(14 days)
The SURFLASH® Plus 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.
The SURFLASH® Plus Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. The devices consist of catheter assembly (catheter, caulking pin and catheter hub containing valve, seal component and plug), 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 SURFLASH® Plus Safety I.V. Catheter has a valve and a seal component inside the catheter hub to minimize the possibility of blood leakage at catheter hub after needle removal. The catheter hub is also provided with a plug inside which penetrates the valve to create a fluid path when a connector is inserted in the catheter hub. The fluid path is permanently opened once a secure luer connection is made. 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cannula including the sharp end of the inner needle is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries.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). The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system.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).
The provided text is a 510(k) summary for the Terumo SURFLASH® Plus Safety I.V. Catheter. It outlines the device's description, intended use, non-clinical tests, and substantial equivalence to predicate devices. However, it does not describe an AI/ML-based medical device. Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.
To directly answer your request, here's what can be extracted from the document regarding the device (the I.V. catheter) meeting its intended performance, even though it's not an AI/ML device:
1. A table of acceptance criteria and the reported device performance:
The document states that "Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Plus 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." It also lists various performance tests conducted.
| Performance Test (Acceptance Criteria Implicitly Met if "X" is checked) | Compliance to ISO 10555-1 | Compliance to ISO 10555-5 | Compliance to ISO 23908 | Testing by Internal Standard (Required by ISO) | Reported Device Performance (Implied "Meets Criteria") |
|---|---|---|---|---|---|
| Force to needle breaking shutter (Puncture resistance of needle shield) | Not required | Not required | X | Required by ISO | Effectively activated. |
| Tensile strength of needle shaft and needle housing (Break strength of safety mechanism) | Not required | Not required | X | Required by ISO | Verified satisfactory. |
| Force to release shutter and reactive force when the shutter opens to cover the cannula tip (Reaction force generated by the activation mechanism) | Not required | Not required | Not required | X | Verified satisfactory. |
| Force to detach needle shaft cover from catheter hub (Force to activate safety feature) | Not required | Not required | X | Required by ISO | All safety features activated effectively. |
| Simulated maximum pressure | Not required | Not required | Not required | X | Verified satisfactory. |
| Burst pressure (whole device) | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Collapse (under negative pressure) | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Catheter to catheter hub tensile strength (Force at break of catheter / hub) | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Strength of union between transparent flash chamber (needle connecting part) and needle | Not required | X | Not required | Required by ISO | Verified satisfactory. |
| Needle attachment to catheter (Initial sliding friction) | Not required | Not required | Not required | X | Verified satisfactory. |
| Detection of flashback at catheter tip | Not required | Not required | Not required | X | Verified satisfactory. |
| Detection of flashback at transparent flash chamber (needle connecting part) | Not required | X | Not required | Required by ISO | Verified satisfactory. |
| Flow rate | Not required | X | Not required | Required by ISO | Verified satisfactory. |
| Vent fitting | Not required | X | Not required | Required by ISO | Verified satisfactory. |
| Protector attachment (Drop test) | Not required | Not required | Not required | X | Verified satisfactory. |
| Conical fittings of catheter hub | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Pressure monitoring | Not required | Not required | Not required | X | Verified satisfactory. |
| Blood leakage at catheter hub | Not required | Not required | Not required | X | Verified satisfactory (Minimized by design). |
| Measurement of valve penetration resistance to catheter hub | Not required | Not required | Not required | X | Verified satisfactory. |
| Simulated use study | Not required | Not required | X | Required by ISO | All safety features activated effectively; no de-activations after discarding; users operated safely and effectively. |
| Corrosion resistance | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Catheter body tensile strength (Force at break) | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Stiffness | Not required | Not required | Not required | X | Verified satisfactory. |
| Elongation | Not required | Not required | Not required | X | Verified satisfactory. |
| Flexural fatigue tolerance | Not required | Not required | Not required | X | Verified satisfactory. |
| Radio-detectability | Not required | X | Not required | Required by ISO | Verified satisfactory. |
| Surface | X | Not required | Not required | Required by ISO | Verified satisfactory. |
| Catheter unit | Not required | X | Not required | Required by ISO | Verified satisfactory. |
| Needle point | Not required | X | Not required | Required by ISO | Verified satisfactory. |
2. Sample size used for the test set and the data provenance:
- Simulated Use Study: "study participants" (number not specified). "Healthcare workers who use these types of safety I.V. catheters."
