STERILE SALINE SOLUTION

K093367 · Cachet Pharmaceuticals Pvt. , Ltd. · LPN · Sep 10, 2010 · Ophthalmic

Device Facts

• Record ID: K093367
• Device Name: STERILE SALINE SOLUTION
• Applicant: Cachet Pharmaceuticals Pvt. , Ltd.
• Product Code: LPN · Ophthalmic
• Decision Date: Sep 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.

Device Story

Sterile Saline Solution is a preservative-free, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, and boric acid. It is supplied in single-use twist-open pods or reusable bottles with dropper tips. The device is intended for use by contact lens wearers to rinse and wet soft (hydrophilic) contact lenses. The solution provides a sterile environment for lens maintenance. Safety is established through non-toxicity and bacteriostasis testing, ensuring no significant growth of common pathogens (e.g., S. aureus, E. coli, P. aeruginosa) in reclosable containers over a 30-day period.

Clinical Evidence

Bench testing only. Studies included cytotoxicity and eye irritation testing, demonstrating no evidence of toxicity. Bacteriostasis testing conducted per Micro Appendix C of FDA guidance confirmed that S. aureus, E. coli, P. aeruginosa, C. albicans, and A. niger do not exhibit significant growth in the solution over a 30-day period.

Technological Characteristics

Aqueous solution containing sodium chloride, sodium borate, and boric acid. Preservative-free. Buffered and isotonic. Packaging includes plastic single-use pods and reusable bottles with tamper-resistant caps. Sterilization method not explicitly stated, but product is labeled sterile.

Indications for Use

Indicated for rinsing and wetting of soft (hydrophilic) contact lenses.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Purilens Saline Solution (K002319)
• Lens Plus Rewetting Drops (K042562)
• Unisol (P790011)

Submission Summary (Full Text)

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Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)

## 510(K) SUMMARY FOR Sterile Saline Solution

SEP 1 0 2010

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

#### Submitter of 510 (K) 1.

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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: [e-mail]

Contact Person (United States): Telephone No. : E mail :

Mr. Haribabu Talasila 732-447-4353 [e-mail].

- 2. Product Code: LPN
- 3. Device Name Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution Sterile Saline Solution

- Legally Marketed Predicate Devices 4. Purilens Saline Solution - K002319 Lens Plus Rewetting Drops - K042562 Unisol -P7900 11

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## Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)

#### 5. Description of the Device

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Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate and Boric Acid.

The solution is packaged in plastic sterile single use twist open pods, reusable bottles with dropper tips and caps. Each bottle is closed with tamper resistant cap with a breakable ring, which must be broken in order to open the bottle.

#### 6. Indications for Use

Sterile Saline Solution is indicated for rinsing & 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, to Purilens Saline Solution -K002319, Lens Plus Rewetting Drops -K042562. Unisol- P790011 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 eve irritation studies of the Sterile Solution were undertaken. In these studies, there was no evidence of toxicity.

#### BacteriostasisT est:

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.

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## Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)

#### 8. Substantial Equivalence

The data provide in this 510 (K) submission concludes that Sterile Saline Solution is substantially equivalent to currently cleared Purilens Saline Solution -K002319, Lens Plus Rewetting Drops -K042562, Unisol- P790011 cleared for marketing under 510 (K) for rinsing and wetting of soft (hydrophilic) contact lenses.

| Substantial<br>Equivalency | Sterile Saline<br>Solution | Purilens<br>Saline<br>Solution<br>K002319 | Lens Plus<br>Rewetting Drops<br>K042562 | Unisol<br>P790011 |
|------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Manufacturer | Marck Bioscicence<br>Ltd. | Purilens Inc. | Advanced<br>Medical Optics | Alcon Research<br>Ltd. |
| Intended use<br>(Indications for<br>use) | For rinsing and<br>wetting of soft<br>(hydrophilic)contact<br>lenses | For cleaning,<br>disinfecting<br>and storing of<br>contact lenses | For moistening<br>and dehydrating<br>of contact lenses | For heat disinfecting<br>rinsing, storage and<br>wetting of soft<br>(hydrophilic) contact<br>lenses |
| Formulation | Sodium chloride,<br>Sodium borate, Boric<br>acid | Sodium<br>chloride, Boric<br>acid | Sodium chloride,<br>Boric acid | Sodium chloride,<br>Sodium borate,<br>Boric acid |
| Preservative | No | No | No | No |
| Sterility claim | Sterile | Sterile | Sterile | Sterile |

## SUBSTANTIAL EQUIVALENCE CHART

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of an eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cachet Pharmaceuticals Pvt., Ltd. c/o Mr. Shivkumar Agrawal 415 Shah Nahar. Worli Mumbai, India 400 018

SEP 1 0 2010

Re: K093367

Trade Name: 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: September 10, 2010 Received: September 10, 2010

#### Dear Mr. Agrawal:

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.

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 (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.

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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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

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

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K093367

# Indications for Use

## 510(k) Number (if known): K093367

SEP 1 0 2010

Device Name: Sterile Saline Solution

· Indications For Use:

Sterile Saline Solution 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 _ (Part 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)

Duise Haufe, ph.D.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K093367

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