(126 days)
Not Found
No
The description focuses on a manually operated mechanical device for delivering fluid, with no mention of AI or ML capabilities.
No.
This device is a delivery system for viscoelastic fluid during ophthalmic surgery, not a therapeutic device itself. The therapeutic agents (viscoelastic fluids) are supplied separately.
No
This device is a surgical instrument designed for the delivery of viscoelastic fluid during ophthalmic surgery, not for diagnosing conditions. Its function is to dispense a substance, not to analyze or identify medical states.
No
The device description clearly outlines a physical, manually operated device with components like a handpiece, reservoir, trigger, cannula, and microcatheter. The performance studies also focus on physical characteristics and functionality of the hardware.
Based on the provided information, the iPRIMETM Viscodelivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended for the delivery of viscoelastic fluid during ophthalmic surgery. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The description details a surgical instrument for dispensing fluid into the eye. It does not involve testing samples of bodily fluids or tissues outside the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The iPRIMETM Viscodelivery System is a surgical tool used for a therapeutic purpose (delivering fluid during surgery), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The iPRIME™ 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.
Product codes (comma separated list FDA assigned to the subject device)
MRH
Device Description
The iPRIME™ 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 iPRIME™ 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 iPRIME™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior chamber of eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained ophthalmic professional in a sterile surgical setting.
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 iPRIME™ Viscodelivery System was subjected to biocompatibility, sterilization, package integrity, and performance tests to ensure its functionality is consistent with cohesive viscoelastic fluid infusion pumps.
The iPRIME device was subjected to the following functional and performance tests to ensure its stability over a three-month 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 10993-1: 2018 to ensure the direct and indirect patient contacting components are biocompatible: Cytotoxicity; Sensitization; Intracutaneous irritation; Systemic toxicity.
Package integrity testing was performed in order to ensure the sterile barrier is maintained throughout the three-month shelf life: Packaging visual inspection; Packaging peel test; Packaging bubble test.
Acceptance criteria for testing was based on the ability to perform according to the intended use and predicate device characteristics. The tests results show that the iPRIME™ Viscodelivery System met all acceptance criteria and performs as intended.
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
§ 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
Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.
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)
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 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.
3
510k Summary
| 510(k) Owner: | Glaukos Corporation
229 Avenida Fabricante
San Clemente, California 92672
Telephone: 949-367-9600
Fax: 949-367-9984 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alex Bhaskarla
Senior Regulatory Affairs Associate
Telephone: 949-481-0672
Fax: 949-367-9984 |
| Date Prepared: | November 19, 2021 |
| Device Trade
Name: | iPRIME™ Viscodelivery System |
| Classification: | II |
| Classification
Name: | Infusion Pump |
| Product Code: | MRH |
| Regulation
Number: | CFR 880.5725 |
| Predicate Device: | Sight Sciences VISCO360™ Viscosurgical System (K171905) |
4
| 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. |
5
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 | |
| iPRIMETM Viscodelivery System | Predicate Device | |
| 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 | ||
| Classification | ||
| Product Code | Class II | |
| MRH | Same | |
| Dispensing | ||
| Design | Passive volume dispensing syringe mechanism | Same |
| Dispensing | ||
| 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 | ||
| Dimensions | Microcatheter (17mm max L, 200 microns OD | Microcatheter (21 mm L, 200 microns OD |
| Viscoelastic | ||
| 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 | ||
| Anatomy | Anterior chamber of eye | Same |
6
| Summary of Non-clinical
Data: | The iPRIMETM Viscodelivery System was subjected to
biocompatibility, sterilization, package integrity, and
performance tests to ensure its functionality is consistent with
cohesive viscoelastic fluid infusion pumps. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The iPRIME device was subjected to the following functional
and performance tests to ensure its stability over a three-month
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
10993-1: 2018 to ensure the direct and indirect patient contacting
components are biocompatible: |
| | Cytotoxicity Sensitization Intracutaneous irritation Systemic toxicity |
| | Package integrity testing was performed in order to ensure the
sterile barrier is maintained throughout the three-month shelf
life: |
| | Packaging visual inspection Packaging peel test Packaging bubble test |
| | Acceptance criteria for testing was based on the ability to
perform according to the intended use and predicate device
characteristics. The tests results show that the iPRIMETM
Viscodelivery System met all acceptance criteria and performs
as intended. |
| Summary of Clinical
Data: | Clinical data are not included in this submission and are not
required. Substantial equivalence is based on technological
comparison. |
| Conclusion from Data: | The iPRIMET™ Viscodelivery System meets all product design
requirements and applicable standards. The iPRIMETM
Viscodelivery System has been shown to be substantially
equivalent to the predicate device. |