(53 days)
PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations.
The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.
This submission describes a 510(k) for a contact lens solution, PuriLens Plus Preservative Free Saline, and argues for its substantial equivalence to a predicate device based on similar formulation, manufacturing, and packaging, and expands its indications for use.
Since this is a submission for substantial equivalence based on a predicate device and there have been no changes to the device design, formulation, or manufacturing, no performance data or studies are presented. Therefore, I cannot provide information on acceptance criteria, specific study details, sample sizes, ground truth establishment, or expert involvement as these were not required or reported in this 510(k) summary.
The summary states: "Because the subject is identical to the predicate in terms of formulation, manufacturing, and packaging, no bench-testing is required to demonstrate substantial equivalence." (Page 5)
As such, for all the requested points regarding acceptance criteria, performance data, sample sizes, ground truth, expert involvement, and comparative effectiveness studies, the answer is that this information is not applicable or not provided in this 510(k) summary due to the nature of the submission (substantial equivalence based on an identical product with expanded indications, requiring no new bench testing).
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May 15, 2020
The LifeStyle Company, Inc. % Michael A. Siano. MA. RAC Regulatory Affairs Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K200747
Trade/Device Name: PuriLens Plus Preservative Free Saline Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: March 18, 2020 Received: March 23, 2020
Dear Michael Siano:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200747
Device Name PuriLens Plus Preservative Free Saline
Indications for Use (Describe)
PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
PuriLens Plus Preservative Free Saline
1. Submission Sponsor
The LifeStyle Company, Inc. 6 Paragon Way Suite 112 Freehold, NJ 07728 USA Tom Seidner, President Email: toms@well.com Phone number: (800) 622-0777
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Michael A. Siano Title: Regulatory Affairs Consultant
3. Date Prepared
3/18/2020
4. Device Identification
| Trade/Proprietary Name: | PuriLens Plus Preservative Free Saline |
|---|---|
| Common/Usual Name: | Accessories, Soft Lens Products Products, Contact Lens Care, Rigid Gas Permeable |
| Regulation Number: | 886.5918, 886.5928 |
| Product Code: | MRC, LPN |
| Class: | Class 2 |
| Classification Panel: | Ophthalmic |
5. Legally Marketed Predicate Device(s)
The LifeStyle Company, Inc., claims substantial equivalence to the Purilens Saline Solution (K002319), Purilens, Inc., in terms of intended use and technological characteristics.
6. Indication for Use
PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft
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(hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
7. Device Description
The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations.
The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.
8. Substantial Equivalence Discussion
The following table compares the PuriLens Plus Preservative Free Saline to the predicate device with respect to intended use, technological characteristics, materials, and performance, forming the basis for the determination of substantial equivalence.
| Attribute | PuriLens Plus Preservative Free Saline | Purilens Saline Solution |
|---|---|---|
| Manufacturer | The LifeStyle Company, Inc. | Purilens, Inc. |
| 510(k) Number | K002319 | |
| Product Code | LPN, MRC | LPN |
| Class | 2 | 2 |
| Classification Panel | Ophthalmic | Ophthalmic |
| Regulation Number | 886.5918886.5928 | 886.5928 |
| Intended Use | Contact lens solution | Contact lens solution |
| Indications for Use | PuriLens Plus Preservative-Free Saline isindicated for use following proper lensdisinfection as recommended by the eyecare practitioner. PuriLens PlusPreservative-Free Saline is for rinsing soft(hydrophilic), rigid gas permeable andhard contact lenses prior to lens insertion.This solution may also be used as aninsertion solution for large diameter(scleral) contact lenses, as a rinse forcontact lens cases, and may be used asneeded throughout the day to rinsecontact lenses. | Purilens Saline Solution is indicated for thecleaning and disinfecting of contact lensesby means of use in a Purilens ElectronicLens Care System. Lenses may by stored indisinfected solution for a period of 24hours following the cleaning anddisinfecting. |
| OTC/Rx | OTC | OTC |
| Volume | 120 mL, 60 mL | 120 mL |
Table 1. Substantial Equivalence Comparison
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| Preservative-Free | Yes | Yes |
|---|---|---|
| Container Usage | Multi-use | Multi-use |
| Sterility | Sterile | Sterile |
| Materials(container) | Plastic resin container with puncture, re-usable cap | Plastic resin container with puncture, re-usable cap |
| Biocompatibility | Evaluated in accordance with FDAGuidance Premarket Notification (510(K))Guidance Document for Contact Lens CareProducts | Evaluated in accordance with FDAGuidance Premarket Notification (510(K))Guidance Document for Contact Lens CareProducts |
9. Equivalence Discussion
Some differences exist between the subject and predicate. None of the minor differences noted raise different questions of safety and effectiveness.
10. Non-Clinical Performance Data
Because the subject is identical to the predicate in terms of formulation, manufacturing, and packaging, no bench-testing is required to demonstrate substantial equivalence.
11. Statement of Substantial Equivalence
The PuriLens Plus Preservative-Free Saline has the same intended use and technological characteristics as the Purilens Saline Solution. Therefore, the PuriLens Plus Preservative-Free Saline is substantially equivalent to the predicate device.
§ 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.”