(83 days)
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.
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.
This 510(k) summary (K031748) is for the VitalCare Sterile Water and 0.9% Saline 10cc, 30cc pre-filled inflation syringes. The document describes the device, its intended use, and compares it to a predicate device (Orion Life Systems Sterile Water and 0.9% 10cc pre-filled inflation syringes) to establish substantial equivalence.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for a diagnostic or AI-driven medical device submission.
Instead, this 510(k) emphasizes substantial equivalence to an already legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as the predicate device based on similar technological characteristics and intended use, rather than conducting a new, detailed performance study against specific acceptance criteria.
Therefore, many of the questions regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of submission.
However, I can extract the relevant information from the provided text based on the 510(k) submission's structure:
1. A table of acceptance criteria and the reported device performance:
This 510(k) submission, being for a pre-filled syringe (a manufacturing and material equivalence claim), does not present specific "acceptance criteria" and "reported device performance" in the way a clinical study would for a diagnostic or AI device. Instead, the "performance" is based on the equivalence of features and contents to the predicate device.
| Feature / Claim | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (VitalCare Device) |
|---|---|---|
| Intended Use | Same as predicate device (catheter balloon inflation; not for wound irrigation or IV administration). | "The intended use is the same." "Used for catheter balloon inflation. The devices are not intended to be used for wound irrigation or IV administration." |
| Contents | Sterile water (for sterile water syringes) and 0.9% Sodium Chloride (for saline syringes); no preservatives or stabilizers. | "Sterile Water\0.9% Sodium Chloride." "The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers." "The containers are filled with distilled water and distilled saline solution." |
| Labeling | Equivalent to predicate device regarding contents, volume, intended use (balloon inflation), and prohibitions (not for injection, no antimicrobial/other substances). | "Sterile Water\Saline 10cc\30cc syringes. For Balloon Inflation. Not for injection. No antimicrobial or other substances added." (Stated as "Similar" to predicate) |
| Materials | Medical grade materials, specifically polypropylene for syringes and Santoprene rubber. | "Polypropylene, Santoprene rubber." "Manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives." (Stated as "Similar" to predicate) |
| Sterilization | Sterilized for single use. | "Sealed, capped and gamma irradiated for single use only." (Implied to be equivalent to predicate in safety and effectiveness) |
| Performance Attributes | Equivalent to predicate device. | "The performance attributes are the same." |
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 510(k) submission for substantial equivalence of a manufacturing product (pre-filled syringes), not a clinical trial or performance study involving a patient test set or data originating from a specific country. The "test" for this type of device is primarily a comparison of its physical and chemical properties, manufacturing processes, and intended use against a legally marketed predicate device.
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 was no "ground truth" to establish in a clinical sense for a test set. The validation for this type of device involves scientific and engineering assessment of material properties, sterilization methods, and product design compared to the predicate device, typically performed by the manufacturer's internal quality and R&D teams and reviewed by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set requiring expert adjudication was conducted for this 510(k) 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 device is a pre-filled syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a pre-filled syringe, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The concept of "ground truth" as used in diagnostic or AI studies is not relevant here. The "truth" for this submission revolves around demonstrating that the device's physical and chemical attributes, along with its manufacturing process, result in a product that is safe and effective and functions equivalently to the predicate device.
8. The sample size for the training set:
Not applicable. There is no "training set" for this product.
9. How the ground truth for the training set was established:
Not applicable. There is no "ground truth" or "training set" for this product.
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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
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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. SterileWater - 0.9% Saline Solution | Orion Life Systems Sterile Water -0.9% Saline Solution |
|---|---|---|
| Contents | Sterile Water\0.9% SodiumChloride. | Similar |
| Labeling | Sterile Water\Saline 10cc\30ccsyringes. For Balloon Inflation.Not for injection. No antimicrobialor 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 |
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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.
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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
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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
§ 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.