iPrime Viscodelivery System

K212797 · Glaukos · MRH · Jan 6, 2022 · General Hospital

Device Facts

• Record ID: K212797
• Device Name: iPrime Viscodelivery System
• Applicant: Glaukos
• Product Code: MRH · General Hospital
• Decision Date: Jan 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc@ from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery.

Device Story

Sterile, single-use ophthalmic surgical instrument; dispenses cohesive viscoelastic fluid (e.g., HEALON PRO, Amvisc, PROVISC) into anterior chamber of eye. Operated by trained ophthalmic professional in sterile surgical setting. Device consists of handpiece with reservoir, dispense trigger, cannula, slide button, rotatable hub, and microcatheter. User fills device at point of use from external OVD source; connects to luer fitting. Slide button adjusts microcatheter length; rotatable hub adjusts cannula angle. Manual forward slide of trigger pumps 2.7 µL of fluid per activation. Provides controlled delivery of viscoelastic fluid to assist in ophthalmic procedures.

Clinical Evidence

No clinical data. Substantial equivalence based on technological comparison and non-clinical bench testing, including biocompatibility (ISO 10993-1:2018), sterilization, package integrity, and functional performance testing.

Technological Characteristics

Manually operated infusion pump. Materials: medical grade stainless steel cannula, ABS molded plastic. Microcatheter: 17mm max length, 200 microns OD. Dispensing: passive volume syringe mechanism, 2.7 µL per trigger activation. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for ophthalmic surgery patients requiring delivery of small amounts of viscoelastic fluid.

Regulatory Classification

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.

Predicate Devices

• Sight Sciences VISCO360™ Viscosurgical System (K171905)

Submission Summary (Full Text)

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January 06, 2022

Glaukos Corporation Alex Bhaskarla Senior Regulatory Affairs Associate 229 Avenida Fabricante San Clemente, CA 92672

Re: K212797

Trade/Device Name: iPrime Viscodelivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH Dated: August 31, 2021 Received: September 2, 2021

Dear Alex Bhaskarla:

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)

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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-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 Advice (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tieuvi Nguven, 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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K212797

Device Name iPRIME™M Viscodelivery System

# Indications for Use (Describe)

The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc@ from Bausch & Lomb, or PROVISC® 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)

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FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services [phone] EF

GLAUKOS CORPORATION RESPONSE FOR iPRIME™ VISCODELIVERY SYSTEM 510(K) - K212797

CONFIDENTIAL VOLUME I OF III, PAGE 33

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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# 510k Summary

| 510(k) Owner: | Glaukos Corporation<br>229 Avenida Fabricante<br>San Clemente, California 92672<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alex Bhaskarla<br>Senior Regulatory Affairs Associate<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | November 19, 2021 |
| Device Trade<br>Name: | iPRIME™ Viscodelivery System |
| Classification: | II |
| Classification<br>Name: | Infusion Pump |
| Product Code: | MRH |
| Regulation<br>Number: | CFR 880.5725 |
| Predicate Device: | Sight Sciences VISCO360™ Viscosurgical System (K171905) |

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| Device Description: | The iPRIMET™ Viscodelivery System is a sterile, single-use ophthalmic surgical instrument for dispensing cohesive viscoelastic fluid (supplied separately, at point of use) during ophthalmic surgery. The iPRIMET™ Viscodelivery System is a delivery device for delivering viscoelastic fluid. The procedure is performed by a trained ophthalmic professional in a sterile surgical setting. The iPRIME device is filled by the user, at the point of use, with FDA approved commercially available cohesive viscoelastic fluid (e.g. HEALON® PRO, Amvisc® or PROVISC®; sold and supplied separately). The iPRIME device consists of a handpiece which includes a reservoir, dispense trigger, cannula, slide button, rotatable hub, and microcatheter manufactured from medical grade materials. The slide button allows the user to adjust the microcatheter length. The dispense trigger dispenses the viscoelastic fluid. The rotatable hub allows the user to adjust the angle of the cannula in order to dispense viscoelastic fluid into other areas within the anterior chamber. The iPRIMET™ Viscodelivery System serves as dispensary means to deliver cohesive viscoelastic fluid. The OVD device containing the viscoelastic fluid is connected to the iPRIME luer fitting and viscoelastic is pumped into the iPRIME device. After the device is fully primed and the microcatheter has been extended to the desired location, the user advances forward the dispense trigger delivering a small amount of viscoelastic fluid into the desired location within the anterior chamber of the eye. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | The iPRIMET™ Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. |

