (e.g., electrical safety, electromagnetic compatibility, software life-cycle processes, usability, particular requirements for surgical laser equipment, laser product classification and requirements).
- Risk Analysis: A Risk Analysis was performed to ISO 14971:2007, and reviewed as part of IEC 60601-1, indicating that identified risks are acceptable.
Observed Device Performance (summarized from tables):
| Characteristic | RevoLix HTL (Proposed Device) | "Acceptance"/Comparison | Substantial Equivalence? |
|---|---|---|---|
| Intended Use | Surgical laser for non-invasive, invasive, and surgically invasive incision, excision, resection, removal, vaporization, and coagulation of soft tissue in urology, and for destruction of stones in the urogenital tract. | Same as primary predicate, large overlap with secondary. | Yes |
| Indications for Use | Soft tissue treatments: Enucleation/Vaporization of prostate, stricture opening, bladder neck incisions, bladder tumor resections, ureter/kidney tumor ablation, condyloma/penile tumor excision. Lithotripsy: bladder, ureter, kidney stones (fragmentation, dusting). | Same indications in urology as predicates. | Yes |
| Laser Type | Tm:YAG Diode Pumped Solid State laser | Same as secondary predicate. | Yes |
| Wavelength | Tm:YAG 2013 nm (±10 nm) | Same as secondary predicate. Different from Holmium (2123 nm) but negligible effect on safety and performance shown in V&V tests. | Equivalent |
| CW Mode Power | 5 - 150W (HTL eco: 5 - 75W) | Lower than RevoLix 200 (max 200W). Higher than Sphinx jr. (not applicable for CW). Similar to Lumenis (not applicable for CW). | Equivalent (lower power therefore lower risk) |
| Pulse Mode Power | Average: 5 - 150W (HTL eco: 5 - 75W) | Higher average power than Sphinx jr. (max 30W), within range of Lumenis (max 120W) and Quanta (max 150W). | Equivalent (technical advancement, unlikely to affect safety/performance) |
| Pulse Peak Power | max. 1.3 kW | Lower than Sphinx jr. (max 18kW), Lumenis (>10kW), Quanta (>10kW). | Equivalent (Lower peak power than Holmium, Thulium allows for lower peak powers increasing safety, reduces retropulsion). |
| Pulse Energy | 0.3 - 4.5 J | In same range as Sphinx jr. (0.3 - 3.5 J) and Lumenis (0.2 - 6 J). | Yes |
| Pulse Repetition Rate | 5 - 300 Hz | In same range as Sphinx jr. (1 - 20 Hz), RevoLix 200 (0.5 - 10 Hz), Lumenis (5 - 80 Hz), Quanta (5 - 80 Hz). | Yes |
| Pulse Duration | 200 - 4750 µs | In same range as Sphinx jr. (max 650 µs), Lumenis (short/mid/long, max 1300 µs), RevoLix 200 (50 - 1000 ms). | Yes |
| Aiming Beam | Wavelength: 532 nm (green); Power: 1 - 3 mW | Equivalent wavelength (offers 532 nm, others may offer 635 nm but negligible effect). Similar power to predicates. | Yes |
| Laser Class | 4 (IEC 60825-1), IV (CDRH) | Identical. | Yes |
| Applied Part | Type (IEC 60601-1): BF | Identical. | Yes |
| Beam Delivery | Silica - silica multimode fibre | Identical. | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set: The document explicitly states: "Clinical data were not deemed necessary as the device is using the same intended use and key technology, operating principles and indications for use as the predicate devices." (Page 13).
- Non-clinical (testing) data: Performance testing was conducted to verify the device's performance against specifications and standards (pages 12-13). This would involve laboratory testing rather than patient data. The document does not specify "sample size" in terms of patients or data examples, but rather emphasizes compliance with engineering and safety standards. The provenance of such non-clinical data is typically tied to the manufacturer's testing facilities (LISA Laser Products GmbH, Germany) and recognized testing laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Since no clinical data or clinical test set was used for proving performance (due to substantial equivalence), there was no need for experts to establish ground truth in a clinical context. The performance was established through non-clinical testing against engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Due to the absence of a clinical test set requiring human interpretation of data for ground truth, no adjudication method was used. Non-clinical testing results are typically objectively measured and evaluated against predetermined specifications and compliance criteria.