- Other Performance Tests: Sample sizes are not explicitly stated for the enumerated tests (e.g., burst pressure, tensile strength).
- Data Provenance: The tests were conducted by Terumo Corporation, presumably within their facilities or via third-party labs on their behalf. The country of origin of the data is not specified beyond the manufacturer's location in Japan, with regulatory affairs in the US. The studies are prospective as they are tests performed on the device to demonstrate conformity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and therefore not provided in the document as this is a physical medical device, not an AI/ML-based device requiring expert annotation for ground truth. For the simulated use study, "healthcare workers who use these types of safety I.V. catheters" were participants, but their role was to evaluate usability and safety activation, not to establish a "ground truth" in the AI/ML sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable in the context of a physical device's performance testing. The simulated use study reported that "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies a very high level of consistent success, not requiring an adjudication method.
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:
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device. The "simulated use study" evaluates the human-device interaction, confirming the safety feature's activation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety function, the "ground truth" is the successful activation of the sharps injury prevention feature and prevention of needle stick injuries during simulated use. This is determined by observation of the device's physical function and user interaction. For other performance tests, the "ground truth" is the established engineering and materials standards (ISO standards and internal standards) for the properties being measured.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
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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
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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 (<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.
C. DEVICE DESCRIPTION (SUMMARY OF TECHNOLOGICAL CHARACTERISTICS)
Principle of Operation/Technology
The SURFLASH® Plus 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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Terumo Corporation TERUMO® SURFLASH® Plus Safety I.V. Catheter 510k II. 510(k) Summary
Design / Construction
The SURFLASH® Plus Safety I.V. Catheter are devices consisting of catheter assembly (catheter, caulking pin and catheter hub containing valve, seal component and plug), 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 SURFLASH® Plus Safety I.V. Catheter has a valve and a seal component inside the catheter hub to minimize the possibility of blood leakage at catheter hub after needle removal. The catheter hub is also provided with a plug inside which penetrates the valve to create a fluid path when a connector is inserted in the catheter hub. The fluid path is permanently opened once a secure luer connection is made.
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).
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Specifications
The SURFLASH® Plus 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.
D. NON-CLINICAL TESTS
Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Plus 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® Plus Safety 1.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:
-
- 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.
-
- 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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Terumo Corporation TERUMO® SURFLASH® Plus Safety I.V. Catheter Response to Comments dated September 20, 2012
Attachment 2
| Performance test | Testing | |||
|---|---|---|---|---|
| Compliance to ISO | ||||
| ISO 10555-1 | ISO 10555-5 | ISO 23908 | Testing byinternalstandard | |
| Force to needle breaking shutter (Puncture resistance of needleshield) | Not required | Not required | X | Required bySO |
| 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 shutteropens to cover the cannula tip (Reaction force generated by theactivation mechanism) | Not required | Not required | Not required | X |
| 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 |
| Blood leakage at catheter hub | Not required | Not required | Not required | X |
| Measurement of valve penetration resistance to catheter hub | Not required | Not required | Not required | X |
| Simulated use study | Not required | Not required | X | Required byISO |
| 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.
. "
Image /page/4/Picture/4 description: The image shows the numbers 00015 written on top of 00000. The numbers are handwritten and appear to be written with a thick marker. The numbers are aligned vertically, with the ones place aligned on the right.
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The SURFLASH® Plus 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 |
E. ADDITIONAL SAFETY INFORMATION
The sterility of the device is assured using a sterilization method validated in accordance with Method C: Half-cycle method in Annex B of ANSI/AAMI/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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F. SUBSTANTIAL EQUIVALENCE
The SURFLASH® Plus Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent to:
-
- K100282 TERUMO® Surshield®-PUR Safety I.V. Catheter (Terumo Corporation)
- TERUMO® SURFLASH® I.V. Catheter (Terumo Corporation) 2. K991406
- BD Insyte Autoguard BC shielded I.V. Catheter (Becton Dickinson) 3. K110443
- BD Insyte TM Autoguard TM shielded I.V. Catheter (Becton Dickinson) 4. 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® Plus Safety I.V. Catheter is substantially equivalent to the predicate devices in intended use and technological characteristics.
