(65 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or capabilities. The device is a simple wound cleansing solution.
Yes.
The device is intended for cleaning, moistening, and debriding wounds and lesions, which are therapeutic actions.
No
The device description and intended use clearly state that it is for "moistening," "debriding," and "cleaning" wounds and for "device irrigation." These are therapeutic and cleansing functions, not diagnostic ones. It does not analyze, detect, or provide information about a medical condition.
No
The device description clearly states it is a "wound and device cleansing solution" and is offered in "various bottle and cup sizes with and without a spray applicator," indicating it is a physical product (liquid solution and packaging) and not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for moistening, debriding, and cleaning wounds and for device irrigation. These are applications directly on or in the body, not for testing samples taken from the body.
- Device Description: The description confirms it's a wound and device cleansing solution applied externally or for irrigation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely external or for irrigation within the body, not for analyzing samples.
N/A
Intended Use / Indications for Use
For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For Prescription Use: For moistening absorbent wound dressings and for moistening, . debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
Product codes
FRO
Device Description
The Wound Flush, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP . The subject device is offered in various bottle and cup sizes with and without a spray applicator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal wounds, dermal lesions (Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions, minor skin irritations)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973784, K003402, K060113, K070463, K042084
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
/K083>φ2 1/2
DEC 1 8 2008
510(k) Section 5 Wound Flush, Sterile Water & Sterile Normal Saline
5-510(k) Summary
(In accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
-
- Submitter's name and address: Nurse Assist Incorporated 3400 Northern Cross Boulevard Fort Worth, Texas 76137
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- Submitter's telephone number and fax number: Tel: (817) 231-1300 Fax: (817) 231-1500
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- Contact person: Bill Kanewske - Vice President of Operations
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- Date this 510(k) summary prepared: October 7, 2008
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- Trade/proprietary name of the device: Wound Flush, Sterile Water & Sterile Normal Saline
6. Device classification
Unclassified, pre-amendment device Product code FRO
7. Legally marketed predicate devices to which substantial equivalence is claimed:
- Welcon Sterile Water and Sterile 0.9% Normal Saline K973784 and K003402 �
- Dermacyn Wound Care; Oculus Innovative Sciences, Incorporated -- K060113 .
- Revera Wound Care; Revalesio Corporation K070463 .
- BioDerm Wound Spray; BioDerm Sciences, Incorporated K042084 .
- Blairex Wound Wash Saline, Blairex Laboratories, Incorporated unknown ●
8. Description of the device that is the subject of this premarket notification:
The Wound Flush, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP . The subject device is offered in various bottle and cup sizes with and without a spray applicator
1
510(k) Section 5 Wound Flush, Sterile Water & Sterile Normal Saline
9. Intended use and indication for use:
- · For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
- For Prescription Use: For moistening absorbent wound dressings and for moistening, . debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
10. Technological characteristics:
The mechanical action of fluid moving across the wound or device provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.
This concludes the 510(k) Summary.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2008
Nurse Assist, Inc. % Shotwell and Carr, Inc. Ms. Denice Gallagher Regulatory Consultant 1415 Halsey Way, Suite 304 Carrollton, Texas 75007-4455
Re: K083042
Trade/Device Name: Wound Flash, Sterile Water & Normal Saline Regulatory Class: Unclassified Product Code: FRO Dated: October 7, 2008 Received: October 14, 2008
Dear Ms. Gallagher:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Denice Gallagher
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulheran
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
083042 1//
510(k) Section 4 Wound Flush, Sterile Water & Sterile Normal Saline
4 -- Indications for Use
510(k) Number (if known): Unknown - not yet assigned by FDA
Device Name: Wound Flush, Sterile Water & Normal Saline
Indications for Use:
For Over-the-Counter Use:
For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For Prescription Use:
For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
Use Prescription Over-The-Counter Use X X AND/OR (Part 21 CFR 801 Subpart D) (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)
Neil R.P. Ogden Forman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083042
Page 1 of 1 (Posted November 13, 2003)
Nurse Assist, Inc. ----