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
- Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, MRMC studies and evaluations of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As stated above, this is a surgical laser device, not an algorithm or AI system. Its performance is evaluated based on its physical properties and its ability to deliver specified laser energy for surgical procedures, as validated through engineering and safety testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Technical Specifications and Industry Standards: The "ground truth" for demonstrating the RevoLix HTL's safety and effectiveness relies on its conformance to established engineering specifications and widely recognized international medical device standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). The "Validation and Verification testing confirms that the device performance meets specifications" (page 12). For example, the wavelength, power output, pulse characteristics, and safety features are measured and compared against their design specifications and acceptable ranges defined by these standards, and against the performance of predicate devices.
8. The sample size for the training set
- Not applicable. This is a hardware medical device and not an AI/machine learning system that requires a "training set" for model development.
9. How the ground truth for the training set was established
- Not applicable. As no training set was used, no ground truth needed to be established for it.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 19, 2022
LISA Laser Products GmbH Ralf Balkenhol Quality Manager Albert-Einstein-Str, 4 Katlenburg-Lindau Niedersachsen 37191 Germany
Re: K211534
Trade/Device Name: RevoLix HTL Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 11, 2022 Received: April 18, 2022
Dear Ralf Balkenhol:
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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). 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,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211534
Device Name RevoLix HTL
Indications for Use (Describe)
Soft tissue treatments and lithotripsy in the field of urology: In CW mode the indications for use are:
Enucleation of the prostate
Vaporization of the prostate
Opening of ureter and urethral strictures
Bladder neck incisions
Bladder tumor resections
Ureter and kidney tumor ablation
Condyloma and penile tumor excision
In PULSED mode the indications for use are: Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting
| 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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510(k) Summary
| General Provisions | |
|---|---|
| 510(k) Owners Name: | LISA Laser Products GmbHAlbert-Einstein-Str. 437191 Katlenburg-Lindau, Germany |
| Contact Person: | Dr. Ralf BalkenholQuality Manager |
| Phone Number: | +49 5556 9938 51 |
| Email: | rbalkenhol@lisalaser.de |
| Fax Number: | +49 5556 9938 10 |
| Classification: | Laser Surgical Instrument for Use in General and PlasticSurgery and in Dermatology |
| Regulation: | 21 CFR § 878.4810 |
| Regulatory Class: | II |
| Proprietary Name: | RevoLix HTL |
| Common Name: | Powered Laser Surgical Instrument |
| Date Summary Prepared: | April 30, 2021 |
Name of Predicate Device(s)
- Sphinx jr. Holmium Laser (Primary Predicate Device) K132975 ●
- RevoLix 200 (Secondary Predicate Device) K110941 ●
- Lumenis Pulse 120H (Reference Device) K140388 ●
- . Quanta 150W laser, (Reference for pulse mode comparison) - (K201455)
Intended Use
The RevoLix HTL is a surgical laser intended for non-invasive, and surgically invasive incision, excision, resection, removal, vaporization and coagulation of soft tissue in urology, and for the invasive and surgically invasive destruction of stones in the urogenital tract (bladder, ureter, kidney).
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Indications for Use
The indications for use of the RevoLix HTL are Soft Tissue treatments and Lithotripsy in the field of urology: In CW mode the indication for use are: Enucleation of the prostate, Vaporization of the prostate, Opening of ureter and urethral strictures, Bladder neck incisions, Bladder tumor resections, Ureter and kidney tumor ablation, Condyloma and penile turnour excision; in PULSED mode the indications for use are: Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting.
Device Description
The RevoLix HTL is a surgical diode-pumped solid-state laser (DPSS). The laser radiation is generated by the excitation of a solid-state Tm-YAG laser crystal using a QCW laser diode. The laser radiation is cw (continuous wave) or delivered in pulses. The emitted laser radiation has a wavelength of 2.013 nm, which is invisible infrared. RevoLix HTL is a floor standing mobile device. The device is operated by using an operating console equipped with a touch screen and control elements. The laser emission is triggered by a foot switch. The RevoLix HTL operating console enables the user selecting the desired treatment parameters such as laser power and laser energy delivery modes: continuous or pulsed. The GUI is also used to display to the user all operational settings and operational states. The laser is activated by a foot switch.
The system design and software ensure that the energy output is delivered as intended by the user. The laser radiation is focused by a fiber coupler into a flexible silica laser fiber which delivers the laser radiation to the surgical site.
