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

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: "Primary Care Solutions Sterile Water and Sterile Saline for Device Irrigation, Moisturizing of Wound Dressings and for use in Jet Lavage for Tissue Debridement".

This is a submission for an unclassified medical device, specifically sterile water and sterile saline. The 510(k) is for an expanded label usage of an existing device, not for a new device concept or a device relying on complex algorithms or imaging for diagnosis/treatment.

Therefore, the concepts of "acceptance criteria" and "studies proving the device meets acceptance criteria" as they relate to performance metrics like sensitivity, specificity, or effect sizes for AI-powered diagnostics do not apply to this type of submission.

Instead, for devices like sterile water and saline, acceptance criteria revolve around:

Sterility: The product must be free of viable microorganisms.
Purity: The water/saline must meet USP (United States Pharmacopeia) standards for purified water or saline.
Material Compatibility: The packaging materials (HDPE bottles, HIPS cups) must be safe and compatible with the contents.
Terminal Sterilization Effectiveness: The gamma irradiation process must effectively sterilize the product.
Packaging Integrity: The seal and container must maintain sterility and product quality.
Labeling Accuracy: The label must accurately reflect the contents and intended use.
Predicate Device Equivalence: The product must be substantially equivalent to previously cleared devices in terms of materials, intended use, and performance claims.

The "study" in this context is the manufacturer's verification and validation (V&V) testing to ensure these criteria are met. This would typically involve:

Sterility testing: USP <71> Sterility Tests.
Chemical/Physical tests: To ensure USP compliance for purified water or saline (e.g., pH, conductivity, endotoxin levels, particulate matter).
Biocompatibility testing: For the packaging materials if there's a new or modified material.
Gamma irradiation validation: Dosimetry and bioburden measurements to confirm effective sterilization.
Package integrity/shelf-life studies: To ensure the product remains sterile and stable over its intended shelf life.

Since the submission is for expanded label usage of an existing device (K000265, K000266), the focus of the 510(k) is on demonstrating that the expanded indications ("Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement") do not introduce new questions of safety or effectiveness and are consistent with the predicate devices. The document explicitly states: "There is no material change involved in this notice to expand labeling. Compliance With Special Controls: No applicable mandatory performance standards or special controls exist for these devices."

Therefore, many of the specific questions about AI/diagnostic study design are not applicable to this documentation.

Here's how to interpret the request in the context of the provided 510(k) for this specific device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance/Evidence
Sterility	Terminally sterilized using gamma irradiation. This implies successful validation of the sterilization process.
Purity (Water/Saline Quality)	"This device is USP purified water or saline". This implies compliance with United States Pharmacopeia standards for purity.
Biocompatibility/Material Safety	"All materials are latex free." Made from HDPE bottles or HIPS cups. Implies standard, well-established biocompatible materials for such applications.
Packaging Integrity	"Sealed in 100mL HDPE bottles or 120mL HIPS cups". Assumed to maintain sterility and product quality based on general manufacturing practices for such devices.
Substantial Equivalence to Predicate	The FDA review determined the device is "substantially equivalent" to predicate devices K000265, K000266 for the expanded indications. "No material change involved in this notice to expand labeling."
Expanded Indications for Use	The FDA cleared the expanded indications: "Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement", confirming they are safe and effective within the context of the substantially equivalent device.
Manufacturing Quality	Establishment registered with ISO Certificate No. GB05/66128, indicating adherence to quality management systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in the traditional sense for a diagnostic device. This is a physical, sterile fluid product. Testing would involve process validation and material testing, not clinical "test sets" for diagnostic accuracy. The 510(k) summary does not mention specific sample sizes for V&V tests, as this is typically part of internal design controls and test reports, not the public 510(k) summary for such a low-risk device. Data provenance would be from internal manufacturing and testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" to establish in the diagnostic/AI sense for sterile water or saline. The "ground truth" for sterility is the absence of microorganisms confirmed by lab tests. The "ground truth" for purity is compliance with USP standards, confirmed by chemical analysis. These are objective laboratory measurements, not subjective expert assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No expert adjudication is involved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For sterility: Laboratory culture results (absence of growth).
For purity: Analytical chemistry results (USP compliance).
For packaging integrity: Physical integrity tests and shelf-life stability studies.
The "ground truth" for this 510(k) filing is primarily that the device meets established standards (USP) and regulatory requirements (sterilization validation, substantial equivalence).

8. The sample size for the training set

Not Applicable. There is no AI training set for this device.

9. How the ground truth for the training set was established

Not Applicable. There is no AI training set for this device.

Summary

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K082330
page 1/2

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:	813-779-7226813-715-4084
Trade Name:	Primary Care Solutions Sterile Water and SterileSaline for Device Irrigation, Moisturizing of WoundDressings and for use in Jet Lavage for Tissue DebridementCatalog numbers 1500, 1600, 1550, 1650, WF1000 andSF1200
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 RoadMulberry, FL 33860 ISO Cert. #
Classification Name:	Sterile Water and Sterile Saline for Moisturizing a WoundDressing and for Device Irrigation
Class:	Unclassified
Reason for Application	Expanded Label Usage of Existing Device
Predicate Devices:	K000265, K000266 Sterile Water and Sterile SalineFor 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 100mLHDPE bottles or 120mL HIPS cups and terminally sterilizedusing gamma irradiation. All materials are latex free.
Intended Label Expansion:	Moisturizing of Wound Dressings, Device Irrigation andJet Lavage for Tissue Debridement

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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.

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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 (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

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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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Regulation Number and Section

N/A