(196 days)
Bausch & Lomb Sensitive Eyes Enzymatic Cleaner.
Not Found
No
The device description and performance studies focus on the chemical and physical properties of an enzymatic contact lens cleaner, with no mention of AI or ML technologies.
No
This device is a contact lens cleaner, used for weekly cleaning of soft contact lenses, and does not directly treat a disease or condition in the body.
No.
The device is a contact lens cleaner, intended for weekly cleaning of soft contact lenses, not for diagnosing medical conditions.
No
The device description clearly states it is supplied in a tablet format containing chemical components, indicating it is a physical product, not software.
Based on the provided information, the Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning soft contact lenses, which are medical devices used on the eye. This is a cleaning and maintenance function for a medical device, not a diagnostic test performed on a biological sample from the human body.
- Device Description: The description details the chemical composition and format of the cleaner, designed to break down protein deposits on contact lenses. It doesn't describe a test or assay for detecting substances in a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Using reagents or assays to detect specific analytes
- Reporting results in a diagnostic context
The studies mentioned focus on the cleaning efficacy, toxicology, and microbiological properties of the cleaner in relation to contact lenses, not on its ability to diagnose a medical condition.
N/A
Intended Use / 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.
Product codes
86 LPN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bausch & Lomb Sensitive Eyes Enzymatic Cleaner.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.”
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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:
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.
1
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.
2
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.
3
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
5
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
Os
V
(Division Sign-Off Division of Ophthalmic Devices 510(k) Number
or
Prescription Use
Over The Counter- Use