Technological Characteristics
Substantial Equivalence - Table
Substantial equivalence of RevoLix HTL (Subject Device) is based on the same intended use and similarities in technological characteristics and operation principle with the Sphinx ir. Holmium Laser (Primary Predicate Device) (K132975) and RevoLix 200 (Secondary Predicate Device) (K110941) and which are legally marketed Class II medical devices under 21 CFR 878.4810, i.e., laser surgical instrument for use in general and plastic surgery and in dermatology.
For aspects concerning the higher pulse repetition rate of the RevoLix HTL compared to the predicate devices, the Lumenis Pulse 120H (K140388), and Quanta 150W laser (K201455), for pulse mode comparison which is legally marketed Class II medical devices under 21 CFR 878.4810, i.e., laser surgical instrument for use in general and plastic surgery and in dermatology, is used as a reference device to provide evidence for safety and effectiveness.
NOTE: "Pages 8-9 show an updated table of the comparison of all technical parameters split to tissue and lithotripsy mode. An additional reference device (Quanta Cyber Ho 150W K201455) has been added to the table."
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| Device Name | RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | RevoLix 200K110941SecondaryPredicate Device | Lumenis Pulse120HK140388Reference Device | SubstantialEquivalence? |
|---|---|---|---|---|---|
| Manufacturer | LISA LaserProducts GmbH | LISA LaserProducts GmbH | LISA LaserProducts GmbH | Lumenis Ltd. | -- |
| Product Code | GEX | GEX | GEX | GEX | Yes, same productcode |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Yes, sameregulation |
| Device Class | II | II | II | II | Yes, same deviceclass |
| Intended Use | The RevoLix HTLis a surgical laserintended for non-invasive, invasive,and surgicallyinvasive incision,excision, resection,removal,vaporization andcoagulation of softtissue in urology,and for theinvasive andsurgically invasivedestruction ofstones in theurogenital tract(bladder, ureter,kidney). | The Sphinx jr.laser system andits fiber opticdelivery system areintended for use insurgicalprocedures usingopen, laparoscopicand endoscopicincision, excision,resection, ablation,vaporization,coagulation andhemostasis of softand hard tissue inuse in medicalspecialtiesincluding:Urology, UrinaryLithotripsy,Gasteroenterology,Arthroscopy,Discectomy,Pulmonary,Gynecology, ENT,Dermatology,Plastic Surgery andGeneralSurgery | The RevoLix 200laser systems andtheir fiber opticdelivery systemare intended foruse in surgicalprocedures usingopen, laparoscopicand endoscopicincision, excision,resection, ablation,vaporization,coagulation andhemostasis of softtissue in use inmedical specialtiesincluding:Urology,Gastroenterology,Thoracic andPulmonary,Gynecology, ENT,Dermatology,Plastic Surgery,General Surgery.and Arthroscopy | Lumenis Pulse120H is intendedfor use in surgicalproceduresinvolving open,laparoscopic andendoscopicablation,vaporization,excision, incision,and coagulation ofsoft tissue inmedical specialtiesincluding: urology;urinary lithotripsy;arthroscopy;discectomy; ENT.surgery;gynecologicalsurgery;pulmonarysurgery;gastroenterologysurgery;dermatology andplastic surgery andgeneral surgery. | Yes, same intendeduse with theprimary predicatedevice.Large degree ofoverlap with thesecondarypredicate |
| Indicationsfor use | Soft tissuetreatments andlithotripsy in thefield of urology:• Enucleation ofthe prostate• Vaporizationof the prostate• Opening ofureter and | - UrologyOpen andendoscopic surgery(incision, excision,resection, ablation,vaporization,coagulation andhemostasis)including: | - UrologyOpen andendoscopic surgery(incision, excision,resection, ablation,vaporization,coagulation andhemostasis)including: | - UrologyEndoscopictransurethralincision of theprostate (TUWP),bladder neckincision of theprostate (BNI),holmium laserablation of theprostate (HoLAP), | Yes, equivalentThe RevoLix HTLhas the sameindications inurology. Predicatedevices haveadditionalindication in otherfields |
