The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.

Device Description

The Crystalsert consists of a plunger, body, drawer and inserter tip. All of the components are manufactured with medical grade polypropylene. There is also a stainless steel spring for the plunger return. The plunger tip is 2.8 mm that requires the lens to be folded when delivered. The body has a loading dock area for placement of the lens with forceps with an additional notch to allow for correct haptic placement. Once the lens is placed in the loading dock, the drawer is pressed closed and then the plunger can be depressed to deliver the lens. Finger flanges are also built onto the body to assist in the deliver.

AI/ML Overview

The provided document describes the Crystalsert™ Crystalens® Delivery System, an intraocular lens inserter. It is a 510(k) submission, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the study information requested (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) is not applicable or not provided in this type of submission. 510(k) clearances typically rely on performance testing that demonstrates the device meets its design specifications and functions as intended, aligning with the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics with specific thresholds that would be used in a clinical study to quantify device efficacy (e.g., sensitivity, specificity for a diagnostic device). Instead, it focuses on demonstrating substantial equivalence to a predicate device (MPort (MP-30)) by comparing technological characteristics and intended use. The "performance" assessment is implied through validation activities.

Feature/Characteristic	Predicate Device (MPort (MP-30))	Subject Device (Crystalsert Inserter)	Comparison/Assessment
Operating Principle	Lens loaded through loading deck, pushed into position by closing drawer. Lens lays flat. Haptic puller used. Delivered by direct forward motion of syringe-type plunger. Single lens inserted through 3 mm tip, folded when pushed.	Lens loaded into loading dock in unfolded flat state. Put in proper position by closing drawer. No haptic puller necessary. Delivered by direct forward motion of syringe-type plunger. Single lens inserted through 2.8 mm tip, folded when pushed.	Substantially Equivalent: Both operate on the principle of folding and delivering an IOL via a plunger. The Crystalsert has a slightly smaller tip (2.8mm vs 3mm) and eliminates the need for a haptic puller by having a notch in the loading area for correct haptic placement, which could be considered an enhancement while maintaining the core operating principle.
Design	Plunger, inserter body, drawer, haptic puller. Loading dock attached to end of body.	Plunger, inserter body, drawer. Loading dock attached to end of body. Additional notch cut in loading area for correct haptic placement.	Substantially Equivalent: Core components are the same. The Crystalsert removed the haptic puller and added a notch in the loading area, a design modification to improve usability while achieving the same function.
Material	Medical Grade Polypropylene with PA-208 lubricant. Stainless steel plunger return spring. Silicone plunger O-ring.	Body and drawer: Medical Grade Polypropylene (Huntsman) with 1% InCon GMB#2 Lubricant. Plunger: medical grade polypropylene (BP Amoco). Stainless steel plunger return spring. No plunger O-ring.	Substantially Equivalent: Both use medical-grade polypropylene and stainless steel springs. Differences in specific lubricant, polypropylene supplier, and absence of an O-ring for the Crystalsert are considered minor material differences for a 510(k) submission, likely supported by biocompatibility and performance testing (not detailed here).
Intended Use/Indications for Use	The Mport Foldable Lens Placement system is indicated for compressing and inserting a Soflex™ series multi-piece intraocular lens into the eye during small incision cataract surgery.	The Crystalsert™ Crystalens delivery system is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.	Substantially Equivalent: Both are IOL delivery systems for cataract surgery. The specific IOL models differ, as the Crystalsert is designed for Crystalens, but the fundamental function (folding and delivering an IOL) is the same.
Cleaning/Sterilization Information	EtO sterilized to SAL of 10-6. Single use. 6-month shelf life.	Same	Identical: No differences reported.
Validations (IOL/Viscoelastic compatibility)	Validated for use with LI61U, LI51U, C31UB and Silens6/Soflex 2. Bausch & Lomb Ocucoat Viscoelastic and Amvisc viscoelastics can used.	Validated with Crystalens models AT-50SE or AT-52SE and validated with Bausch & Lomb Viscoelastic Amvisc Plus.	Functionally Equivalent: Both are validated for specific IOLs and viscoelastics. The specific models differ, as expected, given the Crystalsert's intended use with Crystalens. This indicates internal testing was performed to ensure compatibility and proper function for its indications.

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. As a 510(k) submission for an IOL delivery system, the "test set" would typically refer to the various IOLs and viscoelastic materials validated for use with the device and performance testing to ensure the device consistently delivers these IOLs without damage. Specific sample sizes for such tests are not detailed in this summary. Data provenance is also not specified as there are no clinical trials mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. Ground truth, in the context of diagnostic device validation, is not relevant here. For a device like an IOL inserter, the "truth" is whether it successfully delivers the IOL undamaged, which is determined through engineering and performance testing.

4. Adjudication method for the test set

Not applicable / Not provided. Adjudication methods are typically used in clinical studies with human readers/assessors. For a mechanical device, performance is evaluated against defined specifications.

