The TERUMO Hybria Closed System Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shield feature and the needleless access port aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Device Description

The TERUMO® Hybria™ Closed System Safety I.V. Catheter is a device consisting of an over-the needle, peripheral intravascular catheter made of a slender, flexible, radio-opaque, plastic catheter, integrated extension tubing with a Y or I adaptor (needleless access port and/or filter cap available) and one touch clamp, and a passive needle-shielding mechanism.

The design of the TERUMO® Hybria™ Safety I.V. catheter can be described as a closed system since it protects clinicians and patients from blood exposure during the catheter insertion procedures. Since the needle is withdrawn through a septum that seals after the needle has been removed and ports of the Y or I adapter attached to pre-connected tubing to the IV catheter are closed, blood remains within the TERUMO® Hybria™ Safety I.V. catheter during catheter insertion.

The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The one touch clamp on the integrated extension tubing is provided to minimize blood exposure when connecting with an infusion set.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TERUMO® Hybria™ Closed System Safety I.V. Catheter. This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or a performance table in the typical sense of a clinical or analytical study. Instead, it relies on demonstrating that the new device's specifications (dimensions, flow rates, etc.) are comparable to its predicate devices, implying that if the predicates met their performance criteria, this device would as well. The provided tables (pages 4-6) list the physical specifications of various configurations of the Terumo Hybria catheter, including gauge, length, outer diameter, inner diameter, cannula gauge, tube length, tube OD/ID, adaptor type, connector type, wing type, flow rate, priming volume, and lumen volume. These are design specifications, not performance criteria with associated pass/fail thresholds.

For example, a "flow rate" is listed, but there's no defined acceptance criterion like "Flow rate must be ±X% of predicate device" or "Flow rate must exceed Y ml/min for Z application."

Therefore, a table of explicit acceptance criteria and corresponding performance cannot be constructed from this document. The "performance" assessment is described as "bench tests and simulated use study" which demonstrated "substantial equivalence."

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

The document does not specify the sample sizes used for the "bench tests and simulated use study." It also does not explicitly state the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that it's a 510(k) for a device with a physical function, these studies would typically be conducted in a laboratory setting.

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

This information is not provided in the document. For a physical device like an IV catheter, "ground truth" often refers to engineering specifications, established testing standards, or performance in simulated use protocols rather than expert clinical consensus on an output like image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies where human interpretation of data is being assessed, such as medical imaging. For a physical device, testing against predefined engineering specifications is more common.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or mentioned in this document. MRMC studies are generally relevant for evaluating the impact of AI algorithms or diagnostic tools on human reader performance, which is not applicable to a physical medical device like an IV catheter.

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

No, this question is not applicable as the device is a physical IV catheter and not an algorithm or AI system.

7. The Type of Ground Truth Used

The types of "ground truth" implicitly used for this device would be:

Engineering Specifications: The design parameters (e.g., catheter gauge, length, flow rate) listed in the tables are the 'ground truth' for manufacturing.
Performance Standards: The "bench tests and simulated use study" would have been conducted against established performance standards for IV catheters, likely related to patency, insertion force, flow continuity, and the integrity of the needle safety mechanism.
Biocompatibility Standards: Biocompatibility was evaluated in accordance with ISO 10993-1, which provides the 'ground truth' for material safety. Sterility was validated according to ISO 11135-2007, and EtO residuals to ISO 10993-7.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical IV catheter and not an AI/algorithm that requires a training set.

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

This question is not applicable as the device is a physical IV catheter and not an AI/algorithm that requires a training set.

Summary of the Study and Evidence Presented:

The study described is a set of "bench tests and simulated use study" ([7]) conducted on the TERUMO® Hybria™ Closed System Safety I.V. Catheter. The purpose of these tests was to demonstrate substantial equivalence to predicate devices. This means the study aimed to show that the new device performs comparably to devices already on the market (K991406 TERUMO® SURFLASH® I.V. Catheter, K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System, K032843 Becton Dickinson Nexiva Closed IV Catheter System) in terms of intended use, design, technology/principles of operation, materials, and performance.

