(83 days)
Not Found
Not Found
No
The device description and intended use clearly indicate a simple, sterile solution and syringe for balloon inflation, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is described as syringes containing sterile water and sodium chloride for balloon inflation, and it explicitly states, "Devices are not intended for wound irrigation, injection or IV Administration." This indicates it is for a procedural function (inflation) rather than for treating or curing a disease or condition.
No
The device, VitalCare Sterile Water and 0.9% Sodium Chloride in syringes, is described as being used for "balloon inflation." This function is not related to diagnosing a condition or disease but rather to a procedural or therapeutic step.
No
The device description clearly states it is a physical product consisting of pre-filled syringes containing sterile water and saline solution, manufactured from polypropylene. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "used for balloon inflation." This is a direct application within the body (in vivo) for a medical procedure, not for testing samples taken from the body (in vitro).
- Device Description: The description focuses on the composition of the sterile water and saline solution and the materials of the syringe. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the VitalCare Sterile Water and 0.9% Sodium Chloride syringes, as described, are medical devices intended for in vivo use, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Sterile water and 0.9% Sodium Chloride pre-filled syringes are intended to be used for catheter balloon inflation. The devices are not intended to be used for wound irrigation or IV administration.
VitalCare Sterile Water and 0.9% Sodium Chloride. The10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.
Product codes (comma separated list FDA assigned to the subject device)
JOL, EZL
Device Description
Sterile Water and 0.9% Sodium Chloride are products that have been used in the medical community for decades, the only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The syringes are manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives. The containers are filled with distilled water and distilled saline solution, sealed, capped and gamma irradiated for single use only.
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.
Orion Life Systems- Sterile Water and 0.9% 10cc pre-filled inflation syringes.
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
§ 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
AUG 2 7 2003
510(k) Summary
Submitter:
VitalCare Group Inc. 8935 NW 27th Street Miami Fl. 33172
Contact:
Michael McAvenia Director of Quality Assurance (305) 620-4007 Fax: (305) 620-5220 Internet: michaelm@vitalcare.com
Name of Device: VitalCare Sterile Water and .09% Saline 10cc, 30cc pre-filled inflation syringes.
Predicate Device: Orion Life Systems- Sterile Water and 0.9% 10cc pre-filled inflation syringes.
Description of the New Device: Sterile Water and 0.9% Sodium Chloride are products that have been used in the medical community for decades, the only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The syringes are manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives.
The containers are filled with distilled water and distilled saline solution, sealed, capped and gamma irradiated for single use only.
The Sterile Water and Saline Solutions pre-filled syringes are substantially equivalent to Orion Life Systems. Sterile Water and Saline Solutions pre-filled syringes in that:
- The intended use is the same -
- -The performance attributes are the same
1
Intended Use of the New Device:
Sterile water and 0.9% Sodium Chloride pre-filled syringes are intended to be used for catheter balloon inflation. The devices are not intended to be used for wound irrigation or IV administration.
Comparison of the Technological Features of the New Device and Predicate Device:
The new device features and predicate device features are similar. The components and contents of the containers are similar.
| Feature\Claim | VitalCare Group Inc. Sterile
Water - 0.9% Saline Solution | Orion Life Systems Sterile Water -
0.9% Saline Solution |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Contents | Sterile Water\0.9% Sodium
Chloride. | Similar |
| Labeling | Sterile Water\Saline 10cc\30cc
syringes. For Balloon Inflation.
Not for injection. No antimicrobial
or other substances added. | Similar |
| Materials | Polypropylene, Santoprene rubber | Similar |
Device Common and Classification Name(s):
Inflation Syringe. Common Name: Classification Name: Syringe, Balloon Inflation
Classification Information:
| Class: | Class II |
|---|---|
| Panel: | General Hospital |
| Product Code: | JOL |
| Cite: | 880 |
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a bird or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that converge at the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2003
Mr. Michael Mcavenia Director of Quality Assurance VitalCare Group, Incorporation 8935 N.W. 27th Street Miami, Florida 33172
Re: K031748
Trade/Device Name: VitalCare Sterile Water and 0.9% Saline 10cc, 30cc Pre-Filled Inflation Syringe Regulation Number: 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: April 16, 2003 Received: June 13, 2003
Dear Mr. Mcavenia:
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 vour 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. Mcavenia
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.
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 vours.
Suser Kunne
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
INDICATIONS FOR USE
510(k) Number: K031748
Device Name:
Indications for Use:
VitalCare Sterile Water and 0.9% Sodium Chloride Pre-Filled Syringes.
VitalCare Sterile Water and 0.9% Sodium Chloride. The10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE)
concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or Over-The Counter Use
Petrea Cucurite
(Division Sign Off)
ion of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: K031748