The Bausch + Lomb Iniector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.

AI/ML Overview

Acceptance Criteria and Device Performance for Bausch + Lomb Injector System

This document describes the acceptance criteria and the study that demonstrates the Bausch + Lomb Injector System (BLIS) meets these criteria, based on the provided FDA 510(k) summary (K131958).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes various tests performed to ensure the device's safety and effectiveness. The "acceptance criteria" are implied to be successful completion and conformity to relevant standards and established good practices for medical devices of this type. The "reported device performance" is the successful outcome of these tests.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Cleaning Validation	Manual and automated cleaning processes must be effective in preparing the handpiece for sterilization.	Cleaning validation covered the manual and automated cleaning processes described in the labeling for the Bausch + Lomb Injector System Handpiece. (Implies successful validation).
Sterilization Validation	Autoclave methods for handpiece and ethylene oxide (EtO) process for cartridge must achieve sterility.	Sterilization validation included the autoclave methods described in the labeling for the Bausch + Lomb Injector System Handpiece and the ethylene oxide process for the Bausch + Lomb Injector System Cartridge. (Implies successful validation).
Sterilization Residual Testing	Ethylene oxide residuals must be within acceptable limits for patient safety.	Ethylene oxide residual testing for a device equivalent to the Bausch + Lomb Injector System Cartridge was included in the 510(k). (Implies compliance with limits).
Shipping and Handling Validation	Device integrity and functionality must be maintained after exposure to typical shipping and handling conditions.	Shipping and handling validations were performed on both the Bausch + Lomb Injector System Handpiece and Cartridge. (Implies successful validation).
Stability Testing	The cartridge must maintain its integrity and functionality over its specified shelf life.	Stability testing validated the Bausch + Lomb Injector System Cartridge over the shelf life of the device. (Implies successful validation).
Biocompatibility	Device components in contact with the patient (handpiece and cartridge) must be biocompatible, showing no adverse biological reactions.	Biocompatibility testing was performed on the Bausch + Lomb Injector System Handpiece and cartridge, and both were found to be biocompatible.
Mechanical Properties (Bench Testing)	Device components must meet the mechanical requirements outlined in ISO 11979-3.	Bench testing was performed on both components of the Bausch + Lomb Injector System to demonstrate compliance with ISO 11979-3, Mechanical Properties.

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

The provided 510(k) summary does not specify numerical sample sizes for the test sets used in cleaning, sterilization, shipping, stability, biocompatibility, or bench testing. It indicates that these tests "were performed" or "were included," implying sufficient samples for validation.

The data provenance is internal to the manufacturing and testing processes of Bausch + Lomb. The tests were non-clinical (bench-top and laboratory-based) rather than involving human subjects. Therefore, specific country of origin or retrospective/prospective distinctions as would apply to clinical data are not mentioned.

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

N/A. This device is an injector system, not an AI or diagnostic device that requires expert ground truth for interpretation of output. The ground truth for its performance is derived from standardized testing methodologies and compliance with industry standards (e.g., ISO 11979-3).

4. Adjudication Method

N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or diagnosis, such as those evaluating AI for medical imaging. This device's testing is focused on physical and biological properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not applicable to an intraocular lens injector system. These studies are typically performed for diagnostic devices where human readers interpret medical data (e.g., images) and the impact of AI assistance on their performance is measured. The BLIS is a surgical tool.

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

Yes, in a conceptual sense. All the tests described (cleaning, sterilization, shipping, stability, biocompatibility, bench testing) assess the device's inherent properties and functionality without human intervention in the performance of the core mechanical/biological tests. The device's operation, however, does require a human operator to physically use it. The tests evaluate the "algorithm" of the device's design and materials.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests is objective physical measurements and biological assays that conform to established industry standards and regulatory requirements. This includes:

Sterility assurance levels
Residual levels of sterilants
Material properties (strength, durability, etc.) as defined by ISO 11979-3
Biocompatibility endpoints as per relevant ISO standards (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of algorithm development.

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

N/A. As there is no training set for an algorithm, this question is not applicable.

Summary

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K131958 Bausch + Lomb Injector System

JAN - 9 2014

510(K) SUMMARY

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

The submitter of the 510(k) is:

Jason Smith Global Regulatory Affairs Manager : Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 Phone: 800-393-6642 Fax: 949-398-5764

Date Summary Prepared: January 7, 2014

Subject Device: 1.

Trade name: Bausch + Lomb Injector System Common Name: Intraocular lens Guide Classification Name: .21 CFR 886.4300

2. Predicate Devices:

K113852, Bausch + Lomb IOL Injector K063155, Alcon Monarch III IOL Delivery System

3. Device Description:

4. Indications for Use:

The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling..

