(193 days)
Not Found
No
The summary describes a surgical system for eye procedures and does not mention any AI or ML capabilities.
Yes.
The device is used for surgical treatment of the eye, performing procedures like phacoemulsification and vitrectomy to address pathologies.
No
Explanation: The device description and intended use clearly state that the VISALIS V500/S500 Surgical System is used for surgical treatment of the eye, performing procedures like phacoemulsification, vitrectomy, and coagulation. It does not mention any diagnostic functions.
No
The device description explicitly states it is a "Surgical System" and mentions hardware components and procedures like phacoemulsification, vitrectomy, and bipolar diathermy, which are physical interventions requiring hardware. The summary also mentions "Hardware verification and validation were performed."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The VISALIS V500 and VISALIS S500 Surgical System is described as a surgical system used for performing procedures on the eye (irrigation/suction, phacoemulsification, vitrectomy, coagulation). It is a surgical tool used during a procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "surgical treatment of the eye" and "vitreo-retinal surgery." This is a therapeutic and surgical function, not a diagnostic function performed on a sample.
Therefore, the VISALIS V500 and VISALIS S500 Surgical System falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the anterior segment of the eye by performing irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectomy and coagulation techniques using bipolar diathermy.
The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.
ULITE PHACO HANDPIECE: This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.
DIATHERMY PROBES: The DIATHERMY PROBES are active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.
ENDODIATHERMY PROBES: This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cauterize (stop bleeding) small vessels in the eye bulb and/or on the retina using a high frequency electrical current (generated from the equipment to which it is connected) passed through tissue from one electrode to another.
POSTERIOR VITRECTOMY PROBE: This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cut and aspirate the vitreous humor through its cutting human eye surgery.
ENDOILLUMINATION PROBES: This single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to internally illuminate the eye bulb transmitting the light emitted by a xenon lamp.
Product codes (comma separated list FDA assigned to the subject device)
HQC
Device Description
The VISALIS V500 / VISALIS S500 Surgical System has been designed to be used in surgical theaters by qualified medical personnel (eye surgeon) for surgical methods of treatment of the anterior and posterior segment of the human eye. The equipment has been designed for the performance of irrigation, irrigation/suction, phacoemulsification of crystalline lens, anterior and posterior vitrectomy, bipolar diathermy coagulation techniques, air and silicone oil tamponade, endoocular illumination. The system is intended for use in clinics, hospitals or other human medicine institutions.
To perform the ophthalmic surgery a variety of accessories are available. (See Table 5-1 below). As main accessory the ULITE PHACO HANDPIECE is necessary to perform the surgery. With this handpiece the lens is destroyed by ultrasonic. Furthermore, irrigation and aspiration is provided by the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human eye, anterior segment of the eye, posterior segment of the human eye, vitreous body, retina, eye bulb.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel (eye surgeon) for surgical methods of treatment of the anterior and posterior segment of the human eye. The system is intended for use in clinics, hospitals or other human medicine institutions.
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 following performance data were provided in support of the substantial equivalence determination:
- ISO 14971:2007: Used to demonstrate compliance with risk management processes and to support ANSI/AAMI ES60601-1 and IEC 60601-1-2.
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012: Basic safety and essential performance evaluated, device found in compliance.
- IEC 60601-1-2:2014: Electromagnetic compatibility (EMC) evaluated, device found in compliance with IEC 60601-1-2:2007 standard.
- IEC 60601-2-2:2017: Particular requirements for high frequency surgical equipment and accessories evaluated, device and applicable accessories found in compliance.
- IEC 80601-2-58:2008: Applicable for lens removal devices and vitrectomy devices evaluated, device found in compliance.
- IEC 62304:2006/A1:2015: Software documented and tested, device and software found in compliance.
- IEC 62366-1:2015: Used to demonstrate compliance with usability requirements.
- IEC 15752:2010: Applicable for endoilluminators and optical radiation safety evaluated, device and applicable accessories found in compliance.
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
- ISO 10993-1:2009: Applicable for accessories coming in contact with the patient evaluated, applicable accessories found in compliance.
- ISO 10993-5:2009: Applicable for accessories coming in contact with the patient evaluated, applicable accessories found in compliance.
- ISO 10993-10:2010: Applicable for accessories coming in contact with the patient evaluated, applicable accessories found in compliance.
- ST72:2011/(R)2016: Applicable for accessories coming in contact with the patient evaluated, applicable accessories found in compliance.
- ISO 17665-1:2006: Applicable for re-processable accessories evaluated, applicable accessories found in compliance.
- ISO 11135: 2014: Applicable for ETO sterilized accessories evaluated, applicable accessories found in compliance.
