The 20 mm Vial Fluid Transfer Adapter is a sterile, single use fluid transfer device. The 20 mm Vial Fluid Transfer Adapter is composed of a flexible PVC twist-off cap, PVC tubing, a polycarbonate large bore male luer lock, polycarbonate/LDPE piercing pin, and an inline air filter assembly. The PVC components do not contain DEHP. Components will be solvent bonded to assemble the device. The finished device will be packed and sterilized.

AI/ML Overview

The provided text describes the 510(k) summary for the "20 mm Vial Fluid Transfer Adapter". It focuses on the device's substantial equivalence to a predicate device and its functional performance and material safety, rather than providing details of a study with acceptance criteria in the typical format of an AI/algorithm-based diagnostic device (which would include metrics like sensitivity, specificity, AUC).

This device is a physical medical device (a fluid transfer adapter), not an AI/algorithm. Therefore, many of the requested categories related to AI/algorithm performance studies (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity) are not applicable.

Here's an attempt to extract and reframe the information based on the provided text, focusing on the available details:

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

Acceptance Criteria Category	Specific Criteria (from text)	Reported Device Performance (from text)
Functional Performance	- Pass visual inspection	"All functional performance testing...met the acceptance criteria." "This testing demonstrates that the 20 mm Vial Fluid Transfer Adapter functions as intended." "Functional performance testing...demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device."
	- Meet occlusion requirements
	- Meet pressure requirements
	- Meet pull requirements
	- Meet insertion requirements
	- Meet retention requirements
Biocompatibility	- Material safety demonstrated through biocompatibility testing	"The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria." "Material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device."
Chemical Safety	- Material safety demonstrated through chemical testing	"The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria." "Material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device." The PVC components do not contain DEHP.
Substantial Equivalence	- No new issues of safety or effectiveness compared to the predicate device (IV Fluid Transfer Pin, B. Braun Medical Inc, K925401) through biocompatibility, chemical, and functional testing.	"The 20 mm Vial Fluid Transfer Adapter has a similar intended use and is comprised of components similar to the IV Fluid Transfer Pin (K925401). Both products have a plastic spike used to access the source container and withdraw IV fluid. Biocompatibility, chemical and functional testing have been completed to verify that there are no differences between the proposed device and the predicate device which raise new issues of safety or effectiveness." "...performs similarly to the predicate device."

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

Sample Size: The document does not specify the sample size for the functional, biocompatibility, or chemical testing. It only states that "testing has been executed in the test laboratory."
Data Provenance: Not specified, but implied to be from internal laboratory testing ("in the test laboratory"). This would be prospective for the purpose of the submission.

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)

Not applicable/mentioned. This is for a physical device, and the "ground truth" for functional tests would be based on engineering specifications and direct measurement, not expert medical opinion.

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

Not applicable/mentioned. This concept is for diagnostic interpretation, not functional testing of a physical device.

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 is for a physical medical device, not an AI/algorithm or diagnostic aid.

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

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

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

The "ground truth" for this physical device would be based on engineering specifications, physical/mechanical standards (e.g., for pressure, pull force), and established methods for biocompatibility and chemical safety testing. It's not based on medical pathology or expert consensus on diagnosis.

8. The sample size for the training set

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

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

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

Summary

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K 100640

5. 510(k) SUMMARY

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500
	Contact: Matthew J. HomaSr. Regulatory Affairs AnalystPhone: (610) 596-2558Fax: (610) 266-4962E-mail: matthew.homa@bbraun.com

JUL 22 2010

DATE:	May 17, 2010
DEVICE NAME:	20 mm Vial Fluid Transfer Adapter
COMMON ORUSUAL NAME:	Set, I.V. Fluid Transfer
DEVICECLASSIFICATION:	Class II, Product Code LHI, 21 CFR $880.5440
PREDICATE DEVICE:	IV Fluid Transfer Pin, B. Braun Medical Inc, K925401, ClassII, LHI and 21 CFR §880.5440.
DESCRIPTION:	The 20 mm Vial Fluid Transfer Adapter is a sterile, single usefluid transfer device. The 20 mm Vial Fluid Transfer Adapteris composed of a flexible PVC twist-off cap, PVC tubing, apolycarbonate large bore male luer lock, polycarbonate/LDPEpiercing pin, and an inline air filter assembly. The PVCcomponents do not contain DEHP. Components will besolvent bonded to assemble the device. The finished devicewill be packed and sterilized.
INTENDED USE:	The 20 mm Vial Fluid Transfer Adapter is intended for use intransferring IV fluids/medication from a 20 mm drug vial to anIV fluid administration device.
SUBSTANTIALEQUIVALENCE:	The 20 mm Vial Fluid Transfer Adapter has a similar intendeduse and is comprised of components similar to the IV FluidTransfer Pin (K925401). Both products have a plastic spikeused to access the source container and withdraw IV fluid.Biocompatibility, chemical and functional testing have beencompleted to verify that there are no differences between the

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proposed device and the predicate device which raise new issues of safety or effectiveness.

Transfer Adapter is both safe and effective and performs

NONCLINICAL Non clinical testing of the proposed device was conducted to TESTING: demonstrate safety and effective and substantial equivalence to the predicate device. To verify that the design characteristics and input requirements of the 20 mm Vial Fluid Transfer Adapter are appropriate for the intended use and user requirements, functional performance testing has been executed in the test laboratory. This testing demonstrates that the 20 mm Vial Fluid Transfer Adapter functions as intended. Testing conducted included visual inspection, occlusion, pressure, pull, insertion and retention. The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria. CONCLUSION: Functional performance testing and material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid

similarly to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Mr. Matthew J. Homa Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18196-3941

JUL 2-2 2010

Re: K100640

Trade/Device Name: 20 mm Vial Fluid Transfer Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 16, 2010 Received: July 19, 2010

Dear Mr. Homa:

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 - Mr. Homa

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 vours.

hh for

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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B. Braun Medical Inc. 510(k) Premarket Notification 20 mm Vial Fluid Transfer Adapter

4. INDICATIONS FOR USE STATEMENT

Page _________ of ____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name:

20 mm Vial Fluid Transfer Adapter

Indications For Use:

For use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device.

Prescription Use X (Per 21 CFR 801.109)

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)

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

:10(k) Number: _______________________________________________________________________________________________________________________________________________________________

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.