Note: This is almost the same indications for use as the predicate Bausch + Lomb IOL Injector (K113852). The differences between the two indications are differences in describing which Bausch + Lomb IOLs are appropriate for use with these injectors. The subject device adds more detail to this description than the subject K113852 device. This difference is not critical to the intended therapeutic or surgical use of the device.

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K 131958 Bausch + Lomb Injector System

Brief Summary of Nonclinical Test and Results: 5.

The proposed Bausch + Lomb Injector System was evaluated using cleaning, sterilization, sterilization residual, shipping and handling, biocompatibility, and bench testing. Cleaning validation covered the manual and automated cleaning processes described in the labeling for the Bausch + Lomb Iniector System Handpiece. Sterilization validation included the autoclave methods described in the labeling for the Bausch + Lomb Injector System Handpiece and the ethylene oxide process for the Bausch + Lomb Injector System Cartridge. Ethylene oxide residual testing for a device equivalent to the Bausch + Lomb Injector System Cartridge was included in the 510(k).

Shipping and handling validations were performed on both the Bausch + Lomb Injector System Handpiece and Cartridge. Stability testing validated the Bausch + Lomb Injector System Cartridge over the shelf life of the device.

Biocompatibility testing was performed the Bausch + Lomb Injector System Handpiece and cartridge, and both were found to be biocompatible.

Bench testing was performed on both components of the Bausch + Lomb Injector System to demonstrate compliance with ISO 11979-3, Mechanical Properties.

6. Comparative Analysis

A table comparing the proposed device to the predicate devices is provided on the following page.

7. Conclusion

The Bausch + Lomb Injector System is substantially equivalent to the predicate devices

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K131958 Bausch + Lomb Injector System

mparison of Predicate Devices to the Proposed Bausch + Lomb Iniector Syste C

Characteristic	K113852 Bausch + Lomb IOLInjector	K063155 Alcon Monarch IIIDelivery System.	Bausch+ Lomb Injector System(Proposed Device)
Indications for Use	Folding and injection of Bausch + Lomb IOLs that have the use of this injector in their labeling.	Handpiece: For use with Alcon Monarch III cartridges as specified in the table below (product number 8065977763) for the surgical implantation of Alcon Foldable IOLs.	The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.
		Cartridge: Implantation of Alcon qualified ACrySoft Foldable IOLs. No unqualified lenses should be used with the Monarch III IOL Delivery System..
Contraindications	None	None	None
Anatomical site	Eye	Eye	Eye
Injector configuration(reusable)	Not applicable	Titanium shaft with a titanium screw plunger	Titanium body, plunger tip, knob; stainless steel plunger shaft, plunger threads
Injector configuration (single use)	A syringe-shaped ABS body, coated polyamide tip, ABS push plunger and polypropylene cartridge.	Cartridge	Coated polyamide cartridge
How is the device used?	The IOL is placed in the loading chamber. A plunger pushes the IOL into the tip, which folds the IOL. Pushing the plunger further advances the IOL out through the tip into the eye.	The IOL is placed in the loading cartridge. The catridge is snapped into the handpiece. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye.	The IOL is placed in the loading cartridge. The catridge is snapped into the handpiece. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye.
Single Use	Yes	Handpiece: NoCartridge: Yes	Handpiece: NoCartridge: Yes
Characteristic		En K113852 Bausch + Lomb IOL K063155 Alcon Monarch Illing Bausch+ Lomb Injector System
he product steri	Yes	Handpiece: shipped nonsterilized/resterilized byuseı	landpiece: shipped nonsterile, to beusei
		artridge: shipped steri	Cartridge: shipped steri
ow Sterilize	Ethylene oxide	Handpiece: steam (by user) Cartridge: Ethylene oxide (by	Handpiece: steam (by user) Cartridge: Ethylene oxide (by
Coating	Hydrophilic coating (Medicoat	Handpiece: None	Handpiece: None Cartridge: Hydrophilic coating (Medicoat A)
low Supplie	acks of 10	Handpiece: single Cartridge: packs of 1	Handpiece: single Cartridge: Packs of 10

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K131958 Bausch + Lomb Injector Syster

. :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 9, 2014

Bausch + Lomb c/o Mr. Jason Smith Manager, Global Regulatory Affairs 30 Enterprise, Suite 450 Aliso Viejo, CA 92656

Re: K131958

Trade Name: Bausch + Lomb Injector System, BLIS Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: November 22, 2013 Received: November 25, 2013

Dear Mr. Smith:

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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Page 2 - Mr. Jason Smith

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -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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5 Indications for Use Statement

510(k) Number (if known): 131958

Device Name: Bausch + Lomb Injector System (BLIS)

Indications for Use:

The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.

Prescription Use __ X AND/OR Over-The-Counter 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)

Claudine 2014.01.07 -05'00'

Page 1 of _1

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.