(344 days)
No
The device description focuses on the mechanical operation of a vitreous cutter and its performance characteristics (CPM, gauge sizes). There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies are bench tests evaluating mechanical and material properties, not algorithmic performance.
No.
A therapeutic device is one that treats a disease or condition. This device, a vitreous cutter, is used for surgical removal of the vitreous humor during ophthalmic surgery, which is an intervention or procedure, not a therapy in itself.
No
This device is a single-use surgical tool (vitrectomy cutter) used in ophthalmic surgeries, not for diagnosis.
No
The device description clearly describes a physical, disposable product (vitreous cutter) with mechanical components (diaphragm, spring, inner cutter, outer cutter needle). The performance studies focus on the physical properties and function of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in "anterior and posterior segment (vitrectomy) ophthalmic surgeries." This describes a surgical procedure performed directly on the patient's eye.
- Device Description: The description details a mechanical device (a vitreous cutter) that physically removes tissue during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or other bodily fluids) outside of the body to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
The device is a surgical instrument used in vivo (within the living body) during ophthalmic surgery, not a diagnostic tool used in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.
Product codes (comma separated list FDA assigned to the subject device)
HQE
Device Description
The operation of a vitreous cutter is simple. An air pulse pushes down the diaphragm located inside the vitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, a spring is compressed and forces the diaphragm back to the open port position.
In this submission VisionCare Devices is submitting two new models of vitreous cutter. The first model is the UniVit™ HE, which stands for Universal Vitcutter High Efficiency. The UniVit HE is offered in gauge sizes of 20, 23, 25, and 27). The UniVit™ HE™ operates up to 11,000 CPM depending upon vitrectorny system selection.
The second model offered, in this submission, is the UniVit™ UHS™, which stands for Universal Vitcutter Ultra High Speed. The UniVit UHS is offered gauge sizes of 23, 25, and 27. The UniVit operates up to 11,000 CPM depending upon vitrectory system selection. The inner cutter has a port cut into it which allows for cutting forward and backwards; this in effect doubles the cut rate to 22,000 CPM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic (anterior and posterior segment)
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)
Non-Clinical Tests – Harmonized Standards
The UniVit HE and the UniVit UHS have passed all safety tests for demonstrated compliance with the harmonized standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 11137-1, ISO 11137-2, ISO 11137-3. All results were "Pass".
Non-Clinical Bench Test Summary Reports
- UniVit Needle Deformation - UniVit HE/UHS Outer Cutter (Needle): VisionCare Devices validated the vitrectors deformation or bending of the outer needle to find out how much bend the outer needle can withstand before the outer needle fractures. The UniVit vitrector produced by VCD and the outer cutter attached to the vitrector did not fracture or break in normal operational circumstances. All gauge sizes were tested: 20, 23, 25, and 27. All tests passed without deviation.
- UniVit Diaphragm Burst - UniVit HE/UHS: The UniVit HE/UHS vitrector models must not allow pressure to escape the needle port at any point during operation. The testing was done in an extreme vitrector operational configuration. The worst-case configuration for the vitrector with a compromised diaphragm and an overpressure condition. The handpieces performed as designed and did not allow pressure to exit the port area of the needle during a diaphragm breach or fail event. The testing was done using a final finished device. Only one gauge of handpiece was required for testing due to the UniVit vitrector family internal operation. The internal operation is identical in regards to axial inner-cutter functionality. All tests passed without deviation.
- UniVit Fluidics - UniVit HE/UHS: The UniVit HE/UHS vitrector models were tested utilizing (2) rabbit eyes were dissected and the vitreous was removed. Close examination of the retina was done during the vitreous evacuation to ensure no spikes or pulling forces on the retina occur. Aspiration flow was evaluated for metal flaking. The posterior vitreous removal performed on rabbit eyes provided no evidence or damage to the ocular structures in particular the rabbit eye, other than the incision site. Additionally, there was no evidence of tissue damage from heat and no evidence of metal flaking within the collected samples. All tests passed without deviation.
