The SURFLASH® 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 shaft cover and tip 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. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.

Device Description

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 with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The devices are 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 (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. Whole length cannula including the sharp end of the inner needle is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. The grooved cannula which allows the clinician to visualize flashback detection through the groove indicating that there is confirmation of vessel entry is the same as the TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH™ I.V. Catheter (K991406).

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Test	Acceptance Criteria (Compliance to ISO Standard)	Reported Device Performance
Force to needle breaking shutter (Puncture resistance of needle shield)	ISO 23908	Conformed to ISO 23908
Tensile strength of needle shaft and needle housing (Break strength of safety mechanism)	ISO 23908	Conformed to ISO 23908
Force to release shutter and reactive force when the shutter opens to cover the cannula tip (Reaction force generated by the activation mechanism)	ISO 23908	Conformed to ISO 23908
Force to detach needle shaft cover from catheter hub (Force to activate safety feature)	ISO 23908	Conformed to ISO 23908
Burst pressure (whole device)	ISO 10555-1	Conformed to ISO 10555-1
Collapse (under negative pressure)	ISO 10555-1	Conformed to ISO 10555-1
Catheter to catheter hub tensile strength (Force at break of catheter / hub)	ISO 10555-1	Conformed to ISO 10555-1
Strength of union between transparent flash chamber (needle connecting part) and needle	ISO 10555-5	Conformed to ISO 10555-5
Detection of flashback at transparent flash chamber (needle connecting part)	ISO 10555-5	Conformed to ISO 10555-5
Flow rate	ISO 10555-5	Conformed to ISO 10555-5
Vent fitting	ISO 10555-5	Conformed to ISO 10555-5
Conical fittings of catheter hub	ISO 10555-1	Conformed to ISO 10555-1
Corrosion resistance	ISO 10555-1	Conformed to ISO 10555-1
Catheter body tensile strength (Force at break)	ISO 10555-1	Conformed to ISO 10555-1
Surface	ISO 10555-1	Conformed to ISO 10555-1
Catheter unit	ISO 10555-5	Conformed to ISO 10555-5
Needle point	ISO 10555-5	Conformed to ISO 10555-5
Simulated maximum pressure	Internal Standard	Conformed to internal standard
Needle attachment to catheter (Initial sliding friction)	Internal Standard	Conformed to internal standard
Detection of flashback at catheter tip	Internal Standard	Conformed to internal standard
Protector attachment (Drop test)	Internal Standard	Conformed to internal standard
Pressure monitoring	Internal Standard	Conformed to internal standard
Simulated use study	Internal Standard	All safety features activated effectively; no de-activations; participants could read IFU and operate device safely and effectively
Stiffness	Internal Standard	Conformed to internal standard
Elongation	Internal Standard	Conformed to internal standard
Flexural fatigue tolerance	Internal Standard	Conformed to internal standard
Radio-detectability	ISO 10555-5 (implied through "X" in column)	Conformed to ISO 10555-5
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Pyrogen, Genotoxicity, Implantation/Subchronic toxicity, Hemolysis, Physicochemical Characterization)	FDA G95-1 / ISO 10993	Biocompatible throughout shelf life

Study Proving Device Meets Acceptance Criteria:

A non-clinical performance testing study was conducted to demonstrate the safety and effectiveness of the SURFLASH® Safety I.V. Catheter, its conformity to applicable ISO standards, and substantial equivalence to predicate devices. This study included:

Compliance to ISO Standards: Tests were performed to confirm conformance with relevant parts of ISO 10555-1, ISO 10555-5, and ISO 23908, as detailed in the table above.
Testing by Internal Standard: Additional performance tests, not covered directly by the listed ISO standards, were conducted against internal standards.
Simulated Use Study: This study was conducted in accordance with FDA's Guidance For Industry and Staff, Medical Devices with Sharps Injury Prevention Features (August 9, 2005).

