(77 days)
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is described as a sterile water pre-filled syringe for inflating foley catheter balloons, which is a supportive function for a therapeutic device (foley catheter) rather than being therapeutic itself. Its intended use is mechanical inflation, not biological or direct treatment of a disease or condition.
No
The device is described as a pre-filled syringe for inflating a Foley catheter balloon, which is a functional purpose, not a diagnostic one.
No
The device description clearly states it is a physical syringe made of polypropylene and rubber, pre-filled with water. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A sterile water pre-filled syringe for use in inflating foley catheter balloon." This is a direct medical intervention on a patient (inflating a balloon within the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a syringe pre-filled with sterile water and its components. This aligns with a medical device used for a procedure, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for a procedural use within the body, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
EZL
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Maddix
Vice President, Marketing & Sales |
| Phone:
Fax: | 813-779-7226
813-715-4084 |
| Trade Name: | Primary Care Solutions Prefilled 10cc and Prefilled 30cc
Inflation Syringes with Sterile Water
Catalog numbers 1010 and 1030 respectively |
| Establishment Reg. No. | 1066336 |
| Manufacturing Facility: | PRIMARY CARE SOLUTIONS, INC
40420 Free Fall Ave.
Zephyrhills, FL 33542 |
| Sterilization Facility: | FOOD TECHnology Service, Inc.
502 Prairie Mine Road
Mulberry, 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 Sterile
Water
Orion Medical Products, Inc.
Wheeling, IL 60090 |
| 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. |
| Intended Device Use: | 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. |
:
1
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.
. . . . . . . . . . .
2
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.
3
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
4
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