(56 days)
Not Found
No
The device description and intended use clearly indicate it is sterile water or saline for irrigation and debridement, with no mention of any computational or analytical capabilities.
No
The device is used for moisturizing wound dressings, device irrigation, and tissue debridement, which are not considered therapeutic actions aimed at treating a disease or condition. It acts as a solvent or lubricant rather than providing a medical treatment.
No
The device is described as USP purified water or saline for moisturizing wound dressings, device irrigation, and jet lavage for tissue debridement. These are therapeutic and cleansing functions, not diagnostic ones. Diagnostics involve identifying the nature or cause of a disease or condition, which this device does not do.
No
The device description clearly states it is purified water or saline in bottles or cups, which are physical components, not 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 "Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement." These are all external applications and procedures performed on the body or medical devices, not tests performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The device is sterile water or saline, which are used for irrigation and cleaning, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or other biological specimens. There is no mention of reagents, assays, or any process for obtaining diagnostic information from a sample.
Therefore, this device falls under the category of a medical device used for irrigation and cleaning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
This device is USP purified water or saline sealed in 100mL HDPE bottles or 120mL HIPS cups and terminally sterilized using gamma irradiation. All materials are latex free.
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)
Not Found
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
K082330
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08/11/08 PRIMARY CARE SOLUTIONS, INC. 510(k) SUMMARY
| Applicant Name/Address | Primary Care Solutions, Inc.
40420 Free Fall Ave.
Zephyrhills, FL 33542 | OCT 09 2008 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Ron Maddix, Vice President & Director of Operations | |
| Telephone:
Fax: | 813-779-7226
813-715-4084 | |
| Trade Name: | Primary Care Solutions Sterile Water and Sterile
Saline for Device Irrigation, Moisturizing of Wound
Dressings and for use in Jet Lavage for Tissue Debridement
Catalog numbers 1500, 1600, 1550, 1650, WF1000 and
SF1200 | |
| Establishment Reg. No .: | 1066336, ISO Certificate No. GB05/66128 | |
| Manufacturing Facility: | Primary Care Solutions, Inc.
40420 Free Fall Ave.
Zephyrhills, FL 33542 | |
| Sterilization Facility: | Food Technology Services, Inc.
502 Prairie Mine Road
Mulberry, FL 33860 ISO Cert. # | |
| Classification Name: | Sterile Water and Sterile Saline for Moisturizing a Wound
Dressing and for Device Irrigation | |
| Class: | Unclassified | |
| Reason for Application | Expanded Label Usage of Existing Device | |
| Predicate Devices: | K000265, K000266 Sterile Water and Sterile Saline
For Device Irrigation, Primary Care Solutions, Inc.,
40420 Free Fall Ave., Zephyrhills, FL 33542 | |
| Device Description: | This device is USP purified water or saline sealed in 100mL
HDPE bottles or 120mL HIPS cups and terminally sterilized
using gamma irradiation. All materials are latex free. | |
| Intended Label Expansion: | Moisturizing of Wound Dressings, Device Irrigation and
Jet Lavage for Tissue Debridement | |
:
1
K062330
page 2/2
There is no material change involved in this notice to Material Comparison to Predicate Device: expand labeling.
Compliance With Special Controls:
No applicable mandatory performance standards or special controls exist for these devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2008
Primary Care Solutions, Inc. % Mr. Ronald L. Maddix VP & Director of Operations 40420 Free Fall Avenue Zephyrhills, Florida 33542
Re: K082330
Trade/Device Name: Sterile Water & Sterile Saline Regulatory Class: Unclassified Product Code: FRO Dated: August 11, 2008 Received: September 13, 2008
Dear Mr. Maddix:
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 -- Mr. Ronald L. Maddix
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 vours.
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Sterile water + Sterile Saline
Indications For Use:
Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Murle A. Millener
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
§10(k) Number K082330
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