(119 days)
The Vista Ophthalmics vitrectomy probe is intended to be used to remove vitreous and dissect tissue in the eye as follows:
· Vitreous aspiration & cutting
· Membrane cutting & aspiration
· Lens removal
· Dissect tissue in the eye
The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.
The Vista vitrectomy probe is a pneumatically actuated device which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during anterior and posterior ophthalmic procedures. The Vista vitrectomy probe is offered in a two port bi-blade configuration.
The Vista vitrectomy probe utilizes a pressured air pulse to drive the cutting action. The pressure pulse originates from the operational system of choice and distends or expands a silicone rubber diaphragm inside the handpiece. The pressure pulse fills the pressure chamber of the vitrector, actuating the axial extension of the inner-cutting tube to produce a guillotine-type cutting motion. A vacuum originating from the operational system of choice draws biological materials (tissue and fluid) into the outer cutting port area of the cannula that is inserted into the patient's eye. The vacuum-drawn material entering the outer needle port is then resected by the inner-cutter as it travels down the inside diameter of the outer needle. Once the inner-cutter resects (guillotines) the material as it crosses the distal end of the outer needle port cutting edge, the material is aspirated through the inside diameter of the inner-cutting tube. The material continues to be aspirated through the handpiece and into a collection chamber of the vitrectomy system selected for use with the Vista vitrectomy accessory.
This document describes the 510(k) summary for the Vista Ophthalmics Vitrectomy Probe, K220030. It focuses on demonstrating substantial equivalence to a predicate device, the Alcon Hypervit Vitrectomy Probe (K170520), and a reference device, the Vision Care ProCare Plus (K120170).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific thresholds. Instead, it relies on demonstrating that the Vista Vitrectomy Probe's performance is similar to or meets the performance of the predicate and reference devices in various tests. The key performance evaluations can be inferred from the "Performance Data" section.
| Performance Characteristic | Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-01 for medical devices. Specific tests (Cytotoxicity, Sensitization, Ocular Irritation, Systemic Toxicity, Material Mediated Pyrogenicity) must meet acceptable limits. | Biocompatibility testing of the Vista vitrectomy probe in accordance with ISO 10993-01 including Cytotoxicity (per ISO 10993-5), Sensitization (per ISO 10993-10), Ocular Irritation (per ISO 10993-10), Systemic toxicity (per ISO 10993-11) and Material Mediated Pyrogenicity (per ISO 10993-11) was performed. (Implied acceptable results as it's listed under performance data) |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137. Satisfactory Bioburden testing. | Sterilization conditions were substantiated for the Vista vitrectomy probe to provide a Sterility Assurance Level of 10^-6, in accordance with ISO 11137. Bioburden testing performed. (Implied acceptable results) |
| Bacterial Endotoxin | Compliance with ANSI/AAMI ST72. | Bacterial Endotoxin testing (BET) was performed on the Vista vitrectomy probe in accordance with ANSI/AAMI ST72. (Implied acceptable results) |
| Packaging Qualification | Package and seal integrity requirements must be met after transportation and environmental conditioning studies. | Packaging qualification was performed with the reference device as part of the transportation and environmental conditioning studies to demonstrate that package and seal integrity requirements were met. (Implied acceptable results) |
| Shelf-life / Stability | Establishing an expiration date for the device, implying that performance is maintained over the stated shelf-life. Post-aging performance specs must be met. | Accelerated shelf life testing and device stability testing was performed on a reference device as part of the packaging validation test program for the sterile device to establish the expiration date for the Vista vitrectomy probe (3 years). Post-aging transportation testing (per ISTA 6) and device stability testing of the Vista vitrectomy probe confirmed that performance specifications were met. (Implied acceptable results) |
| Functional Performance | Adequate material cutting and aspiration, resistance to cannula deformation, minimal metal flaking, appropriate cannula penetration force, and operating temperature within safe limits during worst-case operations. These implicitly compare to the performance of equivalent devices on the market (predicate/reference). | Performance evaluations were successfully performed with the finished Vista Vitrectomy probe including material cutting and aspiration and cut speed, validations for the resistance of cannula deformation, metal flaking as well as cannula penetration force testing. Additionally, the operating temperature limits of the cannula tip were simulated in worst-case operations. (All implied to be acceptable and comparable to predicate/reference device performance) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state specific sample sizes for each test in the "Performance Data" section. It broadly states that "All validation processes have demonstrated that the functional requirements and finished device specifications are met." without providing numerical details for the number of units tested.