- UniVit Metal Flaking - UniVit HE/UHS: The UniVit HE/UHS vitrector models must not generate metal flaking at any point during operation. The testing will be done in an extreme vitrector operational configuration. The worst-case operating configuration for the vitrector is running at high speed. VCD will run the vitrector at the highest cuts per minute for 30 minutes. The aspirated fluid will run through a .45 micron filter will be analyzed for metal flaking at 400x magnification. The vitrector functioned as designed regarding metal flaking during vitreous removal. This shows that the vitrector does not shed of flake metal inside the eye and will not adversely affect the patient. The testing was done on a finished device. All tests passed without deviation.
- UniVit Tip Temperature - UniVit HE/UHS: The UniVit HE/UHS vitrector models must not exceed 104°F at any point during operation. The testing will be done running the vitrector at 11,000 cuts per minute, in air. The vitrector was ran in a worse case condition without lubrication in air at 11,000 cpm to ensure needle does not exceed 104 °F. The vitrector outer cutter needle functioned as designed regarding tip temperature on the outer cutter needle did not reach an excessive or unsafe temperature at any time during the testing. All tests passed without deviation.
- UniVit Vibrational Testing - UniVit HE/UHS: The UniVit HE/UHS vitrector models must not exceed 2.5m/S² at any point during operation. The testing will be done in an extreme vitrector operation. The worst-case operating configuration for the vitrector is running at high speed without lubrication. VCD ran the vitrector up to the highest CPM possible to record the vibration data. The UniVit vitrector functioned with very low vibration from 500 to 11,000 cuts per minute. The UniVit vitrector as tested on the finished product was well below the vibration levels according to current handheld tool standards. The UniVit vitrector was also lower in vibration frequency than the competitor model (reference device: DORC EVA under K190875) that was similar in design, operation, and needle gauge as the UniVit under test. All tests passed without deviation.
Clinical Studies
The UniVit™ HE™ and the UniVit UHS™, like the predicate device, did not require clinical trials.
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.
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
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 10, 2022
VisionCare Devices, LLC. % Rick Morgan Owner VisonCare Devices, LLC 6100 Bellevue Lane Anderson, California 96007
Re: K212763
Trade/Device Name: UniVit™ HE, UniVit™ UHS Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration And Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: July 5, 2022 Received: July 8, 2022
Dear Rick Morgan:
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.
1
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 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.
Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212763
Device Name UniVit HETM, UniVit™ UHS
Indications for Use (Describe)
The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.
| 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) |
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3
UniVit™ HE and UniVit™ UHS
| 510(k) Summary | |||
|---|---|---|---|
| SUBMITTER | |||
| Date Prepared | 8/10/2022 | ||
| Submitter/Owner | VisionCare Devices, LLC. | ||
| 6100 Bellevue Lane | |||
| Anderson, California 96007 | |||
| +1-530-364-2271 Phone | |||
| +1-530-364-2275 Fax | |||
| Key Contact | Rick Morgan | ||
| Owner | |||
| Rick@VitCutter.com | |||
| +1-530-364-2271 | |||
| 510(k) Submission Type | This is a Traditional 510(k). | ||
| DEVICE | |||
| Trade Name | UniVit™ HE and UniVit™ UHS | ||
| Common Name | Vitreous Cutter | ||
| Classification Name | Class II | ||
| Panel 86: Ophthalmic | |||
| Subpart E: Surgical Devices | |||
| 886.4150 Vitreous Aspiration and cutting instrument | |||
| Procode: HQE | |||
| PREDICATE DEVICE | |||
| 510(k) No. | Company Name | ||
| Device Name | Product Code | ||
| Predicate Device | K120170 | VisionCare Devices, Inc. | |
| ProCare HSP | HQE | ||
| Reference Device | K190875 | DORC EVA | HQC, HQE |
| The UniVit™ is substantially equivalent to the legally marketed predicate VisionCare Devices, Inc. | |||
| ProCare HSP Vitcutter; K120170. | |||
| DEVICE DESCRIPTION | |||
| UniVit™ HE and UniVit™ UHS – description of the device per 21 CFR 807.92(a) (4) | |||
| The operation of a vitreous cutter is simple. An air pulse pushes down the diaphragm located inside the | |||
| vitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, a | |||
| spring is compressed and forces the diaphragm back to the open port position. | |||
| In this submission VisionCare Devices is submitting two new models of vitreous cutter. The first model is |
the UniVit™ HE, which stands for Universal Vitcutter High Efficiency. The UniVit HE is offered in gauge sizes of 20, 23, 25, and 27). The UniVit™ HE™ operates up to 11,000 CPM depending upon vitrectorny system selection.