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Terumo Corporation
TERUMO® SURFLASH® Plus Safety I.V. Catheter 5
II. 510(k) Summary
omparison of Intended Use/Indications for Use statements
SURFLASH® Plus Safety I.V. Cather intentions for use statements are different from those of the predicate devices as below.
| FLASH®Plusafety I.V.eter (subjectis 510k) | TERUMO®Surshield®-PUR Safety I.V.Catheter | TERUMO®SURFLASH®I.V. CatheterK991406 | BD InsyteAutoguard BCshielded I.V.CatheterK110443 | BD InsyteAutoguardshieldedI.V.CatheterK971339 | BD Saf-T-IntimaClosed I.V.Catheter SystemK923702 | |
|---|---|---|---|---|---|---|
| K100282 | Is a device consisting of aslender, flexible,radiopaque, plasticcatheter with hub.The stainless steel cannula,placed in the catheter tomaintain rigidity,is withdrawn after thecatheter is placed in thevascular system. | The deviceconsists of aslender, flexible,radiopaque, plasticcatheter with ahub... (see belowsection)The steel needle(stylet) placed inthe catheter tomaintain rigidity iswithdrawn after | ||||
| SummarySection | SURFLASH®PlusSafety I.V.Catheter (subjectof this 510k) | TERUMO®Surshield®-PUR Safety I.V.CatheterK100282 | TERUMO®SURFLASH®I.V. CatheterK991406 | BD InsyteAutoguard BCshielded I.V.CatheterK110443 | BD InsyteAutoguardshieldedI.V.CatheterK971339 | BD Saf-T-IntimaClosed I.V.Catheter SystemK923702 |
| II | Inserted intopatient's vascularsystem for shortterm use (<30days) to withdrawblood samples,administer fluidintravenously, ormonitor bloodpressure byattaching amonitoring device | Inserted into thepatient's vascularsystem for shortterm use (<30days) towithdraw bloodsamples,administer fluidintravenously, ormonitor bloodpressure byattaching amonitoring line. | The plastic catheter isinserted into the patient'svascular system for shortterm use to withdrawsamples, administer fluidintravenously or throughwhich to place monitoringequipment such as pressuremonitors. | The BD InsyteAutoguard BCcatheter isinserted into apatient'svascular systemto sample blood,monitor bloodpressure, oradministerfluids. | As indicated in21CFR 870.1200,to sample blood,to monitor bloodpressure, or tointroducesubstances intothe heart andvessels. | the catheter isplaced in thevascular system...that is insertedinto the patient'svascular systemfor short-term useto sample blood,monitor bloodpressure, oradminister fluidsintravenously. |
| SectionSummary | SURFLASH®PlusSafety I.V.Catheter (subjectof this 510k) | TERUMO®Surshield®-PUR Safety I.V.CatheterK100282 | TERUMO®SURFLASH®I.V. CatheterK991406 | BD InsyteAutoguard BCshielded I.V.CatheterK110443 | BD InsyteAutoguardshieldedI.V.CatheterK971339the classification thatapplies to the proposeddevice and the predicatedevices in this subject510k. | BD Saf-T-IntimaClosed I.V.Catheter SystemK923702 |
| The needle shaftcover & tip shieldfeature aids in theprevention ofneedle stickinjuries | The needle shieldfeature aids in theprevention ofneedle stickinjuries. | |||||
| These cathetersmay be used forany patientpopulation withconsideration give | These cathetersmay be used forany patientpopulation withconsideration | These cathetersmay be used forany patientpopulation withconsideration give | ||||
| AI | ||||||
| ASH®Plus | TERUMO®Surshield®(subject to 510k) | TERUMO®-PUR Safety I.V.CatheterK100282 | TERUMO®SURFLASH® | BD InsyteAutoguard BCshielded I.V.CatheterK110443 | BD InsyteAutoguardshieldedI.V.CatheterK971339 | BD Saf-T-IntimaClosed I.V.Catheter SystemK923702 |
| given toadequacy ofanatomy | to patient size,appropriatenessfor the solutionbeing infused, andduration oftherapy. | |||||
| adequacy ofvascular anatomyandappropriatenessfor the solutionbeing infusedand duration oftherapy | ||||||
| The cathetersmaybe used withpower injectorsfor which themaximum ratedpressure is 300psi. | ||||||
| 22 Garefor usepoweris rated formaximum of 325 |
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Terumo Corporation
TERUMO® SURFLASH® Plus Safety I.V. Catheter 51
II. 510(k) Summary
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Terumo Corporation
TERUMO® SURFLASH® Plus Safety I.V. Catheter 5100
11. 510(k) Summary________________________________________________________________________________________
{10}------------------------------------------------
Terumo Corporation
TERUMO® SURFLASH® Plus Safety I.V. Catheter 516
II. 510(k) Summary
11:00 PM
{11}------------------------------------------------
Discussion of Sections of the Intended Use/Indications for Use
I. Device Descriptive section (Full physical description of the device):
A full physical description of the device is not necessary for a discussion in the Intended Use/Indications for Use section. Omission of a physical description in the Intended Use/Indications for use of the proposed device subject of this 510k is not relevant to a comparison of the device's intended use/indication for use. Comparison of the physical description is presented in the comparison of technological characteristics of this 510k. The omission of a physical description in the Intended Use/Indication for use has no impact on the safety and effectiveness. The physical attributes of the proposed device have been tested and compared to the appropriate predicate that has the same/similar physical attribute.
