(344 days)
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.
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.
The provided text describes the UniVit™ HE and UniVit™ UHS devices, which are vitreous aspiration and cutting instruments. The document is a 510(k) summary, indicating that the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel technology requiring extensive clinical trials.
The acceptance criteria and device performance are primarily detailed through a series of "Non-Clinical Bench Test Summary Reports" and compliance with harmonized standards. No clinical studies involving human patients were conducted for this submission, nor were there any studies mentioned that involved human readers or AI assistance in interpretation. Therefore, much of the requested information regarding human expert involvement, MRMC studies, or AI specific performance will not be applicable.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test Name) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Harmonized Standards Compliance | ||
| ISO 10993-1 (Biological evaluation) | Compliance with risk management process for biological evaluation of medical devices. | Pass |
| ISO 10993-5 (In vitro cytotoxicity) | Device materials are not cytotoxic. | Pass |
| ISO 10993-10 (Irritation & skin sensitization) | Device materials do not cause irritation or skin sensitization. | Pass |
| ISO 11137-1 (Radiation sterilization, Part 1) | Requirements for development, validation, and routine control of sterilization process met. | Pass |
| ISO 11137-2 (Radiation sterilization, Part 2) | Requirements for establishing sterilization dose met. | Pass |
| ISO 11137-3 (Radiation sterilization, Part 3) | Guidance on dosimetric aspects of development, validation, and routine control met. | Pass |
| Non-Clinical Bench Tests | ||
| UniVit Needle Deformation | Outer needle should not fracture or break under normal operational circumstances. | The UniVit vitrector and outer cutter did not fracture or break in normal operational circumstances. All gauge sizes (20, 23, 25, 27) passed without deviation. |
| UniVit Diaphragm Burst | No pressure escape from the needle port during operation, even in extreme conditions (compromised diaphragm, overpressure). | Handpieces performed as designed; no pressure exited the port area during a diaphragm breach or fail event. All tests passed without deviation. |
| UniVit Fluidics | No spikes or pulling forces on the retina, no metal flaking, no tissue damage from heat. | Examination of rabbit retinas during vitreous evacuation showed no spikes or pulling forces. No evidence of tissue damage from heat or metal flaking in collected samples. All tests passed without deviation. |
| UniVit Metal Flaking | No metal flaking generated during operation, especially at high speeds. | The vitrector functioned as designed regarding metal flaking during vitreous removal. No shedding or flaking of metal occurred, preventing adverse effects on the patient. All tests passed without deviation. |
| UniVit Tip Temperature | Tip temperature not to exceed 104°F (40°C) during operation. | The vitrector outer cutter needle did not reach an excessive or unsafe temperature (below 104°F) when run in a worst-case condition (11,000 cpm, in air, without lubrication). All tests passed without deviation. |
| UniVit Vibrational Testing | Vibration not to exceed 2.5 m/S² during operation. | The UniVit vitrector exhibited very low vibration (below 2.5 m/S²) from 500 to 11,000 cuts per minute, even when run at the highest possible CPM without lubrication. It was also lower in vibration frequency than a competitor model (DORC EVA, K190875). All tests passed without deviation. |
| Increased Cutting Speed (UniVit HE) | Capable of increased cutting speed up to 8,000 CPM. | Implicitly met as the device description states it operates up to 11,000 CPM, and other tests were conducted at high speeds, including 11,000 CPM to ensure safety and functionality. The text specifically states UniVit HE's cutting speed is "Increased cutting speed to 8K for UniVit HE". |
| Increased Cutting Speed (UniVit UHS) | Capable of increased cutting speed up to 11,000 CPM (effectively 22,000 CPM). | Implicitly met as the device description states it operates up to 11,000 CPM (doubled to 22,000 CPM due to inner cutter design), and tests like tip temperature and vibration were conducted at 11,000 CPM. The text specifically states UniVit UHS's cutting speed is "Increased cutting speed to 11K for UniVit UHS". |
2. Sample Size Used for the Test Set and Data Provenance
- UniVit Needle Deformation: All available gauge sizes (20, 23, 25, 27) were tested. The exact number of devices or iterations per gauge is not specified, but it implies a comprehensive test of each type. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Diaphragm Burst: "Only one gauge of handpiece was required for testing due to the UniVit vitrector family internal operation." This suggests at least one finished device was tested for this specific criterion. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Fluidics: "(2) rabbit eyes" were used. Data provenance is from studies conducted on rabbit eyes, likely internal lab testing by VisionCare Devices, LLC.
- UniVit Metal Flaking: "The testing was done on a finished device." The number of finished devices tested is not specified beyond this. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Tip Temperature: "The vitrector was ran in a worse case condition..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Vibrational Testing: "VCD ran the vitrector up to the highest CPM possible..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.
All tests appear to be retrospective internal bench tests conducted by VisionCare Devices, LLC. There is no indication of external data sources or geographic origin beyond the company's location in California.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no human experts used to establish a "ground truth" in the context of interpretation or diagnosis as this device is a surgical instrument, not an interpretative AI/image analysis device. The ground truth for the bench tests was based on measurable physical properties (e.g., fracture, pressure escape, temperature, vibration) and visual inspection (e.g., metal flaking, retinal damage in fluidics test) following defined protocols.
4. Adjudication Method for the Test Set
Not applicable. This device is a surgical tool, and the tests conducted were objective bench tests measuring physical performance, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not done. The device is a surgical instrument, not an AI or image-analysis tool that affects human reader performance. No human readers or AI assistance are involved in the specified testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way, all the bench tests performed are "standalone" in the sense that they evaluate the device's physical performance independent of human-in-the-loop operation, other than setting up and initiating the tests. However, this is not in the context of an "algorithm only" performance as would be applied to AI/software.
7. The Type of Ground Truth Used
The ground truth for the non-clinical bench tests was based on:
- Pre-defined pass/fail criteria for physical properties (e.g., temperature limits, vibration limits, absence of physical damage or leakage).
- Observational criteria, such as the absence of metal flaking or retinal damage in the fluidics test (using rabbit eyes).
- Compliance with recognized harmonized standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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.
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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
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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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UniVit™ HE and UniVit™ UHS
| 510(k) Summary | |||
|---|---|---|---|
| SUBMITTER | |||
| Date Prepared | 8/10/2022 | ||
| Submitter/Owner | VisionCare Devices, LLC.6100 Bellevue LaneAnderson, California 96007+1-530-364-2271 Phone+1-530-364-2275 Fax | ||
| Key Contact | Rick MorganOwnerRick@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 IIPanel 86: OphthalmicSubpart E: Surgical Devices886.4150 Vitreous Aspiration and cutting instrumentProcode: HQE | ||
| PREDICATE DEVICE | |||
| 510(k) No. | Company NameDevice 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 thevitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, aspring 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.
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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 CuttingPort |
| UHS-25 | UniVit™ UHS 25 Gauge, Single Outer Cutting Port, Inner Cutter with a CuttingPort |
| UHS-27 | UniVit™ UHS 27 Gauge, Single Outer Cutting Port, Inner Cutter with a CuttingPort |
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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 andUniVit™ UHSSubject Device | UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in bothanterior and posterior segment (vitrectomy) ophthalmic surgeries when used with apneumatically-driven vitrectomy system or phacoemulsification system that has apneumatically-driven vitrectomy module. |
| K120170ProCare HSPPredicate | The VCD HSP Vitcutter and Accessories is a single use (disposable) product intended for usein both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with apneumatically-driven vitrectomy system or phacoemulsification system that has apneumatically-driven vitrectomy module. The VCD UniVit™ HE and UniVit™ UHS producthas 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
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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 |
|---|---|---|
| ISO10993-1 | Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk managementprocess | Pass |
| ISO10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Pass |
| ISO10993-10 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass |
| ISO11137-1 | 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 |
| ISO11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | Pass |
| ISO11137-3 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects ofdevelopment, validation, and routine control | Pass |
Deviations and Exclusions
| Standard | Type | Deviation | Exclusions |
|---|---|---|---|
| ISO10993-1 | Biological evaluation of medical devices. Part 1: Evaluation and testingwithin a risk management process | None | None |
| ISO10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitrocytotoxicity | None | None |
| ISO10993-10 | Biological evaluation of medical devices Part 10: Tests for irritation andskin sensitization | None | None |
| ISO11137-1 | Sterilization of health care products - Radiation - Part 1: Requirementsfor development, validation, and routine control of a sterilization processfor medical devices [Including: Amendment 1 (2013)] | None | None |
| ISO11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing thesterilization dose | None | None |
| ISO11137-3 | Sterilization of health care products - Radiation - Part 3: Guidance ondosimetric aspects of development, validation and routine control | None | None |
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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.
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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.
§ 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.