(36 days)
Not Found
No
The summary describes a mechanical luer activated needleless injection site and does not mention any AI or ML components or functionalities.
No
The device is described as an "alternate injection site" and is designed for fluid delivery, but it does not inherently treat or diagnose a condition. It is an accessory for fluid administration sets.
No
The device description indicates it is an "alternate injection site" for fluid delivery, not for diagnosing medical conditions. The performance studies focus on functional specifications and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a "valve" and an "injection site," which are physical hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fluid delivery" with administration sets or syringes. This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description clearly states it's a "valve" and an "injection site" accessed by syringes or IV sets. This aligns with a device used in the process of administering fluids intravenously.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting for testing
The device described is a component used in the delivery of fluids, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The alternate injection site is designed for use with various SIMS Deltec administration sets or syringes for fluid delivery.
The luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.
Product codes
FPA
Device Description
The purpose of this submission is to offer an alternate injection site ("Luer Activated Needleless Injection Site") for use with various Deltec administration sets. The injection site is a valve and is accessed using needleless syringes or IV administration sets.
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)
A. Functional testing
Functional specification testing was performed on the alternate injection site.
Biocompatibility testing was conducted.
Clinical Studies B.
Clinical studies were not deemed necessary regarding the alternate injection site due to its similarity in materials, design and function to current commercially available injection sites.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the alternate injection site functions according to specification and it meets the biocompatibility requirements. Therefore, the alternate injection site is considered acceptable for human use.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Luer Activated Needleless Injection Site for use with Various Deltec Administration Sets
May 6, 1999
GENERAL INFORMATION I.
| Applicant's Name and Address: | SIMS Deltec, Inc. |
|---|---|
| 1265 Grey Fox Road | |
| St. Paul, MN 55112 | |
| Contact Person: | Edward W. Numainville |
| Vice President, Regulatory Affairs and | |
| Quality Systems | |
| Common/Usual Name: | Administration Set with Injection Site |
| Proprietary Name: | For example: CADD-Prizm® High Volume |
| Administration Set with 0.2 µ filter, Add-On | |
| Anti-Siphon Valve, bag spike, luer | |
| activated needleless injection site, male luer, | |
| and clamp | |
| Equivalence Device Comparison: | ULTRASITE™ Needle-free IV System |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an alternate injection site ("Luer Activated Needleless Injection Site") for use with various Deltec administration sets. The injection site is a valve and is accessed using needleless syringes or IV administration sets.
INTENDED USE OF THE DEVICE III.
The alternate injection site is designed for use with various SIMS Deltec administration sets or syringes for fluid delivery.
1
DEVICE COMPARISON IV.
| | Alternate Injection Site for
use with Various Deltec
Administration Sets | Standard Injection Site
used on the CADD-Prizm®
High Volume
Administration Set | ULTRASITE™ Needle-
free IV System |
|-----------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | B. Braun Medical Inc. |
| 510(K) NUMBER | Subject Device | K943310 | Unknown |
| INDICATIONS FOR USE | Designed for use with
various SIMS Deltec
administration sets or
syringes for fluid delivery. | Designed for use with
various SIMS Deltec
administration sets for fluid
delivery. | The ULTRASITE™ Valve
is a specially designed valve
for use on intravenous lines.
It allows you to use a
syringe or IV administration
set without a needle. |
| NEEDLE-FREE VALVE | YES | NO | YES |
| INTEGRAL TO
ADMINISTRATION SET | YES | YES | NO |
V. SUMMARY OF STUDIES
A. Functional testing
Functional specification testing was performed on the alternate injection site.
Biocompatibility testing was conducted.
Clinical Studies B.
Clinical studies were not deemed necessary regarding the alternate injection site due to its similarity in materials, design and function to current commercially available injection sites.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the alternate injection site functions according to specification and it meets the biocompatibility requirements. Therefore, the alternate injection site is considered acceptable for human use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 15 1999
Mr. Edward W. Numainville Vice President Requlatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
K991599 Re: CADD® Administration Set Trade Name: Requlatory Class: II Product Code: FPA Dated: May 6, 1999 May 10, 1999 Received:
Dear Mr. Numainville:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Numainville
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdg.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 991599
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Luer Activated Needleless Injection Site
Indications for Use:
The luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR Over-the-Counter Use __
Palica Cucente
(Division Sign-Off)
510(k) Nun
EN99038