(314 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a saline spray, with no mention of AI or ML technologies.
No.
The intended use of the device is for cleansing minor wounds and scrapes, which is a supportive action rather than a direct therapeutic treatment of a disease or condition.
No
The device is described as a "Wound Wash Saline Spray" intended "To cleanse minor wounds and scrapes." It does not mention any diagnostic capabilities but rather focuses on cleaning.
No
The device description clearly outlines a physical product consisting of a can, bag-on-valve technology, propellant, actuator, and saline solution, which is sterilized by gamma radiation. This is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To cleanse minor wounds and scrapes." This is a topical application for cleaning an external wound, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a sterile saline spray for wound cleansing. It does not involve any reagents, instruments, or systems intended for use in vitro.
- Performance Studies: The performance studies focus on sterility, endotoxins, and cytotoxicity, which are relevant to a topical medical device, not an IVD.
- Predicate Device: The predicate device (K083355 Wound Wash Saline®) is also a wound cleansing product, not an IVD.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to detect diseases, conditions, or infections. This device's function is purely mechanical/physical cleansing of an external wound.
N/A
Intended Use / Indications for Use
"To cleanse minor wounds and scrapes".
The product is not to be used for body cavities, canals, eyes, or mouth.
Product codes
FRO
Device Description
Dr. Mehta's Wound Wash Saline SprayTM consists of drug and preservative-free sterile isotonic saline solution that is delivered in atomized spray form by means of activating the actuator. Dr. Mehta's Wound Wash Saline SprayTM distributed as a single can includes 0.9% saline (sodium chloride) solution. The product utilizes bag-on-valve technology (bag in can). The propellant, 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 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 and scrapes.".
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)
The non-clinical tests performed on the subject device include (i) USP Sterility Test, (ii) LAL Test, & (iii) MEM Elution Test. The subject device passes USP Sterility Test, like the predict to Aevice. The subject device also passes LAL Test or Bacterial Endotoxins Test, & MEM Elution Test or Cytotoxicity Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for NeilMed. The logo is in black and features a bold, sans-serif font. A registered trademark symbol is present to the right of the word "Med".
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: +1 707 525 3784 | |
Fax: +1 707 525 3785 | |
Contact Person: Dr Ketan Mehta | |
Ketan@neilmed.com | |
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 | |
saline solution that is delivered in atomized spray form by means of activating the actuator. Dr. | |
Mehta's Wound Wash Saline SprayTM distributed as a single can includes 0.9% saline (sodium | |
chloride) solution. The product utilizes bag-on-valve technology (bag in can). The propellant, | |
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 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
- Predicate Devices
and scrapes.".
Wound Wash Saline® (K083355) (Blairex Laboratories, Inc.)
- Intended Use / Indications for Use
1
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 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 Sterility Test, (ii) LAL Test, & (iii) MEM Elution Test. The subject device passes USP 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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
3
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 (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/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/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
4
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 " 时时彩玩 .. . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.