4
UniVit™ HE and UniVit™ UHS
| UniVit™ HE (Universal Vitcutter High Efficiency) | |
|---|---|
| UniVit™ HE Base Model Numbers and Descriptions | |
| Model No. | Product Name/Description |
| HE-20 | UniVit™ HE 20 Gauge, Single Outer Cutting Port |
| HE-23 | UniVit™ HE 23 Gauge, Single Outer Cutting Port |
| HE-25 | UniVit™ HE 25 Gauge, Single Outer Cutting Port |
| HE-27 | UniVit™ HE 27 Gauge, Single Outer Cutting Port |
The second model offered, in this submission, is the UniVit™ UHS™, which stands for Universal Vitcutter Ultra High Speed. The UniVit UHS is offered gauge sizes of 23, 25, and 27. The UniVit operates up to 11,000 CPM depending upon vitrectory system selection. The inner cutter has a port cut into it which allows for cutting forward and backwards; this in effect doubles the cut rate to 22,000 CPM.
UniVit™ UHS (Universal Vitcutter Ultra High Speed)
Image /page/4/Figure/6 description: The image shows a medical device, possibly a syringe or an injection tool, with a long, thin needle extending from a cone-shaped body. The body transitions into a wider, ergonomic handle with two cylindrical ports at the end. The device appears to be made of a light-colored, possibly sterile material, and the image is likely a product rendering or a technical illustration.
UniVit™ UHS Base Model Numbers and Descriptions
| Model No. | Product Name/Description |
|---|---|
| UHS-23 | UniVit™ UHS 23 Gauge, Single Outer Cutting Port, Inner Cutter with a Cutting |
| Port | |
| UHS-25 | UniVit™ UHS 25 Gauge, Single Outer Cutting Port, Inner Cutter with a Cutting |
| Port | |
| UHS-27 | UniVit™ UHS 27 Gauge, Single Outer Cutting Port, Inner Cutter with a Cutting |
| Port |
5
UniVit™ HE and UniVit™ UHS
INDICATIONS FOR USE
Intended Use as required per 21 CFR 807.92(a)(5)
The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.