- ISO 10993-7:2008-10: Applicable for ETO sterilized accessories evaluated, applicable accessories found in compliance.
- ISO 11737-2:2009: Applicable for sterilized accessories evaluated, applicable accessories found in compliance.
- F88/F88M-15: Applicable for sterilized accessories evaluated, applicable accessories found in compliance.
- F1929-2015: Applicable for sterilized accessories evaluated, applicable accessories found in compliance.
Conclusion: The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the VISALIS V500 / VISALIS S500 should perform as intended in the specified use conditions. The data demonstrate that the VISALIS V500 / VISALIS S500 performs comparably to the predicate device that is currently marketed for the same intended use.
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
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2020
Carl Zeiss Meditec AG Katrin Faber Regulatory Affairs Manager / MED-RAO Goeschwitzer Strasse 51-52 Jena, 07745 DE Thuringen
Re: K193376
Trade/Device Name: Visalis V500, Visalis S500 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: April 24, 2020 Received: May 6, 2020
Dear Katrin Faber:
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 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
1
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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.
for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193376
Device Name VISALIS V500 / VISALIS S500
Indications for Use (Describe)
The Indication for Use is as follows:
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the eye by performing irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectory and coagulation techniques using bipolar diathermy.
The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.
ACCESSORIES:
ULITE PHACO HANDPIECE
This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.
DIATHERMY PROBES
The DIATHERMY PROBES are active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.
ENDODIATHERMY PROBES
This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cauterize (stop bleeding) small vessels in the eye bulb and/or on the retina using a high frequency electrical current (generated from the equipment to which it is connected) passed through tissue from one electrode to another.
ENDOILLUMINATION PROBES
This single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to internally illuminate the eye bulb transmitting the light emitted by a xenon lamp.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
Image /page/4/Picture/0 description: The image contains the word "ZEISS" in white text on a blue background. The word is written in a bold, sans-serif font. The blue background is a solid rectangle, and the word "ZEISS" is centered within the rectangle. The logo is simple and modern.
510(k) SUMMARY
(per 21 CFR §807.92)
VISALIS V500 / VISALIS S500
| GENERAL INFORMATION | K193376 |
|---|---|
| Manufacturer: | Carl Zeiss Meditec AG |
| Goeschwitzer Strasse 51-52 | |
| 07745 Jena, Germany | |
| +49 7364-201606 (phone) | |
| Contact Person: | Dr. Katrin Faber |
| Senior Regulatory Affairs Manager | |
| Carl Zeiss Meditec AG | |
| Rudolf-Eber-Strasse 11 | |
| 73447 Oberkochen, Germany | |
| +49 7364-201606 (Phone) | |
| E-mail: katrin.faber@zeiss.com | |
| Date prepared: | April 23, 2020 |
| Classification Name: | Phacofragmentation system |
| Product Code and Class: | HQC - Class 2 |
| Classification: | 21 CFR 886.4670 / Panel: Ophthalmic |
| Common Name | Phacofragmentation/ Vitrectomy system |
| Trade/Proprietary Name: | VISALIS V500 |
| VISALIS S500 | |
| Predicate Device | ALCON CONSTELLATION ® Vision System |
| Predicate 510(k) | K141065 |
Carl Zeiss Meditec AG
5
Image /page/5/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The logo is simple and recognizable.
DEVICE DESCRIPTION (21 CFR §807.92(a)(4))
The VISALIS V500 / VISALIS S500 Surgical System has been designed to be used in surgical theaters by qualified medical personnel (eye surgeon) for surgical methods of treatment of the anterior and posterior segment of the human eye. The equipment has been designed for the performance of irrigation, irrigation/suction, phacoemulsification of crystalline lens, anterior and posterior vitrectomy, bipolar diathermy coagulation techniques, air and silicone oil tamponade, endoocular illumination. The system is intended for use in clinics, hospitals or other human medicine institutions.
To perform the ophthalmic surgery a variety of accessories are available. (See Table 5-1 below). As main accessory the ULITE PHACO HANDPIECE is necessary to perform the surgery. With this handpiece the lens is destroyed by ultrasonic. Furthermore, irrigation and aspiration is provided by the handpiece.
| Group | Examples |
|---|---|
| Accessories for VISALIS V500 / VISALIS S500 | Different Footswitches and |
| Controls, Drapes and Covers | |
| Accessories for phacoemulsification | Handpiece, |
| Tips, Sleeves, Test Chambers, | |
| TIP Wrenches | |
| Accessories for irrigation/aspiration | Irrigation and Aspiration (I/A) |
| handpieces, I/A cannulas incl. | |
| sleeves, I/A Tubing sets | |
| Accessories for diathermy and anterior vitrectomy | Diathermy Forceps, Probes to |
| irrigate, cut and aspirate the cut | |
| vitreous material | |
| Accessories for retinal surgery | Posterior vitrectomy probes, |
| Trocar kits, Scleral infusion | |
| cannulas, irrigation tube sets, | |
| Endo-illumination | |
| Accessories for endodiathermy | Endodiathermy probes |
ZEISS decided to separate the accessories into groups as followed:
Table 5-1: Groups of Accessories
6
Image /page/6/Picture/0 description: The image shows the Zeiss logo. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a dark blue background. The background is a square shape with a curved bottom edge.
