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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

AST Products, Inc. William Lee VP, R&D and Regulatory Affairs 9 Linnell Circle Billerica, Massachusetts 01821

Re: K200057

Trade/Device Name: bioli IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: April 26, 2020 Received: April 28, 2020

Dear William Lee:

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 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

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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 (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.

For Tieuvi Nguyen, Ph.D. 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) K200057

Device Name bioli™ IOL Delivery System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, 510(k) summary is provided.

1. Submitter

AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778

2. Official Correspondence/Contact Person

William Lee, Ph.D. VP, R&D and Regulatory Affairs AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778 Email: wlee@astp.com

3. 510(k) Preparer

William Lee, Ph.D. VP, R&D and Requlatory Affairs AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778 Email: wlee@astp.com

4. Product Name

Trade Name: bioli™ IOL Delivery System (Models: BIOLI-C, BIOLI-rC, BIOLI-D)
Common Name: Folders and Injectors, Intraocular Lens (IOL)

5. Device Classification

| Classification Name: Class I (21 CFR § 886.4300 Intraocular lens guide)
Classification Panel: Ophthalmic (86)
Product Code: MSS

6. Legally Marketed Predicates

K182965 BL-Cart™ IOL Delivery Cartridge

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7. Device Description

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 bioli™ IOL Delivery System and the referenced legally marketed predicate, BL-Cart™ IOL Delivery Cartridge, share the same principal method to implant an intraocular lens into the eye. Both utilize the same lens folding system design in which IOLs are folded and/or delivered from an injector system and the resulting optical and physical properties of the IOL remain unchanged as a result of folding/delivery.

Note: LubriMATRIX™ is a proprietary treatment composed of a hydrophilic polymer and a lubricious polymer engrafted onto the surface of the cartridge via a chemical polymerization process. Refer to MAF-1963 for further information. LubriMATRIX™ is applied to AST Products' current line of IOL Delivery Systems: lioli™ IOL Delivery System (K142056), pioli™ IOL Delivery System (K172228), and BL-Cart™ IOL Delivery Cartridge (K182965).

8. Intended Use and Indications for Use

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 only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.

The bioli™ IOL Delivery System and the referenced legally marketed predicate device share the same principal folding method to implant an intraocular lens into the eye and similar intended use and indications for use for lens insertion into the eye, and thus does

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not raise any new questions or concerns regarding safety and effectiveness. Refer to Table 1.

Trade Name	Manufacturer	RegulationNo.	ProductCode	RegulationDescription	510(k) No.	Intended Use &Indications for Use
bioli™ IOLDelivery System(Models: BIOLI-C, BIOLI-rC,BIOLI-D)	AST Products,Inc.	886.4300	MSS	IntraocularLens Guide	New device	The bioli™ IOL Delivery System is asingle-use, sterile device intended toinsert an approved single-piece foldableacrylic intraocular lens (IOL) into thehuman eye through an incision.The bioli™ IOL Delivery System is only forthe insertion of Lenstec Softec I IOL andIOL models validated for use with thisdevice as indicated in the approved IOLlabeling.
BL-Cart™ IOLDeliveryCartridge(Model: Type D)	AST Products,Inc.	886.4300	MSS	IntraocularLens Guide	K182965	The BL-Cart™ IOL Delivery Cartridge is asingle-use, sterile device intended toinsert an approved single-piece foldableacrylic intraocular lens (IOL) into thehuman eye through a surgical procedure.The cartridge is intended to be used inconjunction with Alcon Monarch® III IOLDelivery System injector.The BL-Cart™ IOL Delivery Cartridge isonly for the insertion of Lenstec Softec IIOL and IOL models validated for use withthis device as indicated in the approvedIOL labeling.

Table 1. Device Comparisons – Intended Use and Indications for Use

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9. Technological Characteristics

The bioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering of an intraocular lens into the eye for replacement of the human crystalline lens during cataract surgery. The device consists of a lubricious coated cartridge and a single-use injector with a silicone-tipped plunger used to advance the lens into the capsular bag.

The bioli™ IOL Delivery System shares similar technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application. Refer to Tables 2 and 3.

