(70 days)
The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.
The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.
The CADD® Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD® Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump.
The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
The CADD® Administration Sets with Flow Stop is a modification to the current CADD® Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.
The Flow Stop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the Flow Stop in the open position.
The Add-on Integral Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the Flow Stop.
The provided document describes two devices: the CADD® Medication Cassette Reservoir with Flow Stop and the CADD® Administration Set with Flow Stop. Both devices are modifications of existing products and incorporate a "Flow Stop" component designed to occlude the tube if the reservoir/set is accidentally placed onto the pump incorrectly or becomes detached.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | The device must function according to specifications, specifically that the Flow Stop component effectively occludes the tube if the reservoir/set is incorrectly attached or detached from the pump. | "The results of the testing indicated that the CADD® Medication Cassette Reservoirs with Flow Stop function according to specifications." (for both devices) |
| Biocompatibility | The materials used in the new Flow Stop components must be biocompatible for human use. | "Biocompatibility testing was performed on the new Flow Stop components." and "the materials used in the device are biocompatible." Therefore, the product is considered acceptable for human use. |
| Intended Use | The device must be suitable for its intended use with CADD® pumps (except CADD®-Micro and CADD-TPN®) for delivery of medications and fluids. | The functional testing and biocompatibility support its use as intended, as concluded by the statement "Therefore, the product is considered acceptable for human use." |
Study Information
-
Sample size used for the test set and the data provenance:
- The document states "In-vitro testing was conducted," but does not specify the sample size for the functional testing.
- The data provenance is in-vitro testing, implying a laboratory setting, not human or animal data. The country of origin is not explicitly stated, but the applicant's address is in St. Paul, Minnesota, USA.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The studies were described as "in-vitro testing," suggesting a focus on engineering and material science rather than expert-based ground truth.
-
Adjudication method for the test set:
- This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic studies where human expert consensus is needed. The testing described is functional and biocompatibility testing.
-
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary regarding the CADD® Medication Cassette Reservoirs with Flow Stop due to their similarity in materials, design and function to the current CADD® Medication Cassette Reservoirs." The same statement is made for the Administration Set.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a medical accessory (medication cassette reservoir/administration set), not an algorithm or AI system.
-
The type of ground truth used:
- The ground truth for the functional performance was based on specifications established for the device's function (i.e., the Flow Stop effectively occluding the tube).
- For biocompatibility, the ground truth was based on established biocompatibility standards and tests for medical device materials.
-
The sample size for the training set:
- This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for physical device performance and material properties.
-
How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K040636". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CADD® Medication Cassette Reservoir with Flow Stop
March 9, 2004
GENERAL INFORMATION I.
| Applicant's Name and Address: | Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Patricia A. LaForteRegulatory Affairs Associate |
| Common/Usual Name: | Medication Cassette Reservoir |
| Proprietary Name: | CADD® Medication Cassette Reservoir withFlow Stop |
| Equivalence Device Comparison: | CADD® Medication Cassette Reservoir |
DEVICE DESCRIPTION II.
The CADD® Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD® Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump.
The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
INTENDED USE OF THE DEVICE III.
The CADD® Medication Reservoirs are designed for use with the CADD® pumps (except CADD® Micro) to allow fluid delivery from a flexible container.
{1}------------------------------------------------
IV. DEVICE COMPARISON
The CADD® Medication Cassette Reservoirs with Flow Stop are similar in design, function, and intended use to the current CADD® Medication Cassette Reservoirs. These sets are identical except for the addition of the Flow Stop.
The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoir is accidentally placed onto the pump incorrectly or becomes detached from the pump.
SUMMARY OF STUDIES V.
A. Functional Testing
In-vitro testing was conducted on the CADD® Medication Cassette Reservoirs with Flow Stop.
Biocompatibility testing was performed on the new Flow Stop components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the CADD® Medication Cassette Reservoirs with Flow Stop due to their similarity in materials, design and function to the current CADD® Medication Cassette Reservoirs.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the CADD® Medication Cassette Reservoirs with Flow Stop function according to specifications and the materials used in the device are biocompatible. Therefore, the product is considered acceptable for human use.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image contains a series of handwritten alphanumeric characters. The characters appear to be 'K', followed by a symbol resembling 'Psi', then '4', another 'Psi', '0', '6', '3', and '6'. The writing style is cursive and somewhat stylized, making some characters slightly ambiguous.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CADD® Administration Set with Flow Stop
March 9, 2004
II. GENERAL INFORMATION
| Applicant's Name and Address: | Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Patricia A. LaForteRegulatory Affairs Associate |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | CADD® Administration Set with Flow Stop |
| Equivalence Device Comparison: | CADD® Administration Set |
DEVICE DESCRIPTION II.
The CADD® Administration Sets with Flow Stop is a modification to the current CADD® Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.
The Flow Stop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the Flow Stop in the open position.
The Add-on Integral Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the Flow Stop.
INTENDED USE OF THE DEVICE III.
The CADD® Administration Set is designed for use with the CADD® pumps (except CADD®-Micro) to allow medication delivery from a flexible container.
{3}------------------------------------------------
KφчΦ636
DEVICE COMPARISON IV.
The CADD® Administration Sets with Flow Stop are similar in design, function, and intended use to the current CADD® Administration Sets. These sets are identical except for the addition of the Flow Stop and the removal of the Integral Anti-siphon Valve.
The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.
V. SUMMARY OF STUDIES
Functional Testing A.
In-vitro testing was conducted on the CADD® Administration Set with Flow Stop.
Biocompatibility testing was performed on the new Flow Stop components.
D. Clinical Studies
Clinical studies were not deemed necessary regarding the CADD® Administration Sets with Flow Stop due to their similarity in materials, design and function to the current CADD® Administration Sets.
Conclusions Drawn from the Studies E.
The results of the testing indicated that the CADD® Administration Sets with Flow Stop function according to specifications and the materials used in the device are biocompatible. Therefore, the product is considered acceptable for human use.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2004
Ms. Patricia A. LaForte Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road St Paul, Minnesota 55112
Re: K040636
Trade/Device Name: CADD® Administration Sct with Flow Stop CADD® Medication Cassette Reservoir with Flow Stop Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Codc: FPA Dated: March 9, 2004 Received: March 10, 2004
Dear Ms. LaForte:
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 prodicate devices marketed in interstate commerce prior to May 23, 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 cither 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.
{5}------------------------------------------------
Page 2 - Ms. LaForte
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. or the rever mily 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 and if the (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirents as 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) rins reter notification. The FDA finding of substantial equivalence of your device to a promative methous aredicate 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), r you deents 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 misjon 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.
Chris Lim, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known):_K040636
Device Name: CADD® Medication Cassette Reservoir with Flow Stop
CADD® Administration Set with Flow Stop
Indications For Use:
"The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids."
"The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids."
Prescription Use × AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton D, mnc
Page 1 of 1
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K944636
§ 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.