WOUNDWASH SALINE SPRAY

K123910 · Neilmed Pharmaceuticals, Inc. · FRO · Oct 29, 2013 · SU

Device Facts

• Record ID: K123910
• Device Name: WOUNDWASH SALINE SPRAY
• Applicant: Neilmed Pharmaceuticals, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

To cleanse minor wounds and scrapes. The product is not to be used for body cavities, canals, eyes, or mouth.

Device Story

Dr. Mehta's Wound Wash Saline Spray is an over-the-counter wound cleanser consisting of sterile, preservative-free 0.9% isotonic saline solution. The device utilizes a bag-on-valve system within an aerosol can; compressed air propellant is stored between the bag and the can to dispense the saline. An integrated actuator allows for consistent atomized spray delivery to the wound area in any orientation. The bag is a laminate system with an inner polypropylene layer to maintain sterility. The device is sterilized via gamma radiation. It is intended for use by patients or caregivers to irrigate and cleanse minor wounds and scrapes, facilitating debris removal. The device is non-invasive and provides a mechanical cleansing action.

Clinical Evidence

Bench testing only. Evidence includes USP <71> Sterility Test, LAL (Bacterial Endotoxins) Test, and MEM Elution (Cytotoxicity) Test. The device met all established specifications.

Technological Characteristics

Aerosol bag-on-valve system; laminate bag with inner polypropylene layer; USP grade 0.9% sodium chloride and purified water; compressed air propellant; gamma radiation sterilization per ISO/AAMI 11137; atomized spray actuator.

Indications for Use

Indicated for cleansing minor wounds and scrapes in patients requiring topical wound irrigation. Contraindicated for use in body cavities, canals, eyes, or mouth.

Predicate Devices

• Wound Wash Saline (K083355)

Submission Summary (Full Text)

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K123910

## Attachment 5

#### 510(k) SUMMARY

(As prepared in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

Date Prepared: December 4th 2012

| 1. Submitter's Name, Address, Telephone Number, Contact Person | OCT 2 9 2013 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| NEILMED PHARMACEUTICALS, INC. | |
| Address: 601 Aviation Blvd, Santa Rosa, CA 95403 | |
| Contact: Phone: [phone]<br>Fax: [phone] | |
| Contact Person: Dr Ketan Mehta<br>[e-mail] | |
| 2. Name of Device and Name/Address of Sponsor | |
| Device: Dr. Mehta's Wound Wash Saline SprayTM | |
| Name of Sponsor: NEILMED PHARMACEUTICALS, INC. | |
| Address: 601 Aviation Blvd, Santa Rosa, CA 95403 | |
| 3. Common or Usual Name | |
| Wound Cleanser | |
| 4. Device Classification Name and Classification Code | |
| Name: Dressing, Wound, Drug | |
| Code: FRO | |
| Review Panel: General & Plastic Surgery | |
| Device Class: Unclassified | |
| 5. Description | |
| Dr. Mehta's Wound Wash Saline SprayTM consists of drug and preservative-free sterile isotonic<br>saline solution that is delivered in atomized spray form by means of activating the actuator. Dr.<br>Mehta's Wound Wash Saline SprayTM distributed as a single can includes 0.9% saline (sodium<br>chloride) solution. The product utilizes bag-on-valve technology (bag in can). The propellant,<br>compressed air, is charged into the container between bag and the can creating a means to | |

dispense the contents of the bag, i.e., sterile isotonic salution. The product consists of specially designed actuator to deliver an effective consistent spray of the solution on the wound area. The filled device is sterilized by gamma radiation utilizing parameters those are validated according to ISO/AAMI 11137 requirements (Sterilization of health care products -Requirements for validation and routine control - Radiation sterilization). The product passes USP<71> Sterility Test. Dr. Mehta's Wound Wash Saline Spray™ is available as an over-thecounter product, and will be labeled with the following indication: "To cleanse minor wounds

6. Predicate Devices

and scrapes.".

Wound Wash Saline® (K083355) (Blairex Laboratories, Inc.)

7. Intended Use / Indications for Use

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Indications for OTC Use :

"To cleanse minor wounds and scrapes".

The product is not to be used for body cavities, canals, eyes, or mouth.

### 8. Technological Characteristics

Dr. Mehta's Wound Wash Saline Spray™ consists of an aerosol bag on valve technology which includes a bag-in-can system attached to actuator for spray dispensing in all positions. The is a laminate system including sandwiched aluminum layer providing an impermeable barrier between the propellant (compressed air) and the sterile saline solution within the bag. The solution comes in contact with the inner layer (polypropylene) of the bag. 0.9% sterile saline solution is colorless and consists of USP grade sodium chloride and USP grade purified unter. The propellant, compressed air, is charged into the container between bag and the can creating a means to dispense the contents of the bag, sterile isotonic saline solution. The device manufacturing process includes crimping, pressure testing and filling and packaging for sterilization which is followed by gamma sterilization. The product is tested against established specifications and meets USP<71> sterility requirements. The technological characteristionshow subject device are substantially equivalent to those of the predicate device.

## 9. Substantial Equivalence

Dr. Mehta's Wound Wash Saline Spray™ is as safe as the predicate device. It has the same technological characteristics and basic principles of operation as its predicate devices The technological characteristics with respect to the spray including pressurization method, blog technology and sterilization are the same as the predicate device.

The non-clinical tests performed on the subject device include (i) USP <71> Sterility Test, (ii) LAL Test, & (iii) MEM Elution Test. The subject device passes USP <71> Sterility Test, like the predict to Aevice. The subject device also passes LAL Test or Bacterial Endotoxins Test, & MEM Elution Test or Cytotoxicity Test.

Thus, Dr. Mehta's Wound Wash Saline Spray™ is substantially equivalent to the predicate device.

This concludes the 510(k) Summary.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 29, 2013

NeilMed Pharmaceuticals, Incorporated % Mr. Dinesh Patel Vice President of Quality Assurance and Regulatory Affairs 601 Aviation Boulevard Santa Rosa, California 95403

Re: K123910

Trade/Device Name: Dr. Mehta's Wound Wash Saline Spray Regulation Name: Dressing, Wound, Drug. Regulatory Class: Unclassified Product Code: FRO Dated: August 26, 2013 Received: August 28, 2013

Dear Mr. Patel:

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. Iisting 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

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#### Page 2 - Mr. Dinesh Patel

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

contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K123910

Device Name

Dr. Mehta's WoundWash Saline Spray(TM)

Indications for Use (Describe)

To cleanse minor wounds and scrapes.

The product is not to be used for body cavities, canals, eyes, or mouth.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.