Detailed Information on the Study:

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for each individual test. However, the document mentions "study participants" for the simulated use study but does not quantify them. For other physical and material tests, a specific sample size is not provided, but it is implied that a sufficient number were tested to demonstrate compliance with standards.
Data Provenance: The tests were conducted internally by Terumo Medical Corporation and its Kofu Factory in Japan. The data is retrospective in the sense that it reflects tests completed for the premarket submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Simulated Use Study: Healthcare workers (implied to be experts or trained professionals in I.V. catheter use) were the "participants" in the simulated use study. The number of participants and their specific qualifications (e.g., years of experience) are not explicitly stated, but the intent was to verify proper activation by those who use such devices.
Physical/Material Tests: These tests rely on standardized methods and equipment, not expert consensus on individual cases. The "ground truth" for these tests is the quantitative measurement against defined ISO or internal standard thresholds.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

For the simulated use study, the "adjudication" was based on direct observation of whether "All safety features activated effectively and there were no de-activations after discarding" and if "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies direct observation and evaluation against predefined criteria, not a specific 2+1 or 3+1 expert consensus method.
For the physical and material tests, adjudication is based on whether the measured performance falls within the specified limits of the ISO standard or internal standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study mentioning AI was performed or reported. This device is a manual medical device (intravascular catheter with a passive safety feature), not an AI-assisted diagnostic or interpretative system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm or AI. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Physical/Material Tests: The ground truth is the objective measurement of physical properties and performance characteristics against established technical standards (ISO) and the manufacturer's internal specifications.
Simulated Use Study: The ground truth was based on the observable successful activation of the safety feature and the user's ability to follow instructions and operate the device effectively in a simulated environment. This represents a form of performance outcome directly observed.
Biocompatibility Tests: The ground truth for biocompatibility is whether the materials meet predefined safety criteria as per ISO 10993 and FDA G95-1, assessed through specific biological tests (e.g., cytotoxicity, sensitization, systemic toxicity).

8. The sample size for the training set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on engineering design, material properties, and physical testing.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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K12254"

5 2012 SEP

510(k) SUMMARY

Prepared by Sandi Hartka Manager Regulatory Affairs Terumo Medical Corporation Tel. 410 392-7243 Fax 410 398 6079

Date prepared : August 1, 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

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A. DEVICE NAME

Proprietary Name SURFLASH® 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

INTENDED USE B.

C. DEVICE DESCRIPTION (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.

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Design / Construction

The devices are 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 (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line.

Whole length cannula including the sharp end of the inner needle is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries.

The grooved cannula which allows the clinician to visualize flashback detection through the groove indicating that there is confirmation of vessel entry is the same as the TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH™ I.V. Catheter (K991406).

Material

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 catheter that is advanced into the vessel is made of polyurethane which is the same as the TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH™ I.V. Catheter (K991406).

Specifications

The SURFLASH™ Safety I.V. Catheter are available in 6 sizes with combination of 18, 20, 22 and 24 gauge catheters diameters and 19, 25 and 32 mm catheters length,

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D. NON-CLINICAL TESTS

Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Safety I.V. Catheter throughout the shelf life, to verify conformity to the applicable part of ISO standards and demonstrate substantial equivalence to the predicate devices as mentioned in the table on next pages.

No new issues of safety and effectiveness were raised with the testing performed. Performance testing demonstrates that the SURFLASH® Safety I.V. Catheter conforms to the recognized consensus ISO standards, is substantially equivalent to the predicate devices and acceptable for clinical use throughout the shelf life.

A simulated use study was conducted in accordance with FDA's Guidance For Industry and Staff, Medical Devices with Sharps Injury Prevention Features issued on August 9. 2005. The objectives of this study were designed to confirm that study participants are able to read and follow the Instructions for Use to safely and effectively operate the safety feature of the device. The objectives were:

1. Verify that proper activation of the sharps injury prevention feature of the device can be accomplished in simulated clinical environments by healthcare workers who use these types of Safety I.V. Catheters.
1. Determine if the Instructions for Use are adequate for proper activation of the sharps injury prevention feature.

All safety features activated effectively and there were no de-activations after discarding. All participants were able to read and activate the catheter safety feature without further explanation or training. No adverse events occurred.

Conclusion: The safety feature of the device operates safely and effectively as intended. Users with various levels of experience can read the IFU and operate the device safely and effectively.

