The CytoGuard™ Closed Luer Connector is a bi-directional flow, needle-free, swabable luer access device used as an accessory to an IV Administration Set. It is intended for the administration of parenteral fluids, medication (including hazardous drugs), blood and blood products. With the CytoGuard attached to the standard male luer of a dosing device or container, the CytoGuard valve is in a closed position. Upon connection of its male luer fitting to the female luer fitting of a patient's administration set or catheter, the valve opens to allow medication delivery to the patient. The fluid path then closes, upon disconnect.

Device Description

CytoGuard is a needle-free, bi-directional flow, luer connector that is swabable, MRI Safe and does not contain PVC, DEHP, or natural rubber latex. The CytoGuard™ Closed Luer Connector is designed to be used by healthcare professionals during medication preparation, admixture, fluid transfer, administration or disposal. Using CytoGuard's female luer end CytoGuard is attached to a dosing device's male luer connector, creating a luer locking connection. With the CytoGuard attached, the dosing device is provided with a closed fluid path due to the presence of the CytoGuard's internal valve. The closed valve helps to reduce inadvertent fluid exposure to patients, clinicians and healthcare personnel.

When the CytoGuard's male luer nut is connected to a standard female luer, the fluid path is opened and allows for the movement of fluid. When the female luer is disconnected from the proposed device, the valve and fluid path closes, preventing the flow of fluid through the CytoGuard.

The female luer end of the CytoGuard possesses a spinning locking feature which will not allow the device to be easily removed, further aiding the reduction of fluid exposure. This feature helps to reduce the risk that the female luer end may inadvertently become disconnected or be removed from the male luer of the dosing device.

To further assist in the appropriate use of the device, the male luer nut has been colored a translucent orange to alert users which end of the device that connections and disconnections can be made. The Instructions for Use references an "orange end" to aid in the easy identification of this part of the device.

The CytoGuard will be available for sale as an individually packaged item and a non luer-activating dust cover cap to prevent touch contamination is provided as a separately sold accessory for the CytoGuard for use during transport.

AI/ML Overview

The provided text describes a medical device submission (K112636) for the CytoGuard™ Closed Luer Connector, not an AI/ML powered device. Therefore, a direct comparison of acceptance criteria and reported device performance in the context of AI is not applicable. The document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices through various performance tests.

However, I can extract the information related to the device's performance testing and intended functionalities, which can be interpreted as fulfilling certain "acceptance criteria" for a medical device.

Here's an analysis based on the information provided:

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

Since this is a non-AI/ML device, the concept of "acceptance criteria" is more about demonstrating functional equivalence and safety rather than a performance metric like accuracy or AUC.

Acceptance Criteria (Inferred from description)	Reported Device Performance (as stated in the document)
I. Functional Safety & Equivalence to Predicate Devices:
a. Normally Closed Design (prevents leakage/air ingress when inactive)	"Each of these devices [CytoGuard and predicates] has a normally closed design that is intended to prevent the leakage of fluid or ingress of air when in an inactivated state." "When the female luer is disconnected from the proposed device, the valve and fluid path closes, preventing the flow of fluid through the CytoGuard." "With the CytoGuard attached...the CytoGuard valve is in a closed position." "The fluid path then closes, upon disconnect."
b. Bi-directional Fluid Flow when Activated	"When activated, they all provide a 2-way fluid flow." "When the CytoGuard's male luer nut is connected to a standard female luer, the fluid path is opened and allows for the movement of fluid." "Upon connection of its male luer fitting to the female luer fitting...the valve opens to allow medication delivery to the patient."
c. Swabable	Stated as a feature: "CytoGuard is a needle-free, bi-directional flow, luer connector that is swabable..." "The CytoGuard™ Closed Luer Connector is a bi-directional flow, needle-free, swabable luer access device..."
d. Needle-free access	Stated as a feature: "CytoGuard is a needle-free...connector..." "The CytoGuard™ Closed Luer Connector is a needle-free...device..."
e. Reduction of inadvertent fluid exposure (closed path)	"The closed valve helps to reduce inadvertent fluid exposure to patients, clinicians and healthcare personnel." "The female luer end of the CytoGuard possesses a spinning locking feature which will not allow the device to be easily removed, further aiding the reduction of fluid exposure."
f. Compatibility with various fluids (blood, IV fluids, hazardous drugs)	"Several different fluids were evaluated for compatibility, including blood, general IV fluids, and chemicals identified on the "NIOSH Alert" drugs list, publication number 2004-165 dated September 2004 which is provided within this submission."
g. MRI Safe and absence of PVC, DEHP, or natural rubber latex	Stated as a feature: "CytoGuard is a needle-free, bi-directional flow, luer connector that is swabable, MRI Safe and does not contain PVC, DEHP, or natural rubber latex."
h. Spinning locking feature on female luer (prevents accidental disconnection)	"The female luer end of the CytoGuard possesses a spinning locking feature which will not allow the device to be easily removed, further aiding the reduction of fluid exposure." "This feature helps to reduce the risk that the female luer end may inadvertently become disconnected or be removed from the male luer of the dosing device." "Similar to the Spinning Spiros, the CytoGuard has a locking feature on the female luer end to prevent the device's disconnection during use."
i. Colored luer nut for identification of connection/disconnection end	"To further assist in the appropriate use of the device, the male luer nut has been colored a translucent orange to alert users which end of the device that connections and disconnections can be made." "The Instructions for Use references an "orange end" to aid in the easy identification of this part of the device."
j. No new issues of safety or effectiveness compared to predicate devices	"Functional performance testing, a simulated clinical use study, and testing of the locking feature and colored design features of the proposed device, have each demonstrated that the CytoGuard Closed Luer Connector does not raise new issues of safety or effectiveness."
II. Compliance with Regulatory Standards (Implicit):
a. Substantial equivalence to predicate devices (Spiros™, Spinning Spiros™ and CML™) with similar intended uses.	Stated throughout the document as the basis for 510(k) clearance: "Three predicate devices are utilized for substantial equivalence." "Testing was conducted to demonstrate the performance of the CytoGuard Closed Luer Connector and substantial equivalence with the predicate devices..."

Study Proving Acceptance Criteria:

The document states:

"Therefore, performance testing has been conducted. In addition, testing was performed to support an expanded variety of usage conditions of the CytoGuard. Several different fluids were evaluated for compatibility, including blood, general IV fluids, and chemicals identified on the "NIOSH Alert" drugs list, publication number 2004-165 dated September 2004 which is provided within this submission."

"Functional performance testing, a simulated clinical use study, and testing of the locking feature and colored design features of the proposed device, have each demonstrated that the CytoGuard Closed Luer Connector does not raise new issues of safety or effectiveness."

2. Sample sized used for the test set and the data provenance:

The document mentions "performance testing" and a "simulated clinical use study," but does not specify the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical medical device, not an AI/ML system requiring human expert ground truth for image or data interpretation. The "ground truth" for its performance is derived from physical testing against established standards and predicate device performance.

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

Not applicable. This device is a physical medical device and does not involve subjective interpretations requiring adjudication of expert opinions.

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 physical medical device and is not an AI-assisted diagnostic or decision-support tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The ground truth for this device's performance is established through physical and functional testing against predefined engineering and medical device standards, comparative testing with predicate devices, and potentially some in-vitro or simulated clinical environment performance verification. The document mentions compatibility with various fluids, implying testing against the physical properties and interaction of these fluids with the device components.

8. The sample size for the training set:

Not applicable. This is a manufactured physical device, not an AI/ML model that requires a training set.

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

Not applicable. As above, no training set for an AI/ML model is involved.

Summary

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NOV 2 6 2011

K112636

B. Braun Medical Inc. 510(k) Premarket Notification CytoGuardTM Closed Luer Connector

5. 510(k) SUMMARY

DATE:

September 7, 2011

SUBMITTER:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500

Contact: Angela J. Caravella, Regulatory Affairs Specialist Phone: (610) 596-2966 Fax: (610) 266-4962 E-mail: angela.caravella@bbraun.com

DEVICE NAME:

CytoGuard™ Closed Luer Connector

COMMON OR USUAL NAME:

Closed Luer Connector, Needle free

DEVICE

Class II, per 21 CFR §880.5440, Product Code: FPA CLASSIFICATION:

PREDICATE DEVICES:

Spiros™, ICU Medical Inc., K070532, Class II, FPA, 880.5440. Spinning Spiros™, ICU Medical Inc., K082806, Class II, FPA, 880.5440, CML TM, ICU Medical Inc., K051437, Class II FPA, 880.5440

DESCRIPTION:

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SUBSTANTIAL

EQUIVALENCE:

K112636

ge 2 of 3

INTENDED USE: The CytoGuard™ Closed Luer Connector is a bi-directional flow, needle-free, swabable luer access device used as an accessory to an administration device. It is intended for the administration of parenteral fluids, medication (including hazardous drugs), blood and blood products. With the CytoGuard attached to the standard male luer of a dosing device or container, the CytoGuard valve is in a closed position. Upon connection of its male luer fitting to the female luer fitting of a patient's administration set or catheter, the valve opens to allow medication delivery to the patient. The fluid path then closes, upon disconnect.

Three predicate devices are utilized for substantial equivalence. ICU Medical Inc.'s Spiros™ (K070532), Spinning Spiros™ (K082806) and CML™ (K051437).

The Cytoguard Closed Luer Connector has similar intended uses to ICU Medical's Spiros, Spinning Spiros, and CML in that they each act as a closed male luer that provides access for the administration of fluids from a container (or dosing device) to the patient. Each of these devices has a normally closed design that is intended to prevent the leakage of fluid or ingress of air when in an inactivated state. When activated, they all provide a 2-way fluid flow. The CytoGuard and Spiros devices contain polycarbonate female luers.

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Similar to the Spinning Spiros, the CytoGuard has a locking feature on the female luer end to prevent the device's disconnection during use.

1-112636

Each of these devices has an open and closed state; however, the mechanism used to achieve it differs between the proposed and predicate devices. Therefore, performance testing has been conducted. In addition, testing was performed to support an expanded variety of usage conditions of the CytoGuard. Several different fluids were evaluated for compatibility, including blood, general IV fluids, and chemicals identified on the "NIOSH Alert" drugs list, publication number 2004-165 dated September 2004 which is provided within this submission.

CONCLUSION: Testing was conducted to demonstrate the performance of the CytoGuard Closed Luer Connector and substantial equivalence with the predicate devices: ICU Medical's Spinning Spiros™, Spiros™ and CMLTM. Functional performance testing, a simulated clinical use study, and testing of the locking feature and colored design features of the proposed device, have each demonstrated that the CytoGuard Closed Luer Connector does not raise new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Angela J. Caravella Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

NOV 2 6 2011

Re: K112636

Trade/Device Name: CytoGuard™ Closed Luer Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 7, 2011 Received: September 9, 2011

Dear Ms. Caravella

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Caravella

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); medical device reportung (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Anatra

Anthony D. Watson, B.S., M.S., M.B.A. 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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4. INDICATIONS FOR USE STATEMENT

Page ________________of

K112636 510(k) Number (if known):

Device Name:

CytoGuard™ Closed Luer Connector

Indications For Use:

Prescription Use	X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 11/28/4

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K 112636

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.