(111 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of sterile water and saline solutions for wound cleaning, with no mention of AI or ML technologies.
Yes
The device is described for moistening and debriding acute and chronic dermal lesions, including ulcers and burns, which are therapeutic applications.
No
The device is described as wound and device cleaning solutions for moistening and debriding dermal wounds and for device irrigation. It does not perform any diagnostic function.
No
The device description clearly states it is a "wound and device cleaning solution" offered in bottles and cups, indicating a physical product (liquid and container) rather than 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 moistening, debriding, and cleaning wounds and for device irrigation. This is a direct application to the body or medical devices used on the body.
- Device Description: The device is a solution (sterile water or saline) for cleaning and irrigation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) or for cleaning devices used on the body.
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, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP . The devices are offered in 100 mL, 250 mL and 500 mL bottles and 120 mL cups
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal wounds, skin, foot, device
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)
Biocompatibility testing of Sterile Water and Sterile Normal Saline has been conducted. The devices were found to be non-cytotoxic, non-irritating and nonsensitizing in ISO 10993 standard tests; results which are similar to those reported for the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
Strukmyer Medical LLC % Mr. Richard Hamer Richard Hamer Associates LLC 705 Spring Lakes Blvd. Bradenton, Florida 34210
Re: K161311
Trade/Device Name: USP Sterile Water. 120 Ml Cup, USP Sterile Normal Saline (0.9% Sodium Chloride), 120 Ml Cup, USP Sterile Water, 100 Ml,250 Ml And 500 Ml Bottles, USP Sterile Normal Saline (0.9% Sodium Chloride), 100 Ml, 250 Ml And 500 Ml Bottles Regulatory Class: Unclassified
Product Code: FRO Dated: August 4, 2016 Received: August 9, 2016
Dear Mr. Hamer:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161311
Device Name
Sterile Water and Sterile Normal Saline
Indications for Use (Describe)
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, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | X Over-The-Counter Use (21 CFR 801 Subpart C) |
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. The seat comments of the comments of the comments of the comments of the comments of the comments of
510(k) SUMMARY
I. ADMINISTRATIVE
Submitter: Strukmyer Medical 1801 Big Town, Suite 100 Mesquite, TX 75149
(214) 275-9595
Contact Person: Robert (Bob) Delk
Date of Preparation: August 5, 2016
II. DEVICE NAME
Proprietary Name: Sterile Water and Sterile Normal Saline
Classification Name: Unclassified, pre-amendment device; Product Code FRO
III.PREDICATE DEVICE
Sterile Water and Sterile Normal Saline ; K083042, Nurse Assist, Inc.
IV. DEVICE DESCRIPTION
The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP . The devices are offered in 100 mL, 250 mL and 500 mL bottles and 120 mL cups
V. INTENDED 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.
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- . 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.
VI.COMPARISON TO PREDICATE DEVICE
Sterile Water and Sterile Normal Saline have the same technological characteristics and provide the same mechanism of action as the predicate devices; i.e., the mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. They are labeled for the same intended uses and are supplied sterile in containers of identical composition. Biocompatibility testing of Sterile Water and Sterile Normal Saline has been conducted. The devices were found to be non-cytotoxic, non-irritating and nonsensitizing in ISO 10993 standard tests; results which are similar to those reported for the predicate devices.
VI. CONCLUSION
Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that Sterile Normal Saline perform at least as well as the predicate devices. Sterile Water and Sterile Normal Saline are therefore considered to be substantially equivalent to the above-mentioned predicate devices.