Litho 60

K172025 · Quanta System Spa · GEX · Jul 31, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172025
• Device Name: Litho 60
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 31, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LITHO 60 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 haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Device Story

Litho 60 is a Holmium laser system used for surgical soft tissue procedures. It delivers laser energy via a fiber optic delivery system to perform incision, excision, resection, ablation, vaporization, coagulation, and haemostasis. Operated by physicians in clinical settings (OR, endoscopic suites), the device provides precise tissue interaction controlled by the surgeon. It is used for diverse applications including urological lithotripsy, gastroenterology, arthroscopy, and ENT surgery. The device functions as a modification of the previously cleared Cyber Ho system, maintaining the same fundamental scientific technology. Clinical benefit is derived from the laser's ability to perform minimally invasive surgical tasks with controlled thermal effects on tissue.

Clinical Evidence

Bench testing only. The device underwent performance testing and software verification/validation to demonstrate compliance with IEC 60601-2-22:2007+A1:2012 and IEC 60825-1 Ed. 3.0 (2014). No clinical data was required or provided.

Technological Characteristics

Holmium laser surgical instrument. Energy source: Laser. Connectivity: Not specified. Sterilization: Not specified. Software: Embedded firmware for laser control. Standards: IEC 60601-2-22 (safety/performance of surgical laser equipment), IEC 60825-1 (laser safety).

Indications for Use

Indicated for patients requiring surgical incision, excision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue across urology (e.g., BPH, tumors, strictures), urinary lithotripsy (calculi fragmentation), gastroenterology, arthroscopy (small/large joints, spinal disc decompression), gynaecology, ENT (endonasal/sinus), 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

• Cyber Ho (K170331)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2017

Quanta System SPA Francesco Dell' Antonio Vice President Regulatory Affairs and QA Via Acquedotto. 109 Samarate (VA), Italy 21017

Re: K172025

Trade/Device Name: 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: June 27, 2017 Received: July 5, 2017

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. The general controls provisions of the Actinclude 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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172025

Device Name litho 60

LITHO 60 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, 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 (BHP),
- · 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

{3}------------------------------------------------

· Non Bleeding Ulcers

- · Pancreatitas
- Haemorrhoids
- · Cholecvstectomy
- · 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, excision, resection, ablation, vaporization 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)

#### 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)

#### This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

## 5. Special 510(K) SUMMARY - Device Modifications

## Introduction:

This document contains the 510(k) Summary for the device Litho 60. The basis of this submission is Modifications to a Device already cleared. The content of this summary is based on the requirements of 21 CFR 807.92(c).

| Applicant /<br>Manufacturer<br>Name and Address: | Quanta System SPA<br>Via Acquedotto, 109<br>Samarate (VA)<br>Italy, 21017 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) Contact 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: | June 27th 2017 |
| Device Name: | Litho 60 |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Basis for Submission: | Device modifications |
| Legally Marketed Device | Cyber Ho (K170331) - Quanta System SPA |

## Performance Standards:

There are no mandatory performance standards for this device.

{6}------------------------------------------------

## Description of the modifications:

This Special 510(k) of the modified device Litho 60 is submitted due to Device Modifications of the already cleared device Cyber Ho (K170331) due to some technical changes.

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.

## Intended Use/Indications for Use

The modified device Litho 60 has the same intended use of the unmodified device, as follows:

LITHO 60 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 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 (BHP), ●
- 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
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

{7}------------------------------------------------

#### 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 ●

{8}------------------------------------------------

- 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:

- o Appendectomy
- Skin incision
- Excision of external and internal lesions
- . Complete of partial resection of internal organs, tumors and lesions
- Biopsy

{9}------------------------------------------------

#### Substantial Equivalence:

The modified and unmodified devices have the same intended use and the same fundamental scientific technology, based on Holmium laser sources, thus the modified device Litho 60 is substantially equivalent to its identified predicate devices.

### Performace testing

The modified device Litho 60 was subjected to performance testing in accordance with the following recognized consensus standards:

> IEC 60601-2-22:2007+ A1:2012 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 modified device Litho 60 passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.