(113 days)
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses). Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve dryness, discomfort and irritation that may be associated with lens wear. Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses by placing a drop on the lens prior to application on to the eye.
REFRESH® CONTACTS™ Lubricating and Rewetting Drops is a sterile, buffered, isotonic preserved solution containing sodium carboxymethylcellulose as the demulcent and preserved with PURITE® (stabilized oxychloro complex 0.005%). Boric acid, sodium chloride, potassium chloride, calcium chloride and magnesium chloride act as buffering and tonicity agents. REFRESH® CONTACTS™ Lubricating and Rewetting Drops is supplied sterile, packaged in plastic bottles with controlled dropper tips and labeled with lot number and 24 month expiration date.
Here's an analysis of the provided text regarding the acceptance criteria and study for REFRESH® CONTACTS™ Lubricating and Rewetting Drops:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Non-toxic to ocular tissue | Demonstrated by in-vivo preclinical testing in laboratory animals. |
| Safety: Compatibility with soft (hydrophilic) contact lenses | Demonstrated by in-vitro lens compatibility testing. |
| Safety: Compatibility with RGP contact lenses | Demonstrated by in-vitro lens compatibility testing. |
| Safety (Clinical): Safety comparable to predicate devices (COMPLETE® for hydrogel, CLARIS® for RGP) as measured by slit lamp findings. | Clinical study results showed safety comparable to predicate devices. |
| Acceptability (Clinical): Acceptability comparable to predicate devices (COMPLETE® for hydrogel, CLARIS® for RGP) as measured by symptoms of discomfort. | Clinical study results showed acceptability comparable to predicate devices. |
| Effectiveness/Successful Use (Clinical): One month successful use by hydrogel lens wearers. | 100% of hydrogel lens wearers (25/25) had successful use for one month. |
| Effectiveness/Successful Use (Clinical): One month successful use by RGP lens wearers. | 100% of RGP lens wearers (25/25) had successful use for one month. |
| Substantial Equivalence: Physical, chemical, and microbiological properties substantially equivalent to predicate devices. | Preclinical studies indicate physical, chemical, and microbiological properties are substantially equivalent to REFRESH® CL, COMPLETE®, and CLARIS®. |
| Substantial Equivalence: Action, indications for use, safety, and effectiveness substantially equivalent to predicate devices. | Clinical study and overall assessment determined substantial equivalence in terms of action, indications for use, safety, and effectiveness to REFRESH® CL, COMPLETE®, and CLARIS®. Any differences between the new device and its predicates do not affect the use of this product. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study):
- 25 hydrogel lens wearers
- 25 RGP lens wearers
- Total: 50 subjects
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it describes a "one month clinical study conducted to evaluate the safety and acceptability."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. The "ground truth" for safety was determined by "slit lamp findings" and for acceptability by "symptoms of discomfort," presumably assessed by the clinical investigators or study staff, but specific details on expert involvement are not given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a lubricating and rewetting drop, not an imaging device that would typically involve human readers interpreting cases. The comparison was between the new device and predicate devices in terms of patient safety and acceptability.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to a lubricating and rewetting drop. There is no "algorithm" or standalone performance for this type of medical device. Its performance is assessed through its direct interaction with the eye and contact lenses in human subjects.
7. The Type of Ground Truth Used
The ground truth for the clinical study appears to be:
- Clinical Observations: Slit lamp findings for safety assessments.
- Patient-Reported Outcomes/Symptoms: Symptoms of discomfort for acceptability assessments.
- Successful Use: Defined as 100% of subjects having successful use over one month.
For preclinical testing, ground truth was established through:
- In-vivo preclinical animal testing for ocular tissue toxicity.
- In-vitro lens compatibility testing for compatibility with different lens types.
- In-vitro chemical, toxicological, and microbiological studies to assess properties.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI/ML algorithm. This device is not an AI/ML product. The preclinical and clinical studies described are for safety and efficacy evaluation of the physical product itself.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an AI/ML algorithm. The ground truth for the product's performance was established through the various preclinical and clinical tests outlined above.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS REFRESH® CONTACTS™ Lubricating and Rewetting Drops
1. Submitter Information:
Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534
| Contact Person: | Paul J. Nowacki |
|---|---|
| Telephone: | Manager, Regulatory Affairs |
| (714) 246-6761 (voice) | |
| (714) 246-5457 (fax) |
2. Device Name:
| Common Name: | In-Eye Soft (Hydrophilic) Contact Lens and Rigid GasPermeable Contact Lens Lubricating and RewettingSolution |
|---|---|
| Trade Name: | REFRESH® CONTACTS™ Lubricating & RewettingDrops |
| Device Classification: | Accessories to Contact Lenses - Cleaning and WettingAgents (86LPN) |
3. Predicate Device:
The Allergan products, REFRESH® CL Lubricating and Rewetting Drops, COMPLETE® Lubricating and Rewetting Drops and CLARIS® Rewerting Drops were selected as the predicate device for REFRESH® CONTACTS™ Lubricating and Rewetting Drops.