| Device Name | RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | RevoLix 200K110941SecondaryPredicate Device | Lumenis Pulse120HK140388Reference Device | SubstantialEquivalence? |
| urethral strictures Bladder neck incisions Bladder tumor resections Ureter and kidney tumor ablation Condyloma and penile tumor excision Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting | Urethral StricturesBladder Neck IncisionsAblation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors.Ablation of Benign Prostatic Hypertrophy (BHP)Resection of the ProstateCondylomasLesions of external genitaliaLithotripsy and Percutaneous Urinary LithotripsyEndoscopic fragmentation of urethral, ureteral, bladder and renal calculiEndoscopic fragmentation of kidney calculiTreatment of steinstrasse when guide wire cannot be passedGastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic surgery, General Surgery,Arthroscopy | Urethral StricturesBladder Neck Incisions (BNI)Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors.Ablation of Benign Prostatic Hypertrophy (BHP),Transurethral incision of the prostate (TUIP)Laser Resection of the Prostate (HoLRP)Laser Enucleation of the Prostate (HoLEP)Laser Ablation of the Prostate (HoLAP)CondylomasLesions of external genitaliaGastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic surgery, General Surgery, Arthroscopy | enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of. bladder; superficial and invasive bladder, urethral and ureteral tumors; condylomas; lesions of external genitalia; ureteral and penile haemangioma; ureteral strictures; bladder neck obstructions Urinary Lithotripsy including:endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, | ||
| Device Name | RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | RevoLix 200K110941SecondaryPredicate Device | Lumenis Pulse120HK140388Reference Device | SubstantialEquivalence? |
| including cystine,calcium oxalate,monohydrate andcalcium oxalatedihydrate stones;treatment of distalimpactedfragments ofsteinstrasse whenguide wires cannotbe passed. | |||||
| Arthroscopy,General Surgery,ENT Surgery,GynecologicalSurgery,GastroenterologySurgery,PulmonarySurgery,Dermatology andPlastic Surgery | |||||
| Laser type | Tm:YAG DiodePumped SolidState laser | -- | Tm:YAG DiodePumped SolidState laser | Yes, same lasertype | |
| -- | HoYAG flash lamppumped solid statelaser | -- | HoYAG flash lamppumped solid statelaser | ||
| Wavelength | Tm:YAG 2013 nm(±10 nm) | -- | 2.01 μm | Yes, samewavelength | |
| -- | 2123 nm (± 3 nm) | -- | 2.1 μm | Equivalent, thedifference inwavelengths hasbeen shown inV&V tests to havenegligible effect onsafety andperformance. | |
| CW mode | Power: 5 - 150WRevoLix HTL eco:5 - 75 W | -- | Power: max 200W | Equivalent, higherpower in CWmode.Same / lowerpower compared toreference device | |
| Pulse mode | Average power:5 - 150W | Average power:max. 30W | Average Power:max. 200W | Average Power:max 120W | Equivalent, theaverage power inPulsed mode for |
| Device Name | RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | RevoLix 200K110941SecondaryPredicate Device | Lumenis Pulse120HK140388Reference Device | SubstantialEquivalence? |
| RevoLix HTL eco:5 - 75 W | RevoLix HTLexceeds that of theSphinx jr. Thisrepresents atechnicaladvancement andis unlikely to affectsafety andperformance of theRevoLix HTL. | ||||
| Pulse peak power:max. 1.3 kW | Pulse peak power:max. 18 kW | Pulse peak power:max. 200W | unknown | The RevoLix HTLhas a lower pulsepeak power. | |
| Pulse energy:0.3 - 4.5 J | Pulse energy:0.3 - 3.5 J | n/a | 0.2 - 6 J | The RevoLix HTLis capable ofachieving a pulseenergy in the samerange as in theequivalent devices. | |
| Pulse repetitionrate:5 - 300 Hz | Pulse repetitionrate:1 - 20 Hz | Pulse repetitionrate:0.5 - 10 Hz | Pulse repetitionrate:5 - 80 Hz | The RevoLix HTLis capable ofachieving a pulserepetition rate inthe same range asin the equivalentdevices. | |
| Pulse duration:200 - 4750 µs | Pulse duration:max. 650 µs | Pulse duration:50 - 1000 ms | Pulse duration:short / mid / longmax 1300 µs | The RevoLix HTLis capable ofachieving a pulseduration in thesame range as inthe equivalentdevices. | |
