(25 days)
Not Found
No
The summary describes a mechanical medical device (I.V. catheter) with a passive safety mechanism and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used for withdrawing blood samples, administering fluids, or monitoring blood pressure, which are diagnostic or supportive functions rather than direct therapeutic treatment.
No
The device is described as an I.V. catheter for administering fluids, withdrawing blood samples, or monitoring blood pressure, which are therapeutic or monitoring functions, not diagnostic ones.
No
The device description clearly outlines a physical medical device (catheter, needle, hub, guard) intended for insertion into the vascular system. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be inserted into the patient's vascular system for direct interaction with the body (withdrawing blood, administering fluids, monitoring blood pressure). This is a direct medical intervention, not a test performed in vitro (outside the body) on a sample.
- Device Description: The description details a physical device inserted into the body, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is used inside the body for therapeutic and monitoring purposes.
N/A
Intended Use / Indications for Use
The TERUMO® Surshield®-PUR 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
Section II: 510(k) Summary FEB 2 6 2010
Page
| A. | Device Name | 16 |
|---|---|---|
| B. | Predicate Device | 16 |
| C. | Intended Use | 17 |
| D. | Description | 17 |
| E. | Principle of Operation / Technology | 17 |
| F. | Design / Materials | 17 |
| G. | Specifications | 18 |
| H. | Performance | 18 |
| I. | Substantial Equivalence | 18 |
| J. | Submitter Information | 19 |
| List of Tables | ||
| Table II-1: Device Specifications for the | ||
| TERUMO Surshield-PUR Safety I.V. Catheter | 18 |
00015
1
Device Name A.
Proprietary Name
TERUMO Surshield-PUR Safety I.V. Catheter
Classification Name
Intravascular Catheter (880.5200)
Panel & Product Code: 80FOZ
Classification: Class II
Common Name
Intravascular catheter with needle protection device
B. Predicate Device
The TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent with respect to intended use, safety mechanism, design, materials, manufacturing, sterilization, technology/principles of operation, and performance to the following:
Polyurethane catheter material
-K991406 TERUMO Surflash I.V. Catheter
AND
-K082997 TERUMO Hybria Closed System Safety I.V. Catheter
Ethylene Terafluoro Ethylene catheter material
-K082362 TERUMO Surshield Safety I.V. Catheter
AND
1 A statement of substantially equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used a evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits' 42 Fed. Reg. 42,520, et seq. (1977)
2
-K090973 TERUMO Surshield Safety I.V. Catheter (51mm catheter
length)
The differences between the devices do not raise any new issues of safety or effectiveness.
C. Intended Use
The TERUMO Surshield-PUR Safety I.V. Catheter is inserted into the patient's vascular system for short term use ( Phone: (410) 392-7241 Fax: (410) 398-6079
Submitter Information J.
01/28/2010 Date Prepared:
Christina Flanagan Prepared by: Regulatory Affairs Specialist ﻨﺪ Terumo Medical Corporation . 950 Elkton Boulevard .' ··· Elkton, MD 21921
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
MAR 2 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Terumo Corporation C/O Ms. Christina Flanagan Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921
Re: K100282
Trade/Device Name: TERUMO® Surshield® -PUR SAFETY I.V. CATHETER Regulation Number: 211CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 28, 2010 Received: February 01, 2010
Dear Ms. Flanagan:
This letter corrects our substantially equivalent letter of February 26, 2010.
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 (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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2- Ms. Flanagan
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthsiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: _________ TERUMO® Surshield®-PUR SAFETY I.V. CATHETER
Indications For Use:
The TERUMO® Surshield®-PUR SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (