The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end.

A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.

The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap.

The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient.

The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.

AI/ML Overview

Here's an analysis of the provided text regarding the FlowEase Subcutaneous Infusion Set, focusing on the requested information:

Analysis of Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, specific acceptance criteria and detailed device performance studies (like those for an AI/ML medical device) are not explicitly described in the manner requested. This document is a traditional 510(k) premarket notification for a Class II medical device, an infusion set. For such devices, "acceptance criteria" are generally met through adherence to recognized standards, functional testing, and demonstrating substantial equivalence to predicate devices, rather than through performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML devices.

The document primarily focuses on demonstrating substantial equivalence to already cleared predicate devices.

Let's address each of your points based on the available information:

Table of Acceptance Criteria and Reported Device Performance

As noted above, specific performance metrics with acceptance criteria like sensitivity/specificity are not detailed here. The "performance" described is about meeting general functional and safety requirements through testing against established standards.

Acceptance Criteria (Implied)	Reported Device Performance
Functional performance	Verified through functional testing.
Biocompatibility	Verified through biocompatibility testing.
Safety	Verified through functional and biocompatibility testing.
Sterility	Provided Gamma sterilized.
Non-pyrogenic	Provided non-pyrogenic.
Risk Management	Conducts risk analysis according to ISO 14971:2007.
Substantial Equivalence	"Substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use."

Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. For a traditional medical device like an infusion set, "test set" and "data provenance" often refer to laboratory or bench testing on a certain number of devices, rather than a clinical dataset in the way an AI/ML study would define it. The document states "functional and biocompatibility testing" was done, but specific sample sizes and the nature/origin of the data are not detailed. It is highly likely this was bench/lab testing, not human subject data.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided and is generally not applicable to the type of device and submission method (traditional 510(k) for an infusion set) described. Ground truth as established by experts (e.g., radiologists) is typical for diagnostic AI devices, not for a physical device like an infusion set where performance is measured objectively against standards.
Adjudication Method for the Test Set

This information is not provided and is not applicable for this type of device and submission. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or expert review processes, which are not detailed as part of the "functional and biocompatibility testing" for this infusion set.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not mentioned. Such studies are relevant for diagnostic devices (especially imaging-based AI) to assess how AI assistance impacts human reader performance. This device is an infusion set, not a diagnostic tool.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.
The Type of Ground Truth Used

The "ground truth" for this device's performance relies on objective measurements from functional and biocompatibility testing performed against established standards (e.g., ISO standards for luer locks, tubing integrity, material compatibility). It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be. The overarching "ground truth" for regulatory clearance is "substantial equivalence" to predicate devices demonstrated through these tests.
The Sample Size for the Training Set

This information is not provided and is not applicable. This device is a physical medical product, not an AI/ML model that requires a training set.
How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable, as there is no "training set" for this physical device.

Summary of Device and Approval:

The FlowEase Subcutaneous Infusion Set is a single-use, disposable device for subcutaneous infusion of fluid medicines. It consists of a luer lock connector, tubing, a hub with wings, a 24-gauge stainless steel needle, an adhesive, a slide clamp, and a needle protector. It comes in 6mm, 9mm, and 12mm needle lengths. The device is Gamma sterilized and non-pyrogenic.

The submission is a traditional 510(k), and the primary method of demonstrating safety and effectiveness is through proving substantial equivalence to existing predicate devices (Baxter SUB-Q-Set, RMS Subcutaneous Needle Set, and Evans SubQ). This equivalence is asserted based on:

Similar intended use.
Similar technological characteristics.
Verification through functional and biocompatibility testing.
Adherence to risk analysis principles (ISO 14971:2007).

The FDA concurred with the substantial equivalence conclusion and cleared the device for market on June 29, 2012.

Summary

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Kızıфaz

Page 1 of 3 Section 5. 510(k) Summary

Traditional 510(k) Premarket Notification FlowEase [Subcuraneous| Infusion Set

5. 510(K) SUMMARY

JUN 2 9 2012

DATE SUMMARY PREPARED: 05 February 2012

OWNER:

CONTACT PERSON:

Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 Niedre M. Heckman, MS, MPH, RAC Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village. CA 91362 Telephone: 805-372-4096 Fax: 805-372-3042 Email: niedre_heckman @ baxter.com Trade Name:

DEVICE NAME:

FlowEase [Subcutaneous] Infusion Set IV Administration Set 21 CFR 880.5440, Set, Administration, Intravascular Class II FPA

Table 5-1. Predicate Devices

Common Name:

Classification:

Product Code:

Class:

Predicate510(k)	Device Name	Company	ClearanceDate
K925362	Baxter SUB-Q-Set® Subcutaneous InfusionSet	Baxter Healthcare Corporation	08/28/1993
K102512	RMS Subcutaneous Needle Set	Repro-Med Systems, Inc.	05/20/2011
K020530	Evans SubQ	Evans Medical Inc.	04/29/2002

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Traditional 510(k) Premarket Notification
FlowEase [Subcutaneous] Infusion Set

112409

Page 2 of 3 Section 5, 510(k) Summary

DEVICE DESCRIPTION:

FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines.

A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.

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K.121092

Traditional 510(k) Premarker Notification FlowEase (Subcutaneous) Infusion Set

Page 3 of 3 Section 5, 510(k) Summary

STATEMENT OF INTENDED USE: TECHNOLOGICAL CHARACTERISTICS:

ASSESSMENT OF NONCLINICAL DATA:

CONCLUSIONS:

Intended for the subcutaneous infusion of fluid medicines.

The FlowEase [Subcutancous] Infusion Set is substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use.

Baxter Healthcare Corporation conducts risk analysis according to the requirements of ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices.

Device performance and safety have been verified through functional and biocompatibility testing.

The FlowEase [Subcutaneous] Infusion Set is substantially equivalent to the predicate devices. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Niedre Heckman Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village, California 91362

JUN 2 9 2012

Re: K121092

Trade/Device Name: FlowEase Subcutaneous Infusion Set Regulation Number: 21 CFR 880,5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 6, 2012 Received: April 10, 2012

Dear Ms. Heckman:

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 (sec 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. Heckman

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 (OS) 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/ ucm 15809.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/MedicalDcvices/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/McdicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for the benefit of

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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KI2I\$\$92

Traditional SI0(k) Premarket Notification FlowEase (Subcutaneous) Infusion Set

Page I of I Section 4. Indications for Use

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

FlowEase [Subcutaneous] Infusion Set

Indication(s) for Use:

Intended for the subcutaneous infusion of fluid medicines.

D Prescription Use: 21 CFR 801 Subpart D

AND/OR

Over-the-Counter Use: T 21 CFR 801 Subpan C

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C Chapman 6/28/12

Page _ of

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

21092 510(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.