(141 days)
Not Found
No
The device description and intended use are for a simple plastic cup for eye washing, with no mention of any computational or analytical capabilities.
No
The device is an eye wash cup intended to hold liquids for flushing the eye, not to directly treat a medical condition. It's an accessory for an eye wash solution, which would be the therapeutic agent if any.
No
Explanation: The device is an eye wash cup used to flush the eye with solution, not to diagnose any condition. Its intended use is to hold liquids for eye flushing, and the description details its physical properties and how it's used for washing the eye. There is no mention of it being used to detect or identify a disease or condition.
No
The device description clearly states it is a "plastic cup" and describes its physical material and design, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hold liquids such as eye wash solutions, used to flush out the eye." This describes a physical device used for a therapeutic or cleansing purpose on the body, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a plastic cup designed to be filled with eyewash and placed over the eye. This aligns with the intended use and does not suggest any diagnostic function.
- 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.)
- Detecting specific analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is a simple medical device used for administering a solution to the eye.
N/A
Intended Use / Indications for Use
The Flents Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
The Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
Product codes (comma separated list FDA assigned to the subject device)
LXQ
Device Description
The Flents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plastic cup manufactured with Chi- Mei ABS PA-757 White plastic that is designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The Flents Plastic Eye Wash Cup is non-sterile and is reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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)
Biocompatibility testing performed by third party laboratories demonstrated the material is safe for use in contact with solutions used to wash the affected eye.
Biocompatibility testing of the applicant material and colorant included Acute Systemic Toxicity, In-vitro Cytotoxicity, Ocular Irritation and Maximization Sensitization. Studies were performed to assess the biocompatibility of the Flents Plastic Eye Wash Cup. Results of the biocompatibility testing show no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials used in the manufacture of the Flents Plastic Eye Wash Cup have demonstrated to be substantially equivalent with regards to safety and effectiveness, to their predicate devices and safe for its intended use.
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
N/A
0
othecary Products, Inc.®
JUL 0 9 2014
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 (c)
The assigned 510(k) number is: __ K 1 4 0 4 0 9
Applicant: Apothecary Products, Inc. 11750 12th Avenue South Burnsville, MN 55337 FDA Establishment Registration Number: 2183416
Flents Plastic Eye Wash Cup
Contact person: James Jenkins Sr. Regulatory Affairs Specialist Phone: 952.808.8364 Fax: 952.890.0418
Date prepared: June 12, 2014
Name of Device:
| Device Classification Name: | Cup, Eye |
|---|---|
| Common or usual name: | Eye Cup |
| Classification: | Ophthalmic - Unclassified - Pre-Amendment |
| Product Code: | LXQ |
| Predicate Device information: | K051414 |
Device Description:
The Flents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plastic cup manufactured with Chi- Mei ABS PA-757 White plastic that is designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The Flents Plastic Eye Wash Cup is non-sterile and is reusable.
intended Use: The Flents Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
,""
1
pothecary Products, Inc.®
Comparison to Predicate Device:
The Flents Plastic Eye Wash Cup has the same intended use and a similar design as the predicate device and is substantially equivalent with regards to safety and effectiveness.
Discussion of Non-Clinical Tests Performed in Determination of Substantial Equivalence:
Biocompatibility testing performed by third party laboratories demonstrated the material is safe for use in contact with solutions used to wash the affected eye.
| Attribute | Applicant Device; Flents
Plastic Eye Wash Cup | Predicate Device; Tollot
Pty.Ltd.(Aaxis Pacific), Non-
sterile K051414 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Classification
Name | Cup, Eye | Cup, Eye |
| Intended Use | The Flents Plastic Eye Wash
Cup is intended to hold liquids
such as eye wash solutions,
used to flush out the eye. | A cup that holds liquids, such as
eye wash solution, used to flush
out the eye. |
| Design | ABS Plastic receptacle for
eyewash solutions. | Similar |
| Colors | TZE Kun Plastic Materials, No.
216941 White | Unknown |
| Dimensions | 1.903 in x 1.353 in | Similar from redacted drawings |
| Volume | 0.65 fl. oz. (19 mL) | Unknown |
| Materials | Chi Mei ABS PA-757 | Unknown |
| Sterile | Non-sterile | Sterile/Non-sterile |
| Reuse | Reusable | Sterile Cup not reusable |
Comparison to Predicate Device
Differences:
The Flents Plastic Eye Wash Cup is a non-sterile reusable device. The predicate device includes a sterile and non-sterile configuration that may not be reusable. The Flents Plastic Eye Wash Cup provides instructions to "Wash cup thoroughly with soap and warm water before use. Rinse well and dry" to ensure eye wash cup is not contaminated with any previous liquids or materials prior to each use. The Flents Plastic Eye Wash Cup is not packaged as sterile, however if cleaned as directed prior to each use, the eye cup is safe and effective "to hold liquids such as eye wash solutions used to flush out the eye" for its intended use, and is substantially equivalent with
2
pothecary Products, Inc.®
regards to safety and effectiveness as the predicate device based on our eye cup material biocompatibility testing.
Summary of Safety and Effectiveness of Applicant Device
Biocompatibility testing of the applicant material and colorant included Acute Systemic Toxicity, In-vitro Cytotoxicity, Ocular Irritation and Maximization Sensitization. Studies were performed to assess the biocompatibility of the Flents Plastic Eye Wash Cup. Results of the biocompatibility testing show no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials used in the manufacture of the Flents Plastic Eye Wash Cup have demonstrated to be substantially equivalent with regards to safety and effectiveness, to their predicate devices and safe for its intended use.
Conclusion:
The Flents Plastic Eye Wash Cup is substantially equivalent to the predicate device in regards to intended use, design, and substantially equivalent with regards to safety and effectiveness. All the materials used in the Flents Plastic Eye Wash Cup have passed the relevant biocompatibility tests and have demonstrated to be safe and effective for the applicant intended use.
3
Truthful and Accuracy Statement
Truth and Accuracy Statement : ... ・、 1 : : : : : : : :
I certify that, in my capacity as Senior Regulatory Specialist of Apothecary Products Inc., I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and no material fact has been omitted (as required by 21 CFR 807.87(k)).
ﺮﺡ
(Signature)
James Jenkins
February 12, 2014
(Premarket Notification [510(k)] Number)
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G649 Silver Spring, MD 20993-0002
July 9, 2014
Apothecary Products, Inc. Mr. James Jenkins Senior Regulatory Specialist 11750 12th Avenue South Burnsville, MN 55337-1295
Re: K140409
Trade/Device Name; Flents Plastic Eye Wash Cup Regulation Number: None Regulation Name: Eye Cup Regulatory Class: Unclassified Product Code: LXQ Dated: 06/12/2014 Received: 06/19/2014
Dear Mr. Jenkins:
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. 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.
5
Page 2 - Mr. James Jenkins
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
r Product 11750 12th Avenue South
- 690-1940 FAX (952) 890
Indications for Use
510(k) Number (if known): _K140409
Device Name: Plastic Eye Wash Cup
Indications for Use:
The Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Naima B. Jacobs-el -S 2014.07.09 10:08:29 -04'00'