(28 days)
No
The description focuses on the mechanical and passive safety features of the device, with no mention of AI or ML.
Yes
The device is used for administering fluids intravenously and withdrawing blood samples, which are therapeutic and diagnostic procedures.
No
The device is an I.V. catheter used for administering fluids, withdrawing blood samples, or monitoring blood pressure. It does not perform diagnostic functions but rather facilitates interventions or measurements.
No
The device description clearly outlines physical components like a catheter assembly, needle assembly, and a passive needle-shielding mechanism, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "insert into the patient's vascular system for short term use (
N/A
Intended Use / Indications for Use
The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (
§ 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
MAY 3 0 2014
510(k) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by: Phillip Michael Lester · Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079
Prepared for: Owner/Operator Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo, Japan 151-0072 Registration Number: 8010026
Manufacturer and Sterilization Facility
Kofu Factory of Terumo Corporation 1727-1, Tsuijiarai, Showa-Cho Nakakoma-Gun, Yamanashi, Japan 409-3853 Registration Number: 9681835
Contact Person: Phillip Michael Lester Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: philmichael.lester@terumomedical.com
Date prepared: May 1, 2014
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | SURFLASH® Safety I.V. Catheter |
|---|---|
| Common Name: | Intravascular Catheter |
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than |
| 30 Days | |
| Regulation Number: | 21 CFR 880.5200 |
| Regulatory Class: | II |
| Review Panel: | General Hospital |
| Product Code: | FOZ |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is the current device, SURFLASH® Safety I.V. Catheter (K122544), manufactured by Kofu Factory of Terumo Corporation.
D. REASON FOR 510(K) SUBMISSION
This Special 510(k) is being submitted due to a design modification to the previously cleared device to extend the range of product offering to include 14G and 16G catheters and a new length of 51 mm (2").
E. DEVICE DESCRIPTION (807.92(a)(4))
(SUMMARY OF TECHNOLOGICAL CHARACTERISTICS)
Principle of Operation/Technology
The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter.
Design/Construction
The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder).
The devices are an over-the needle, peripheral catheter made of a slender, flexible,
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radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."