(230 days)
Not Found
No
The summary describes a standard I.V. catheter and does not mention any AI or ML components or functionalities.
No
The device is used to access the vascular system for diagnostics (blood sampling, blood pressure monitoring) or administration of fluids, rather than for directly treating a disease or condition.
No
The device is used to withdraw blood samples, administer fluids, or monitor blood pressure, which are functions related to treatment and data collection, not diagnosis. It does not analyze data or provide diagnostic information.
No
The device description clearly states it is a physical catheter assembly and needle assembly, which are hardware components, not software.
Based on the provided information, the TERUMO® SURFLO® I.V. Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is inserted into the patient's vascular system for purposes like withdrawing blood samples, monitoring blood pressure, or administering fluids intravenously. These are all procedures performed on the patient's body, not on samples outside the body.
- Device Description: The description details a physical device (catheter, needle, etc.) designed for insertion into the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed for direct interaction with the patient's vascular system.
N/A
Intended Use / Indications for Use
TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The TERUMO® SURFLO® I.V. Catheter is manually operated.
The SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter).
The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (
§ 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).
0
K133280
JUN 1 2 2014
510(k) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
: TERUMO (PHILIPPINES) CORPORATION Prepared for 124 East Main Avenue, Laguna Technopark, Binan, Laguna,Philippines
Prepared by : Ma. Cristina Faderagao - Supervisor, Regulatory Affairs Tel. (+63) 49 541 2111 Fax (+63) 49 541 2121
Date prepared : September 26, 2013
Contact Person : Phillip Michael Lester
Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Phone#: (410)392-7321 Fax#: (410)398-6079 E-mail: philmichael.lester@terumomedical.com
1
B. DEVICE NAME (807.92(a)(2))
Proprietary Name
TERUMO® SURFLO® I.V. Catheter or similar proprietary name
Classification Name
Intravascular Catheter (880.5200)
Product Code: FOZ
Panel: General Hospital
Classification: Class II
Common Name
Intravascular catheter
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is the TERUMO® SURFLO® I.V. Catheter (K891087), manufactured by Terumo Medical Corporation, Elkton, Maryland.
D. REASON FOR 510(K) SUBMISSION
This premarket notification (510(k)) is being submitted for the TERUMO® SURFLO® I.V. Catheter, an intravascular device, manufactured by Terumo (Philippines) Corporation, as a new device.
E. INTENDED USE (807.92(a)(5))
TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.
Note: This intended use is substantially equivalent to the predicate device, TERUMO® SURFLO® I.V. Catheter (K891087).
2
F. DEVICE DESCRIPTION (807.92(a)(4))
(Summary of Technological Characteristics)
Principle of Operation and Technology
The TERUMO® SURFLO® I.V. Catheter is manually operated.
Design/Construction
The SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter).
The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term ( Performance testing other than to the above ISO Standards was also performed on the device. The device complies with the acceptance criteria for each test:
| Performance Test | Results |
|---|---|
| Cannula and needle hub fitting force | Meets acceptance criteria |
| Catheter tube and catheter hub fitting force | Meets acceptance criteria |
| Catheter tube and catheter hub leakage | Meets acceptance criteria |
| Catheter tube and needle fitting force | Meets acceptance criteria |
| Flashback | Meets acceptance criteria |
| Needle and needle hub leakage | Meets acceptance criteria |
| Needle heel and catheter tip distance | Meets acceptance criteria |
| Needle penetration | Meets acceptance criteria |
Biocompatibility
The TERUMO® SURFLO® I.V. Catheter is classified as:
- -Catheter and lubricant: Externally Communicating Device, Circulating Blood, Prolonged Exposure (24 hours to 30 days):
- Cannula with lubricant: Externally Communicating Device, Circulating -Blood, Short Term ( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by Richard C. Chapman -S Date: 2014.06.12 11:24:54 -04'00'
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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