The Caresite Luer Access Device (LAD) is a needleless connector intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device (LAD) may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.

Device Description

The Caresite Luer Access Device (LAD) is a positive displacement needleless connector intended to provide needle-free access to IV gravity sets, extension sets and catheters for the administration of IV fluids and blood. The Caresite Luer Access Device (LAD) is a 3-piece assembly containing an elastomeric piston with a slit septum, which is housed within a clear, rigid body. The Caresite Luer Access Device (LAD) requires swabbing to disinfect prior to insertion of a male luer connector. The Caresite Luer Access Device (LAD) does not require a specific clamping sequence or technique in order to be used safely. The Caresite Luer Access Device (LAD) may be used with power injectors with a maximum pressure rating of 400 psi and a maximum flow rate of 15mL/sec. The Caresite Luer Access Device (LAD) is individually packaged and is supplied as a sterile, non-pyrogenic, single use, disposable device.

AI/ML Overview

The input document describes a 510(k) submission for a medical device (Caresite Luer Access Device), which is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Crucially, a 510(k) filing for a device like a needle-free luer access device typically does NOT involve the kind of elaborate clinical studies (MRMC, expert consensus for AI training/testing, etc.) that would lead to the specific information requested in your prompt. These studies are far more common for novel, high-risk devices, or AI-driven diagnostic/therapeutic tools.

The document states:

"Performance testing was performed to demonstrate safety and effectiveness."
"Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Caresite Luer Access Device (LAD) is considered substantially equivalent to the predicate device and is safe and effective for its intended use."

The performance testing mentioned here likely refers to bench testing, engineering verification, and perhaps some in-vitro studies to confirm properties like:

Pressure resistance (e.g., 400 psi)
Flow rate (e.g., 15 mL/sec)
Durability (e.g., number of activations)
Leakage prevention
Microbial ingress prevention
Biocompatibility (in accordance with ISO 10993-1)

Therefore, many of your requested points cannot be directly answered from the provided text. The document is for a physical medical device, not an AI/algorithm-driven one, hence the absence of metrics like "effect size of how much human readers improve with AI vs without AI assistance" or "number of experts used to establish ground truth."

Here's an attempt to address your prompt based on the provided text, and explicitly stating where the information is not applicable (N/A) or not provided (N/P) given the nature of a 510(k) for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Principle)

The acceptance criteria for a 510(k) submission like this are primarily to demonstrate substantial equivalence to a predicate device in terms of:

Indications for Use: The Caresite Luer Access Device has similar indications for use to the predicate device.
Technological Characteristics: Similar physical and technical characteristics, materials, and components as the predicate.
Performance: Safety and effectiveness demonstrated through performance testing, showing it performs at least as well as the predicate for its intended use, and meets specific functional requirements.

Given the absence of specific quantitative acceptance thresholds in the provided text for "performance testing," the table below reflects what can be inferred or is explicitly stated as characteristics of the device. The "acceptance criteria" here are implied by the device's functional specifications and the successful 510(k) clearance, meaning it performs acceptably for its intended use compared to the predicate.

Acceptance Criterion (Implied/Stated from text)	Reported Device Performance (from text)
Indications for Use Equivalence	Intended for aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Similar to predicate.
Power Injector Compatibility	Max pressure rating of 400 psi.
Flow Rate Compatibility	Max flow rate of 15 mL/sec.
Sterility	Must be supplied as sterile.
Biocompatibility	Must meet biocompatibility standards (e.g., ISO 10993-1).
Disinfection Procedure	Requires swabbing to disinfect.
Clamping Sequence Requirement	No specific clamping sequence.

