TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
Device Facts
| Record ID | K082997 |
|---|---|
| Device Name | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER |
| Applicant | Terumo Medical Corp. |
| Product Code | FOZ · General Hospital |
| Decision Date | Apr 15, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Intended Use
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 Story
Peripheral intravascular catheter system for short-term vascular access. Device consists of flexible radio-opaque catheter, integrated extension tubing with Y or I adaptor (needleless access port/filter cap), one-touch clamp, and passive needle-shielding mechanism. Operated manually by clinicians in clinical settings. Closed system design prevents blood exposure during insertion; needle withdrawal through a septum wipes blood from needle; ports remain closed. Provides secure access for fluid infusion, blood sampling, or pressure monitoring. Needle shield and needleless access port reduce risk of needle stick injuries. Benefits include clinician/patient protection from bloodborne pathogens and reduced exposure during catheterization.
Clinical Evidence
Bench testing and simulated use studies performed to demonstrate substantial equivalence. No clinical data provided.
Technological Characteristics
Peripheral IV catheter; materials same as K991406. Features: extension tubing, Y/I adaptor, needleless access port, one-touch clamp, passive needle-shielding mechanism. Biocompatibility per ISO 10993. Sterilization via ethylene oxide per ISO 11135-2007; SAL 10^-6. Manual operation.
Indications for Use
Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling, intravenous fluid administration, or blood pressure monitoring. Use depends on vascular anatomy, solution appropriateness, and therapy duration.
Regulatory Classification
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.
Predicate Devices
- TERUMO® SURFLASH® I.V. Catheter (K991406)
- Becton Dickinson Saf-T-Intima Closed I.V. Catheter System (K923702)
- Becton Dickinson Nexiva Closed IV Catheter System (K032843)
Related Devices
- K160374 — 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System · Tangent Medical Technologies, Inc. · Mar 11, 2016
- K213085 — Introcan Safety 3 Closed IV Catheter · B.Braun Medical, Inc. · Oct 25, 2021
- K182870 — Introcan Safety 3 Closed IV Catheter · B.Braun Medical, Inc. · Mar 7, 2019
- K102520 — BD NEXIVA CLOSED IV CATHETER SYSTEM · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 6, 2011
- K163358 — Introcan Safety 3 Closed IV Catheter · B.Braun Melsungen AG · Apr 28, 2017
Submission Summary (Full Text)
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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
- 2. K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System
- 3. 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
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.
### Description D.
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.
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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
| Catheter<br>gauge | Color code | Product code | Catheter length | Catheter O.D | Catheter I.D | Cannula gauge | Tube length |
|-------------------|------------|-------------------------------------------------------------------------|-----------------|--------------|--------------|---------------|-------------|
| 18G | Deep Green | HY*W1832SD2<br>HY*W1832FD2<br>HY*W1832CD2<br>HY*W1832ED2<br>HY*W1832GD2 | 1-1/4"(32mm) | 1.3mm | 0.95mm | 20G | |
| 20G | Pink | HY*W2032SD2<br>HY*W2032FD2<br>HY*W2032CD2<br>HY*W2032ED2<br>HY*W2032GD2 | 1-1/4"(32mm) | 1.1mm | 0.80mm | 22G | 150mm |
| 22G | Deep Blue | HY*W2225SD2<br>HY*W2225FD2<br>HY*W2225CD2<br>HY*W2225ED2<br>HY*W2225GD2 | 1"(25mm) | 0.9mm | 0.60mm | 24G | |
| 24G | Yellow | HY*W2419SD2<br>HY*W2419FD2<br>HY*W2419CD2<br>HY*W2419ED2<br>HY*W2419GD2 | 3/4"(19mm) | 0.7mm | 0.47mm | 27G | |
| 18G | Deep Green | HY*S1832SD2<br>HY*S1832FD2<br>HY*S1832CD2<br>HY*S1832ED2<br>HY*S1832GD2 | 1-1/4"(32mm) | 1.3mm | 0.95mm | 20G | |
| 20G | Pink | HY*S2032SD2<br>HY*S2032FD2<br>HY*S2032CD2<br>HY*S2032ED2<br>HY*S2032GD2 | 1-1/4"(32mm) | 1.1mm | 0.80mm | 22G | 150mm |
| 22G | Deep Blue | HY*S2225SD2<br>HY*S2225FD2<br>HY*S2225CD2 | 1"(25mm) | 0.9mm | 0.60mm | 24G | |
Revised 3/30/0
K082997 p. 4 of 9
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| Catheter<br>gauge | Color code | Product code | Catheter length | Catheter O.D | Catheter I.D | Cannula gauge | Tube length |
|-------------------|------------|-------------------------------------------------------------------------------------------------------|-----------------|--------------|--------------|---------------|-------------|
| 24G | Yellow | HY*S2225ED2<br>HY*S2225GD2<br>HY*S2419SD2<br>HY*S2419FD2<br>HY*S2419CD2<br>HY*S2419ED2<br>HY*S2419GD2 | 3/4"(19mm) | 0.7mm | 0.47mm | 27G | |
| 18G | Deep Green | HY*N1832SD2<br>HY*N1832FD2<br>HY*N1832CD2<br>HY*N1832ED2<br>HY*N1832GD2 | 1-1/4"(32mm) | 1.3mm | 0.95mm | 20G | |
| 20G | Pink | HY*N2032SD2<br>HY*N2032FD2<br>HY*N2032CD2<br>HY*N2032ED2<br>HY*N2032GD2 | 1-1/4"(32mm) | 1.1mm | 0.80mm | 22G | 150mm |
| 22G | Deep Blue | HY*N2225SD2<br>HY*N2225FD2<br>HY*N2225CD2<br>HY*N2225ED2<br>HY*N2225GD2 | 1"(25mm) | 0.9mm | 0.60mm | 24G | |
| 24G | Yellow | HY*N2419SD2<br>HY*N2419FD2<br>HY*N2419CD2<br>HY*N2419ED2 | 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 |
| Catheter<br>gauge | Product code | Tube<br>O.D | Tube<br>I.D | adaptor | Connector | Wing | Flow rate | Priming<br>volume | Lumen<br>volume |
|-------------------|--------------|-------------|-------------|---------|---------------------------------------|----------------|-----------|-------------------|-----------------|
| 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 | 3.30<br>mm | 2.10<br>mm | Y | Needleless access port×1、Filter cap×1 | Large<br>Wing | 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 | 3.30<br>mm | 2.10<br>mm | | Needleless access port | Small<br>Wing | 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 | |
| Catheter<br>gauge | Product code | Tube<br>O.D | Tube<br>I.D | adaptor | Connector | Wing | Flow rate | Priming<br>volume | Lumen<br>volume |
| | 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-w<br>inged | 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
- 2. 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:
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.
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
