PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND by PRIMARY CARE SOLUTIONS, INC.

The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation. The intended use of the device is identical to that of the predicate device and other similar devices in the market. The syringe is employed by connecting the syringe tip to the valve on the side arm of foley catheter and forcing sterile water through a lumen into the balloon for inflation.

A sterile water pre-filled syringe for use in inflating foley catheter balloon

Device Description

The device is a 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: "Primary Care Solutions Prefilled 10cc and Prefilled 30cc Inflation Syringes with Sterile Water."

This document does not describe an AI/ML powered device, nor does it detail a study proving the device meets acceptance criteria in the way typically expected for such technologies. Instead, it is a submission for a conventional medical device (pre-filled syringes for foley catheter balloon inflation) seeking clearance based on substantial equivalence to an existing predicate device.

Therefore, many of the requested elements for describing an AI/ML study (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.

The "acceptance criteria" here refer to meeting the requirements for substantial equivalence to a predicate device, primarily focusing on materials, intended use, and general performance characteristics rather than complex performance metrics like sensitivity or specificity.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for a simple medical device, there aren't explicit quantifiable "acceptance criteria" and "reported device performance" in the way one would see for diagnostic AI. Instead, the "performance" is implicitly demonstrated by the device's identical materials and intended use compared to the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device "Performance" / Characteristics
Material Composition: Must be identical or acceptably equivalent to the predicate device.	"The predicate device contains exactly the same material components as the pre-market notice subject device...produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover."
Intended Use: Must be identical to the predicate device.	"The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation. The intended use of the device is identical to that of the predicate device and other similar devices in the market."
Sterility: Must be sterile (as it's a pre-filled syringe with sterile water for medical use).	"gamma irradiated." and "A sterile water pre-filled syringe..."
Performance for Stated Use: Must be capable of inflating foley catheter balloons effectively.	"The syringe is employed by connecting the syringe tip to the valve on the side arm of foley catheter and forcing sterile water through a lumen into the balloon for inflation." (Implied to perform this function reliably given material and design equivalence).
Compliance with Special Controls: Must meet any applicable mandatory performance standards or special controls.	"No applicable mandatory performance standards or special controls exist for these devices."

Regarding the study that "proves the device meets the acceptance criteria":

The "study" in this context is the comparison to the identified predicate device (K943836 - Pre-Filled 10cc Inflation Syringe with Sterile Water from Orion Medical Products, Inc.) and the determination of substantial equivalence by the FDA. The document explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."

The core "proof" is the detailed comparison in the submission (summarized here) highlighting the identical material components and identical intended use.

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. This is a substantial equivalence submission for a non-AI/ML device. There is no "test set" in the context of data for an algorithm. The evaluation is based on device design, materials, and intended use comparison to a predicate.

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. No expert consensus "ground truth" for a test set is involved. The FDA regulatory body makes a determination of substantial equivalence based on the submitted application and its comparison to the predicate device.

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

Not applicable. No test set or expert adjudication is relevant to this type of device submission.

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/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. For this submission, the "ground truth" (if one could even call it that) is the legally marketed status and characteristics of the predicate device to which substantial equivalence is claimed.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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人030813

MAY 3 0 2003

PRIMARY CARE SOLUTIONS, INC 510(K) SUMMARY

Applicant Name/Address	PRIMARY CARE SOLUTIONS, INC.40420 Free Fall Ave.Zephyrhills, FL 33542
Contact:	Ron MaddixVice President, Marketing & Sales
Phone:Fax:	813-779-7226813-715-4084
Trade Name:	Primary Care Solutions Prefilled 10cc and Prefilled 30ccInflation Syringes with Sterile WaterCatalog numbers 1010 and 1030 respectively
Establishment Reg. No.	1066336
Manufacturing Facility:	PRIMARY CARE SOLUTIONS, INC40420 Free Fall Ave.Zephyrhills, FL 33542
Sterilization Facility:	FOOD TECHnology Service, Inc.502 Prairie Mine RoadMulberry, FL 33860
Classification Name:	Syringe, Balloon Inflation
Class:	II
Reason for Application:	New Devices to Primary Care Solutions, Inc.
Predicate Devices:	K943836 - Pre-Filled 10cc Inflation Syringe with SterileWaterOrion Medical Products, Inc.Wheeling, IL 60090
Device Description	The device is a 10cc and 30cc syringe pre-filled withUSP purified water and gamma irradiated. The syringeis produced using polypropylene for the device barreland plunger and pharmaceutical grade latex free rubber forboth the plunger gasket and syringe tip cover.
Intended Device Use:	The 10cc and 30cc pre-filled syringes are intended to beused for foley catheter balloon inflation. The intended useof the device is identical to that of the predicate device andother similar devices in the market. The syringe is employedby connecting the syringe tip to the valve on the side arm offoley catheter and forcing sterile water through a lumen intothe balloon for inflation.

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Material Comparison to Predicate Device: The predicate device contains exactly the same material components as the pre-market notice subject device as indicated in the device description summary above. :

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

Mr. Ron Maddix Vice President, Marketing & Sales Primary Care Solutions, Incorporated 40420 Free Fall Avenue Zephyrhills, Florida 33542

Re: K030813

Trade/Device Name: Primary Care Solutions Pre-Filled 10cc and Pre-Filled 30cc Balloon Inflation Syringe with Sterile Water Regulation Number: 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: March 4, 2003 Received: March 14, 2003

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.

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Page 2 — Mr. Maddix

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 (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.

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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Rusine

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ of

510(K) Number: K030813

Device Name: Primary Care Solutions Pre-Filled 10cc and Pre-Filled 30cc Balloon Inflation Syringe with Sterile Water

Indications For Use: A sterile water pre-filled syringe for use in inflating foley catheter balloon

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Evaluation (ODE)

Concurrence of CDRH, Office of Device

Patua Cucurite

Infecti

510(k) Number. K050813

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.