The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lens identifying the Crystalsert Delivery System in their approved labeling.

Device Description

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens (AT-52SE, AT-50SE, HD520, HD500, AT50AO, AT52AO), Trulign™ Toric, and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.

AI/ML Overview

The provided document describes the Bausch & Lomb Crystalsert Delivery System, an intraocular lens guide. It outlines the device's description, indications for use, and a comparison to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria in the format typically expected for clinical or performance studies with quantitative results.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K123736, Crystalsert Delivery System) based on similar indications for use, contraindications, materials, single-use nature, sterility, sterilization method, sterility assurance level, and shelf life.

The "Brief Summary of Nonclinical Test and Results" section states: "The Crystalsert Delivery System has successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." However, it does not provide specific acceptance criteria or the reported device performance from these tests. The details of these tests (e.g., sample sizes, methodology, and quantitative results) are not included in this summary document.

Therefore, most of the requested information regarding acceptance criteria and a study demonstrating the device meets these criteria cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the information available in the provided text, with explicit notes where information is missing:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantified acceptance criteria with corresponding performance data from a specific study. Instead, it relies on demonstrating equivalence to a predicate device by matching various characteristics.

Characteristic	Predicate (Acceptance Basis - assumed "meets predicate")	Proposed Device Performance (Reported as equivalent)
Indications for use	The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.	The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.
Contraindications	None	None
Materials	Body, drawer, plunger: polypropylene; Spring: stainless steel	Body, drawer, plunger: polypropylene; Spring: stainless steel
Single use	Single use	Single use
Sterile	Sterile	Sterile
How sterilized	Ethylene oxide	Ethylene oxide
Sterility assurance level	10-6	10-6
Shelf life	12 months	12 months
Functional and biocompatibility testing	"successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." (Specific criteria and results not provided)	"successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." (Specific criteria and results not provided)

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

Sample Size: Not specified in the provided summary.
Data Provenance: Not specified in the provided summary. The summary only states that "functional and biocompatibility testing" was performed.

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

This information is not applicable and not provided. The document describes a medical device (an IOL delivery system), and the testing mentioned (functional, biocompatibility) typically involves engineering and laboratory assessments against standards, rather than expert-derived ground truth as might be seen in diagnostic AI.

4. Adjudication method for the test set

Not applicable and not provided, as the tests mentioned are functional and biocompatibility, not expert-based 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

Not applicable. This device is a delivery system, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a physical delivery system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional and biocompatibility testing, the "ground truth" would be adherence to established industry standards or internal specifications for mechanical performance and biological safety. The specific standards or specifications are not detailed in this summary.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable. This device is a physical product, not an AI algorithm.

Summary

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32593

510(k) Summ

This summary document has been prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Yi Gao Regulatory Affairs Specialist Bausch & Lomb, Inc. 30 Enterprise, Suite 450 Aliso Viejo, CA Phone: 949-521-7933 Fax: 949-521-7760

Date Summary Prepared: August 16, 2013

1 7 2013

1. Subject Device:

Trade name: Common Name: Classification Name: Crystalsert Delivery System Intraocular lens Guide 21 CFR 886.4300

Predicate Device: 2.

K 123736, Crystalsert Delivery System

3. Device Description:

Indications for Use: 4.

This is the same exact indications for use as the predicate device.

CONFIDENTIAL

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BAUSCH + LOMB

5. Brief Summary of Nonclinical Test and Results:

The Crystalsert Delivery System has successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards.

Comparative Analysis 6.

A table comparing the proposed device to the predicate devices is provided below.

Table 6-1: Comparison of Predicate Device to the Proposed Crystalsert Delivery
System

Characteristic	Predicate K123736Crystalsert Delivery System	"Crystalsert Delivery System(Proposed Device)
Indications for use	The Crystalsert Delivery System isintended to be used to fold and deliverthe Crystalens accommodatingintraocular lens and other intraocularlenses identifying the CrystalsertDelivery System in their approvedlabeling.	The Crystalsert Delivery System isintended to be used to fold and deliverthe Crystalens accommodatingintraocular lens and other intraocularlenses identifying the CrystalsertDelivery System in their approvedlabeling.
Contraindications	None	None
Materials	Body, drawer, plunger: polypropyleneSpring: stainless steel	Body, drawer, plunger: polypropyleneSpring: stainless steel
Single use?	Single use	Single use
Sterile?	Sterile	Sterile
How sterilized	Ethylene oxide	Ethylene oxide
Sterility assurancelevel	10-6	10-6
Shelf life	12 months	12 months

7. Conclusion

The Crystalsert Delivery System is substantially equivalent to the predicate device.

CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, rendered in black.

September 17, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Bausch & Lomb, Inc. Ms. Yi Gao Regulatory Affairs Specialist 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Re: K132593

Trade/Device Name: Crystalsert Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: August 16, 2013 Received: August 19, 2013

Dear Ms. Gao:

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 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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Y Alexander -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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Indications for Use Statement

30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com

K132593

510(k) Number (if known):

Device Name: Crystalsert Delivery System

Indications for Use:

X_____________________________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tieuvi 2013.0

CONFIDENTIAL

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.