Comparison of Intended Uses for Subject Device and Predicate
| Name | Indications for Use/Intended Use |
|---|---|
| UniVit™ HE and | |
| UniVit™ UHS | |
| Subject Device | UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both |
| anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a | |
| pneumatically-driven vitrectomy system or phacoemulsification system that has a | |
| pneumatically-driven vitrectomy module. | |
| K120170 | |
| ProCare HSP | |
| Predicate | The VCD HSP Vitcutter and Accessories is a single use (disposable) product intended for use |
| in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a | |
| pneumatically-driven vitrectomy system or phacoemulsification system that has a | |
| pneumatically-driven vitrectomy module. The VCD UniVit™ HE and UniVit™ UHS product | |
| has been sterilized by gamma radiation. |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
|---|---|---|---|
| Device | Current Submission | Primary Predicate | |
| UniVit™ HE | UniVit™ UHS | ProCare Plus HSP | |
| Aspiration Channel | Through the cutter tubing cannula | Identical | Identical |
| Patient Contact Material | Stainless Steel | Identical | Identical |
| Overall length of probe (nominal) | 3.3 inches | Identical | Identical |
| Single-use/Reusable | Single use only | Identical | Identical |
| Shelf-life | 3 Years | Identical | Identical |
| Sterile product packaging | Tyvek pouch | Identical | Identical |
| Sterility Method | Gamma | Identical | Identical |
| Connector | Connectors for pneumatic lines. Leuer connectors for aspiration line | Identical | Identical |
| Handpiece Material | ABS | Identical | Identical |
| Tubing Set | Polypropylene | Identical | Identical |
| Power Source for cutter activation | Pneumatic Pressure Pulse | Identical | Identical |
| Cutting Action Format | Guillotine | Identical | Identical |
| Cutter Return Mechanism | Spring | Spring | Spring |
| Differences | |||
| Item of Comparison | Description/Rationale | ||
| Handpiece | Ergonomic Changes | ||
| Needle | Addition of 25 and 27 gauge options | ||
| Back cap | Color coded back cap to denote gauge size. |
Added coating to inner cutter to reduce friction UniVit HE and UniVit UHS Inner Cutter
6
UniVit™ HE and UniVit™ UHS
| Cutting Speed | Increased cutting speed to 8K for UniVit HE |
|---|---|
| Cutting Speed | Increased cutting speed to 11K for UniVit UHS |
Substantial Equivalence Summary
Operational and technological characteristics for the determination of substantial equivalence of the UniVit™ HE and UniVit™ UHS with the legally marketed predicate devices (K120170). The UniVit™ UHS is substantially equivalent to the predicate devices.
PERFORMANCE DATA Summaries
Non-Clinical Tests – Harmonized Standards
The UniVit HE and the UniVit UHS have passed all safety tests for demonstrated compliance with the harmonized standards below.
| Standard | Device Conforms | Results |
|---|---|---|
| ISO | ||
| 10993-1 | Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management | |
| process | Pass | |
| ISO | ||
| 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Pass |
| ISO | ||
| 10993-10 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass |
| ISO | ||
| 11137-1 | Sterilization of health care products - Radiation - Part 1: Requirements for development, | |
| validation, and routine control of a sterilization process for medical devices [Including: | ||
| Amendment 1 (2013)] | Pass | |
| ISO | ||
| 11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | Pass |
| ISO | ||
| 11137-3 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of | |
| development, validation, and routine control | Pass |
Deviations and Exclusions
| Standard | Type | Deviation | Exclusions |
|---|---|---|---|
| ISO | |||
| 10993-1 | Biological evaluation of medical devices. Part 1: Evaluation and testing | ||
| within a risk management process | None | None | |
| ISO | |||
| 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro | ||
| cytotoxicity | None | None | |
| ISO | |||
| 10993-10 | Biological evaluation of medical devices Part 10: Tests for irritation and | ||
| skin sensitization | None | None | |
| ISO | |||
| 11137-1 | Sterilization of health care products - Radiation - Part 1: Requirements | ||
| for development, validation, and routine control of a sterilization process | |||
| for medical devices [Including: Amendment 1 (2013)] | None | None | |
| ISO | |||
| 11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the | ||
| sterilization dose | None | None | |
| ISO | |||
| 11137-3 | Sterilization of health care products - Radiation - Part 3: Guidance on | ||
| dosimetric aspects of development, validation and routine control | None | None |
7
UniVit™ HE and UniVit™ UHS
Non-Clinical Bench Test Summary Reports
UniVit Needle Deformation - UniVit HE/UHS Outer Cutter (Needle)
VisionCare Devices validated the vitrectors deformation or bending of the outer needle to find out how much bend the outer needle can withstand before the outer needle fractures. The UniVit vitrector produced by VCD and the outer cutter attached to the vitrector did not fracture or break in normal operational circumstances. All gauge sizes were tested: 20, 23, 25, and 27. All tests passed without deviation.
