The BAXJECT II Hi-Flow Needleless Transfer Device is a double-sided needleless transfer device designed for transferring and mixing of drugs contained in two vials into a syringe.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the BAXJECT II Hi-Flow Needleless Transfer Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the way a PMA (Pre-Market Approval) or a de novo submission would.

Therefore, many of the typical questions regarding acceptance criteria, study design, expert ground truth, and multi-reader multi-case studies are not directly applicable or are addressed through different means in a 510(k).

Here's an analysis of the provided information in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, primarily through technological characteristics, performance, and intended use. There isn't a table of specific numerical performance metrics and their corresponding acceptance criteria as there would be for a novel device or a device requiring clinical efficacy data.

Instead, the submission indicates:

Acceptance Criterion (Primary Focus in 510(k))	Reported Device Performance
Substantial Equivalence to Predicate Device	The device is substantially equivalent to the predicate devices (BAXJECT II Needleless Transfer Device, K042410, and Needleless Transfer Device, K001831) with regard to technological characteristics, performance, and intended use.
Safety and Effectiveness	Testing against established standards and guidelines for its intended use demonstrated that the proposed device is as safe and effective as the predicate device.
Risk Management (ISO 14971:2007)	Baxter Healthcare Corporation conducts risk analysis according to ISO 14971:2007.
Material/Sterilization Standards	The device continues to meet the same material testing standards and sterilization process standards as the predicate devices.
Functional and Biocompatibility Testing	Device verification testing of performance has been verified through functional and biocompatibility testing.

Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Device verification testing of performance has been verified through functional and biocompatibility testing." This, coupled with the assertion of meeting "established standards and guidelines," forms the basis of the substantial equivalence claim. Specific details of these tests (e.g., specific protocols, results, statistical analyses) are not provided in the summary documents, as they are typically part of the more extensive 510(k) submission.

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

This document does not specify a "test set" in the context of a clinical study or a labeled dataset for AI. The verification testing mentioned (functional and biocompatibility) would have involved a sample of the manufactured devices. The specific sample sizes for these engineering and lab tests are not detailed in this summary. The data provenance is internal to Baxter Healthcare Corporation, based on their testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for this type of submission. Ground truth, in the context of clinical expert consensus, is not relevant for demonstrating substantial equivalence for a needleless transfer device. The "ground truth" here is compliance with engineering standards and performance specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for establishing expert ground truth for medical image interpretation or similar tasks. This device's evaluation is based on engineering and performance testing.

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 not an AI-powered diagnostic or assistive tool for human readers. It's a physical medical device for drug transfer.

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

Not applicable. This submission is not for an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's evaluation would be defined by:

Engineering Specifications and Standards: The device's performance (e.g., flow rate, sealing integrity, absence of leakage, material compatibility) meeting predetermined technical specifications and industry standards.
Biocompatibility Standards: The materials used in the device meeting established biocompatibility requirements to ensure safety for patient contact.
Sterilization Standards: The device meeting sterility assurance levels.

8. The Sample Size for the Training Set

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

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

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

Summary

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Traditional 510(k) Premarket Notification BAXJECT II Hi-Flow Needleless Transfer Device

Section 5, 510(k) Summary

OCT 3 0 2009 DEVICE DESCRIPTION: The BAXJECT II Hi-Flow Needleless Transfer Device is a double-sided needleless transfer device designed for transferring and mixing of drugs contained in two vials into a syringe. STATEMENT OF The BAXJECT II Hi-Flow Needleless Transfer Device is INTENDED USE: intended for transferring and mixing of drugs contained in two vials into a syringe. The BAXJECT II Hi-Flow Needleless Transfer Device is TECHNOLOGICAL CHARACTERISTICS: substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use. ASSESSMENT OF Baxter Healthcare Corporation conducts risk analysis NONCLINICAL according to the requirements of ISO 14971:2007 Medical DATA: Devices-Application of Risk Management to Medical Devices. The device continues to meet the same material testing standards and sterilization process standards as the predicate devices. Device verification testing of performance has been verified through functional and biocompatibility testing. CONCLUSIONS: The BAXJECT II Hi-Flow Needleless Transfer Device is substantially equivalent to the predicate device. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate device.

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Traditional 510(k) Premarket Notification BAXJECT II Hi-Flow Needleless Transfer Device Section 5, 510(k) Summary

5. 510(k) SUMMARY
DATE:	July 20, 2009
OWNER	Baxter Healthcare CorporationOne Baxter ParkwayDeerfield, IL 60015
CONTACT PERSON:	Valerie FollowellManager, Global Regulatory Affairs1620 Waukegan Road, MPGR-ALMcGaw Park, IL 60085Telephone: 847-270-4375Fax: 847-785-5116Email: valerie_followell@baxter.com
DEVICE NAME:	Trade name: BAXJECT II Hi-FlowCommon name: Needleless Transfer Device Set, IV Fluid TransferClassification: Intravascular administration set, Vial adapterClass: Class IIProduct Code: LHI

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PREDICATE DEVICE(S):

Previously cleared 510(k) for Baxter Healthcare Corporation, BAXJECT II Needleless Transfer Device

Predicate510(k)	DeviceName	Indication	Clearance date	Company
K042410	BAXJECT IINeedleless TransferDevice	Transfer and mixing ofdrugs contained in two vialsinto a syringe	10/08/2004	BaxterHealthcareCorporation
K001831	Needleless TransferDevice	Transfer and mixing ofdrugs contained in two vialsinto a syringe	07/11/2000	MediMopMedical Products

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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 consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Baxter Healthcare Corporation C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

OCT 3 0 2009

Re: K092318

Trade/Device Name: BAXJECT II Hi-Flow Needleless Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 15, 2009 Received: October 16, 2009

Dear Mr. Devine:

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 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. Devine

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Antrim Co. Antrim

Susan Runner, D.D.S., M.A. Acting 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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INDICATIONS FOR USE STATEMENT

K092318 510(k) Number (if known):

Device Name:

BAXJECT II Hi-Flow Needleless Transfer Device

Indication(s) for Use:

The BAXJECT II Hi-Flow Needleless Transfer Device is intended for transferring and mixing of drugs contained in two vials into a syringe.

Prescription Use: ি

AND/OR

Over-the-Counter Use: I 21 CFR 801 Subpart C

21 CFR 801 Subpart D

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antti O. Niemi

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

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510(k) Number: 15492318

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.