Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60

K192600 · Quanta System Spa · GEX · Feb 21, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192600
• Device Name: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 21, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Multicavity Holmium laser system (Litho/Cyber Ho series) uses pulsed Ho:YAG laser source to perform soft tissue surgery. Input: user-selected parameters via control electronics; Output: laser energy delivered via optical fibers. Operation: footswitch-triggered laser emission. Modification adds 'Virtual Basket' mode using pulse modulation. Used in OR/clinic by surgeons for incision, ablation, coagulation, and lithotripsy. Output allows precise tissue interaction/stone fragmentation, benefiting patients through minimally invasive surgical options.

Clinical Evidence

Bench testing only. No clinical data provided. Bench testing compared the new 'Virtual Basket' emission mode to the standard emission mode of the predicate device. Software verification and validation were conducted per FDA guidance.

Technological Characteristics

Pulsed Holmium laser (Ho:YAG) source, 2.1 µm wavelength. Max output 105W (100W version) or 60W (60W version). Pulse duration up to 1100 µs. Energy up to 5.0 J. Frequency 3-80 Hz. Delivery via optical fibers. Aiming beam: green diode laser < 5 mW. Cooling system, power/control electronics. Software-controlled pulse modulation (Virtual Basket mode).

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, resection, ablation, vaporization, coagulation, haemostasis) in urology (e.g., BPH, tumors, strictures, lithotripsy), gastroenterology (e.g., ulcers, polyps, neoplasms), arthroscopy (e.g., joint debridement, meniscectomy), spinal surgery (disc decompression), gynaecology, ENT (e.g., sinus surgery), and general surgery.

Regulatory Classification

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.

Predicate Devices

• Litho 60 (K172025)
• Litho 100 (K180922)

Reference Devices

• Family of Holmium Surgical Lasers (K170121)

Submission Summary (Full Text)

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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. 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

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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 ([e-mail]) or phone [phone] 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

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#### 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)

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· 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

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## · 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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# K192600 510(K) SUMMARY

| Applicant /<br>Manufacturer<br>Name and Address: | Quanta System SPA<br>Via Acquedotto, 109<br>Samarate (VA)<br>Italy, 21017 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) Contact<br>Person: | Francesco Dell'Antonio<br>Vice President Regulatory Affairs and QA<br>Quanta System SPA |
| | Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| 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<br>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.

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### 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<br>Litho 60/100 | K172025<br>K180922 |
|-------------------------------------|---------------------------------------------|--------------------|
| Laser Source | Unchanged | - |
| Laser cavity | Unchanged | - |
| Maximum output<br>power | Unchanged | - |
| Maximum emission<br>frequency power | Unchanged | - |
| Hardware | Unchanged | - |
| Software | Updated to support the new emission<br>mode | - |
| External appearance | Unchanged | - |
| Graphic user<br>interface | Unchanged | - |
| Virtual basket mode | Added | Not present |

### Summary of the technological characteristics

| | Subject device | predicate device(s) | additional reference<br>device |
|--------------|---------------------------------------------------|----------------------------------------------------|-----------------------------------|
| 510(k) | - | K172025/ K180922 | K170121 |
| model name | Litho 100, Cyber Ho 100, Litho 60,<br>Cyber Ho 60 | Litho 100, Cyber Ho 100 /<br>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<br>(CHT:YAG) | Pulsed Holmium laser<br>(CHT:YAG) |

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| Wavelength<br>(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<br>pulse | up to 5.0 Joule | up to 5.0 Joule | up to 6.0 J |
| Frequency | from 3 to 80 Hz (100W version)<br>from 3 to 60 Hz (60W version | from 3 to 80 Hz (100W<br>version)<br>from 3 to 60 Hz( 60W<br>version | from 5 to 80 Hz |
| Max average<br>power | 105 W (100W version)<br>60W (60W version) | 105 W (100W version)<br>60W (60W version) | 120 W |
| Pulse<br>modulation<br>mode | Virtual basket mode | | Moses effect |
| | | | |
| Delivery<br>system | Optical fibers | Optical fibers | Optical fibers |
| Aiming beam | Green diode laser < 5 mW | Green diode laser < 5 mW | Green diode laser < 5 mW |

## 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, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate
- dehydrate stones.
- . Endoscopic fragmentation of kidney calculi

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- 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

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- 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, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue

# ENT

Endoscopic endonasal surgery (incision, excision, 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, excision, 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

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### Accessories

This device is intended to be used together with delivery optical fiber that separately received a FDA clearance for an intended use compatible with the one of this device.

#### Performance testing

The subject device was subject to changes that do not affect the compliance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances.

The following testing were not repeated on the modified device, as there was no hardware or architecture change that could affect the following standards:

- -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

The following testing were performed on the modified device:

- -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".

#### Comparison with predicate device:

The subject and unmodified devices have intended use and the same fundamental scientific technology, based on Holmium laser sources.

#### Summary

The subject device is substantially equivalent to its identified predicate device.