Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner is indicated for use with either heat or chemical lens care systems in the weekly cleaning of soft contact lenses.

Device Description

Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner is supplied in a tablet format packaged in a foil strip. The tablets contain a proteolytic enzyme, Subtilisin, Polyethylene Glycol 3350 as a binding agent and salts for effervescence and tonicity. The tablet may be dissolved in either preserved or sterile un-preserved saline solution or Bausch & Lomb ReNu® MultiPurpose Solution.

AI/ML Overview

The ReNu Effervescent Enzymatic Contact Lens Cleaner did not undergo a clinical study to establish acceptance criteria and prove its performance in that context. The manufacturer, Bausch & Lomb, determined that a clinical study was not required based on the FDA's guidance document "Premarket Notification 510(k) Guidance Document for Contact Lens Care Products" (May 1, 1997). This decision was based on the device having the same qualitative formulation, manufacturing process, and similar quality standards as its predicate device, the Bausch & Lomb Sensitive Eyes® Enzymatic Cleaner. Therefore, the device's safety and effectiveness were established through substantial equivalence to the predicate device, rather than new clinical outcome measures.

Here's a breakdown of the information provided, tailored to your request, but acknowledging the absence of a clinical study for direct performance metrics:

Acceptance Criteria and Device Performance

Since no clinical study with predefined acceptance criteria for clinical outcomes was performed, the "acceptance criteria" here refer to the demonstration of substantial equivalence to a predicate device through non-clinical studies. The "reported device performance" is the determination that it is substantially equivalent.

Acceptance Criterion (Demonstrated through Non-Clinical Studies)	Reported Device Performance (Conclusion)
Physical Properties	Substantially equivalent to predicate device
Chemical Properties	Substantially equivalent to predicate device
Cleaning Efficacy	Substantially equivalent to predicate device
Toxicology	Substantially equivalent to predicate device
Microbiological Studies	Substantially equivalent to predicate device

2. Sample Size and Data Provenance

Sample Size (Test Set): Not applicable, as a clinical study with a test set of human subjects was not performed. The non-clinical studies would have involved laboratory samples for testing physical, chemical, cleaning efficacy, toxicological, and microbiological properties. The sizes of these experimental samples are not specified in the provided text.
Data Provenance: Not applicable for a clinical test set. The non-clinical studies were performed by Bausch & Lomb, but the specific location or retrospective/prospective nature of the non-clinical data collection is not detailed.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable, as the ground truth for clinical performance was not established through expert consensus on a test set.
Qualifications of Experts: N/A.

4. Adjudication Method

Adjudication Method: Not applicable, as no human-reviewed test set requiring adjudication was used to establish clinical ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed. The submission explicitly states that a clinical study was not required.
Effect Size: Not applicable.

6. Standalone Performance Study

Standalone Performance Study: No, a standalone algorithm-only performance study was not performed, as this is a contact lens cleaning device, not a diagnostic algorithm. The non-clinical studies assessed the device's inherent properties and performance in controlled laboratory settings for cleaning efficacy, toxicology, and microbiology, but this is distinct from "standalone performance" in the AI/algorithm context.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the safety and effectiveness of the device as presented in the 510(k) submission was substantial equivalence to a legally marketed predicate device. This was established through a series of non-clinical studies (physical, chemical, cleaning efficacy, toxicology, and microbiological studies) demonstrating that the new device shares the "same qualitative formulation" and is manufactured with the "same process and similar quality standards" as the predicate.

8. Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm and therefore does not have a "training set" in that sense.

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

Ground Truth Establishment (Training Set): Not applicable. There is no training set for this device.

Summary

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510K Premarket Notification for Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner

510 (k) Summary

Of Safety and Effectiveness

Bausch & Lomb ReNu Effervescent Enzymatic Contact Lens Cleaner

1. Submitter Information:

Bausch & Lomb Incorporated Global Vision Care Division 1400 N Goodman Street Rochester N.Y 14692 - 0450

Contact Person: Yvonne Middlefell Global Regulatory Affairs Manager

Telephone Number: 716-338- 8460 716- 338- 0702 Fax Number:

2. Device Name:

Classification Name: Soft (Hydrophilic) Contact Lens Periodic Cleaner Bausch & Lomb ReNu® Effervescent Enzymatic Contact Proprietary Name: Lens Cleaner.

3. Predicate Device:

Bausch & Lomb Sensitive Eyes Enzymatic Cleaner.

4. Description of Device:

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510K Premarket Notification for Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner

510 (k) Summary

Of Safety and Effectiveness

Bausch & Lomb ReNu Effervescent Enzymatic Contact Lens Cleaner

5. Indications for use:

Bausch & Lomb ReNu Effervescent Enzymatic Contact Lens Cleaner is indicated for use with either heat or chemical lens care systems in the weekly cleaning of soft contact lenses.

6. Description of Safety and Substantial Equivalence.

A series of non- clinical studies were completed for Bausch & Lomb ReNu Effervescent Enzymatic Contact Lens Cleaner. These studies evaluated the physical and chemical properties of the product under specified storage conditions. Cleaning Efficacy, Toxicology and Microbiological studies were also performed to demonstrate the safety and effectiveness of the device in conformance with the FDA document entitled Premarket Notification 510 (k) Guidance Document for Contact Lens Care Products dated May 1 1997.

The results of these studies indicate that the Physical, Chemical, Microbiological and Toxicological Properties of for Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner are substantially equivalent to the Bausch & Lomb Sensitive Eyes® Enzymatic Cleaner.

7. Clinical Study:

In accordance with the FDA document entitled Premarket Notification 510 (k) Guidance Document for Contact Lens Care Products. May 1 1997, Bausch & Lomb made the determination that a clinical study is not required to demonstrate the safety and effectiveness of this device.

The product has the same qualitative formulation and is manufactured following the same process and similar quality standards as the predicate device, Bausch & Lomb Sensitive Eyes® Enzymatic Cleaner.

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510 (k) Summary

Of Safety and Effectiveness

Bausch & Lomb ReNu ® Effervescent Enzymatic Contact Lens Cleaner

8. Substantial Equivalence:

The Bausch & Lomb ReNu ® Effervescent Enzymatic Contact Lens Cleaner is substantially equivalent to the Bausch & Lomb Sensitive Eyes® Enzymatic Cleaner.

Both of these products have the same indications for use, the same qualitative formulation and are manufactured following the same process and similar quality standards.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 1999

Yvonne Middlefell Manager, Global Regulatory Affairs Bausch & Lomb Incorporated 1400 N Goodman Street Rochester, NY. 14692-0450

Re: K983225

Trade Name: Bausch & Lomb ReNu ® Effervescent Enzymatic Contact Lens Cleaner Regulatory Class: II Product Code: 86 LPN Dated: February 3, 1999 Received: February 4, 1999

Dear Ms. Middlefell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Ms. Yvonne Middlefell, Manager, Global Regulatory Affairs

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl lorenttal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510k Premarket Notification for Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner

Bausch & Lomb Incorporated 1400 N. Goodman Street Rochester N.Y. 14692-0450

Indications For Use Statement

983225 510(K) Number (if known):

Device Name: Bausch & Lomb ReNu Effervescent Enzymatic Contact Lens Cleaner

Indications for Use:

Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner is indicated for use with either heat or chemical lens care systems in the weekly cleaning of soft contact lenses.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nui-Chuen Shui

(Division Sign-Off Division of Ophthalmic Devices 510(k) Number

Prescription Use

Over The Counter- Use

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”