(143 days)
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.
The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.
The bioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The bioli™ IOL Delivery System is intended for use during cataract surgery.
The bioli™ IOL Delivery System is composed of two parts:
- (1) a cartridge that holds the intraocular lens in position in preparation for loading and folding, and
- (2) a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag
The cartridge incorporates a smooth, internal geometry that progressively folds the lens for delivery through conventional nozzle geometry. A coating is applied to the cartridge including the inner surfaces to increase lubricity.
The cartridge is loaded by positioning the intraocular lens into the cartridge, folding the trailing haptic onto the anterior side of the optic, and finally pushing the optic edge of the lens to position it as far into the cartridge as the forceps will permit. After the cartridge is attached onto the injector, the system is now ready for the advancement of the plunger to deliver the lens.
The document provided is a 510(k) summary for the bioli™ IOL Delivery System. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a formal table of acceptance criteria alongside reported device performance for all tests. However, it states that various tests "met the defined acceptance criteria and requirements," or "showed passing results," or "demonstrated that the device can successfully deliver" or "was able to."
Here's a summary of the performance claims, with acceptance criteria implied by the "passing" or "successful delivery" statements:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable biocompatibility per ISO 10993 parts 5, 10, and 11 | "The biocompatibility testing was found acceptable." This included cytotoxicity, sensitization, ocular irritation, acute systemic toxicity, and material-mediated pyrogenicity. |
| IOL Delivery Performance (Mechanical) | Successful delivery of IOLs without affecting functionality, damage, or out-of-spec dimensions. | "All lenses were delivered through the bioli™ IOL Delivery System according to the loading and delivery instructions." "After delivery, lenses were observed for possible damages or scratches using a 10x microscope and showed passing results, and were within dimensional specifications. The bioli™ IOL Delivery System also showed no damage after lens delivery." "The resulting data from simulated surgical manipulation... showed that the device can successfully deliver Lenstec's hydrophilic Softec 1 IQLs of low to high diopters and IOL models validated for use with this device... without affecting the functionality of the lens." |
| IOL Optical and Dimensional Properties | Maintain optical properties, dimensional properties, and surface/bulk homogeneity before and after delivery per ISO 11979-3:2012. | IOLs were "evaluated for optical properties, dimensional properties and overall surface and bulk homoqeneity before and after being surgically manipulated... IOL optical properties and overall surface and bulk homogeneity inspection were conducted in accordance with ISO 11979-3:2012... showed passing results, and were within dimensional specifications." |
| Lens Opening Time | Unspecified, but evaluated to ensure proper IOL function. | IOLs were "evaluated for... lens opening time after folding." (Results implied as acceptable by overall successful delivery statement) |
| Cartridge Performance | Maintain overall surface and bulk homogeneity. | "The bioli™ IOL Delivery System was also evaluated for its cartridge performance, such as overall cartridge surface and bulk homogeneity." (Results implied as acceptable by overall successful delivery statement) |
| Shelf-Life (Package & Performance Stability) | 5-year shelf-life, meeting acceptance criteria for visual inspection, package seal, and package integrity per ASTM F1980-2007 (2011 reapproved), ASTM F88-09, ASTM F1929-12, ISO 11737-2:2009, USP 35 and ASTM F1140/F1140M-2013. | "Package stability and performance stability test results met the defined acceptance criteria and requirements for a shelf-life claim of 5 years. Visual inspection, package seal and package integrity of the sterile barrier system of bioli™ IOL Delivery System met the requirements in accordance with ASTM F1980-2007(2011 reapproved). The post aging tests were carried out in accordance with ASTM F88-09, ASTM F1929-12, ISO 11737-2:2009, USP 35 and ASTM F1140/F1140M-2013." |
| Sterilization Validation | Sterilization using EtO with residual EO within safe levels post-aeration period per ISO 11135:2014. | "Results from sterilization validation testing conducted in accordance with ISO 11135:2014 demonstrated that bioli™ IOL Delivery System is able to be sterilized using EtO sterilization parameters with residual EO found to be within safe levels post-aeration period." |
| Transport Stability | Resist physical damage from drop, vibration, and short extreme temperature impacts per ISO 2233:2001, ASTM D4169-16, ASTM F88/F88M-15, ASTM F2096-11, and ASTM F1929-15. | "The results demonstrated that bioli™ IOL Delivery System was able to resist the physical damage caused by drop, vibration and short extreme temperature impacts during transportation." |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact sample sizes (number of IOLs or devices) used for the non-clinical tests. It generally refers to "All lenses" being delivered and evaluated.
- Data Provenance: The document does not specify the country of origin of the data, nor whether the non-clinical tests were conducted retrospectively or prospectively. The tests are described as "simulated surgical manipulation" and "performed," suggesting prospective testing in a laboratory setting.
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)
This is a medical device submission, not an AI/algorithm-based diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of diagnostic interpretation is not directly applicable. The "ground truth" for this device's performance relies on objective measurements and established engineering and biocompatibility standards. For instance, IOL damage/scratches were assessed using a "10x microscope," and optical/dimensional properties were assessed against ISO standards. The expertise would be in the technicians and engineers conducting these standardized tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI diagnostic device requiring expert adjudication of interpretations. The tests involve objective measurements against predefined criteria and standards.
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
Not applicable. The bioli™ IOL Delivery System is a physical medical device (an intraocular lens injector), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance described is of the physical device in laboratory simulations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bioli™ IOL Delivery System's performance is based on:
- Objective measurements against established industry standards: Such as ISO 11979-3:2012 for IOL properties, ISO 10993 series for biocompatibility, ASTM standards for packaging and transport.
- Visual inspection under magnification: For damage or scratches to IOLs and the device.
- Functional tests: Ensuring successful delivery of IOLs "without affecting the functionality of the lens."
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.