(29 days)
No
The document describes hardware and software changes to a laser system for surgical procedures and lithotripsy, but there is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on electrical safety and laser performance standards.
Yes
The device is indicated for use in surgical procedures to perform various therapeutic actions like incision, resection, ablation, vaporization, coagulation, haemostasis of soft tissue, and lithotripsy of stones.
No
The device description focuses on surgical procedures (incision, resection, ablation, vaporization, coagulation, haemostasis, lithotripsy) which are therapeutic, not diagnostic. While some laser equipment can be diagnostic, the specific indications for this device do not include diagnosis.
No
The device description explicitly states "hardware and software change" and the performance studies section lists standards related to electrical safety and laser equipment, indicating a physical hardware component.
Based on the provided text, 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 like incision, resection, ablation, vaporization, coagulation, haemostasis of soft tissue, and lithotripsy of stones. These are all direct surgical interventions on the body.
- Device Description: The description confirms it's a laser system with hardware and software modifications for surgical use.
- 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) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Cyber Ho laser system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, stones
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)
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.
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.
Not Found
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/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, stacked on top of each other.
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
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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: | UrologyGastroenterologyArthroscopyNeurosurgeryPulmonaryGynecologyENTDermatologyPlastic SurgeryGeneral Surgery |
| Type of Use (Select one or both, as applicable) | 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)
| FORM FDA 3881 (1/14) | Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
3
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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 /
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: | February 1st 2017 |
| Device Name: | Cyber Ho |
| 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 | Litho (K163009) - Quanta System SPA
Lumenis Pulse 120h (K140388) - Lumenis LTD |
Performance Standards:
There are no mandatory performance standards for this device.
5
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 .
6
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.