(10 days)
ULTRACARE Neutralizing Tablets are part of the ULTRACARE System, a disinfecting, neutralizing and storage system for daily and extended wear soft (hydrophilic) contact lenses in a chemical (not heat) lens care system.
The ULTRACARE Neutralizing Tablets are indicated for use to neutralize the ULTRACARE Disinfecting Solution in the ULTRACARE System. ULTRACARE Neutralizing Tablets are added at the beginning of the disinfection cycle so that disinfection and neutralization occur without any additional steps.
ULTRACARE Neutralizing Tablets are smooth, round, beige to pale pink tablets that contain catalase, hydroxypropyl methylcellulose, and cyanocobalamin (Vitamin B12) as a color indicator, with buffering and tableting agents.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ULTRACARE® Neutralizing Tablets:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes a submission for a 510(k) premarket notification, which usually focuses on demonstrating "substantial equivalence" to a predicate device rather than setting explicit, quantifiable acceptance criteria for novel performance claims. However, we can infer performance targets based on the comparison to the predicate and the types of studies conducted.
| Aspect of Performance | Acceptance Criteria (Implied/Predicate-based) | Reported Device Performance |
|---|---|---|
| Lens Compatibility | Comparable to predicate device; no significant changes in lens parameters (power, diameter, basecurve, spectral transmittance, surface) after 30 regimen cycles. | "The results indicated that ULTRACARE Neutralizing Tablets used in combination with ULTRACARE Disinfecting Solution and ULTRAZYME Enzymatic Cleaner are compatible with hydrogel contact lenses and perform comparably to the predicate device." |
| Antimicrobial Efficacy | Meet FDA criteria for "stand-alone" contact lens disinfecting products (against FDA's recommended panel of microorganisms). | "The test results showed that the disinfection system using ULTRACARE Neutralizing Tablets met the criteria for 'stand-alone' contact lens disinfecting products." |
| Ocular Safety (Toxicology) | No clinically significant ocular discomfort, irritation, or toxicity. | "The results of this study showed no clinically significant ocular discomfort, irritation or toxicity." |
| Clinical Safety & Acceptability (Overall) | Safe and acceptable for intended use; no apparent difference in key safety (corneal staining) and acceptability (lens comfort) variables compared to predicate. | "The results of the study showed that the ULTRACARE lens care regimen is safe and acceptable for its intended use based on: - Successful use by 96.7% (55/59) of evaluable subjects. - No apparent difference in the key safety variable of corneal staining compared to the predicate device. - No apparent difference in the key acceptability variable of lens comfort compared to the predicate device." |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Clinical Study: 59 evaluable subjects.
- Lens Compatibility: Representative lenses from FDA Lens Groups 1 and 4. (Specific number not provided, but implies multiple lenses per group to demonstrate compatibility).
- Microbiology/Toxicology: Not explicitly stated, but these are typically in-vitro and in-vivo lab tests (e.g., animal models for toxicology), not human subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly probable the studies were conducted prospectively with data relevant to US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" in the way it might be stated for, say, an imaging AI device. The ground truth for this medical device is established directly through clinical outcomes, objective measurements, and established microbiological standards:
- Clinical Study: Evaluated "corneal staining" and "lens comfort." These would be assessed by ophthalmologists or optometrists associated with the clinical trial, though their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.
- Microbiology: Comparison to "FDA's recommended panel of microorganisms" and "criteria for 'stand-alone' contact lens disinfecting products." This implies adherence to established regulatory standards, not expert consensus on individual cases.
- Toxicology: Assessment of "clinically significant ocular discomfort, irritation or toxicity" would be made by clinical investigators/ophthalmologists.
- Lens Compatibility: Objective measurements (power, diameter, basecurve, spectral transmittance) and material surface changes, likely performed by laboratory technicians and assessed by material scientists or optical engineers.
4. Adjudication Method
Not applicable in the conventional sense for this type of medical device study. There isn't a "test set" of images or cases needing independent review for classification. Clinical endpoints (e.g., corneal staining, comfort) were likely assessed by investigators in the clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a contact lens care product, not an imaging AI device where multiple readers evaluate cases. The clinical study compares the new device regimen to a predicate device regimen, but it's not described as an MRMC study designed to measure human reader improvement with AI assistance.
6. Standalone Performance Study
Yes, in a conceptual sense. The "Microbiology" testing evaluated the "antimicrobial efficacy of the ULTRACARE® System...met the criteria for 'stand-alone' contact lens disinfecting products." This indicates the system (inclusive of the neutralizing tablets) performs its primary function (disinfection and neutralization) without human intervention beyond the user following instructions.
7. Type of Ground Truth Used
The ground truth is a combination of:
- Clinical Outcomes/Observations: For the clinical study, this includes successful use rate, corneal staining, and lens comfort.
- Regulatory Standards: For microbiology, adherence to "FDA's recommended panel of microorganisms" and "criteria for 'stand-alone' contact lens disinfecting products."
- Objective Measurements: For lens compatibility, changes in physical and optical properties of the lenses.
- Toxicological Assessment: For ocular safety, absence of clinically significant discomfort, irritation, or toxicity.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" is used to develop an algorithm. The development of the ULTRACARE® Neutralizing Tablets would involve formulation science, chemical engineering, and manufacturing processes, not data training in an AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm. The "ground truth" for the development of the product itself would be based on established scientific principles, chemical efficacy, material science, and prior regulatory experience with similar products.
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2525 Dupont Drive, P.O. Box 19534, Irvine, California, USA 92623-9534 Telephone: (714) 246-4500 Website: www.allergan.com
Image /page/0/Picture/3 description: The image shows a black and white abstract design. The design consists of several horizontal lines of varying lengths, stacked vertically. The lines are thicker in the middle and taper towards the ends, creating a rounded, capsule-like shape for each line. The overall arrangement of the lines forms a symmetrical, somewhat oval or diamond-like pattern.
