(245 days)
The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).
Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.
This 510(k) summary describes a medical device, the Ultimate Vit Enhancer (UVE), which is a vitrectomy device. The submission focuses on substantial equivalence to a predicate device and outlines performance testing rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML-driven devices.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. Instead, it broadly states that "functional requirements and specifications have been met." The performance data described are related to the mechanical and physical attributes of the device.
| Performance Aspect | Reported Device Performance |
|---|---|
| Heat generation | "Testing was conducted to measure heat generation in the vitreous cutter operated at a range of cut rates.""Requirements as outlined in the testing were met." |
| Cutter integrity | "Cutter integrity, including evaluation of the potential for metal flaking, was tested during extended exercising of the vitreous cutter at a range of cut rates.""Requirements as outlined in the testing were met." |
| Fluid dynamics | "Fluid dynamics were evaluated by measuring displacement of a marker in vitreous at a range of cut rates.""Requirements as outlined in the testing were met." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of patient data or clinical samples. The testing described appears to be laboratory-based bench testing on the device itself and potentially on simulated vitreous material (for fluid dynamics). No patient data is mentioned, thus no country of origin or retrospective/prospective nature can be determined.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The testing described is for a mechanical device's physical performance, not for interpreting medical images or making diagnoses that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication is mentioned or implied for the type of bench testing performed.
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
No. This device is a mechanical vitrectomy instrument, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a standalone hardware console used in conjunction with a standard vitrectomy machine and a specific vitreous cutter. It is not an algorithm, and its performance is not evaluated in terms of "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned (heat generation, cutter integrity, fluid dynamics), the "ground truth" would be the direct measurements obtained from the physical testing itself against pre-defined engineering specifications and requirements. This is not medical ground truth established by experts or pathology.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system and does not involve a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML system and does not involve a training set or its associated ground truth establishment.
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5io(k): k1022222
510(k) Summary of Safety and Effectiveness
APR - 8 2011
| Contact Person: | Linda UptonMID Labs, Inc.557 McCormick StreetSan Leandro, CA 94577(510) 357-3952 |
|---|---|
| Date Prepared: | April 5, 2011 |
| Trade Name: | Ultimate Vit Enhancer (UVE) |
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument(86 HQE, 21CFR 886.4150) |
Device Description/ Intended Use: Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.
Predicate Device: MID Labs AVE
| DeviceDescription | UVEUltimate Vit Enhancer | AVE |
|---|---|---|
| 510(k)Number | Current | K020911 |
| Intended Use | Vitreous cutting | Vitreous cutting |
| VitreousCutter Type | Guillotine | Guillotine |
| User interface | Frequency setting and displayon front panel | Frequency setting and displayon front panel |
| Energy source | External input pneumaticenergy | Internal input pneumaticenergy |
| Internalpressurecontrol | Electronic pressure regulator | Pressure regulator to controlthe pneumatic energy |
| Output valvetype | Solenoid valve | Solenoid valve |
| Outputfrequencycontrol | Electronic signal at userscalable function of Hostsystem frequency | Electronic signal at usersettable frequencies |
Predicate Device Comparison Table
Performance Data: Testing and validations have demonstrated that the functional requirements and specifications have been met. Testing was conducted to measure heat generation in the vitreous cutter operated at a range of cut rates. Cutter integrity, including evaluation of the potential for metal flaking, was tested during extended exercising of the vitreous cutter at a range of cut rates. Fluid dynamics were evaluated by measuring displacement of a marker in vitreous at a range of cut rates. Requirements as outlined in the testing were met. Test data and documentation has been submitted to support system function.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
APR - 8 2511
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medical Instrument Development Laboratories, Inc. c/o Ms. Linda Upton Vice President 557 McCormick Street San Leandro, CA 94577
Re: K102222
Trade/Device Name: MID Labs Ultimate Vit Enhancer Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: II Product Code: HQE Dated: March 23, 2011 Received: March 25, 2011
Dear Ms. Upton:
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. 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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
11
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102222
Device name: Ultimate Vit Enhancer (UVE) MID Labs Vitreous Cutter labeled for use with the UVE
Indications For Use:
The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).
Prescription Use X (Part 21 CFR 801 SubpartD)
AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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510(k) Number K122222
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§ 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.