Specific details about the methodology, sample sizes, or outcome thresholds for these bench and simulated-use tests are not provided in this 510(k) summary. The document relies on the assertion that these tests were performed and demonstrated equivalence, alongside adherence to relevant ISO standards for biocompatibility and sterilization. The core argument for acceptance is the demonstrated equivalence to already approved devices, indicating that the new device does not raise "any new issues of safety or effectiveness."

Summary

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K082997 p.1 of 9

APR 1 5 2009

Section II. 510(k) SUMMARY

Device Name A.

Proprietary Name

TERUMO® Hybria™ Closed System Safety I.V. Catheter or similar proprietary name

Classification Name

Intravascular Catheter (880.5200) Panel & Product Code: FOZ Classification: Class II

Common Name

Intravascular catheter with needle protection device

Predicate Device B.

The TERUMO® Hybria™ Closed System Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent with respect to intended use, design, technology/principles of operation, materials and performance to the following:

1. K991406 TERUMO® SURFLASH® I.V. Catheter
1. K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System
1. K032843 Becton Dickinson Nexiva Closed IV Catheter System

The differences between the devices do not raise any new issues of safety or effectiveness.

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f2997 f. 2 of 19

C. Intended Use

Description D.

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K082997 p. 3 of 29

Principle of Operation / Technology E.

The TERUMO® Hybria™ Closed System Safety I.V. Catheter is operated manually.

Design / Materials F.

The materials of catheter and needle on the TERUMO® Hybria™ Closed System Safety I.V. Catheter are the same materials as used in the TERUMO® SURFLASH® I.V. Catheter (K991406). The Hybria™ Closed System Safety I.V. Catheter consists of extension tubing with a Y or I adaptor (needleless access port and/or filter cap available), one touch clamp, and a passive needle-shielding mechanism. The biocompatibility of blood contacting materials were evaluated in accordance with the tests recommended in the FDA General Program Memorandum #95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

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Specification

Cathetergauge	Color code	Product code	Catheter length	Catheter O.D	Catheter I.D	Cannula gauge	Tube length
18G	Deep Green	HYW1832SD2HYW1832FD2HYW1832CD2HYW1832ED2HY*W1832GD2	1-1/4"(32mm)	1.3mm	0.95mm	20G
20G	Pink	HYW2032SD2HYW2032FD2HYW2032CD2HYW2032ED2HY*W2032GD2	1-1/4"(32mm)	1.1mm	0.80mm	22G	150mm
22G	Deep Blue	HYW2225SD2HYW2225FD2HYW2225CD2HYW2225ED2HY*W2225GD2	1"(25mm)	0.9mm	0.60mm	24G
24G	Yellow	HYW2419SD2HYW2419FD2HYW2419CD2HYW2419ED2HY*W2419GD2	3/4"(19mm)	0.7mm	0.47mm	27G
18G	Deep Green	HYS1832SD2HYS1832FD2HYS1832CD2HYS1832ED2HY*S1832GD2	1-1/4"(32mm)	1.3mm	0.95mm	20G
20G	Pink	HYS2032SD2HYS2032FD2HYS2032CD2HYS2032ED2HY*S2032GD2	1-1/4"(32mm)	1.1mm	0.80mm	22G	150mm
22G	Deep Blue	HYS2225SD2HYS2225FD2HY*S2225CD2	1"(25mm)	0.9mm	0.60mm	24G

Revised 3/30/0

K082997 p. 4 of 9

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Cathetergauge	Color code	Product code	Catheter length	Catheter O.D	Catheter I.D	Cannula gauge	Tube length
24G	Yellow	HYS2225ED2HYS2225GD2HYS2419SD2HYS2419FD2HYS2419CD2HYS2419ED2HY*S2419GD2	3/4"(19mm)	0.7mm	0.47mm	27G
18G	Deep Green	HYN1832SD2HYN1832FD2HYN1832CD2HYN1832ED2HY*N1832GD2	1-1/4"(32mm)	1.3mm	0.95mm	20G
20G	Pink	HYN2032SD2HYN2032FD2HYN2032CD2HYN2032ED2HY*N2032GD2	1-1/4"(32mm)	1.1mm	0.80mm	22G	150mm
22G	Deep Blue	HYN2225SD2HYN2225FD2HYN2225CD2HYN2225ED2HY*N2225GD2	1"(25mm)	0.9mm	0.60mm	24G
24G	Yellow	HYN2419SD2HYN2419FD2HYN2419CD2HYN2419ED2	3/4"(19mm)	0.7mm	0.47mm	27G

Catalysis O.D.S. is a silica-based adsorbent. It is indicated for laboratory use.