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Trade Name	Design	Operating Principle	AdvancementMechanism	Biocomp.	SterilizationMethod	Setting Used	PatientContact	Recommendedfor Use With	HumanFactors	PerformanceCriteria Met
bioli™ IOLDelivery System(Models: BIOLI-C,BIOLI-rC, BIOLI-D)	A sterile,single-usedisposabledevice	The cartridge is loadedinto the injection systemand the IOL is pushedthrough the cartridgeinto the eye.	Plunger /syringe type	Yes	ETO sterilizationSAL level 1x10-6	Hospital/Surgerycenter	Distal end ofcartridge toplace lens ineye	FDA-approvedviscoelastic	For usebydoctorsonly	Yes
BL-Cart™ IOLDelivery Cartridge(Model: Type D)	A sterile,single-usedisposablecoatedcartridge	The one-piecedisposable cartridge isloaded into a reusablehandpiece injectionsystem and the IOL ispushed through thecartridge into the eye	Plunger-like,non-screw type	Yes	ETO sterilizationSAL level 1x10-6	Hospital/Surgerycenter	Distal end ofcartridge toplace lens ineye	FDA-approvedviscoelastic	For usebydoctorsonly	Yes

Table 2. Device Comparisons – Technological Characteristics

Table 3. Device Comparisons – Materials

Trade Name	Device Materials	Standards Met
bioli™ IOL Delivery System(Models: BIOLI-C, BIOLI-rC, BIOLI-D)	Injector Barrel - Polycarbonate (144R)Plunger - ABS (PA-758)Silicone Tip - Silicone (R 401)Cartridge - Polypropylene (RJ880MO-12)Spring - Stainless Steel (SS304)	ISO 11979-3:2012ISO10993-5: 2009ISO 10993-10: 2010
BL-Cart™ IOL Delivery Cartridge (Model: Type D)	Cartridge - Polypropylene (RJ880MO-12)	ISO 11979-3:2012ISO10993-5: 2009ISO 10993-10: 2010

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10. Performance Data (Nonclinical and/or Clinical)

Non-clinical Tests:
The bioli™ IOL Delivery System contacts the patient's eye directly for a limited (≤24hr) time. The device also has limited contact with the IOL. Based on the contact duration, cytotoxicity, sensitization and ocular irritation tests were performed. In addition, acute systemic toxicity and material-mediated pyrogenicity tests were also performed. The biocompatibility testing was performed in accordance with International Standard Orqanization (ISO) Biocompatibility evaluation of medical devices- parts 5, 10 and 11. The biocompatibility testing was found acceptable.

All lenses were delivered through the bioli™ IOL Delivery System according to the loading and delivery instructions.

The IOLs were evaluated for optical properties, dimensional properties and overall surface and bulk homoqeneity before and after being surgically manipulated using the bioli™ IOL Delivery System, as well as lens opening time after folding. The bioli™ IOL Delivery System was also evaluated for its cartridge performance, such as overall cartridge surface and bulk homogeneity.

IOL optical properties and overall surface and bulk homogeneity inspection were conducted in accordance with ISO 11979-3:2012, Ophthalmic implants – Intraocular lenses - Part 3: Mechanical properties and test methods.

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 of bioli™ IOL Delivery System (Models: BIOLI-C, BIOLI-IC, BIOLI-D) to deliver intraocular lenses 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 as indicated in the IOL approved labeling without affecting the functionality of the lens.

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.

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.

A transport stability study was conducted according to requirements in 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

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resist the physical damage caused by drop, vibration and short extreme temperature impacts during transportation.

Clinical Tests: Not required for this device.

11. Conclusion

The resulting data from simulated surgical manipulation of bioli™ IOL Delivery System to deliver intraocular lenses showed that bioli™ (Models: BIOLI-C, BIOLI-rC, BIOLI-D) can successfully deliver Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling without affecting the functionality of the lens.

Based on the assessment of these findings, along with the results of Biocompatibility, Sterilization and Shelf-life testing, we conclude that the bioli™ IOL Delivery System is substantially equivalent to the referenced legally marketed predicate device provided in this 510(k) premarket notification submission.

Regulation Number and Section

§ 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.