(31 days)
Not Found
No
The description details a manually operated mechanical device for fluid delivery, with no mention of computational processing, algorithms, or learning capabilities.
No.
The device is used for the delivery of viscoelastic fluid during ophthalmic surgery, which is a procedural aid rather than a direct therapeutic intervention by the device itself.
No
The device delivers viscoelastic fluid during ophthalmic surgery and does not perform any diagnostic function.
No
The device description clearly outlines a physical, manually operated instrument with components like a cannula, microcatheter, reservoir, plunger tube, and finger wheels, indicating it is a hardware device.
Based on the provided information, the Sight Sciences VISCO360® Viscosurgical System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver viscoelastic fluid during ophthalmic surgery. This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body (in vitro).
- Device Description: The device is described as a "manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery." This reinforces its use in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze a sample (blood, urine, tissue, etc.) to provide diagnostic information. Its function is purely for the delivery of a substance during surgery.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The VISCO360 does not fit this description.
N/A
Intended Use / Indications for Use
The Sight Sciences VISCO360® Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.
Product codes
MRH
Device Description
The Sight Sciences VISCO360 Viscosurgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The VISCO360 is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (OD or OS) using either hand.
The VISCO360 device consists of the following components and accessories:
- ► Cannula
- Microcatheter A
- A Internal reservoir
- A Plunger tube
-
Finger wheels
The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The components responsible for the fluid dispensing are the following:
- The reservoir within the handle is analogous to a syringe plunger. Prior to use, the viscoelastic fluid is loaded into the reservoir.
- The plunger tube is connected to the microcatheter and it communicates with the reservoir. During use the plunger tube acts like a graduated cylinder.
- The microcatheter, initially located within the cannula, advances and retracts from the device to dispense fluid. The microcatheter is analogous to a syringe dispensing-tip.
- The user interfaces with the device by using the finger wheels. This action is analogous to moving the dispensing tip to the desired location and depressing the plunger handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists / ophthalmic surgery
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
Performance testing was conducted to evaluate friction force necessary to advance the plunger tube into the reservoir. Acceptance criteria was based on the modified device having a significant reduction in this friction force in comparison to the primary predicate device. Testing demonstrated that the modified device passed this functional test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected, and they form a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
July 27, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sight Sciences, Inc. Anne-Marie Ripley VP. Clinical & Regulatory Affairs 3000 Sand Hill Road. Building 3 Suite 105 Menlo Park, CA 94025
Re: K171905
Trade/Device Name: VISCO 360 Viscosurgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH Dated: June 23, 2017 Received: June 26, 2017
Dear Anne-Marie Ripley:
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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
FDA Form 3881: Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name VISCO360® VISCOSURGICAL SYSTEM
Indications for Use (Describe)
The Sight Sciences VISCO360® Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISCTM from Alcon, during ophthalmic 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
FORM FDA 3881 (8/14)
Page 1 of 1
3
510(k) Summary of Safety and Effectiveness 1.
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Sight Sciences, Inc.
3000 Sand Hill Road
Building 3, Suite 105
Menlo Park, CA 94025
Tel: (877) 266-1144 | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| OFFICIAL CORRESPONDENT | Anne-Marie Ripley
Sight Sciences, Inc.
3000 Sand Hill Road
Bldg. 3, Suite 105
Menlo Park, CA 94025
Anne@sightsciences.com
661-645-8546 (cell) | |
| TRADE NAME: | VISCO360® Viscosurgical System | |
| CLASSIFICATION NAME: | Pump, infusion, ophthalmic | |
| DEVICE CLASSIFICATION AND
PRODUCT CODE: | Class II per 21 CFR 880.5725, MRH | |
| PREDICATE DEVICE: | DEVICE NAME | 510k NUMBER |
| | Sight Sciences Viscoelastic Injector | K143205 |
SUBSTANTIAL EQUIVALENCE:
The modified Sight Sciences VISCO360® Viscosurgical System is substantially equivalent to the original Sight Sciences Viscoelastic Injector cleared under K143205. A minor design modification was made to the O-ring to reduce the force required to advance the plunger tube into the viscoelastic reservoir. The modified VISCO360 device has the same intended use and basic scientific technology as the original model.
4
Description Of The Device:
The Sight Sciences VISCO360 Viscosurgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The VISCO360 is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (OD or OS) using either hand.
Image /page/4/Figure/3 description: The image shows a VISCO360 Viscosurgical System. The system includes a cannula, microcatheter, advancement wheels, reservoir, and retainer pin. There is also a close up of the microcatheter showing the viscoelastic fluid.
5
Indications For Use:
The Sight Sciences VISCO360® Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.
TECHNICAL CHARACTERISTICS:
The VISCO360 device consists of the following components and accessories:
- ► Cannula
- Microcatheter A
- A Internal reservoir
- A Plunger tube
-
Finger wheels
The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The components responsible for the fluid dispensing are the following:
- The reservoir within the handle is analogous to a syringe plunger. Prior to use, the viscoelastic fluid is loaded into the reservoir.
- The plunger tube is connected to the microcatheter and it communicates with the reservoir. During use the plunger tube acts like a graduated cylinder.
- The microcatheter, initially located within the cannula, advances and retracts from the device to dispense fluid. The microcatheter is analogous to a syringe dispensing-tip.
- The user interfaces with the device by using the finger wheels. This action is analogous to moving the dispensing tip to the desired location and depressing the plunger handle.
PERFORMANCE DATA:
The VISCO360's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate device. Additionally, performance testing was conducted to evaluate friction force necessary to advance the plunger tube into the reservoir. Acceptance criteria was based on the modified device having a significant reduction in this friction force in comparison to the primary predicate device.
6
Testing demonstrated that the modified device passed this functional test.
Conclusion:
The Sight Sciences VISCO360 Viscosurgical System meets all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device, the device has been shown to be substantially equivalent to the predicate device, and is safe and effective.