(56 days)
No
The summary describes a laser system with standard components and software for controlling device functions and user selections. There is no mention of AI, ML, or image processing, which are common indicators of AI/ML integration in medical devices. The performance studies focus on electrical safety, EMC, and software validation according to standard guidance, not AI/ML specific performance metrics.
Yes
The device is described for use in various surgical procedures involving incision, resection, ablation, vaporization, coagulation, and haemostasis, which are therapeutic interventions. Additionally, it is specifically indicated for "Lithotripsy," which is a known therapeutic procedure to break down calculi.
No
The device is a laser system intended for surgical procedures, including incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue, not for diagnostic purposes.
No
The device description clearly states it is a laser system with multiple hardware components (Holmium laser source, optical delivery system, power electronics, control electronics, cooling system) in addition to software.
Based on the provided information, the Litho EVO laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used in surgical procedures for direct interaction with soft tissue and calculi within the body (in vivo). This includes procedures like incision, resection, ablation, vaporization, coagulation, haemostasis, and fragmentation of stones.
- Device Description: The device description details a laser system that delivers energy through fiber optics to the tissue. This is consistent with a surgical laser, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) for the purpose of providing information about a physiological state, health, disease, or congenital abnormality.
In summary, the Litho EVO is a surgical laser system used for therapeutic procedures directly on the patient, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Litho EVO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynaecology, ENT and General Surgery.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation,
- vaporization, coagulation and haemostasis) including:
- · Urethral Strictures
- · Bladder Neck Incisions (BNI)
- · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
- · Ablation of Benign Prostatic Hypertrophy (BPH).
- · Transurethral incision of the prostate (TUIP)
- · Holmium Laser Resection of the Prostrate (HoLRP)
- · Holmium Laser Enucleation of the Prostate (HoLEP)
- · Holmium laser Ablation of the Prostate (HoLAP)
- · Condylomas
- · Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
- monohydrate and calcium oxalate dehydrate stones.
- · Endoscopic fragmentation of kidney calculi
- · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Polyps
- · Biopsy
- · Gall Bladder calculi
- Biliary/Bile duct calculi
- · Ulcers
- · Gastric ulcers
- · Duodenal ulcers
- · Non Bleeding Ulcers
- Pancreatitas
- Haemorrhoids
- · Cholecystectomy
- Benign and Malignant Neoplasm
- Angiodysplasia
- Colorectal cancer
- · Telangiectasias
- · Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- · Gastritis
- · Esophagitis
- Esophageal ulcers
- Varices
- · Colitis
- · Mallory-Weiss tear
- · Gastric Erosions
Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
- · Ligament and tendon Release
- · Contouring and sculpting of articular surfaces
- · Capsulectomy in the Knee
- · Chondreplasty in the Knee
- Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- Chondromalacia and tears
- · Plica Removal
- · Meniscectomy
- Loose Body Debridement
- · Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
- · Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
- Percutaneous Thoracic Disc Decompression/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
- · Endonasal/sinus Surgery
- · Partial turbinectomy
- · Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- · Maxillary antrostomy
- · Functional endoscopic sinus surgery
General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Skin incision
- · Excision of external and internal lesions
- · Complete of partial resection of internal organs, tumors and lesions
- Biopsv
Product codes
GEX
Device Description
Litho Evo is based on Holmium laser cavity emitting at 2100nm.
Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system.
Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, ureteral, bladder, renal, kidney, prostate, external genitalia, bladder, uretheral, ureteral, gall bladder, biliary/bile duct, gastric, duodenal, gastrointestinal tract, colon, esophagus, knee, small and large joints of the body (excluding spine), L4-5 and L5-SI lumbar discs, cervical disc, thoracic disc, female pelvic organs/tissues, nose/sinuses, skin, internal organs.
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)
Litho Evo was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:
-IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
-IEC 60601-2-22: 2012-10 ed 3.1, 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 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements
-Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Litho Evo passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards.
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.
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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, there is a circular seal with an abstract design of human figures. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG ADMINISTRATION' are written in a bold, sans-serif font. The words 'FOOD & DRUG' are on the top line, and the word 'ADMINISTRATION' is on the bottom line.
December 20, 2019
Quanta System SPA Francesco Dell'Antonio Vice President Regulatory Affairs and QA via Acquedotto 109 Samarate (Va), 21017 IT
Re: K192990
Trade/Device Name: Litho Evo 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: September 27, 2019 Received: October 25, 2019
Dear Francesco Dell'antonio:
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192990
Device Name Litho EVO
Indications for Use (Describe)
The Litho EVO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynaecology, ENT and General Surgery.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation,
- vaporization, coagulation and haemostasis) including:
- · Urethral Strictures
- · Bladder Neck Incisions (BNI)
- · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
- · Ablation of Benign Prostatic Hypertrophy (BPH).