II. Basic Device description and use as prescribed in 21CFR 880.5200
The proposed device and the predicate devices are classified under 21CFR880.5200 which states:
" 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 davs) 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. "
The proposed device and the predicate devices use a similar statement (underlined portion) regarding the actual use of the device.
Note: BD Insyte Autoguard states in the 510k that the device is classified under 21CFR 870.1200, however, FDA has classified this 510k (K971339) under 21CFR880.5200 which is identical to the proposed device subject of this 510k and the predicate devices.
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III. Description of Sharps Injury Protection
Terumo has included the description of the sharps injury protection feature in the Intended Use/Indications for Use statement for the proposed device and for one predicate device (TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282). Although three of the other predicate devices (K110443, K971339 & K923702) contain a sharps injury protection feature, the manufacturers have not included this description in their Intended Use/Indication for Use statement of their cleared 510k (this feature is discussed in the Technological Characteristics section). Even though the descriptive statement does not appear in the Intended Use/Indication for Use for those predicates, the feature is cleared under the respective 510ks.
Note: The predicate cleared under K991406 does not include a sharps injury protection feature as discussed in the Technological Characteristics section and, therefore, does not have this feature described herein.
IV. Discussion of usage in populations
The proposed device and two of the predicate devices (K100282 and K971339) clarify that these devices may be used in any population based on medical judgment. There is no restriction placed on the use of devices in any specific population and no specific indication of use in a specific population, but rather the statement indicates these devices can be used wherever medical judgment deems appropriate. These devices are general medical use devices and can be used in any population deemed acceptable by a medical professional. These devices are "Rx only."
These clarifying statements have no impact on the general use of the products and do not affect the safety or effectiveness nor the determination of substantial equivalence.
V. Use with Power Injectors
The proposed device and one of the predicate devices (K971339) include an indication for use with Power Injectors. The other three predicate devices do not include this indication. Appropriate testing has been included in this 510k to address the new issues of safety and effectiveness raised by this indication. The test results demonstrate the substantial equivalence of this indication with the product covered under K971339. This indication in
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Terumo Corporation TERUMO® SURFLASH® Plus Safety I.V. Catheter 510k II. 510(k) Summary
the 510(k) subject device has no impact on the other indications for use for which substantial equivalence is being claimed. This indication can effectively be reviewed separately regarding substantial equivalence.
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Terumo Corporation
TERUMO® SURFLASH® Plus Safety 1.V. Catheter 5 I
II. 510(k) Summary
It - Torinal Partier State Plan Safety I V. Catheter are similar to the predicate devices in terms of principle
| Trade Name | Subject of this 510(k) | Manufacturer | Operation principle | Design /Construction | Needle Shape/Material | Flashback | II. 510(k) SummaryTrade Name | SURFLASH® PlusSafety I.V.Catheter | TERUMO®Surshield®-PURSafety I.V.Catheter | TERUMO®SURFLASH®I.V. Catheter | BD InsyteAutoguard BCshielded I.V.Catheter | BD InsyteAutoguardshielded I.V.Catheter | Saf-T-IntimaClosed IVCatheter System | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SURFLASH® Plus Safety I.V. Catheter | Terumo Corporation | Conduit as fluid pathway Operated manually. | a. Catheter assemblyb. Needle assemblyc. Needle shield assemblyd. Filtere. Needle protectorf. Valveg. Seal componenth. Plug | Notched cannula Stainless steel | Visible through | Subject of this 510(k) | Subject of this 510(k) | K100282 | K991406 | K110443 | K971339 | K923702 | ||