The data provenance is internal testing performed by Vista Ophthalmics LLC. There is no mention of country of origin for data or whether it's retrospective or prospective, as these are typically not applicable to bench and lab testing of a physical medical device for 510(k) clearance based on equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and 510(k) submission. "Ground truth" established by experts is typically relevant for AI/ML-based diagnostic devices where clinical interpretation is involved. For a surgical instrument like a vitrectomy probe, "ground truth" is established by adherence to engineering specifications, validated test methods, and compliance with recognized standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used for clinical studies involving multiple human readers to resolve discrepancies in diagnoses or assessments, particularly in AI device performance evaluations. The performance data presented here are for technical specifications and material properties of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The Vista Ophthalmics Vitrectomy Probe is a surgical instrument, not an AI-assisted diagnostic or decision-support device. Therefore, MRMC studies and evaluations of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated above, this is a surgical instrument and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
For the performance evaluations, the "ground truth" is established by:
- Recognized standards: ISO 10993-01 (Biocompatibility), ISO 11137 (Sterilization), ANSI/AAMI ST72 (Bacterial Endotoxin), ISTA 6 (Transportation Testing).
- Engineering specifications and validated test methods: For material cutting/aspiration, resistance to deformation, metal flaking, penetration force, and temperature limits. These would be defined internally by the manufacturer, often based on industry best practices and comparison to predicate devices.
- Predicate device performance: The basis for substantial equivalence is that the new device performs similarly to or better than the legally marketed predicate device.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense of a clinical diagnostic truth for this type of device's 510(k) submission.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
May 4, 2022
Vista Ophthalmics LLC % Debe Deck SVP, Program Management & Client Services Regulatory Pathways Group Inc. 340 S. Lemon Ave. #2471 Walnut, CA 91789
Re: K220030
Trade/Device Name: Vista Ophthalmics Vitrectomy Probe Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration And Cutting Instrument Regulatory Class: Class II Product Code: MLZ Dated: March 22, 2022 Received: March 24, 2022
Dear Debe Deck:
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
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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 (OS) 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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220030
Device Name Vista Ophthalmics Vitrectomy Probe
Indications for Use (Describe)
The Vista Ophthalmics vitrectorny probe is intended to be used to remove vitreous and dissect tissue in the eye as follows: · Vitreous aspiration & cutting
- Membrane cutting & aspiration
- · Lens removal
- · Dissect tissue in the eye
The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.
| 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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| APPLICANT: | Vista Ophthalmics23510 Kingsland Blvd. #200Katy, TX 77494 |
|---|---|
| OFFICIAL CORRESPONDENT: | Debe DeckRegulatory Pathways Group Inc.(949) 375-4387ddeck@regulatorypathways.com |
| DATE SUMMARY PREPARED: | May 2, 2022 |
| TRADE NAME: | Vista Ophthalmics Vitrectomy Probe |
| COMMON NAME: | Same |
| DEVICE CLASSIFICATION /CODE | Class II886.4150 Vitreous aspiration and cutting instrumentMLZ |
| PREDICATE DEVICE: | Alcon Hypervit Vitrectomy ProbeAlcon, Inc.K170520 |
| REFERENCE DEVICE: | Vision Care ProCare PlusVision Care Devices, LLC.K120170 |
DEVICE DESCRIPTION
The Vista vitrectomy probe is a pneumatically actuated device which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during anterior and posterior ophthalmic procedures. The Vista vitrectomy probe is offered in a two port bi-blade configuration.
The Vista vitrectomy probe utilizes a pressured air pulse to drive the cutting action. The pressure pulse originates from the operational system of choice and distends or expands a silicone rubber diaphragm inside the handpiece. The pressure pulse fills the pressure chamber of the vitrector, actuating the axial extension of the inner-cutting tube to produce a guillotine-type cutting motion. A vacuum originating from the operational system of choice draws biological materials (tissue and fluid) into the outer cutting port area of the cannula that is inserted into the patient's eye. The vacuum-drawn material entering the outer needle port is then resected by the inner-cutter as it travels down the inside diameter of the outer needle. Once the inner-cutter resects (guillotines) the material as it crosses the distal end of the outer needle port cutting edge,
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Page 2 of 5
the material is aspirated through the inside diameter of the inner-cutting tube. The material continues to be aspirated through the handpiece and into a collection chamber of the vitrectomy system selected for use with the Vista vitrectomy accessory.
INDICATIONS FOR USE
The Vista Ophthalmics vitrectomy probe is intended to remove vitreous and dissect tissue in the eye as follows:
- · Vitreous aspiration & cutting
- · Membrane cutting & aspiration
- · Lens removal
- · Dissect tissue in the eye
The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The technological characteristics of the Vista vitrectomy probe are substantially equivalent to those of the predicate device, the Alcon Hypervit (K170520), and reference device, the VisionCare (K120170). These devices share the similar actuation energy source (pneumatic pulses) and cutting speeds, the same type of aspiration source (low vacuum), and the same mechanism of action (guillotine style cutting).
