The Dual Spike Transfer Device is a device containing two opposing spikes. Each spike contains a second lumen (adjacent to the spike). which facilitates direct flow of fluid/medication from one container (glass or flexible comainer) to another (glass or flexible container).

The proposed device is designed for, use by healthcare professionals during medication preparation, admixture, or fluid transfer. When the Dual Spike Transfer device is attached to the additive container, only air within the vial or flexible container is released into the recipient container. Once fluid transfer is complete, the transfer device attached to the additive container is discarded. This device is intended for admixture only.

The Dual Spike Transfer Device is individually packaged with two guards placed on each spike that provide protection to the spike ends of the device and prevent touch contamination.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Dual Spike Transfer Device." However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI or diagnostic device.

Here's why and what can be extracted from the document given its nature:

Nature of the Device: The Dual Spike Transfer Device is a fluid transfer device, not an AI or diagnostic tool. Its performance is assessed through safety and functional testing, not statistical metrics like sensitivity, specificity, or AUC, or a clinical study with human readers.
510(k) Process: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device. This often involves comparing technological characteristics, intended use, and performance testing to show that the new device is as safe and effective as the legally marketed predicate. It's not typically a full-scale clinical trial with complex statistical analysis.

Given these points, I will extract what is available regarding performance testing and interpret the "acceptance criteria" in the context of a 510(k) for a physical transfer device.

Acceptance Criteria and Study for the Dual Spike Transfer Device

Based on the provided 510(k) summary, the "acceptance criteria" for the Dual Spike Transfer Device are implicitly met by demonstrating its safety and functional performance, and by demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the safety and functional testing conducted.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance
Material & Component Safety: Similar to predicate device.	Manufactured from similar materials and components as the predicate.
Sterility & Non-pyrogenicity: Similar to predicate device.	Sterile and non-pyrogenic.
Functionality (Fluid Transfer): Direct transfer of fluids/medications between rubber-stoppered containers, and to/from flexible containers.	Designed for direct transfer. Performance testing conducted to support design and intended use, including transfer to/from flexible containers.
Spike Protection: Protection against damage and touch contamination.	Individually packaged with two guards on each spike for protection.
Single Use & Disposable: Designed for one-time use.	Disposable, single-use.
No New Issues of Safety or Efficacy: Differences from predicate do not raise new concerns.	Results of testing show that differences between the proposed device and the predicate do not raise new issues of safety or efficacy.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size used for the safety and functional testing. It only states "Safety and functional testing were conducted."
Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by B. Braun Medical Inc. It would be prospective testing on manufactured devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable to this type of device and submission. The "ground truth" for a fluid transfer device's function is its physical ability to perform the transfer without leaks, contamination, or damage. This is assessed through engineering and quality control testing, not expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert opinions, typically in diagnostic imaging studies. The performance of this physical device is determined by objective functional and safety tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist them. The Dual Spike Transfer Device is a mechanical fluid transfer device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through objective engineering and safety testing against predefined specifications for:
- Material compatibility
- Sterility
- Fluid transfer efficiency and integrity (no leaks, proper flow)
- Spike integrity and protection mechanisms
- Biocompatibility (implied by material safety and non-pyrogenicity)
It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no training set for this type of device.

Summary

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B. Braun Medical Inc. 510(k) Premarket Notification Dual Spike Transfer Device

K128150

5. 510(k) SUMMARY

DATE:

SUBMITTER:

May 18, 2012

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

Dual Spike Transfer Device

Fluid Transfer Device

21 CFR 8880.5440

flexible container).

Contact: Bonnie J. Kincaid Phone: (610) 596-2970 (610) 266-4962 Fax: E-mail: bonnie kincaid(a)bbraun.com

DEVICE NAME:

COMMON OR USUAL NAME:

DEVICE CLASSIFICATION:

PREDICATE DEVICES:

DESCRIPTION:

MAY 2 4 2012

The Dual Spike Transfer Device is a device containing two opposing spikes. Each spike contains a second lumen (adjacent to the spike). which facilitates direct flow of fluid/medication from

one container (glass or flexible comainer) to another (glass or

B. Braun Medical Inc.'s IV Fluid Transfer Pin, K925401, LHI,

Class II, per 21 CFR §880.5440, Product Code: LHI

The Dual Spike Transfer Device is individually packaged with two guards placed on each spike that provide protection to the spike ends of the device and prevent touch contamination.

INTENDED USE:

For the direct transfer of fluids/medications from one rubberstoppered contamer to another.

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B. Braun Medical Inc. 519(k) Premarket Notification Dual Spike Transfer Device

SUBSTANTIAL EQUIVALENCE:

A single predicate, the IV Fluid Transfer Pin, was used for comparison with the proposed device. The Dual Spike Transfer Device has an intended use similar to the IV Fluid Transfer Pin. Both devices are used in admixture programs and they are not intended for direct patient administration. Each of these molded devices has a piercing spike designed for spiking a rubber stopper and a flange to assist in spiking. The spike ends are siliconized and capped by vented molded guards to protect the spike end from damage or touch containination. The proposed device and the predicate are manufactured in a similar process from similar matcrials and components. They are both sterile, non-pyrogenic, disposable, single use, individually packaged, fluid transfer devices.

While each device is designed for spiking a rubber stopper, the IV Fluid, Transfer Device is also intended to be luer connected to a syringe or other luer compatible container for subsequent transfer Direct transfer to or from rubber stoppered to a container. containers to or from a flexible container can be achieved with the use of the proposed device. Therefore, performance testing has been conducted to support the design and intended use of the device.

CONCLUSION:

Safety and functional testing were conducted on the Dual Spike Transfer Device to demonstrate that the performance of the device and the safety of its materials and components. Results of this testing show that differences between the proposed device and the predicate do not raise new issues of safety or efficacy.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is often associated with healthcare and medicine.

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

Ms. Bonnie J. Kincaid Manager, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

2 4 2012 MAY

Re: K120150

Trade/Device Name: Dual Spike Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: May 18, 2012 Received: May 21, 2012

Dear Ms. Kincaid:

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. Kincaid

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) (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

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B. Braun Medical Inc.
510(k) Premarket Notification Dual Spike Transfer Device

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	Page 1 of 1
510(k) Number (if known):
Device Name:	Dual Spike Transfer Device

Indications For Use:

The Dual Spike Transfer Device is intended for the direct transfer of fluid/medication from one rubber-stoppered container to another.

Prescription Use (Per 21 CFR 801.109)	X OR Over-The-Counter Use
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	120150
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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.