(170 days)
P850045
Not Found
No
The device is a sterile saline solution for contact lenses, and the description and testing focus on its chemical composition, sterility, and non-toxicity, with no mention of AI or ML.
No.
This device is identified as a "Sterile Saline Solution" for rinsing and wetting contact lenses, a common over-the-counter product, not a therapeutic device used for treating a disease or condition. The document also refers to its "substantial equivalence to previously approved predicate device(s)", suggesting it's primarily a cleaning or maintenance solution.
No
Explanation: The device is a 'Sterile Saline Solution' indicated for 'rinsing and wetting of soft (hydrophilic) contact lenses'. Its purpose is to clean and maintain contact lenses, not to diagnose a disease or condition.
No
The device is a sterile saline solution, which is a physical product (liquid) packaged in a container, 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 wetting of soft (hydrophilic) contact lenses." This is a direct application to a medical device (contact lenses) that is used on the body, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a sterile saline solution for contact lens care, not a reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information. The performance studies focus on toxicity and bacteriostasis related to contact lens care, not diagnostic accuracy.
Therefore, this device falls under the category of a medical device used for contact lens care, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.
Product codes
LPN
Device Description
Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate, Boric Acid and Nitrogen as Propellant.
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)
A series of studies were completed to demonstrate the substantial equivalence of Sterile Saline Solution to the predicate device(s). All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and is comparable to other currently marketed soft contact lens solutions. Results from all tests demonstrate the substantial equivalence to previously approved predicate device(s).
Toxicity: A series of cytotoxicity and eye irritation studies of the Sterile Solution were undertaken. In these studies, there was no evidence of toxicity
Bacteriostasis Test: A bacteriostasis study was conducted in accordance with Micro Appendix C of the Premarket Notification 510 (K) Guidance Document for Contact Lens Care Products. The purpose of the study is to evaluate the ability of bacteria to survive in the reclosable containers containing Sterile Saline Solution (unpreserved borate buffered saline). The results show that Staphylococcus aureous. Escherichia coli. Pseudomonas aeruginosa. Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desire discard statement on label up to 30 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P850045 Blairex Sterile Saline Solution
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)
510(K) SUMMARY FOR
JAN 1 9 2011
Sterile Saline Solution
This summary is provided in accordance with the Safe Medical Devices Act (SMDA) of 1990. The information provided in the 510 (K), Premarket Notification, was in accordance with 21 CFR 807.87
l. Submitter of 510 (K)
Cachet Pharmaceuticals Pvt. Ltd. 415 Shah Nahar, Worli Mumbai 400 018 India
Contact Person: Mr. Shivkumar Agrawal Telephone No .: 91-22-4082-9999 or 2496-5831 91-22-2497-3691 Fax: E.mail: skagrawal@cachetindia.com
Contact Person (United States): Mr. Haribabu Talasila Telephone No .: 732-447-4353 Fax: 732 287 1798 E.mail: htalasila@chemtexinternational.com
-
- Product Code: LPN
3. Device Name
- Classification Name: Proprietary Name:
Soft (hydrophilic) Contact Lens Solution Sterile Saline Solution-
4. Legally Marketed Predicate Devices
Blairex Sterile Saline Solution - P850045
ક. Description of the Device
Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate, Boric Acid and Nitrogen as Propellant.
1
Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)
The solution is packaged in lacquered aluminum spray containers with caps. Each container is sealed with a tamper evident hologram seal at the junction of the container and the cap.
ર્ . Indications for Use
Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.
7. Description of Safety and Substantial Equivalence:
A series of studies were completed to demonstrate the substantial equivalence of Sterile Saline Solution to the predicate device(s). All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and is comparable to other currently marketed soft contact lens solutions. Results from all tests demonstrate the substantial equivalence to previously approved predicate device(s).
Sterile Saline Solution is substantially equivalent in terms of its actions and indications for use Blairex Sterile Saline Solution - P850045 cleared for marketing under 510(K). Sterile Saline Solution meets the guideline set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products.
Toxicity:
A series of cytotoxicity and eye irritation studies of the Sterile Solution were undertaken. In these studies, there was no evidence of toxicity
Bacteriostasis Test:
A bacteriostasis study was conducted in accordance with Micro Appendix C of the Premarket Notification 510 (K) Guidance Document for Contact Lens Care Products. The purpose of the study is to evaluate the ability of bacteria to survive in the reclosable containers containing Sterile Saline Solution (unpreserved borate buffered saline). The results show that Staphylococcus aureous. Escherichia coli. Pseudomonas aeruginosa. Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desire discard statement on label up to 30 days.
2
Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)
KID2165
8. Substantial Equivalence
The data provide in this 510(K) submission concludes that Sterile Saline Solution is substantially equivalent to currently cleared Blairex Sterile Saline Solution - P850045 cleared for marketing under 510(K) for rinsing and wetting of soft (hydrophilic) contact lenses.
SUBSTANTIAL EQUIVALENCE CHART
| Substantial
Equivalency | Sterile Saline
Solution | Blairex Sterile Saline
Solution
P850045 |
|------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------|
| Manufacturer | Shegfried S.V. | Blairex Laboratories
Inc. |
| Intended Use
(Indications
for Use) | For rinsing and wetting
of soft (hydrophilic)
contact lenses | For rinsing, and wetting
of soft (hydrophilic)
contact lenses |
| Formulation | Sodium Chloride,
Sodium borate Boric
Acid
Purified Water | Sodium Chloride,
Sodium borate, Boric
Acid
Purified Water |
| Propellant | Nitrogen | Nitrogen |
| Preservative | No | No |
| Sterility claim | Sterile | Sterile |
3
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 image of a bird or eagle with its wings spread, formed by three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the top half of the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Cachet Pharmaceuticals Pvt. Ltd. c/o Mr. Shivkumar Agrawal 415, Shah Nahar, Dr. E. Moses Road Worli, Mumbai 400018 India
FEB - 9 2011
Re: K102165
Sterile Saline Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: January 19, 2011 Received: January 19, 2011
Dear Mr. Agwaral:
This letter corrects our substantially equivalent letter of January 19, 2011.
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 (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.
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.
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
4
Page 2 - Mr. Shivkumar Agrawal
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/default.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 Small Manufacturers, International and Consumer Assistance 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,
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Sterile Saline Solution Device Name:
Indications For Use:
Sterile saline is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ausarau
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number_________________________________________________________________________________________________________________________________________________________________