4. Device Description:
REFRESH® CONTACTS™ Lubricating and Rewetting Drops is a sterile, buffered, isotonic preserved solution containing sodium carboxymethylcellulose as the demulcent and preserved with PURITE® (stabilized oxychloro complex 0.005%). Boric acid, sodium chloride, potassium chloride, calcium chloride and magnesium chloride act as buffering and tonicity agents.
REFRESH® CONTACTS™ Lubricating and Rewetting Drops is supplied sterile, packaged in plastic bottles with controlled dropper tips and labeled with lot number and 24 month expiration date.
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5. Indications for Use:
- Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and . rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses).
- Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve . dryness, discomfort and irritation that may be associated with lens wear.
- Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses . by placing a drop on the lens prior to application on to the eye.
6. Description of Safety and Substantial Equivalence:
A series of preclinical tests and clinical testing was performed to demonstrate the safety and effectiveness of REFRESH® CONTACTSTM Lubricating and Rewetting Drops. The following is a summary of the test results.
Preclinical Testing
A series of in-vitro and in-vivo preclinical chemical, toxicological and microbiological studies were performed to assess the safety and effectiveness of REFRESH® CONTACTS™ Lubricating and Rewerting Drops. 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 results of these studies indicate that the physical, chemical and microbiological properties of REFRESH® CONTACTS™ Lubricating and Rewetting Drops are substantially equivalent to the predicate devices REFRESH® CL Lubricating and Rewetting Drops, COMPLETE® Lubricating and Rewetting Drops and CLARIS® Rewetting Drops.
The solution is non-toxic to the ocular tissue as demonstrated by in-vivo preclinical testing in laboratory animals. In-vitro lens compatibility testing was conducted to establish product compatibility with both soft (hydrophilic) contact lenses and RGP contact lenses.
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Clinical Testing
A one month clinical study was conducted to evaluate the safety and acceptability of REFRESH® CONTACTS™ Lubricating and Rewetting Drops for both hydrogel and rigid gas permeable (RGP) contact lenses. The results of the study showed that the product is safe and acceptable for its intended use based on:
- One month successful use by 100% of subjects- (25/25) hydrogel lens wearers and . (25/25) RGP lens wearers.
- Safety comparable to COMPLETE® Lubricating and Rewerting Drops (hydrogel . lens wearers) or CLARIS® Rewetting Drops (RGP lens wearers) as measured by slit lamp findings.
- Acceptability comparable to COMPLETE® Lubricating and Rewetting Drops . (hydrogel lens wearers) or CLARIS® Rewetting Drops (RGP lens wearers) as measured by symptoms of discomfort.
Results of the clinical study demonstrate the safety, acceptability and substantial equivalence of REFRESH® CONTACTS™ Lubricating and Rewetting Drops to the predicate devices for lubricating and rewetting both soft (hydrophilic) and RGP contact lenses.
Substantial Equivalence
REFRESH® CONTACTS™ Lubricating and Rewetting Drops are substantially equivalent in terms of action, indications for use, safety and effectiveness to the predicate devices. REFRESH® CL Lubricating and Rewetting Drops (approved for marketing under PMA P960012), COMPLETE® Lubricating and Rewetting Drops (approved for marketing under P910075/S7) and CLARIS® Rewetting Drops (approved for marketing under P900047/S5). Any differences between the new device and its predicates do not effect the use of this product.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 1999
Mr. Paul J. Nowacki Manager, Regulatory Affairs Allergan 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534
Re: K992028
Trade Name: REFRESH® CONTACTS™ Lubricating and Rewetting Drops Regulatory Class: II Product Code: 86 LPN Dated: September 10, 1999 Received: September 13, 1999
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 (OS) 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. forenthal
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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Indications for Use Statement
| 510(k)Number(if known) | K992028 |
|---|---|
| Device Name | REFRESH ® CONTACTS TM Lubricating and Rewetting Drops |
| Indicationsfor Use | Use REFRESH® CONTACTSTM Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses).Use REFRESH® CONTACTSTM Lubricating and Rewetting Drops to help relieve dryness, discomfort and irritation that may be associated with lens wear.Use REFRESH® CONTACTSTM Lubricating and Rewetting Drops to cushion lenses by placing a drop on the lens prior to application on to the eye. |
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 | K992028 |
| Prescription Use(Per 21 CFR 801.109 | OR | Over-The-Counter Use ✓ |
|---|---|---|
| ----------------------------------------- | ---- | ------------------------- |
§ 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.”