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# Comparison of Technological Characteristics with the Predicate Device

The technical characteristics of the iPRIME™ Viscodelivery System are substantially equivalent to the predicate device VISCO™ 360 Viscosurgical System (K171905). The iPRIME™ Viscodelivery System and predicate device are manually operated devices for the controlled delivery of small amounts of viscoelastic fluid and dispenses these fluids based on the principle of exchanging volumes much like a syringe. Table 1 below compares the attributes of the iPRIME™ Viscodelivery System with the predicate device. The iPRIME™ Viscodelivery System is substantially equivalent to the predicate device as indicated below:

| TABLE 1. SUBJECT AND PREDICATE DEVICE COMPARISON SUMMARY | | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Proposed Device<br>iPRIMETM Viscodelivery System | Predicate Device<br>VISCOTM360 Viscosurgical System (K171905) |
| Intended Use | User manually operated handheld device for delivery of viscoelastic fluid during ophthalmic surgery | Same |
| Indications for Use | The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. | The Sight Sciences VISCOTM360 Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HealonTM or HealonGVTM from Abbot Medical Optics (AMO), AmviscTM from Bausch & Lomb, or PROVISCTM from Alcon, during ophthalmic surgery. |
| Device<br>Classification<br>Product Code | Class II<br>MRH | Same |
| Dispensing<br>Design | Passive volume dispensing syringe mechanism | Same |
| Dispensing<br>Control | Manual forward slide of trigger to dispense viscoelastic fluid | Manual rotation of actuator wheel to dispense viscoelastic fluid |
| Materials | Medical grade stainless steel cannula and ABS molded plastic components | Same |
| Microcatheter<br>Dimensions | Microcatheter (17mm max L, 200 microns OD | Microcatheter (21 mm L, 200 microns OD |
| Viscoelastic<br>Fluid | 2.7 µL of cohesive viscoelastic fluid (supplied separately) per activation of dispense trigger. No total volume limit | 4.5 µL per delivery, 9 µL total volume dispensed |
| Target<br>Anatomy | Anterior chamber of eye | Same |

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| Summary of Non-clinical<br>Data: | The iPRIMETM Viscodelivery System was subjected to<br>biocompatibility, sterilization, package integrity, and<br>performance tests to ensure its functionality is consistent with<br>cohesive viscoelastic fluid infusion pumps. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The iPRIME device was subjected to the following functional<br>and performance tests to ensure its stability over a three-month<br>shelf life: |
| | Joint strength testing Microcatheter and cannula extension/retraction testing Priming/dispense volume testing Corrosion testing Human factors engineering evaluation |
| | Biocompatibility testing was performed in accordance with ISO<br>10993-1: 2018 to ensure the direct and indirect patient contacting<br>components are biocompatible: |
| | Cytotoxicity Sensitization Intracutaneous irritation Systemic toxicity |
| | Package integrity testing was performed in order to ensure the<br>sterile barrier is maintained throughout the three-month shelf<br>life: |
| | Packaging visual inspection Packaging peel test Packaging bubble test |
| | Acceptance criteria for testing was based on the ability to<br>perform according to the intended use and predicate device<br>characteristics. The tests results show that the iPRIMETM<br>Viscodelivery System met all acceptance criteria and performs<br>as intended. |
| Summary of Clinical<br>Data: | Clinical data are not included in this submission and are not<br>required. Substantial equivalence is based on technological<br>comparison. |
| Conclusion from Data: | The iPRIMET™ Viscodelivery System meets all product design<br>requirements and applicable standards. The iPRIMETM<br>Viscodelivery System has been shown to be substantially<br>equivalent to the predicate device. |