| Aiming beam | Wavelength:532 nm (green) | Wavelength:635 nm (red)or 532 nm (green) | Wavelength:635 nm (red) | Wavelength:532 nm (green) | Yes, equivalent.RevoLix HTL onlyoffers a 532 nmbeam, the otherdevices also offer a635 nm beam. Thewavelength of theaiming beam hasnegligible effect onsafety andperformance. |
| Power: 1 - 3 mW | Power: max. 5mW | Power: max. 1mW, | Power: max. 5mW, | Yes, similar.The power of theaiming beamoffered byRevoLix HTL lies |
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| Device Name | RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | RevoLix 200K110941SecondaryPredicate Device | Lumenis Pulse120HK140388Reference Device | SubstantialEquivalence? |
|---|---|---|---|---|---|
| Laser Class | 4 (IEC 60825-1)IV (CDRH) | 4 (IEC 60825-1) | 4 (IEC 60825-1) | 4 (IEC 60825-1)IV (CDRH) | Yes, identical |
| Applied part | Type (IEC 60601-1): BF | Type (IEC 60601-1): BF | Type (IEC 60601-1): BF | Type (IEC 60601-1): BF | Yes, identical |
| Beam delivery:silica - silicamultimode fibre | Beam delivery:silica - silicamultimode fibre | Beam delivery:silica - silicamultimode fibre | Beam delivery:silica - silicamultimode fibre | Yes, identical | |
| User panel | Colour LCDdisplay (GUI),touch sensitive | Colour LCDDisplay (GUI),touch sensitive | White/blue LCDdisplay (GUI), 3buttons, 1thumbwheel | Colour LCDdisplay (GUI),touch sensitive | Yes, identical withSecondarypredicate.Similar to primarypredicate |
| Laser trigger | Foot switch | Foot switch | Foot switch | Foot switch | Yes, identical |
| Treatmentparameters | User selected | User selected | User selected | User selected | Yes, identical |
| OperatingConditions | Temperature:+15 - +28 °C,Relative humidity:10 - 90 % (non-condensing),Air pressure:700 - 1060 hPa | Temperature:+15 - +28 °C,Relative humidity:10 - 90 % (non-condensing), andAir pressure:700 - 1060 hPa | Temperature:+18 - +28 °C,Relative humidity:10 - 90 % (non-condensing),Air pressure:700 - 1060 hPa | Temperature:+10 - +24 °CRelative humidity:max. 75 %(non-condensing)Air pressure:77 - 106 kPa | Yes, identical |
| Shipping &storageConditions | Temperature:0 - +70 °C,Relative humidity:10 - 90 % (non-condensing),Air pressure:700 - 1060 hPa | Temperature:-5 - +70 °C,Relative humidity:10 - 90 % (non-condensing),Air pressure:700 - 1060 hPa | Temperature:+3 - +45 °C,Relative humidity:10 - 90 % (non-condensing),Air pressure:700 - 1060 hPa | Temperature:- 20 - 70 °CRelative humidity:95% at 20 °C non-condensingAir pressure:77 - 106 kPa | Yes, similar. |
| Input power | 200 V - 240 V,50/60 Hz, Max. 10A (1~, N, PE)110 V - 115 V,50/60 Hz, Max. 20A (1~, N, PE) | 210 V - 230 V,50/60 Hz, max. 10A (1~, N, PE)110 V - 115 V,50/60 Hz, max. 20A (1~, N, PE) | 230 V AC, 50/60Hz, (1~, N, PE),max. 20 A | 200 - 240 V AC,50/60 Hz, max. 46A | Yes, consistentvalues for USmarket |
| Weight | 108 kg | 95 kg | approx. 140 kg | 240 kg | Yes, similar |
| Size(HxWxD) | 1025 x 450 x 740mm | 1000 x 450 x 740mm | 950 x 420 x 890mm | 105 x 47 x 116 cm | Yes, equivalentsizes.Mobile floorstanding deviceswith castors |
| Laser safety | FDA CDRH 21CFR 1040 (LaserNotice 56) | FDA CDRH 21CFR 1040 (LaserNotice 56) | FDA CDRH 21CFR 1040 (LaserNotice 56) | FDA CDRH 21CFR 1040 | Yes |
| Device Name | RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | RevoLix 200K110941SecondaryPredicate Device | Lumenis Pulse120HK140388Reference Device | SubstantialEquivalence? |
| IEC 60601-2-22;IEC 60825-1 | IEC 60601-2-22;IEC 60825-1 | IEC 60601-2-22;IEC 60825-1 | IEC 60601-2-22;IEC 60825-1 |
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| TISSUE | |||||||
|---|---|---|---|---|---|---|---|
| ContinuousWave (CW) Mode | |||||||
| Device Name | RevoLix HTLProposed Device | RevoLix 200K110941Secondary Predicate Device | Modification | ||||
| CW mode | Power: 5 - 150WRevoLix HTL eco:5 - 75 W | Power: max 200W | Lower outputpower thereforelower risk | ||||
| Laser type | Tm:YAG Diode Pumped Solid Statelaser | Tm:YAG Diode Pumped Solid Statelaser | No change | ||||
| Wavelength | 2013 nm | 2013 nm | No change | ||||
