(154 days)
No
The description focuses on the hardware components and basic software control, with no mention of AI or ML capabilities.
Yes
The device is a therapeutic device because its intended use includes surgical procedures for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue, which directly treats medical conditions.
No
The device description and intended use clearly state that it is a surgical laser system used for procedures like incision, resection, ablation, and coagulation of soft tissue. It is not described as detecting or monitoring medical conditions.
No
The device description explicitly lists hardware components such as a Holmium laser source, power electronics, optical delivery system, control electronics, cooling system, and a footswitch. While software controls the device, it is an integral part of a larger hardware system.
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 procedures directly on soft tissue within the body (incision, resection, ablation, etc.). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a laser source, power electronics, optical delivery system, control electronics, and cooling system. These are components of a surgical device, not a device designed to analyze samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device performs surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
The Multicavity Holmium 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: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, 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 urethral, 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
- Biopsy
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source.
The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, Urethral, Bladder, Renal, Ureteral, Prostate, External genitalia, Appendix, Colon, Gall Bladder, Biliary/Bile duct, Stomach, Duodenum, Pancreas, Rectum, Esophagus, Joints (Knee), Ligaments, Tendons, Spine (L4-5, L5-S1 lumbar discs, cervical, thoracic discs), Nose, Sinuses.
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)
Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device
Software Verification and Validation Testing: 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".
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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Quanta System Spa Francesco Dell'antonio Vice President Regulatory Affairs and QA via Acquedotto 109 Samarate (Va), 21017 It
Re: K192600
Trade/Device Name: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 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: November 21, 2019 Received: November 22, 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.
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
1
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,
Jessica Mavadia-Shukla, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192600
Device Name
Litho 100, Cyber Ho 100, Litho 60, Cyber Ho 60
Indications for Use (Describe)
The Multicavity Holmium 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: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, 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 urethral, 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
FORM FDA 3881 (1/14)
3
· 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
4
· 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
- · Biopsy
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
K192600 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: | September 12th 2019 |
| Brand Names: | Litho 100, Cyber Ho 100, Litho 60, Cyber Ho 60 |
| Common name: | Multicavity Holmium laser |
| 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 |
| Predicate Device | Litho 60 (K172025) – Quanta System SPA |
| Predicate Device | Litho 100 (K180922) — Quanta System SPA |
| Reference Device | Family of Holmium Surgical Lasers (K170121) - Lumenis LTD |
The subject device is derived from the legally marketed (predicate) deviced Litho 60 (K172025) and Litho 100 (K180922).
Performance Standards:
There are no mandatory performance standards for this device.
6
Description of the device:
The devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source.
The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.
Description of the modifications:
The device has the same technological characteristics as the predicate device.
This Special 510(k) is submitted due to Device Modifications of the original device due to a change to the software, adding an emission mode (Virtual Basket) based on pulse modulation.
The modified device has the same intended use of the predicate 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 software verifications and validation according to the relevant standards.
| | Subject device
Litho 60/100 | K172025
K180922 |
|-------------------------------------|---------------------------------------------|--------------------|
| Laser Source | Unchanged | - |
| Laser cavity | Unchanged | - |
| Maximum output
power | Unchanged | - |
| Maximum emission
frequency power | Unchanged | - |
| Hardware | Unchanged | - |
| Software | Updated to support the new emission
mode | - |
| External appearance | Unchanged | - |
| Graphic user
interface | Unchanged | - |
| Virtual basket mode | Added | Not present |
Summary of the technological characteristics
| | Subject device | predicate device(s) | additional reference
device |
|--------------|---------------------------------------------------|----------------------------------------------------|-----------------------------------|
| 510(k) | - | K172025/ K180922 | K170121 |
| model name | Litho 100, Cyber Ho 100, Litho 60,
Cyber Ho 60 | Litho 100, Cyber Ho 100 /
Litho 60, Cyber Ho 60 | Holmium Surgical Lasers |
| manufacturer | Quanta System SpA | Quanta System SpA | Lumenis LTD |
| Laser Source | Pulsed Holmium laser (CHT:YAG) | Pulsed Holmium laser
(CHT:YAG) | Pulsed Holmium laser
(CHT:YAG) |
7
| Wavelength
| (nm) | 2.1 µm | 2.1 µm | 2.1 µm |
|---|---|---|---|
| Emission | pulsed | pulsed | pulsed |
| Pulse duration | up to 1100 µs | up to 1100 µs | up to 1300 us |
| Energy per | |||
| pulse | up to 5.0 Joule | up to 5.0 Joule | up to 6.0 J |
| Frequency | from 3 to 80 Hz (100W version) | ||
| from 3 to 60 Hz (60W version | from 3 to 80 Hz (100W | ||
| version) | |||
| from 3 to 60 Hz( 60W | |||
| version | from 5 to 80 Hz | ||
| Max average | |||
| power | 105 W (100W version) | ||
| 60W (60W version) | 105 W (100W version) | ||
| 60W (60W version) | 120 W | ||
| Pulse | |||
| modulation | |||
| mode | Virtual basket mode | Moses effect | |
| Delivery | |||
| system | Optical fibers | Optical fibers | Optical fibers |
| Aiming beam | Green diode laser |