- · Transurethral incision of the prostate (TUIP)
- · Holmium Laser Resection of the Prostrate (HoLRP)
- · Holmium Laser Enucleation of the Prostate (HoLEP)
- · Holmium laser Ablation of the Prostate (HoLAP)
- · Condylomas
- · Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
- monohydrate and calcium oxalate dehydrate stones.
- · Endoscopic fragmentation of kidney calculi
- · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Polyps
- · Biopsy
- · Gall Bladder calculi
- Biliary/Bile duct calculi
- · Ulcers
- · Gastric ulcers
- · Duodenal ulcers
- · Non Bleeding Ulcers
- Pancreatitas
- Haemorrhoids
FORM FDA 3881 (1/14)
3
- · Cholecystectomy
- Benign and Malignant Neoplasm
- Angiodysplasia
- Colorectal cancer
- · Telangiectasias
- · Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- · Gastritis
- · Esophagitis
- Esophageal ulcers
- Varices
- · Colitis
- · Mallory-Weiss tear
- · Gastric Erosions
Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
- · Ligament and tendon Release
- · Contouring and sculpting of articular surfaces
- · Capsulectomy in the Knee
- · Chondreplasty in the Knee
- Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- Chondromalacia and tears
- · Plica Removal
- · Meniscectomy
- Loose Body Debridement
- · Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
- · Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
- Percutaneous Thoracic Disc Decompression/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
- · Endonasal/sinus Surgery
- · Partial turbinectomy
- · Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- · Maxillary antrostomy
4
· Functional endoscopic sinus surgery
General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Skin incision
- · Excision of external and internal lesions
- · Complete of partial resection of internal organs, tumors and lesions
- Biopsv
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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5
K192990 510(K) SUMMARY
| Applicant /
Manufacturer
Name and Address: | Quanta System SPA
Via Acquedotto, 109
Samarate (VA)
Italy, 21017 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio
Vice President Regulatory Affairs and QA
Quanta System SPA |
| | Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 |
| Date Prepared: | 27th September 2019 |
| Common name: | Holmium laser device |
| Brand name: | Litho Evo |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery
and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Basis for Submission: | Device modifications |
| Legally Marketed Device: | Olympus Empower H35 (K180426) – Quanta System SPA |
| Reference predicate device: | Litho 100 (K180922) – Quanta System SPA |
The modified device Litho Evo is derived from the legally marketed (unmodified) device Olympus Empower H35 (K180426).
Performance Standards:
There are no mandatory performance standards for this device.
6
Description of the device:
Litho Evo is based on Holmium laser cavity emitting at 2100nm.
Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system.
Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
Description of the modifications:
This Special 510(k) of Litho Evo is submitted due to Device Modifications of the already cleared device Olympus Empower H35 (K180426) due to some technical modifications.
The subject device has the same technological characteristics (design, material, components, energy source) as the predicate device except for the differences shown in the table below.
| | Subject device Litho Evo | Main predicate device
Empower H35 | Reference predicate
device Litho 100 |
|---------------------------------------------|-------------------------------------------------------|--------------------------------------|-----------------------------------------|
| External
appearance | Cosmetic change from the
main predicate | - | - |
| Graphic user
interface and
software | Same as the reference
predicate | - | - |
| Footswitch | Double footswitch, Same as
the reference predicate | Single footswitch | Double footswitch |
| Hardware,
components and
performances | Same as main predicate | - | - |
The modified device has the same intended use of the unmodified device. Moreover, the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.
A comparison of the technical characteristics of the subject device and its predicates follows:
| Subject device | Main predicate device | Reference predicate device | |
|---|---|---|---|
| model name | Litho Evo | Empower H35 | Litho 100 |
| manufacturer | Quanta System SpA | Quanta System SpA | Quanta System SpA |
| 510(k) | - | K180426 | K180922 |
| Laser Source | Pulsed Holmium laser | ||
| (CHT:YAG) | Pulsed Holmium laser | ||
| (CHT:YAG) | Pulsed Holmium laser | ||
| (CHT:YAG) |
7
| | Subject device | Main predicate device | Reference predicate
device |
|----------------------|-------------------|--------------------------|-------------------------------|
| Wavelength
(nm) | 2.1 μm | 2.1 μm | 2.1 μm |
| Emission | pulsed | pulsed | pulsed |
| Pulse
duration | Up to 1100µs | Up to 1500 µs | Up to 1100µs |
| Energy per
pulse | up to 5.0 Joule | up to 5.0 Joule | up to 5.0 Joule |
| Frequency | from 3 to 30 Hz | from 3 to 30 Hz | from 3 to 80 Hz |
| Max average
power | 35 W | 35 W | 105W |
| Delivery
system | Optical fibers | Optical fibers | Optical fibers |
| Aiming beam | green 532nm