PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION

K082330 · Primary Care Solutions, Inc. · FRO · Oct 9, 2008 · SU

Device Facts

• Record ID: K082330
• Device Name: PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
• Applicant: Primary Care Solutions, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement

Device Story

Device consists of USP purified water or saline solution. Packaged in 100mL HDPE bottles or 120mL HIPS cups. Terminally sterilized via gamma irradiation. Used for moisturizing wound dressings, irrigating medical devices, and performing jet lavage for tissue debridement. No specific operator or clinical setting restricted; intended for general medical use. Provides sterile fluid for cleaning and hydration, facilitating wound management and device maintenance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

USP purified water or saline solution. Materials: HDPE bottles, HIPS cups. Latex-free. Sterilization: Gamma irradiation. Form factor: 100mL bottles or 120mL cups.

Indications for Use

Indicated for moisturizing wound dressings, device irrigation, and jet lavage for tissue debridement in patients requiring wound care or medical device cleaning.

Predicate Devices

• Sterile Water and Sterile Saline For Device Irrigation (K000265)
• Sterile Water and Sterile Saline For Device Irrigation (K000266)

Submission Summary (Full Text)

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K082330
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## 08/11/08 PRIMARY CARE SOLUTIONS, INC. 510(k) SUMMARY

| Applicant Name/Address | Primary Care Solutions, Inc.<br>40420 Free Fall Ave.<br>Zephyrhills, FL 33542 | OCT 09 2008 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Ron Maddix, Vice President & Director of Operations | |
| Telephone:<br>Fax: | 813-779-7226<br>813-715-4084 | |
| Trade Name: | Primary Care Solutions Sterile Water and Sterile<br>Saline for Device Irrigation, Moisturizing of Wound<br>Dressings and for use in Jet Lavage for Tissue Debridement<br>Catalog numbers 1500, 1600, 1550, 1650, WF1000 and<br>SF1200 | |
| Establishment Reg. No .: | 1066336, ISO Certificate No. GB05/66128 | |
| Manufacturing Facility: | Primary Care Solutions, Inc.<br>40420 Free Fall Ave.<br>Zephyrhills, FL 33542 | |
| Sterilization Facility: | Food Technology Services, Inc.<br>502 Prairie Mine Road<br>Mulberry, FL 33860 ISO Cert. # | |
| Classification Name: | Sterile Water and Sterile Saline for Moisturizing a Wound<br>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<br>For Device Irrigation, Primary Care Solutions, Inc.,<br>40420 Free Fall Ave., Zephyrhills, FL 33542 | |
| Device Description: | This device is USP purified water or saline sealed in 100mL<br>HDPE bottles or 120mL HIPS cups and terminally sterilized<br>using gamma irradiation. All materials are latex free. | |
| Intended Label Expansion: | Moisturizing of Wound Dressings, Device Irrigation and<br>Jet Lavage for Tissue Debridement | |

:

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K062330
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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.

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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.

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/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

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K082330

## 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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