K082997 p.5 of 9

: 00028

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Terumo Corporation
TERUMO® Hybria™ Closed System Safety I.V. Catheter
II. 510(k) Summary

Cathetergauge	Product code	TubeO.D	TubeI.D	adaptor	Connector	Wing	Flow rate	Primingvolume	Lumenvolume
18G	HY*W1832SD2			I	Needleless access port		58 ml/min	0.8 ml	23μl
	HY*W1832FD2			I	Filter cap		68 ml/min	0.9 ml
	HY*W1832CD2				Protector cap		68 ml/min	0.8 ml
	HY*W1832ED2			Y	Needleless access port×2		58 ml/min	1.2 ml
	HY*W1832GD2			Y	Needleless access port×1、Filter cap×1		58 ml/min	1.3 ml
20G	HY*W2032SD2				Needleless access port		47 ml/min	0.8 ml
	HY*W2032FD2			I	Filter cap		50 ml/min	0.9 ml
	HY*W2032CD2				Protector cap		50 ml/min	0.7 ml	16μl
	HY*W2032ED2			Y	Needleless access port×2		47 ml/min	1.2 ml
	HY*W2032GD2	3.30mm	2.10mm	Y	Needleless access port×1、Filter cap×1	LargeWing	47 ml/min	1.3 ml
22G	HY*W2225SD2				Needleless access port		30 ml/min	0.8 ml
	HY*W2225FD2			I	Filter cap		30 ml/min	0.9 ml	7μl
	HY*W2225CD2				Protector cap		30 ml/min	0.7 ml
	HY*W2225ED2			Y	Needleless access port×2		30 ml/min	1.2 ml
	HY*W2225GD2			Y	Needleless access port×1、Filter cap×1		30 ml/min	1.3 ml
24G	HY*W2419SD2				Needleless access port		16 ml/min	0.8 ml
	HY*W2419FD2			I	Filter cap		16 ml/min	0.9 ml
	HY*W2419CD2				Protector cap		16 ml/min	0.7 ml	3μl
	HY*W2419ED2			Y	Needleless access port×2		16 ml/min	1.1 ml
	HY*W2419GD2			Y	Needleless access port×1、Filter cap×1		16 ml/min	1.3 ml
18G	HY*S1832SD2				Needleless access port		58 ml/min	0.8 ml
	HY*S1832FD2			I	Filter cap		68 ml/min	0.9 ml	23μl
	HY*S1832CD2				Protector cap		68 ml/min	0.8 ml
	HY*S1832ED2			Y	Needleless access port×2		58 ml/min	1.2 ml
	HY*S1832GD2			Y	Needleless access port×1、Filter cap×1		58 ml/min	1.3 ml
20G	HY*S2032SD2	3.30mm	2.10mm		Needleless access port	SmallWing	47 ml/min	0.8 ml
	HY*S2032FD2			I	Filter cap		50 ml/min	0.9 ml	16μl
	HY*S2032CD2				Protector cap		50 ml/min	0.7 ml
	HY*S2032ED2			Y	Needleless access port×2		47 ml/min	1.2 ml
	HY*S2032GD2			Y	Needleless access port×1、Filter cap×1		47 ml/min	1.3 ml
22G	HY*S2225SD2				Needleless access port		30 ml/min	0.8 ml
	HY*S2225FD2			I	Filter cap		30 ml/min	0.9 ml	7μl
	HY*S2225CD2				Protector cap		30 ml/min	0.7 ml
Cathetergauge	Product code	TubeO.D	TubeI.D	adaptor	Connector	Wing	Flow rate	Primingvolume	Lumenvolume
	HY*S2225ED2			Y	Needleless access port×2		30 ml/min	1.2 ml	3μl
	HY*S2225GD2			Y	Needleless access port×1、Filter cap×1		30 ml/min	1.3 ml
24G	HY*S2419SD2			I	Needleless access port		16 ml/min	0.8 ml
	HY*S2419FD2			I	Filter cap		16 ml/min	0.9 ml
	HY*S2419CD2				Protector cap		16 ml/min	0.7 ml
	HY*S2419ED2			Y	Needleless access port×2		16 ml/min	1.1 ml
	HY*S2419GD2			Y	Needleless access port×1、Filter cap×1		16 ml/min	1.3 ml
	HY*N1832SD2			I	Needleless access port		58 ml/min	0.8 ml
	HY*N1832FD2			I	Filter cap		68 ml/min	0.9 ml
8G	HY*N1832CD2				Protector cap		68 ml/min	0.8 ml	23μl
	HY*N1832ED2			Y	Needleless access port×2		58 ml/min	1.2 ml
	HY*N1832GD2			Y	Needleless access port×1、Filter cap×1		58 ml/min	1.3 ml
	HY*N2032SD2			I	Needleless access port		47 ml/min	0.8 ml
	HY*N2032FD2			I	Filter cap		50 ml/min	0.9 ml
20G	HY*N2032CD2				Protector cap		50 ml/min	0.7 ml	16μl
	HY*N2032ED2			Y	Needleless access port×2		47 ml/min	1.2 ml
	HY*N2032GD2	3.30 mm	2.10 mm	Y	Needleless access port×1、Filter cap×1	Non-winged	47 ml/min	1.3 ml
	HY*N2225SD2			I	Needleless access port		30 ml/min	0.8 ml
	HY*N2225FD2			I	Filter cap		30 ml/min	0.9 ml
22G	HY*N2225CD2				Protector cap		30 ml/min	0.7 ml	7μl
	HY*N2225ED2			Y	Needleless access port×2		30 ml/min	1.2 ml
	HY*N2225GD2			Y	Needleless access port×1、Filter cap×1		30 ml/min	1.3 ml
	HY*N2419SD2			I	Needleless access port		16 ml/min	0.8ml
	HY*N2419FD2			I	Filter cap		16 ml/min	0.9 ml
24G	HY*N2419CD2				Protector cap		16 ml/min	0.7 ml	3μl
	HY*N2419ED2			Y	Needleless access port×2		16 ml/min	1.1 ml
	HY*N2419GD2			Y	Needleless access port×1、Filter cap×1		16 ml/min	1.3 ml