UniVit Diaphragm Burst - UniVit HE/UHS
The UniVit HE/UHS vitrector models must not allow pressure to escape the needle port at any point during operation. The testing was done in an extreme vitrector operational configuration. The worst-case configuration for the vitrector with a compromised diaphragm and an overpressure condition. The handpieces performed as designed and did not allow pressure to exit the port area of the needle during a diaphragm breach or fail event. The testing was done using a final finished device. Only one gauge of handpiece was required for testing due to the UniVit vitrector family internal operation. The internal operation is identical in regards to axial inner-cutter functionality. All tests passed without deviation.
UniVit Fluidics - UniVit HE/UHS
The UniVit HE/UHS vitrector models were tested utilizing (2) rabbit eyes were dissected and the vitreous was removed. Close examination of the retina was done during the vitreous evacuation to ensure no spikes or pulling forces on the retina occur. Aspiration flow was evaluated for metal flaking, The posterior vitreous removal performed on rabbit eyes provided no evidence or damage to the ocular structures in particular the rabbit eye, other than the incision site. Additionally, there was no evidence of tissue damage from heat and no evidence of metal flaking within the collected samples. All tests passed without deviation.
UniVit Metal Flaking - UniVit HE/UHS
The UniVit HE/UHS vitrector models must not generate metal flaking at any point during operation. The testing will be done in an extreme vitrector operational configuration. The worst-case operating configuration for the vitrector is running at high speed. VCD will run the vitrector at the highest cuts per minute for 30 minutes. The aspirated fluid will run through a .45 micron filter will be analyzed for metal flaking at 400x magnification. The vitrector functioned as designed regarding metal flaking during vitreous removal. This shows that the vitrector does not shed of flake metal inside the eye and will not adversely affect the patient. The testing was done on a finished device. All tests passed without deviation.
8
UniVit™ HE and UniVit™ UHS
UniVit Tip Temperature - UniVit HE/UHS
The UniVit HE/UHS vitrector models must not exceed 104°F at any point during operation. The testing will be done running the vitrector at 11,000 cuts per minute, in air. The vitrector was ran in a worse case condition without lubrication in air at 11,000 cpm to ensure needle does not exceed 104 °F. The vitrector outer cutter needle functioned as designed regarding tip temperature on the outer cutter needle did not reach an excessive or unsafe temperature at any time during the testing. All tests passed without deviation.
UniVit Vibrational Testing - UniVit HE/UHS
The UniVit HE/UHS vitrector models must not exceed 2.5m/S² at any point during operation. The testing will be done in an extreme vitrector operation. The worst-case operating configuration for the vitrector is running at high speed without lubrication. VCD ran the vitrector up to the highest CPM possible to record the vibration data. The UniVit vitrector functioned with very low vibration from 500 to 11,000 cuts per minute. The UniVit vitrector as tested on the finished product was well below the vibration levels according to current handheld tool standards. The UniVit vitrector was also lower in vibration frequency than the competitor model (reference device: DORC EVA under K190875) that was similar in design, operation, and needle gauge as the UniVit under test. All tests passed without deviation.
Clinical Studies
The UniVit™ HE™ and the UniVit UHS™, like the predicate device, did not require clinical trials.
FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, usability validation, and risk management activities have taken place for the UniVit™ HE and UniVit™ UHS
Conclusions
The UniVit™ HE™ and the UniVit UHS™ vitrectory cutters were found to be substantially equivalent to the predicate device, demonstrated by performance testing and device comparisons. The UniVit™ HE™ and the UniVit UHS™ vitrectomy cutters share identical indications for use, similar design features and functional features with, and thus are substantially equivalent to, the predicate device.