(14 days)
No
The device description and performance studies focus on mechanical and passive safety features, with no mention of AI or ML.
Yes
The device is used to administer fluid intravenously and monitor blood pressure, which are therapeutic functions aimed at treating or managing a patient's condition.
No
The device is an I.V. catheter used for administering fluids, withdrawing blood samples, or monitoring blood pressure. It is not used for diagnosing medical conditions.
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, the SURFLASH® Plus Safety I.V. Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into the patient's vascular system for purposes like withdrawing blood samples, administering fluids, or monitoring blood pressure. These are direct interactions with the patient's body.
- Device Description: The description details a physical device designed for insertion into a blood vessel. It focuses on features related to insertion, fluid flow, and safety mechanisms for preventing needle sticks.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the SURFLASH® Plus Safety I.V. Catheter does not mention any such in vitro examination or analysis of specimens. While it can be used to withdraw blood samples, the device itself is not performing any diagnostic test on that sample.
Therefore, the SURFLASH® Plus Safety I.V. Catheter is a medical device used for accessing the vascular system, not an IVD.
N/A
Intended Use / Indications for Use
The SURFLASH® Plus 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
Terumo Corporation TERUMO® SURFLASH® Plus Safety I.V. Catheter 510k II. 510(k) Summary
510(k) SUMMARY
NOV 2 2012
Prepared by Sandi Hartka Manager Regulatory Affairs Terumo Medical Corporation Tel. 410 392-7243 Fax 410 398 6079
Date prepared : September 11, 2012
Prepared for : Owner/Operator
TERUMO CORP. 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo, JAPAN 151-0072 Registration Number: 8010026
Manufacturer and Sterilization Facility
KOFU FACTORY OF TERUMO CORP. 1727-1, Tsuijiarai, Showa-Cho Nakakoma-Gun, Yamanashi, JAPAN 409-3853 Registration Number: 9681835
Contact Person
SANDI HARTKA Regulatory Affairs Manager TERUMO MEDICAL CORP. 950 Elkton, Blvd. Elkton, MD 21921 Phone: 410 3927243 Ext Fax: 410 3986079 Sandi.hartka@terumomedical.com
1
erumo Corporation RUMO® SURFLASH® Plus Safety I.V. Catheter 510k II. 510(k) Summary
A. DEVICE NAME
Proprietary Name
SURFLASH® Plus Safety I.V. Catheter
Classification Name
Intravascular Catheter
Intravascular Catheter (880.5200) Product Code: FOZ Panel: General Hospital Classification: Class II
Common Name
Intravascular catheter with needle protection device
B. INTENDED USE
The SURFLASH® Plus Safety I.V. Catheter is inserted into the patient's vascular system for short term use (