Revised 3/30/0

K082997 p. 6 of 9

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.. .

. ...

Note: Flow rate, priming volume, and lumen volume are specific

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s2997 p. 8 of 9

Performance H.

The bench tests and simulated use study were performed on the TERUMO® Hybria™ Closed System Safety I.V. Catheter manufactured by Terumo Corporation to demonstrate substantial equivalence of the subject device to the predicate devices.

Additional Safety Information I.

The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135-2007. The TERUMO® Hybria™ Closed System Safety I.V. Catheter is sterilized to provide a Sterility Assurance Level (SAL) of 10-8

Ethylene oxide residual levels (EtO and ECH) resulting from EtO sterilization will not exceed the maximum residue limits in accordance with ISO 10993-7: Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals and AAMI TIR19 Guidance for ANSI / AAMI / ISO 10993-7:1995, Biological Evaluation for Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (and amendment).

The addition of the safety devices requires no additional biocompatibility testing, because there is no blood/fluid contact.

Substantial Equivalence J.

The TERUMO® HybriaTM Closed System Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance:

1. K991406 TERUMO® SURFLASH® I.V. Catheter
1. K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System

The differences between the devices do not raise any new issues of safety or effectiveness.

Revised 3/30/09

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K082997 p. 9 of 9

K. Submitter Information

Date Prepared: 9/30/2008

Prepared by: Eileen Dorsey Regulatory Affairs Specialist Terumo Medical Corporation 950 Blue Ball Road Elkton, MD 21921 Phone: (410) 392-7241 Fax: (410) 398-6079

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2009

Terumo Medical Corporation C/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K082997

Trade/Device Name: TERUMO® Hybria™ Closed System Safety I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulatory Class: II Product Code: FOZ Dated: April 1, 2009 Received: April 2, 2009

Dear Mr. Job:

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 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.

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Page 2- Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Anthony V. Arthur An

Susan Runner, D.D.S., MA 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

510(k) Number (if known):

Device Name: TERUMO® Hybria™ Closed System Safety I.V. Catheter

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ching Branch Chie LCDR. Scott Colburn 04/15/09

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

510(k) Number: Ko82997

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).