The TERUMO® Surshield®-PUR SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The needle-shield feature 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 Description

The TERUMO Surshield-PUR Safety I.V. Catheters are devices consisting of 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 use (<30 days) to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from the catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

AI/ML Overview

The provided text is a 510(k) Summary for the TERUMO Surshield-PUR Safety I.V. Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment (which are common for AI/ML device submissions) are not present in this K100282 document.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing was conducted in accordance with the consensus standards and design control requirements. All performance testing conducted on the TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., minimum flow rate, maximum needle stick rate, specific tensile strength values) and the reported device performance against those criteria are not explicitly listed in the provided summary. The summary focuses on stating that the device met whatever criteria were used to establish substantial equivalence.

Missing:

Specific numerical acceptance criteria for various performance metrics.
Quantifiable reported performance data for the device against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "test set" sample sizes, as it doesn't describe a typical diagnostic performance study. It mentions the catheter's types and specifications but not a test set for performance evaluation in the context of diagnostic accuracy.

Missing:

Sample size for any test set.
Data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

As this is a medical device (intravascular catheter) and not a diagnostic device relying on image interpretation or similar expert-dependent outputs, there's no mention of experts establishing a "ground truth" for a test set. Evaluation would typically involve engineers and biocompatibility specialists, not clinical experts for ground truth in the AI/ML sense.

Missing:

Number of experts.
Qualifications of experts.

4. Adjudication Method for the Test Set

Since there's no mention of experts or a "test set" in the context of diagnostic ground truth, there is no adjudication method described.

Missing:

Adjudication method (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI. This is a medical device (catheter) and does not involve human readers interpreting cases.

Missing:

Information on MRMC study.
Effect size of human readers improvement with AI.

6. Standalone (Algorithm Only) Performance

This concept is not applicable to an intravascular catheter, which is a physical device, not an algorithm.

Missing:

Information on standalone performance.

7. Type of Ground Truth Used

For an intrusive medical device like a catheter, "ground truth" would relate to its physical and biological performance (e.g., integrity, biocompatibility, flow rates, ease of insertion, safety mechanism activation). These are established through engineering tests, material analysis, and possibly bench and animal testing, rather than "expert consensus" on diagnostic cases or pathology. The document indicates that testing was "in accordance with the consensus standards and design control requirements." This implies standards for device performance, not clinical ground truth in the diagnostic sense.

Partial Answer:

Type of Ground Truth: Established by adherence to "consensus standards and design control requirements" for physical, mechanical, and safety performance of the catheter. This would involve objective measurements and tests for criteria such as flow rate, cannula strength, safety mechanism activation, etc.
Missing: Specific details of these ground truth determinations per standard.

8. Sample Size for the Training Set

The concept of a "training set" is for AI/ML models. This device is a physical product, not an AI/ML model, so there is no training set.

Missing:

Sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

Similarly, this is not applicable for a physical medical device.

Missing:

How ground truth for the training set was established.

In summary, the K100282 document focuses on demonstrating substantial equivalence of a physical medical device (intravascular catheter) to existing predicate devices. It states that performance testing was done according to standards, but does not provide granular details about specific acceptance criteria or performance results, nor does it involve the type of diagnostic study (with test sets, ground truth panels, and AI/ML metrics) that would typically be associated with the requested information points.

Summary

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K100282

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 theTERUMO Surshield-PUR Safety I.V. Catheter	18

00015

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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)

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-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 (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shield feature 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.

Principle of Operation / Technology IC.

The TERUMO Surshield-PUR Safety I.V. Catheter is operated manually.

Design / Materials F.

The design of the TERUMO Surshield-PUR Safety I.V. Catheter and the materials used to manufacture the TERUMO Surshield-PUR Safety I.V. Catheter are identical to the currently marketed TERUMO Surshield Safety I.V. Catheter (K082362 and K090973) except for the catheter portion. Polyurethane is the catheter material used in the manufacture of the currently marketed TERUMO Surflash I.V. Catheter (K991406) and TERUMO Hybria Closed System Safety I.V. Catheter (K082997). The catheter gauge,

11:14

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length and diameter ranges are all within the range of the currently marketed predicate devices.

G. Specifications

TABLE II-1: Device Specifications for TERUMO Surshield -PUR Safety I.V. Catheter
Product code	Cathetergauge	Color code	Catheter length	CatheterO.D*(I.D)	Flow rate	Lumenvolume*
SR*SFF1832A	18G	Deep Green	1-1/4""(32mm)	1.3 (0.95) mm	100mL/min	23µL
SR*SFF1851A	18G	Deep Green	2"(51mm)	1.3 (0.95) mm	90mL/min	36µL
SR*SFF2025A	20G	Pink	1""(25mm)	1.1(0.80)mm	65mL/min	13µL
SR*SFF2032A	20G	Pink	1-1/4""(32mm)	1.1(0.80)mm	60mL/min	16µL
SR*SFF2051A	20G	Pink	2"(51mm)	1.1(0.80)mm	55mL/min	26µL
SR*SFF2225A	22G	Deep blue	1""(25mm)	0.9(0.60)mm	35mL/min	7µL
SR*SFF2232A	22G	Deep blue	1-1/4""(32mm)	0.9 (0.60)mm	30mL/min	9µL
SR*SFF2419A	24G	Yellow	3/4"(19mm)	0.7(0.47)mm	15mL/min	3µL

Product code numbers and specifications are provided in Table II-1.

*Catheter O.D. is labeled value. * * Catheter only

ਜ਼. Performance

Performance testing was conducted in accordance with the consensus standards and design control requirements. All performance testing conducted on the TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate devices.

Substantial Equivalence I.

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Polyurethane catheter material

-K991406 TERUMO Surflash I.V. Catheter

AND

. .

ું

-K082997 TERUMO Hybria Closed System Safety I.V. Catheter

Ethylene Tetrafluoro Ethylene catheter material

-K082362 TERUMO Surshield Safety I.V. Catheter

AND

-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.

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

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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.

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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

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Indications for Use

510(k) Number (if known):

Device Name: _________ TERUMO® Surshield®-PUR SAFETY I.V. CATHETER

Indications For Use:

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)

Charles R. Bogle

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number. K100282

: ਉପଡିଓଡ଼ି

Regulation Number and Section

§ 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).