The Vista vitrectomy probe incorporates a biocompatible chromium coating on the inner cutter surface to allow for low-force entry of the Vista Ophthalmics handpiece into the eye without the need for other blades or entry system accessories.
Table 1 on the following page provides a comparison of the technological characteristics of the proposed Vista vitrectomy probe and the substantially equivalent predicate device: the Alcon Hypervit (K170520).
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| TABLE 1 |
|---|
| TECHNOLOGICAL COMPARISON OF THE VISTA VITRECTOMY PROBE TO THE PREDICATE DEVICE |
| Vista Ophthalmics | HyperVit Vitrectomy Probe | |
|---|---|---|
| Characteristic | Vitrectomy Probe | K170520 |
| (Proposed device) | (Predicate Device) | |
| Regulation/Product Code | 886.4150 / MLZ | 886.4150 / MLZ |
| Intended use/Indications for use | The Vista Ophthalmics vitrectomy probe isintended to be used to remove vitreous anddissect tissue in the eye as follows:· Vitreous aspiration & cutting· Membrane cutting & aspiration· Lens removal· Dissect tissue in the eyeThe Vista Ophthalmics probe is designed as astand-alone handpiece for use with ophthalmicsurgical systems having pneumatically drivenvitreoretinal functionality | The HyperVit™ Vitrectomy Probe is designedfor use with the Constellation® Vision Systemand is intended to be used to remove vitreousand dissect tissue in the eye(23 and 25 gauge)The HyperVit™ Vitrectomy Probe is designedfor use with the Constellation® Vision Systemand is intended for use as follows: (27 gauge)· Vitreous aspiration & cutting· Membrane cutting & aspiration· Lens removal· Dissect tissue in the eye |
| Power source for cutter activation | Forward pneumatic pressurepulses with spring return | Forward and return pneumatic pressure pulses |
| Probe needle gauge | 27 | 25, 27 |
| Cutting port format | Side port, 2 | Side port, 2 |
| Cutting action format | Guillotine | Guillotine |
| Cutter activation speed | 11,000 max cycles/minute | 10,000 max cycles/minute |
| Cutting speed | 22,000 max cuts/minute | 20,000 max cuts/minute |
| Aspiration means | Through inner cutter tubing | Through inner cutter tubing |
| Patient contacting material | Stainless steel w/ ME-92 coating | Stainless steel |
| Overall length of probe, nominal | 55 mm | 84 mm |
| Single-use / Reusable | Single use only | Single use only |
| Characteristic | Vista OphthalmicsVitrectomy Probe(Proposed device) | HyperVit Vitrectomy ProbeK170520(Predicate Device) |
| How Supplied | Sterile | Sterile |
| Sterile product packaging | Tyvek pouch | Tyvek pouch |
| Method of Sterilization | Gamma | EtO-sterilized |
| Shelf-life | 3 years | 2 years |
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Page 5 of 5
PERFORMANCE DATA
The descriptive characteristics of the Vista vitrectomy probe have been fully defined and are adequate to ensure equivalence to the predicate device. All validation processes have demonstrated that the functional requirements and finished device specifications are met.
An overview of key performance tests conducted with the finished Vista probe and reference device is provided below.
- . Biocompatibility testing of the Vista vitrectomy probe in accordance with ISO 10993-01 including Cytotoxicity (per ISO 10993-5), Sensitization (per ISO 10993-10), Ocular Irritation (per ISO 10993-10), Systemic toxicity (per ISO 10993-11) and Material Mediated Pyrogenicity (per ISO 10993-11).
- Sterilization conditions were substantiated for the Vista vitrectomy probe to . provide a Sterility Assurance Level of 106, in accordance with ISO 11137. Bioburden testing.
- . Bacterial Endotoxin testing (BET) was performed on the Vista vitrectomy probe in accordance with ANSI/AAMI ST72.
- Packaging qualification was performed with the reference device as part of . the transportation and environmental conditioning studies to demonstrate that package and seal integrity requirements were met.
- . Accelerated shelf life testing and device stability testing was performed on a reference device as part of the packaging validation test program for the sterile device to establish the expiration date for the Vista vitrectomy probe.
- Post-aging transportation testing (per ISTA 6) and device stability testing of . the Vista vitrecotmy probe confirmed that performance specifications were met.
- Performance evaluations were successfully performed with the finished Vista . Vitrectomy probe including material cutting and aspiration and cut speed, validations for the resistance of cannula deformation, metal flaking as well as cannula penetration force testing. Additionally, the operating temperature limits of the cannula tip were simulated in worst-case operations.
CONCLUSION
The Vista vitrectomy probe meets all product design requirements and applicable standards. The device has the same intended use and kev technological characteristics as the predicate devices. Therefore, the device has been shown to be substantially equivalent to the predicate devices.
§ 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.