(366 days)
No
The device description focuses on the hardware and basic software control of a laser system, with no mention of AI or ML capabilities for image processing, data analysis, or automated decision-making.
Yes
The device is used for soft tissue treatments and lithotripsy in the field of urology, including enucleation/vaporization of the prostate, opening of strictures, tumor resections/ablation, and lithotripsy of stones. These are all therapeutic medical procedures.
No
The RevoLix HTL is described as a surgical laser used for various soft tissue treatments and lithotripsy procedures in urology. Its function is to deliver laser radiation for therapeutic purposes, such as tissue enucleation, vaporization, tumor ablation, and stone fragmentation, not to diagnose medical conditions.
No
The device description clearly states it is a "surgical diode-pumped solid-state laser (DPSS)" and describes physical components like a "floor standing mobile device," "operating console," "touch screen," "control elements," "foot switch," and "flexible silica laser fiber." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for treating soft tissues and performing lithotripsy within the urogenital tract. These are direct surgical interventions on the body, not tests performed on samples taken from the body.
- Device Description: The device description details a surgical laser that delivers radiation via a fiber to a surgical site. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for 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).
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urogenital tract (bladder, ureter, kidney), prostate, urethra, penis.
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)
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), IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 (Ed. 3.1), IEC 62304:2006+A1:2015, IEC 60601-1-6:2010 + A1:2013 (Ed. 3.1), IEC 60601-2-22:2007 + A1:2012 (Ed. 3.1), IEC 60825-1:2014/AC:2017. 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. 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. 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.
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.
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 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.
1
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
2
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 GmbH |
| Albert-Einstein-Str. 4 | |
| 37191 Katlenburg-Lindau, Germany | |
| Contact Person: | Dr. Ralf Balkenhol |
| Quality 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 Plastic |
| Surgery 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).
4
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 HTL
Proposed Device | Sphinx jr.
K132975
Primary
Predicate Device | RevoLix 200
K110941
Secondary
Predicate Device | Lumenis Pulse
120H
K140388
Reference Device | Substantial
Equivalence? |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | LISA Laser
Products GmbH | LISA Laser
Products GmbH | LISA Laser
Products GmbH | Lumenis Ltd. | -- |
| Product Code | GEX | GEX | GEX | GEX | Yes, same product
code |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Yes, same
regulation |
| Device Class | II | II | II | II | Yes, same device
class |
| Intended Use | The RevoLix HTL
is a surgical laser
intended for non-
invasive, 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). | The Sphinx jr.
laser system and
its fiber optic
delivery system are
intended for use in
surgical
procedures using
open, laparoscopic
and endoscopic
incision, excision,
resection, ablation,
vaporization,
coagulation and
hemostasis of soft
and hard tissue in
use in medical
specialties
including:
Urology, Urinary
Lithotripsy,
Gasteroenterology,
Arthroscopy,
Discectomy,
Pulmonary,
Gynecology, ENT,
Dermatology,
Plastic Surgery and
General
Surgery | The RevoLix 200
laser systems and
their fiber optic
delivery system
are intended for
use in surgical
procedures using
open, laparoscopic
and endoscopic
incision, excision,
resection, ablation,
vaporization,
coagulation and
hemostasis of soft
tissue in use in
medical specialties
including:
Urology,
Gastroenterology,
Thoracic and
Pulmonary,
Gynecology, ENT,
Dermatology,
Plastic Surgery,
General Surgery.
and Arthroscopy | Lumenis Pulse
120H is intended
for use in surgical
procedures
involving open,
laparoscopic and
endoscopic
ablation,
vaporization,
excision, incision,
and coagulation of
soft tissue in
medical specialties
including: urology;
urinary lithotripsy;
arthroscopy;
discectomy; ENT.
surgery;
gynecological
surgery;
pulmonary
surgery;
gastroenterology
surgery;
dermatology and
plastic surgery and
general surgery. | Yes, same intended
use with the
primary predicate
device.
Large degree of
overlap with the
secondary
predicate |
| Indications
for use | Soft tissue
treatments and
lithotripsy in the
field of urology:
• Enucleation of
the prostate
• Vaporization
of the prostate
• Opening of
ureter and | - Urology
Open and
endoscopic surgery
(incision, excision,
resection, ablation,
vaporization,
coagulation and
hemostasis)
including: | - Urology
Open and
endoscopic surgery
(incision, excision,
resection, ablation,
vaporization,
coagulation and
hemostasis)
including: | - Urology
Endoscopic
transurethral
incision of the
prostate (TUWP),
bladder neck
incision of the
prostate (BNI),
holmium laser
ablation of the
prostate (HoLAP), | Yes, equivalent
The RevoLix HTL
has the same
indications in
urology. Predicate
devices have
additional
indication in other
fields |
| Device Name | RevoLix HTL
Proposed Device | Sphinx jr.