K 98 4383
December 4. 1998
510(k) SUMMARY
Submitter Information 1.
Allergan 2525 Dupont Drive Irvine, California 92612
| Contact Person: | Paul J. Nowacki |
|---|---|
| Manager, Regulatory Affairs |
Telephone Number: (714) 246-6761
Device Name 2.
| Classification Name: | Soft (hydrophilic) contact lens care products |
|---|---|
| Proprietary Name | ULTRACARE® Neutralizing Tablets |
Predicate Device 3.
The predicate device is ULTRACARE® Neutralizing Tablet with Color Indicator.
Description of the Device 4.
ULTRACARE Neutralizing Tablets are smooth, round, beige to pale pink tablets that contain catalase, hydroxypropyl methylcellulose, and cyanocobalamin (Vitamin B12) as a color indicator, with buffering and tableting agents.
ਨੰ Indications for Use
ULTRACARE Neutralizing Tablets are part of the ULTRACARE® System, a disinfecting, neutralizing and storage system for daily and extended wear soft (hydrophilic) contact lenses in a chemical (not heat) lens care system.
The ULTRACARE Neutralizing Tablets are indicated for use to neutralize the ULTRACARE® Disinfecting Solution in the ULTRACARE System. ULTRACARE Neutralizing Tablets are added at the beginning of the disinfection cycle so that disinfection and neutralization occur without any additional steps.
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Description of Safety and Substantial Equivalence 6.
A series of preclinical tests and clinical testing was performed to demonstrate the safety and effectiveness of ULTRACARE® Neutralizing Tablets. The tests were designed and performed in accordance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry - Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products. The following is a summary of the test results.
Preclinical Testing
A series of in-vitro and in-vivo preclinical chemical, microbiological and toxicological studies were performed to assess the safety and effectiveness of ULTRACARE Neutralizing Tablets. The results of these studies indicate that ULTRACARE Neutralizing Tablets are substantially equivalent to the predicate device.
Lens compatibility
A study was conducted to determine the compatibility of hydrogel contact lenses with the ULTRACARE® lens care regimen consisting of ULTRACARE® Disinfecting Solution, ULTRACARE® Neutralizing Tablets and ULTRAZYME® Enzymatic Cleaner. A control regimen using the predicate device was also tested.
Representative lenses from FDA Lens Groups 1 and 4 were monitored for changes in power, diameter, basecurve, spectral transmittance and material surface changes during and after 30 regimen cycles.
The results indicated that ULTRACARE Neutralizing Tablets used in combination with ULTRACARE Disinfecting Solution and ULTRAZYME Enzymatic Cleaner are compatible with hydrogel contact lenses and perform comparably to the predicate device.
Microbiology
The antimicrobial efficacy of the ULTRACARE® System using ULTRACARE Neutralizing Tablets was evaluated, in the presence and absence of ULTRAZYME Enzymatic Cleaner, against FDA's recommended panel of microorganisms.
The test results showed that the disinfection system using ULTRACARE Neutralizing Tablets met the criteria for "stand-alone" contact lens disinfecting products.
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Toxicology
A 28-day subacute ocular safety study was performed using ULTRACARE® Neutralizing Tablets in conjunction with ULTRACARE® Disinfecting Solution and ULTRAZYME® Enzymatic Cleaner. The results of this study showed no clinically significant ocular discomfort, irritation or toxicity.
Clinical Testing
A three-month clinical study was conducted to evaluate the safety and acceptability of ULTRACARE Neutralizing Tablets when used with ULTRACARE Disinfecting Solution for hydrogel contact lenses.. The results of the study showed that the ULTRACARE lens care regimen is safe and acceptable for its intended use based on:
- Successful use by 96.7% (55/59) of evaluable subjects .
- No apparent difference in the key safety variable of corneal staining compared . to the predicate device
- No apparent difference in the key acceptability variable of lens comfort . compared to the predicate device.
Results of the clinical study demonstrate the safety, acceptability and substantial equivalence of ULTRACARE Neutralizing Tablets to the predicate device for its intended use.
7. Substantial Equivalence
ULTRACARE Neutralizing Tablets are substantially equivalent in terms of actions, indications for use, safety, and effectiveness to the predicate device: ULTRACARE Neutralizing Tablets with Color Indicator (approved for marketing under PMA P850088/S36).
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Mr. Paul J. Nowacki Manager, Regulatory Affairs Allergan 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534
Re: K984383 Trade Name: ULTRACARE ® Neutralizing Tablets with Color Indicator Regulatory Class: II Product Code: 86 LPN Dated: December 4, 1998 Received: December 8, 1998
Dear Mr. Nowacki:
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 - Mr. Paul J. Nowacki
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 rosenthal
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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Attachment 2
Indications for Use Statement
・
:
| 510(k)Number(if known) | The predicate device, ULTRACARE® Neutralizing Tablets withColor Indicator, was approved under PMA P850088/S36. |
|---|---|
| Device Name | ULTRACARE® Neutralizing Tablets |
| IndicationsFor Use | ULTRACARE Neutralizing Tablets are part of the ULTRACARESystem, a disinfecting, neutralizing and storage system for daily andextended wear soft (hydrophilic) contact lenses in a chemical (notheat) lens care system.The ULTRACARE Neutralizing Tablets are indicated for use toneutralize the ULTRACARE Disinfecting Solution in theULTRACARE System. ULTRACARE Neutralizing Tablets are addedat the beginning of the disinfection cycle so that disinfection andneutralization occur without any additional steps. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K984383 |
Prescription Use ____ (Per 21 CFR 801.109) OR Over-The-Counter Use X
§ 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.”