The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraccular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the Lenstec Softee I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

Device Description

The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on the IOL approved labeling.

The set consists of a single-use, sterile svringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.

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.

AI/ML Overview

The provided document is a 510(k) summary for the pioli™ IOL Delivery System. It describes the device, its intended use, and its equivalence to a predicate device. The document details performance data from non-clinical tests to demonstrate that the device meets its acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
IOLs show no damage or scratches after delivery.	All delivered lenses showed no damages or scratches.
IOLs are within dimensional specifications after delivery.	All delivered lenses were within dimensional specifications.
Cartridges show no damage after lens delivery.	All cartridges showed no damages after lens delivery.
IOL optical properties, sagitta, and overall surface/bulk homogeneity are maintained after surgical manipulation with the pioli™ IOL Delivery System. (Evaluated per ISO 11979-2 and ISO 11979-3).	The resulting data from simulated surgical manipulation showed that the pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device... without affecting the functionality of the lens.
The pioli™ IOL Delivery System can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and other validated IOL models without affecting lens functionality.	The resulting data... showed that pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device as indicated on the IOL approved labeling without affecting the functionality of the lens.
Packaging validation: packaging seals meet specified parameters (e.g., appearance, peeling strength, adhesion).	The resulting data from packaging validation showed that the most suitable parameter to seal the packaging of pioli™ IOL Delivery System was under the condition of 129°C, 3.6 seconds, with all blisters passing the appearance inspection, peeling strength and adhesion tests.
Biocompatibility of components in direct/indirect patient contact is established. (Implied, as based on similarity to predicate device).	The components of pioli™ IOL Delivery System that have direct and indirect contact with the patient are manufactured of the same materials and same manufacturing processes as the predicate device, lioli™ IOL Delivery System. Therefore, the biocompatibility testing on the predicate device is applicable to the subject device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for the IOLs and cartridges tested in the non-clinical performance study. It mentions "All lenses were delivered..." and "All delivered lenses showed no damages..." and "all cartridges showed no damages...", which implies that a set of lenses and cartridges were tested, but the specific number is not provided.

Sample Size: Not explicitly stated (referred to as "All lenses" and "all cartridges").
Data Provenance: The study was a "simulated surgical manipulation" non-clinical test conducted by the device manufacturer (AST Products, Inc.). The country of origin of the data is not specified, but the manufacturer is based in Billerica, MA, USA. It is a prospective non-clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the non-clinical performance tests. The evaluation of IOL damage/scratches, dimensional specifications, and cartridge damage appears to be based on objective inspection and adherence to ISO standards, rather than expert interpretation of a 'ground truth' per se.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. The non-clinical tests described involve objective measurements and observations against pre-defined criteria (e.g., ISO standards, presence of damage, dimensional specifications). It does not involve subjective assessment requiring adjudication.

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, a TRMC comparative effectiveness study was not done. The device is an IOL delivery system, not an AI-assisted diagnostic or interpretive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The pioli™ IOL Delivery System is a physical medical device (an IOL delivery system), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance study was based on objective measurements and observations per established standards and specifications. This includes:
- ISO standards: ISO 11979-2 (Optical properties and test methods) and ISO 11979-3 (Mechanical properties and test methods) for IOL evaluation.
- Visual inspection: For damages, scratches, and homogeneity of IOLs and cartridges.
- Dimensional specifications: For IOLs after delivery.
- Functional assessment: The ability to successfully deliver IOLs without affecting their functionality.
- Packaging tests: Appearance inspection, peeling strength, and adhesion tests.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The "training" for such a device involves engineering design, material selection, and manufacturing processes validation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an IOL delivery system as described.

Summary

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December 15, 2017

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

Re: K172228

Trade/Device Name: pioli™ IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 2, 2017 Received: November 6, 2017

Dear William Lee, Ph.D .:

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.

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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 (reporting of medical devicerelated 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.

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172228

Device Name pioli™ IOL Delivery System

Indications for Use (Describe)

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

Requlatory Doctor™ RCTC, LLC 3955 Riner Road, Box 148 Riner. VA 24149 Tel: (800) 321-8567 Email: info@regulatorydoctor.com

4. Product Name

Trade Name: pioli™ IOL Delivery System
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

K142056: lioli™ IOL Delivery System (Models: LIOLI-18, LIOLI-22, LIOLI-24)

7. Device Description

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through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on the IOL approved labeling.

The set consists of a single-use, sterile svringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

8. Intended Use and Indications for Use

The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eve through a surqical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

The pioli™ IOL Delivery System shares the same intended use and indications for use for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application. Refer to Table 1.