K132975
Primary
Predicate Device | RevoLix 200
K110941
Secondary
Predicate Device | Lumenis Pulse
120H
K140388
Reference Device | Substantial
Equivalence? |
| | 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 Strictures
Bladder Neck Incisions
Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors.
Ablation of Benign Prostatic Hypertrophy (BHP)
Resection of the Prostate
Condylomas
Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi
Endoscopic fragmentation of kidney calculi
Treatment of steinstrasse when guide wire cannot be passed
Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic surgery, General Surgery,
Arthroscopy | Urethral Strictures
Bladder 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)
Condylomas
Lesions of external genitalia
Gastroenterology, 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 HTL
Proposed Device | Sphinx jr.
K132975
Primary
Predicate Device | RevoLix 200
K110941
Secondary
Predicate Device | Lumenis Pulse
120H
K140388
Reference Device | Substantial
Equivalence? |
| | | | | including cystine,
calcium oxalate,
monohydrate and
calcium oxalate
dihydrate stones;
treatment of distal
impacted
fragments of
steinstrasse when
guide wires cannot
be passed. | |
| | | | | Arthroscopy,
General Surgery,
ENT Surgery,
Gynecological
Surgery,
Gastroenterology
Surgery,
Pulmonary
Surgery,
Dermatology and
Plastic Surgery | |
| Laser type | Tm:YAG Diode
Pumped Solid
State laser | -- | Tm:YAG Diode
Pumped Solid
State laser | | Yes, same laser
type |
| | -- | HoYAG flash lamp
pumped solid state
laser | -- | HoYAG flash lamp
pumped solid state
laser | |
| Wavelength | Tm:YAG 2013 nm
(±10 nm) | -- | 2.01 μm | | Yes, same
wavelength |
| | -- | 2123 nm (± 3 nm) | -- | 2.1 μm | Equivalent, the
difference in
wavelengths has
been shown in
V&V tests to have
negligible effect on
safety and
performance. |
| CW mode | Power: 5 - 150W
RevoLix HTL eco:
5 - 75 W | -- | Power: max 200W | | Equivalent, higher
power in CW
mode.
Same / lower
power compared to
reference device |
| Pulse mode | Average power:
5 - 150W | Average power:
max. 30W | Average Power:
max. 200W | Average Power:
max 120W | Equivalent, the
average power in
Pulsed mode for |
| Device Name | RevoLix HTL
Proposed Device | Sphinx jr.
K132975
Primary
Predicate Device | RevoLix 200
K110941
Secondary
Predicate Device | Lumenis Pulse
120H
K140388
Reference Device | Substantial
Equivalence? |
| | RevoLix HTL eco:
5 - 75 W | | | | RevoLix HTL
exceeds that of the
Sphinx jr. This
represents a
technical
advancement and
is unlikely to affect
safety and
performance of the
RevoLix HTL. |
| | Pulse peak power:
max. 1.3 kW | Pulse peak power:
max. 18 kW | Pulse peak power:
max. 200W | unknown | The RevoLix HTL
has a lower pulse
peak power. |
| | Pulse energy:
0.3 - 4.5 J | Pulse energy:
0.3 - 3.5 J | n/a | 0.2 - 6 J | The RevoLix HTL
is capable of
achieving a pulse
energy in the same
range as in the
equivalent devices. |
| | Pulse repetition
rate:
5 - 300 Hz | Pulse repetition
rate:
1 - 20 Hz | Pulse repetition
rate:
0.5 - 10 Hz | Pulse repetition
rate:
5 - 80 Hz | The RevoLix HTL
is capable of
achieving a pulse
repetition rate in
the same range as
in the equivalent
devices. |
| | Pulse duration:
200 - 4750 µs | Pulse duration:
max. 650 µs | Pulse duration:
50 - 1000 ms | Pulse duration:
short / mid / long
max 1300 µs | The RevoLix HTL
is capable of
achieving a pulse
duration in the
same range as in
the equivalent
devices. |
| 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 only
offers a 532 nm
beam, the other
devices also offer a
635 nm beam. The
wavelength of the
aiming beam has
negligible effect on
safety and
performance. |
| | Power: 1 - 3 mW | Power: max. 5
mW | Power: max. 1
mW, | Power: max. 5
mW, | Yes, similar.
The power of the
aiming beam
offered by
RevoLix HTL lies |
6
7
8
9
| Device Name | RevoLix HTL
Proposed Device | Sphinx jr.