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 / Not provided. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of results. This device is an IOL delivery system.

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

Not applicable / Not provided. This is also relevant for AI-powered diagnostic devices. The Crystalsert is a mechanical delivery system. Its "standalone performance" would be assessed by its ability to reliably fold and insert an IOL, which is implied by the "Validations" section.

7. The type of ground truth used

Not applicable / Not provided. For this type of device, ground truth would be synonymous with demonstrable mechanical performance and successful, undamaged IOL delivery, established through bench testing and engineering validation, rather than expert consensus, pathology, or outcomes data from a clinical trial.

8. The sample size for the training set

Not applicable / Not provided. Training sets are used for machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable / Not provided. Training sets are used for machine learning algorithms.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, materials, and intended use, supported by internal validation testing (e.g., IOL compatibility). It does not involve the types of clinical studies or AI-related assessments that would provide the requested information about sample sizes, expert ground truth, or reader studies.

Summary

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K082944

OCT 1 6 2008

Section 15 SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.

Submitter's name, address, telephone number, contact person, and date 1. summary prepared

-Bausch & Lomb Incorporated દ્યા. 1400 N. Goodman Street Rochester, N.Y. 14609 (585) 338-8467
Contact Person: David U. Thomas, M.S., R.A.C. b. Manager, Global Regulatory Affairs
Date Summary Prepared: September 4, 2008. C.
Name of device, including trade name and classification name: 2.
- Crystalsert™ Crystalens® Delivery System Trade/Proprietary Name: a.
- Intraocular lens guide b. Classification Name:
1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Chiron Vision Corporation (currently acquired by Bausch & Lomb Corporation
Device:	MPort (MP-30)
510(k)	K970727
Date Cleared:	December 17, 1997

A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant

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Bausch & Lomb Incorporated Crystalsert™ Crystalens® Delivery System

physical and performance characteristics (design, material, physical properties):

5. Statement of intended use:

The Crystalsert™ Crystalens delivery system is intended to be used to fold and deliver the Crystalens® (AT-50SE and AT-52SE) accommodating intraocular lens into the capsular bag.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

MPort (MP-30)	Crystalsert Inserter
Operating Principle
Lens is loaded into inserter throughloading deck and then pushed intoposition by closing drawer. Lens islaying flat in loading deck whendrawer is closed. Haptic puller isused to place leading haptic incorrect loading position.	Lens is loaded into loading dockin unfolded flat state. Lens is putin proper position for loading byclosing drawer. No haptic pulleris necessary.
Lens is delivered by direct forwardmotion of syringe-type plunger	same
Single lens is inserted through a 3mm inserter tip. Lens is foldedwhen pushed through tip.	Single lens is inserted through2.8 mm inserter tip. Lens isfolded when pushed through tip.
Design
The inserter consists of plunger,inserter body, drawer and haptic puller.	The inserter consists of plunger,inserter body, and drawer. A loading

A loading dock is attached to the end ofthe inserter body.	dock is attached to end of inserterbody. Additional notch is cut inloading area to allow for correcthaptic placement.
Material
The inserter is single use and consistsof Medical Grade Polypropylene withPA-208 lubricant. The plunger returnspring is stainless steel and the plungerO-ring consists of silicone.	The body and drawer consist MedicalGrade Polypropylene material((Huntsman) with 1% by weightInCon GMB#2 Lubricant) and thePlunger is medical gradepolypropylene from BP Amoco.Plunger return spring is stainlesssteel. No plunger O-ring is used withthis plunger.
Labeling
Indications for Use:	Indications for Use:
The Mport Foldable Lens Placementsystem is indicated for compressing andinserting a Soflex™ series multi-pieceintraocular lens into the eye duringsmall incision cataract surgery.	The Crystalsert™ Crystalens deliverysystem is intended to be used to foldand deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500)accommodating intraocular lens intothe capsular bag.
Cleaning/Sterilization Information
Product is EtO sterilized to a SAL of10-6. No cleaning is necessary orrecommended.Product is Single-Use only.The inserter will be labeled with a 6month shelf life.	same
Validations
Validated for use with LI61U, LI51U,C31UB and Silens6/Soflex 2. Bausch& Lomb Ocucoat Viscoelastic andAmvisc viscoelastics can used.	Validated with Crystalens modelsAT-50SE or AT-52SE and validatedwith Bausch & Lomb ViscoelasticAmvisc Plus.

Technical Comparison Matrix

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2008

Bausch & Lomb, Inc. c/o Jay Y. Kogoma Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K082944

Trade/Device Name: Cystalsert™ Crystalens® Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: IOL Inserter/Injector Regulatory Class: I Product Code: MSS Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Kogoma:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Malvina B. Edwards, und

Malvina B, Eydelman, M 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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Indications for Use

K082944 510(k) Number (if known):

Device Name: Crystalsert™ Crystalens® Delivery System

Indications For Use:

The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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)

Kesia Hexander
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K082944

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.