| TERUMO® Sursbield®-PUR Safety I.V. Catheter | K100282 | Terumo Corporation | Conduit as fluid pathway Operated manually. | a. Catheter assemblyb. Needle assemblyc. Needle shield assemblyd. Filter cap with filtere. Protector | Notched cannula Stainless steel | Visible through | Catheter material | ditch on the cannula surface.PolyurethaneBiocompatibility of material confirmed. | ditch on the cannula surface.PolyurethaneBiocompatibility of material confirmed. | ditch on the cannula surface.PolyurethaneBiocompatibility of material confirmed. | on the cannula surface.Polyurethane | on the cannula surface.Polyurethane | needle lumen to tube.Polyurethane | |
| TERUMO® SURFLASH® I.V. Catheter | K991406 | Terumo Corporation | Conduit as fluid pathway Operated manually. | a. Catheter assemblyb. Needle assemblyc. Filter cap with filterd. Protector | Notched cannula. Stainless steel | Visible through | Radiopaque medium | Yes (Barium sulfate) | Yes (Barium sulfate) | Yes (Barium sulfate) | Yes (material not identified) | Yes (material not identified) | Yes (material not identified) | |
| BD Insyte Autoguard BC shielded I.V. Catheter | K110443 | Becton Dickinson | Conduit as fluid pathway Operated manually. | a. Catheter assemblyb. Needle assemblyc. Needle shield assemblyd. Filtere. Needle protectorf. Valve (called Septum)g. plug* | Holed cannula. Stainless steel | Visible through hole | Safety mechanism | Passive needle shielding | Passive needle shielding | None | Passively needle shielding | Passively needle shielding | Passive needle shielding | |
| BD Insyte Autoguard shielded I.V. Catheter | K971339 | Becton Dickinson | Conduit as fluid pathway Operated manually. | a. Catheter assemblyb. Needle assemblyc. Needle shield assemblyd. Filtere. Needle protector | Holed cannula. Stainless steel | Visible through hole | Valve | YES to reduce the blood leakage at catheter hub in view of blood exposure risk | No | No | YES to reduce the blood leakage at catheter hub in view of blood exposure risk | No | No | |
| Saf-T-Intima Closed IV Catheter System | K923702 | Becton Dickinson | Conduit as fluid pathway Operated manually | a. Catheter assembly with tube and I or Y adaptorb. Needle assemblyc. Needle shieldd. Filter cap with air filtere. Needle coverf. IV access portg. Wings available Notched cannula. | Stainless steel | Visible through | Color code of catheter hub | In accordance with ISO 10555-5 | In accordance with ISO 10555-5 | In accordance with ISO 10555-5 | In accordance with ISO 10555-5 | In accordance with ISO 10555-5 | In accordance with ISO 10555-5 | |
| Package | Sterility barrier:Blister packageUnit boxCardboard | Sterility barrier:CasingUnit boxCardboard | Sterility barrier:CasingUnit boxCardboard | Sterility barrier:Blister package | Sterility barrier:Blister package | Sterility barrier:Blister Package | ||||||||
| Sterilization method | Ethylene oxide | Ethylene oxide | Ethylene oxide | Ethylene oxide | Ethylene oxide | Ethylene oxide |
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Terumo Corporation
TERUMO® SURFLASH® Plus Safety I.V. Catheter 510
L. 510/k) Summary
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Terumo Corporation
TERUMO® SURFLASH® Plus Safety I.V. Catheter 5
II. 510(k) Summary
II. 510(k) Summary
Conclusion
SURFLASH® Plus Safety I.V. Catheter and the predicate devices have the same Technological Characteristics excep
- e predicate cleared under K991406 does not include a sharps injury protection teature as mentioned in the above table.
ne predicates cleared under K100282, K991406, K971339
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/17/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a person embracing or supporting another, conveying a sense of care and assistance. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Kofu Factory of Terumo Corporation C/O Terumo Medical Corporation Ms. Sandi Hartka Regulatory Affairs Manager 950 Elkton Boulevard Elkton, Maryland 21921
November 2, 2012
Re: K123267
Trade/Device Name: SURFLASH® Plus Safety I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 18, 2012 Received: October 19, 2012
Dear Ms. Hartka:
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.
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Page 2 - Ms. Hartka
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/ucm1115809.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.
Digitally signed by Anthony D. Watson DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300092402 Date: 2012.11.02 13:08:22 -04/00'
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
510(k) Number (if known): _KIL 326 7
SURFLASH® Plus Safety I.V. Catheter Device Name:
Indications for Use:
The SURFLASH® Plus 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
.
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)
Khd. Chay 11/1/2012
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anest. Dental Devices
510(k) Number:
Page of
§ 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).