K132975
Primary
Predicate Device | RevoLix 200
K110941
Secondary
Predicate Device | Lumenis Pulse
120H
K140388
Reference Device | Substantial
Equivalence? |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 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 - silica
multimode fibre | Beam delivery:
silica - silica
multimode fibre | Beam delivery:
silica - silica
multimode fibre | Beam delivery:
silica - silica
multimode fibre | Yes, identical |
| User panel | Colour LCD
display (GUI),
touch sensitive | Colour LCD
Display (GUI),
touch sensitive | White/blue LCD
display (GUI), 3
buttons, 1
thumbwheel | Colour LCD
display (GUI),
touch sensitive | Yes, identical with
Secondary
predicate.
Similar to primary
predicate |
| Laser trigger | Foot switch | Foot switch | Foot switch | Foot switch | Yes, identical |
| Treatment
parameters | User selected | User selected | User selected | User selected | Yes, identical |
| Operating
Conditions | 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), and
Air pressure:
700 - 1060 hPa | Temperature:
+18 - +28 °C,
Relative humidity:
10 - 90 % (non-
condensing),
Air pressure:
700 - 1060 hPa | Temperature:
+10 - +24 °C
Relative humidity:
max. 75 %(non-
condensing)
Air pressure:
77 - 106 kPa | Yes, identical |
| Shipping &
storage
Conditions | 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 °C
Relative humidity:
95% at 20 °C non-
condensing
Air pressure:
77 - 106 kPa | Yes, similar. |
| Input power | 200 V - 240 V,
50/60 Hz, Max. 10
A (1~, N, PE)
110 V - 115 V,
50/60 Hz, Max. 20
A (1~, N, PE) | 210 V - 230 V,
50/60 Hz, max. 10
A (1~, N, PE)
110 V - 115 V,
50/60 Hz, max. 20
A (1~, N, PE) | 230 V AC, 50/60
Hz, (1~, N, PE),
max. 20 A | 200 - 240 V AC,
50/60 Hz, max. 46
A | Yes, consistent
values for US
market |
| Weight | 108 kg | 95 kg | approx. 140 kg | 240 kg | Yes, similar |
| Size
(HxWxD) | 1025 x 450 x 740
mm | 1000 x 450 x 740
mm | 950 x 420 x 890
mm | 105 x 47 x 116 cm | Yes, equivalent
sizes.
Mobile floor
standing devices
with castors |
| Laser safety | FDA CDRH 21
CFR 1040 (Laser
Notice 56) | FDA CDRH 21
CFR 1040 (Laser
Notice 56) | FDA CDRH 21
CFR 1040 (Laser
Notice 56) | FDA CDRH 21
CFR 1040 | Yes |
| Device Name | RevoLix HTL
Proposed Device | Sphinx jr.
K132975
Primary
Predicate Device | RevoLix 200
K110941
Secondary
Predicate Device | Lumenis Pulse
120H
K140388
Reference Device | Substantial
Equivalence? |
| | 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 | |
10
| TISSUE | |||||||
|---|---|---|---|---|---|---|---|
| ContinuousWave (CW) Mode | |||||||
| Device Name | RevoLix HTL | ||||||
| Proposed Device | RevoLix 200 | ||||||
| K110941 | |||||||
| Secondary Predicate Device | Modification | ||||||
| CW mode | Power: 5 - 150W | ||||||
| RevoLix HTL eco: | |||||||
| 5 - 75 W | Power: max 200W | Lower output | |||||
| power therefore | |||||||
| lower risk | |||||||
| Laser type | Tm:YAG Diode Pumped Solid State | ||||||
| laser | Tm:YAG Diode Pumped Solid State | ||||||
| laser | No change | ||||||
| Wavelength | 2013 nm | 2013 nm | No change | ||||
| LITHOTRIPSY | |||||||
| PULSED MODE | |||||||
| RevoLix HTL | |||||||
| Proposed Device | Sphinx jr. | ||||||
| K132975 | |||||||
| Primary | |||||||
| Predicate Device | Lumenis Pulse | ||||||
| 120H | |||||||
| K140388 | |||||||
| Reference Device | Quanta Cyber Ho | ||||||
| 150W | |||||||
| K201455 Second | |||||||
| Reference | Modification | ||||||
| Pulse mode | Average power: | ||||||
| 5 - 150W | |||||||
| RevoLix HTL eco: | |||||||
| 5 - 75 W | Average power: | ||||||
| max. 30W | Average Power: | ||||||
| max 120W | Average Power: | ||||||
| max 150W | Same range of | ||||||
| average power | |||||||
| Pulse peak | |||||||
| power | max. 1.3 kW | max. 18 kW | >10kW | >10kW | Lower peak power | ||
| than Holmium | |||||||
| based lasers. | |||||||
| Thulium higher | |||||||
| absorption allows | |||||||
| for lower pulse | |||||||
| peak powers | |||||||
| increasing safety. | |||||||
| See graph. | |||||||
| Lower pulse peak | |||||||
| powers | |||||||
| significantly reduce | |||||||
| the retropulsion of |
11
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.
12
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.
13
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.