INDICATIONS FOR USE (21 CFR §807.92(a)(5))
MAIN DEVICE
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the anterior segment of the eye by performing irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectomy and coagulation techniques using bipolar diathermy.
The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.
ACCESSORIES
ULITE PHACO HANDPIECE
This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.
DIATHERMY PROBES
The DIATHERMY PROBES are active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.
ENDODIATHERMY PROBES
This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cauterize (stop bleeding) small vessels in the eye bulb and/or on the retina using a high frequency electrical current (generated from the equipment to which it is connected) passed through tissue from one electrode to another.
POSTERIOR VITRECTOMY PROBE
This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cut and aspirate the vitreous humor through its cutting human eye surgery.
ENDOILLUMINATION PROBES
This single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to internally illuminate the eye bulb transmitting the light emitted by a xenon lamp.
7
Image /page/7/Picture/0 description: The image features the word "ZEISS" in a bold, sans-serif font. The word is white and is set against a solid dark blue background. The background extends beyond the word, creating a rectangular shape. The bottom of the image has a curved white shape, which could be part of a lens or other optical element, suggesting a connection to the company's focus on optics and related technologies.
RISK MANAGEMENT
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means, protection measures and user instructions. To confirm that the measures are effective and that the product meets its intended uses, verification of requirements and standards, and validation of the clinical was performed. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.
The device labeling contains instructions for use and any necessary cautions and warnings for safe and effective use of the device.
VISALIS V500 / VISALIS S500 is provided with an Instruction for Use. In this Instruction for Use the available accessory is listed.
Every accessory or accessory set is provided with a separate Instruction for Use.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a) (6))
Substantial Equivalence is demonstrated to ALCON CONSTELLATION® Vision System (K141065). This predicate has not been subject to a design-related recall.
Each ophthalmic system is designed to be used for the anterior segment of the eye. However, the ZEISS device is not yet equipped with a laser source.
Both systems are provided with various accessories, in particular with a handpiece for emulsification of the lens. A general overview is given in the following comparison table:
| Criteria | VISALIS V500 / VISALIS S500 | ALCON CONSTELLATION ® Vision System |
|---|---|---|
| Design Aspects | ||
| Hardware | - Illumination |
- Irrigation / Aspiration
- Vitrectomy
- Diathermy
- Ultrasound
- Air tamponate
- Silicone tamponade | - Illumination
- Irrigation / Aspiration
- Vitrectomy
- Diathermy
- Ultrasound
- Air tamponate
- Silicone tamponade
- Laser |
| Irrigation | ||
|---|---|---|
| Liquid supply: - | - Gravity irrigation |
- Controlled irrigation
- Combined irrigation | - Pressurized Infusion only |
8
Image /page/8/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a dark blue background. The background is shaped like a banner or flag, with a curved bottom edge. The overall design is simple, clean, and recognizable, reflecting the company's focus on precision and quality.
| Criteria | VISALIS V500 / VISALIS
S500 | ALCON CONSTELLATION ®
Vision System |
|----------------------------|--------------------------------|----------------------------------------|
| Aspiration | | |
| Types of aspiration pumps: | Peristaltic and Venturi pump | Perestaltic pump |
| Phacoemulsification | ||
|---|---|---|
| Type of handpiece: | piezoelectrical | piezoelectrical |
| Diath (Diathermy) | |
|---|---|
| Operating frequency: | 2 MHz (± 20 %) |
| 1.5 Mhz ± 10%. |
| Vit (Vitrectomy) | ||
|---|---|---|
| Cutting mode: | Back-and-forth | |
| Single cut mode available | 3D, Momentary, PropVac, VitWet | |
| Single cut mode available |
| Scissors | ||
|---|---|---|
| Cutting mode: | Horizontal scissors | Proportional, Multi-Cut |
| Air infusion | ||
|---|---|---|
| Pressure source: | integral rotary vane | |
| compressor | From external source | |
| Silicone oil injection | ||
| Pressure source: | Compressed air from external | |
| source | From external source |
| Illumination | ||
|---|---|---|
| Type: | Two independent light | |
| sources | One light source | |
| Color temperature: | Lamp 1: 4300 K | |
| Lamp 2: 5000 K | Just one color temperature | |
| Filters: | Green filter, retina protection | |
| filter (blue barrier filter) | Fixed UV and IR filters | |
| Safety filter: | IR-UV-blocking filter | Fixed UV and IR filters |
Table 5-2: General Comparison Table
Evaluation performed on the VISALIS V500 / VISALIS S500 supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness.
