(53 days)
No
The device is a saline solution for contact lenses, and the 510(k) summary explicitly states there is no change in device design, formulation, or manufacturing from the predicate device, which was cleared in 2000. There are no mentions of AI, ML, or related concepts.
No
The device is a saline solution for rinsing and storing contact lenses, which does not inherently qualify it as a therapeutic device. Its purpose is for hygiene and comfort related to contact lens use, not to treat a disease or condition.
No
The PuriLens Plus Preservative-Free Saline is indicated for cleaning and rinsing contact lenses, not for diagnosing medical conditions.
No
The device is a sterile, buffered saline solution, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for rinsing and inserting contact lenses, rinsing contact lens cases, and as a rinse throughout the day. This is a direct interaction with a medical device (contact lenses) and the user's eye, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the composition and purpose of the saline solution for contact lens care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device falls under the category of a medical device used for the care and maintenance of other medical devices (contact lenses) and for direct application to the eye.
N/A
Intended Use / Indications 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
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.
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)
Because the subject is identical to the predicate in terms of formulation, manufacturing, and packaging, no bench-testing is required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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
4
(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 | 886.5918 | |
| 886.5928 | 886.5928 | |
| Intended Use | Contact lens solution | Contact lens solution |
| Indications 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 | ||
| (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. | Purilens Saline Solution is indicated for the | |
| cleaning and disinfecting of contact lenses | ||
| by means of use in a Purilens Electronic | ||
| Lens Care System. Lenses may by stored in | ||
| disinfected solution for a period of 24 | ||
| hours following the cleaning and | ||
| disinfecting. | ||
| 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 FDA | |
| Guidance Premarket Notification (510(K)) | ||
| Guidance Document for Contact Lens Care | ||
| Products | Evaluated in accordance with FDA | |
| Guidance Premarket Notification (510(K)) | ||
| Guidance Document for Contact Lens Care | ||
| Products |
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.