The CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion.

Device Description

The CADD™ Medication Cassette Reservoir with Flow Stop feature is a modification to the current CADD™ Medication Cassette Reservoir with Flow Stop. The modification incorporates a 250 mL reservoir and a two-part housing assembly. It is provided with a medication bag and pump tube, extension tube, pressure plate with Flow Stop feature, rear housing, clamp and leur assembled with the cover set into the rear housing assembly but not snapped together. This two-part housing design is intended to allow manipulation of the medication bag for removal of air bubbles prior to permanently snapping the housing together.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the CADD™ Medication Cassette Reservoir. This document outlines general information about the device, its intended use, and a summary of studies performed. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states that the device "meets the acceptance criteria for the safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications." However, it does not list specific acceptance criteria (e.g., maximum flow rate deviation, burst pressure, material compatibility thresholds).
Reported Device Performance: Similarly, while it states "All tests performed demonstrate that the CADD™ Medication Cassette Reservoir with Flow Stop meets the acceptance criteria," it does not provide specific performance data or values for any of these tests.

Therefore, a table cannot be constructed with the information provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Functional Testing," but it does not specify the sample size for any tests conducted.
Data Provenance: This information is not available in the provided text.

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)

Since there were no human clinical studies (see point 5 and 6), there was no ground truth established by experts in the context of the device's functional performance. The "ground truth" here would be the engineering specifications against which the device was tested.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there were no clinical studies involving human interpretation or adjudication.

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

No MRMC study was done. The document explicitly states: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD™ Medication Cassette Reservoir with Flow Stop."
AI assistance is not relevant for this type of medical device (a medication cassette reservoir).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical reservoir, not an algorithm or AI system. The "Functional Testing" described would be considered a standalone performance evaluation of the device itself against its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" used for this device would be its engineering specifications and design requirements. The functional tests were conducted to ensure the device performs according to these pre-defined (but not enumerated in the document) criteria. This is implicitly stated as "meets the acceptance criteria for the safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications."

8. The sample size for the training set

This question is not applicable as the device is a physical medical component, not a learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary of available information regarding acceptance criteria and studies:

The document states that the CADD™ Medication Cassette Reservoir with Flow Stop was subjected to functional testing to demonstrate compliance with its internal specifications.

Acceptance Criteria: Not explicitly listed but referred to as "safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications."
Study Type: Functional Testing (engineering/bench testing).
Outcomes: "All tests performed demonstrate that the CADD™ Medication Cassette Reservoir with Flow Stop meets the acceptance criteria..."
Clinical Studies: Deemed "not necessary."
Predominant Ground Truth: Engineering and design specifications.

Summary

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K∅81156

Page 1 of 2

510(k) SUMMARY

JUL 1 8 2008

CADD™ Medication Cassette Reservoir

I. GENERAL INFORMATION

Applicant's Name and Address:	Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	David H. ShortDirector Regulatory Affairs andDesign Assurance
Common/Usual Name:	Medication Cassette Reservoir
Proprietary Name:	CADD™ Medication Cassette Reservoir
Equivalence Device Comparison:	CADD™ Medication Cassette Reservoirwith Flow StopFlexible Medication Reservoir

II. DEVICE DESCRIPTION

III. INTENDED USE OF THE DEVICE

The CADD™ Medication Reservoirs are designed for use with the CADD® pumps (except CADD® Micro, CADD-MSTM 3, and CADD TPN®) for medication delivery.

IV. DEVICE COMPARISON

The CADD™ Medication Cassette Rescrvoir with Flow Stop is similar in design, function, and intended use to the predecessor CADD™ Medication Cassette Reservoir with Flow Stop, K040636. These sets are identical except for size and

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Lø8 1156 page 2

assembly method of the housing prior to use with the pump. The reservoir housing for the predecessor device, 50 mL and 100 mL capacity, is ultrasonically welded to the pressure plate, whereas the 250 mL reservoir housing is a two-piece design that is snapped together by the clinician prior to attachment to the pump.

V. SUMMARY OF STUDIES

Functional Testing A.

The CADD™ Medication Cassette Reservoir with Flow Stop was subjected to verification and validation testing. All tests performed demonstrate that the CADD™ Medication Cassette Reservoir with Flow Stop meets the acceptance criteria for the safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications.

B. Clinical Studies

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD™ Medication Cassette Reservoir with Flow Stop.

C. Conclusions Drawn from the Studies

Based upon the information provided, CADD " Medication Cassette Reservoir with Flow Stop is safe, effective and performs to established specifications

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2008

Mr. David H Short Director Regulatory Affairs and Design Assurance Smiths Medical Md. Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re: K081156

Trade/Device Name: CADD Medication Cassette Reservoir Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 22, 2008 Received: April 23, 2008

Dear Mr. Short:

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.

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Page 2 - Mr. Short

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 80) ); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
TKlamrelk Ludi. my for/ch

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

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K081156

SMITHS MEDICAL MD, INC. 510(k) Premarket Notification CADD™ Medication Cassette Reservoir

Indications for Use

510(k) Number:

Device Name: CADD™ Medication Cassette Reservoir

Indications for Use:

"The CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion."

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for now 7/18/08
(Division Sign-Off)

(Division Sig Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. _ KO 8/1/5 ماك

Regulation Number and Section

§ 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.