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	Testing
Performance test	Compliance to ISO			Testing byinternalstandard
	ISO 10555-1	ISO 10555-5	ISO23908
Force to needle breaking shutter (Puncture resistance of needleshield)	Not required	Not required	X	Required byISO
Tensile strength of needle shaft and needle housing (Breakstrength of safety mechanism)	Not required	Not required	X	Required byISO
Force to release shutter and reactive force when the shutter opensto cover the cannula tip (Reaction force generated by theactivation mechanism)	Not required	Not required	X	Required byISO
Force to detach needle shaft cover from catheter hub (Force toactivate safety feature)	Not required	Not required	X	Required byISO
Simulated maximum pressure	Not required	Not required	Not required	X
Burst pressure ( whole device)	X	Not required	Not required	Required byISO
Collapse (under negative pressure)	X	Not required	Not required	Required byISO
Catheter to catheter hub tensile strength (Force at break ofcatheter / hub)	X	Not required	Not required	Required byISO
Strength of union between transparent flash chamber (needleconnecting part) and needle	Not required	X	Not required	Required byISO
Needle attachment to catheter (Initial sliding friction)	Not required	Not required	Not required	X
Detection of flashback at catheter tip	Not required	Not required	Not required	X
Detection of flashback at transparent flash chamber (needleconnecting part)	Not required	X	Not required	Required byISO
Flow rate	Not required	X	Not required	Required byISO
Vent fitting	Not required	X	Not required	Required byISO
Protector attachment (Drop test)	Not required	Not required	Not required	X
Conical fittings of catheter hub	X	Not required	Not required	Required byISO
Pressure monitoring	Not required	Not required	Not required	X
Simulated use study	Not required	Not required	Not required	X
Corrosion resistance	X	Not required	Not required	Required byISO
Catheter body tensile strength (Force at break)	X	Not required	Not required	Required byISO
Stiffness	Not required	Not required	Not required	X
Elongation	Not required	Not required	Not required	X
Flexural fatigue tolerance	Not required	Not required	Not required	X
Radio-detectatbility	Not required	X	Not required	Required byISO
Surface	X	Not required	Not required	Required byISO
Catheter unit	Not required	X	Not required	Required byISO
Needle point	Not required	X	Not required	Required byISO

X: Confirmed the conformance to the standard.

No deviations to recognized consensus ISO standards were identified in the recognized standards testing.

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The TERUMO SURFLASH Safety I.V Catheter is classified as

-Catheter and lubricant: Externally Communicating Device, Circulating Blood, Prolonged Exposure (24hrs - 30 days).

-All other materials contacting with patient's body: Externally Communicating Devices, Blood path indirect, Prolonged Exposure (24 hrs to 30 days)

As mentioned below table, the device's materials contacting with patient's body were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO - 10993, "Biological Evaluation of Medical Devices part 1: Evaluation and Testing." Screening tests were performed on accelerated aged whole devices to show that the biocompatibility is maintained throughout the shelf life of the product. Results of the testing demonstrate that the materials contacting with patient's body are biocompatible throughout the shelf life of the product.

Test
Cytotoxicity
Sensitization
Intracutaneous reactivity
Systemic toxicity (acute)
Pyrogen
Genotoxicity
Implantation / Subchronic toxicity
Hemolysis
Physicochemical
Characterization

ADDITIONAL SAFETY INFORMATION E.

The sterility of the device is assured using a sterilization method validated in accordance with Method C: Half-cycle method in Annex B of ANSIJA AMI/ISO 11135: Sterilization of health care products - ethylene oxide. The product is sterilized to provide a Sterility Assurance Level (SAL) of 10°.

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SUBSTANTIAL EQUIVALENCE F.

The SURFLASH® Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent to:

1. K100282 Surshield®-PUR Safety I.V. Catheter (Terumo Corporation)
1. K991406 SURFLASH® I.V. Catheter (Terumo Corporation)
BD Insyte 114 Autoguard™ shielded I.V. Catheter (Becton Dickinson) 3. K971339
Saf-T-Intima Closed IV Catheter System (Becton Dickinson) 4. K923702

Comparison of the intended use/indication for use statements and technological characteristics are summarized in the following pages.

The minor differences of intended use and the technological differences do not impact the safety and effectiveness of the device in clinical settings.

G. CONCLUSION

The SURFLASH® Safety I.V. Catheter is substantially equivalent to the predicate devices in intended use and technological characteristics.

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Terumo Corporation C/O Mr. Mark Job Regulatory Technology Services, Limited Liability Company 1394 25TH Street, North West Buffalo, Minnesota 55313

Re: K122544

Trade/Device Name: Surflash® Safety I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: August 20, 2012 Received: August 21, 2012

Dear Mr. Job:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

SEP 5 2012

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Page 2- Mr. Job

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

R. Sheli
Stam

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, 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 Form

Indications for Use

122544 510(k) Number (if known):

SURFLASH® Safety I.V. Catheter Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

510(k) Numb

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aldi Chape 9/4/2012

esthesiology, General Hospital

Page of

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).