Study Details (As Applicable for this Device Type)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/P. For a physical device of this nature, "test set" would refer to the number of devices tested during performance (bench) and biocompatibility testing. This information is not typically detailed in the 510(k) summary provided, but would be in the full submission. The data provenance would be from manufacturing/testing facilities, likely in the US (where the applicant is based). These would be prospective tests.
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):
- N/A. This device is not an AI/diagnostic imaging device, so the concept of "experts establishing ground truth" in the context of clinical images or algorithmic output is not applicable. The "truth" here is engineering specification, material safety, and functional performance as observed in bench tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective interpretations of data (e.g., radiological reads) or clinical outcomes. Not applicable for this physical device's performance testing.
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:
- N/A. This is a physical medical device, not an AI/diagnostic tool. MRMC studies are not relevant for its clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device, "ground truth" would be established through:
  - Engineering Specifications/Standards: Performance measured against predefined industry standards (e.g., ISO for biocompatibility) and engineering design specifications (e.g., pressure, flow rates).
  - Predicate Device Performance: The predicate device's established performance serves as a benchmark for substantial equivalence.
  - Biocompatibility Standards: Adherence to ISO 10993-1.
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- N/A. There is no "training set" as this is not an AI/machine learning device.

Summary

{0}------------------------------------------------

5. 510(k) SUMMARY

DATE:

February 7, 2014

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500
------------	-------------------------------------------------------------------------------------------

Contact:	Kimberly Smith, Regulatory Affairs SpecialistPhone: (610) 596-2326Fax: (610) 266-4962E-mail: kim.smith@bbraun.com
----------	-------------------------------------------------------------------------------------------------------------------------------

DEVICE NAME:	Caresite Luer Access Device
COMMON NAME:	Needle-free Injection Site; Needle-free Luer Access Device; Needleless Connector

DEVICECLASSIFICATION:	21 CFR §880.5440, Class IIIntravascular Administration SetClassification Product Code: FPA
---------------------------	----------------------------------------------------------------------------------------------------

PREDICATE DEVICE:	510(k) Number: K083723Device Name: A6 Luer Access DeviceClassification Product Code: FPA
-------------------	--------------------------------------------------------------------------------------------------

Applicant: B. Braun Medical Inc.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

Regulation Number: $880.5440. Class II

The Caresite Luer Access Device (LAD) may be used with power injectors with a maximum pressure rating of 400 psi and a maximum flow rate of 15mL/sec. The Caresite Luer Access Device (LAD) is individually packaged and is supplied as a sterile, non-pyrogenic, single use, disposable device.

{1}------------------------------------------------

B. Braun Medical Inc. 510(k) Premarket Notification Caresite Luer Access Device

INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE

The B. Braun Medical Inc. Caresite Luer Access Device (LAD) is substantially equivalent to the predicate device having similar indications for use, technological properties and performance.

Technical Characteristics

The Caresite Luer Access Device (LAD) has similar physical and technical characteristics to the predicate device. Both the Caresite Luer Access Device (LAD) and the predicate device are comprised of a body, piston and luer nut. Both devices are comprised of similar materials and components.

Performance Data

Biocompatibility and performance testing was performed on the Caresite Luer Access Device (LAD) to support substantial equivalence to the predicate device. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing was performed to demonstrate safety and effectiveness.

CONCLUSION

Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Caresite Luer Access Device (LAD) is considered substantially equivalent to the predicate device and is safe and effective for its intended use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol consists of a series of curved lines that form a shape reminiscent of a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2014

B. Braun Medical Incorporated Ms. Kimberly Smith Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, PA 18109

Re: K140311

Trade/Device Name: Caresite Luer Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 7, 2014 Received: February 7, 2014

Dear Ms. Smith:

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.

{3}------------------------------------------------

Page 2 - Ms. Smith

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 reporting (reporting of medical device-related adverse events) (2) 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 contact the Division of Industry and Consumer Education at its toll-lice number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/industry/default.htm. 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 Industry and Consumer Education 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,

Mary S. Runner -S

Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

Device Name

Caresite Luer Access Device

Indications for Use (Describe)

The Caresite Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of V fluids and blood upon insection of a male luer connector. The Carest Luer Access Device may be used with power injectors at a maximum presure of 400 psi and a maximum flow rate of 15 mL/sec.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Parl 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
	Digitally signed by
	Richard C. Chapman
	Date: 2014.05.06
	14:53:58 -04'00'
FORM FDA 3881 (1/14)		Page 1 of 2

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.