9
Image /page/9/Picture/0 description: The image shows the Zeiss logo. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a dark blue square background. The logo is simple and modern.
SUMMARY OF PERFORMANCE DATA (21 CFR §807.92(B))
The following performance data were provided in support of the substantial equivalence determination.
- . ISO 14971:2007 is a general standard with no specific test acceptance criteria. This standard was used to demonstrate compliance with risk management processes and to support ANSI/AAMI ES60601-1 and IEC 60601-1-2.
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012
Basic safety and essential performance has been evaluated for the VISALIS V500 / VISALIS S500. VISALIS V500 / VISALIS S500 has been found to be in compliance with the ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 standard.
IEC 60601-1-2:2014
Electromagnetic compatibility (EMC) has been evaluated for VISALIS V500 / VISALIS S500. VISALIS V500 / VISALIS S500 has been found to be in compliance with the IEC 60601-1-2:2007 standard.
. IEC 60601-2-2:2017
The particular requirements for high frequency surgical equipment and high frequency accessories were evaluated for VISALIS V500 / VISALIS S500 and applicable accessories. VISALIS V500 / VISALIS S500 as well as the applicable accessories has been found to be in compliance with the IEC 60601-2-2:2017 standard.
IEC 80601-2-58:2008 ●
IEC 80601-2-58, applicable for lens removal devices and vitrectomy devices has been evaluated for the VISALIS V500 / VISALIS S500 and applicable accessories. The VISALIS V500 / VISALIS S500 has been found to be in compliance with the IEC 80601-2-58 standard.
IEC 62304:2006/A1:2015 ●
The Software for the VISALIS V500 / VISALIS S500 was documented and tested according to IEC 62304. Details can be found under Section 16 of this submission. The device and its software has been found to be in compliance with IEC 62304 standard.
10
Image /page/10/Picture/0 description: The image features the ZEISS logo, which is displayed in white text against a solid blue background. The word "ZEISS" is written in a bold, sans-serif font, with each letter clearly defined. The blue background is a solid, uniform color, providing a stark contrast that makes the logo stand out prominently.
● IEC 62366-1:2015
IEC 62366 is a general standard with no specific test acceptance criteria. This standard was used to demonstrate compliance with the usability requirements of the VISALIS V500 / VISALIS S500 and its accessories.
IEC 15752:2010 ●
IEC 15752, applicable for the endoilluminators and that optical radiation safety has been evaluated for the VISALIS V500 / VISALIS S500 and applicable accessories. The VISALIS V500 / VISALIS S500 as well as the applicable accessories has been found to be in compliance with the IEC 15752 standard.
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
ISO 10993-1:2009 .
ISO 10993-1:2009, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-1 standard.
. ISO 10993-5:2009
ISO 10993-5:2009, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-5 standard.
● ISO 10993-10:2010
ISO 10993-10:2009, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-10 standard.
. ST72:2011/(R)2016
ST72, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ST72 standard.
● ISO 17665-1:2006
ISO 17665-1, applicable for re-processable accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 17665-1 standard.
. ISO 11135: 2014
ISO 11135, applicable for ETO sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 11135 standard.
11
Image /page/11/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue square. The logo is simple, clean, and easily recognizable.
● ISO 10993-7:2008-10
ISO 10993-7, applicable for ETO sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-7 standard.
ISO 11737-2:2009 ●
ISO 11737-2, applicable for sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 11737-2 standard.
● F88/F88M-15
F88/F88M-15, applicable for sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the F88/F88M standard.
● F1929-2015
F1929, applicable for sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the F1929 standard.
Conclusion
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the VISALIS V500 / VISALIS S500 should perform as intended in the specified use conditions.
The data demonstrate that the VISALIS V500 / VISALIS S500 performs comparably to the predicate device that is currently marketed for the same intended use.
SUBSTANTIAL EQUIVALENCE TO PREDICATE (21 CFR §807.92(B)(1))
As previously indicated VISALIS V500 / VISALIS S500 has been tested to meet the product requirements and is considered to be substantially equivalent to the predicate as indicated above.
SUMMARY (21 CFR §807.92(C))
In summary, based on the successful verification and validation testing, it is Carl Zeiss Meditec AG's opinion that VISALIS V500 / VISALIS S500 does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate device.
Additionally, all testing deemed necessary was conducted on VISALIS V500 / VISALIS S500 to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate device.