Cyber Ho

K170331 · Quanta System Spa · GEX · Mar 3, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170331
• Device Name: Cyber Ho
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. It is indicated in medical specialties including, but not limited to: Urology Gastroenterology Arthroscopy Neurosurgery Pulmonary Gynecology ENT Dermatology Plastic Surgery General Surgery

Device Story

Cyber Ho is a Holmium laser surgical system; utilizes fiber optic delivery system to transmit laser energy to target tissue or stones. Operates via incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue; performs lithotripsy. Used in OR or clinical settings by physicians (urologists, surgeons, etc.). Device provides controlled laser emission; parameters (power, energy, frequency) adjusted by operator to achieve desired surgical effect. Benefits include precise tissue management and stone fragmentation. Modifications from predicate Litho include hardware/software changes and expanded emission parameter ranges.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (EN 60601-1-6), laser-specific performance (IEC 60601-2-22), and laser safety (IEC 60825-1).

Technological Characteristics

Holmium laser source; fiber optic delivery. Complies with IEC 60601-1, IEC 60601-1-2, EN 60601-1-6, IEC 60601-2-22, and IEC 60825-1. Hardware and software modified from predicate; expanded power, energy, and frequency ranges.

Indications for Use

Indicated for patients requiring surgical soft tissue procedures (incision, excision, resection, ablation, vaporization, coagulation, hemostasis) or lithotripsy across various specialties including urology, gastroenterology, arthroscopy, neurosurgery, pulmonary, gynecology, ENT, dermatology, plastic, 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 (K163009)
• Lumenis Pulse 120h (K140388)

Submission Summary (Full Text)

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

March 3, 2017

Quanta System Spa Francesco Dell'Antonio Vice President Regulatory Affairs and QA Via Acquedotto 109 Samarate (va), 21017 IT

Re: K170331

Trade/Device Name: Cyber Ho 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: February 1, 2017 Received: February 2, 2017

Dear Mr. 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 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

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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.

Sincerely,

# Jennifer R. Stevenson -S

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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K170331 |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Cyber Ho |
| Indications for Use (Describe) | The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. |
| It is indicated in medical specialties including, but not limited to: | <ul><li>Urology</li><li>Gastroenterology</li><li>Arthroscopy</li><li>Neurosurgery</li><li>Pulmonary</li><li>Gynecology</li><li>ENT</li><li>Dermatology</li><li>Plastic Surgery</li><li>General Surgery</li></ul> |
| Type of Use (Select one or both, as applicable) | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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)

| FORM FDA 3881 (1/14) | Page 1 of 2 | PSC Publishing Services [phone] EF |
|----------------------|-------------|-------------------------------------------|
|----------------------|-------------|-------------------------------------------|

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

## Introduction:

This document contains the 510(k) Summary for the device Cyber Ho. 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: | February 1st 2017 |
| Device Name: | Cyber Ho |
| 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 | Litho (K163009) - Quanta System SPA<br>Lumenis Pulse 120h (K140388) - Lumenis LTD |

## Performance Standards:

There are no mandatory performance standards for this device.

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## Description of the modifications:

This Special 510(k) of the modified device Cyber Ho is submitted due to Device Modifications of the already cleared device Litho (K163009) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power, energy and frequency.

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 electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards.

## Intended Use/Indications for Use

The modified device Cyber Ho has the same intended use of the unmodified device, as follows:

The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and in Lithotripsy of stones.

It is indicated in medical specialties including, but not limited to:

- . Urology
- Gastroenterology
- Arthroscopy .
- . Neurosurgery
- Pulmonary .
- . Gynecology
- 0 ENT
- Dermatology 0
- Plastic Surgery ●
- General Surgery .

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#### Substantial Equivalence:

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

The modified device Cyber Ho has a broader range of emission parameters compared to the unmodified device Litho, therefore another predicate device, Lumenis Pulse 120h (K140388), has been considered in order to demonstrate the safety and effectiveness of the parameters combinations not included in the unmodified device.

Thus the modified device Cyber Ho is substantially equivalent to its identified predicate devices.

## Performace testing

The modified device Cyber Ho 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 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

> IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

> EN 60601-1-6:2010 + A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

> 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. 2.0 (2007) Safety of laser products - Part 1: Equipment classification and requirements

The modified device Cyber Ho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.