| LITHOTRIPSYPULSED MODE | |||||||
| RevoLix HTLProposed Device | Sphinx jr.K132975PrimaryPredicate Device | Lumenis Pulse120HK140388Reference Device | Quanta Cyber Ho150WK201455 SecondReference | Modification | |||
| Pulse mode | Average power:5 - 150WRevoLix HTL eco:5 - 75 W | Average power:max. 30W | Average Power:max 120W | Average Power:max 150W | Same range ofaverage power | ||
| Pulse peakpower | max. 1.3 kW | max. 18 kW | >10kW | >10kW | Lower peak powerthan Holmiumbased lasers.Thulium higherabsorption allowsfor lower pulsepeak powersincreasing safety.See graph.Lower pulse peakpowerssignificantly reducethe retropulsion of |
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Image /page/11/Figure/0 description: The image contains a table and a graph. The table lists pulse energy, pulse repetition rate, and pulse duration for different laser types. The graph shows the penetration depth in micrometers as a function of wavelength in nanometers, with curves indicating the penetration depths for Holmium crystal, Thulium crystal, and Fiber/industrial lasers.
Wavelength [nm]
The blue line of the graph shows the penetration depth of water and aqueous biomedical materials for different laser wavelengths. Holmium lasers emit at 2130 nm and the corresponding penetration depth into tissue/stones is 420 µm. When comparing with Thulium lasers at 2013 nm the penetration is less than 50% (170 um) lower which enables a higher precision of the ablation process.
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Risk Analvsis
Risk Analysis was performed to ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices. The Risk Analysis was reviewed by as part of IEC 60601-1 by a recognized testing Laboratory.
Summary of Performance Testing
Performance testing was conducted to verify the performance of the RevoLix HTL and its substantial equivalence with respect to safety and effectiveness to the cleared predicate system.
- Validation and Verification testing confirms that the device performance meets specifications . and assures the safety and effectiveness of the System Laser.
- Electrical and laser safety, electromagnetic compatibility testing and other standard tests . required to conform to the regulatory standards as follows:
- IEC 60601-1-2 (Ed. 4.0) Medical electrical equipment Part 1-2: General o requirements for safety - Collateral standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 (Ed. 3.1) Medical electrical o equipment - Part 1: General requirements for basic safety and essential performance
- IEC 62304:2006+A1:2015 Medical devices software Software life-cycle processes O
- IEC 60601-1-6:2010 + A1:2013 (Ed. 3.1) Medical electrical equipment Part 1-6: o General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-22:2007 + A1:2012 (Ed. 3.1) Medical electrical equipment Part 2-22: o Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014/AC:2017 Safety of laser products Part 1: Equipment o classification and requirements
Non-Clinical Performance Testing
Software verification and validation testing was conducted, and documentation provided as recommended by FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304.
Biocompatibility of the patient contacting materials (laser fibers) was previously submitted in predicate device 510(k)s listed above.
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Clinical Performance Data
Clinical data were not deemed necessary as the device is using the same intended use and key technology, operating principles and indications for use as the predicate devices.
Conclusion
The RevoLix HTL device presents the same intended use and similar indications for use as its predicate devices. The RevoLix HTL performs in accordance with its requirements and specifications, in similarity to the predicate devices. The minor design differences do not raise any new safety and/or effectiveness as demonstrated by the performance data. Consequently, the RevoLix HTL was found to perform as well as its predicate and is substantially equivalent to the predicate device.
§ 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.