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TradeName	Manufacturer	RegulationNo.	ProductCode	RegulationDescription	510(k) No.	Intended Use &Indications for Use
pioli™ IOLDeliverySystem	AST Products, Inc.	886.4300	MSS	IntraocularLens Guide	New device	The pioli™ IOL Delivery System is asingle-use, sterile device intended toinsert a one-piece foldable intraocularlens (IOL) into the human eye througha surgical procedure. The systemprovides a tubular pathway for lensimplantation through an incision. Thepioli™ IOL Delivery System is only forthe insertion of Lenstec Softec I IOLand IOL models validated for use withthis device as indicated on the IOLapproved labeling.
lioli™ IOLDeliverySystem	AST Products, Inc.	886.4300	MSS	IntraocularLens Guide	K142056	The lioli™ IOL Delivery System is asingle-use, sterile device intended toinsert a one-piece foldable intraocularlens (IOL) into the human eye througha surgical procedure. The systemprovides a tubular pathway for lensimplantation through an incision. Onlyfor the insertion of IOL modelsvalidated for use with this device asindicated in the IOL approved labeling.

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

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9. Technological Characteristics

The pioli™ 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 device consists of:

(1) a lubricious coated cartridge structure in preparation for intraocular lens loading and lens folding (2) a single-use injector with a silicone-tipped plunger used to advance the lens into the capsular bag.

The pioli™ IOL Delivery System is intended for use during cataract surgery.

An intraocular lens folded into the cartridge reduces the surgical incision size.

The pioli™ IOL Delivery System shares many 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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Table 2. Device Comparisons – Technological Characteristics

Trade Name	Design	Operating Principle	Forward Motion Principle	Biocomp.	Sterilization Method	Setting Used	Patient Contact	Recommended for Use With	Human Factors	Performance Criteria Met?
Dioli™ IOLDelivery System	A sterile, single use disposable device	The cartridge is back loaded into the injection system and the IOL is pushed through the cartridge into the eye	Plunger/Syringe type	Yes	ETO sterilizationSAL level 1x10-6	Hospital/Surgery center	Distal end of cartridge to place lens in eye	FDA-approved viscoelastic	For use by doctors only	Yes
ioli™ IOLDelivery System	A sterile, single use disposable device	The cartridge is loaded into the injection system and the IOL is pushed through the cartridge into the eye	Plunger/Syringe type	Yes	ETO sterilizationSAL level 1x10-6	Hospital/Surgery center	Distal end of cartridge to place lens in eye	FDA-approved viscoelastic	For use by doctors only	Yes

Table 3. Device Comparisons – Materials

Trade Name	Device Materials	Standards Met
pioli™ IOLDelivery System	Injector - Polycarbonate (144R)Plunger - Polycarbonate (144R)Silicone Tip - Silicone (R 401)Cartridge - Polypropylene (HD850MO)Spring - Stainless Steel (SS304)	ISO 11979-3:2012ISO10993-5: 2009ISO 10993-10: 2010
lioli™ IOLDelivery System	Injector - Polycarbonate (144R)Plunger - ABSSilicone Tip - Silicone (R 401)Cartridge - Polypropylene (HD850MO)Spring - Stainless Steel (SS304)	ISO 11979-3:2012ISO10993-5: 2009ISO 10993-10: 2010

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10. Performance Data (Nonclinical and/or Clinical)

Non-clinical Tests:
All lenses were delivered through the pioli™ according to the loading and delivery procedure in the Indications for Use (IFU).

The IOLs were evaluated for the optical properties, sagitta, and overall surface and bulk homogeneity before and after being surgically manipulated using the pioli™ IOL Delivery System, as well as lens opening time after folding. The pioli™ 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 11979-2. Ophthalmic implants – Intraocular lenses - Part 2: Optical properties and test methods and ISO 11979-3, Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods.

After delivery, all lenses were observed for possible damages or scratches using a microscope. All delivered lenses showed no damaqes or scratches, and were within dimensional specifications. Also, all cartridges showed no damages after lens delivery.

The resulting data from simulated surgical manipulation of pioli™ IOL Delivery System to deliver intraocular lenses (IOLs) showed that pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device as indicated on the IOL approved labeling without affecting the functionality of the lens.

The components of pioli™ IOL Delivery System that have direct and indirect contact with the patient are manufactured of the same materials and same manufacturing processes as the predicate device, lioli™ IOL Delivery System.

Since the same materials and the same manufacturing processes have been used for components that have direct and indirect contact with the patient in both medical devices, we therefore conclude that the biocompatibility testing on particularly the cartridge and the silicone tip of the predicate device are applicable to the subject device.

The resulting data from packaging validation showed that the most suitable parameter to seal the packaging of pioli™ IOL Delivery System was under the condition of 129°C, 3.6 seconds, with all blisters passing the appearance inspection, peeling strength and adhesion tests.

Clinical Tests: Not required for this device. |

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11. Conclusion

The pioli™ IOL Delivery System shares the same intended use and indications for use, and technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application.

Based on the assessment of these findings, along with the results of Biocompatibility, Sterilization and Shelf-Life testing, the pioli™ 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.