(261 days)
The Supercath 5 is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.
The Supercath 5 (Proposed) is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 (Proposed) is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi. The Supercath 5 (Proposed) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub. The Supercath 5 (Proposed) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows up and through the side-notch and returns down along the inside of the catheter tube. The Supercath 5 (Proposed) is available in 14G, 16G, 18G, 20G, 22G, 24G and 26G.
The provided text is a 510(k) summary for the Supercath 5, an intravascular catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic output.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance for an AI/diagnostic algorithm.
- Sample sizes used for a test set or data provenance for such a study.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication methods for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance data.
- Type of ground truth used for an AI/diagnostic algorithm.
- Sample size for a training set.
- How ground truth for a training set was established.
The performance data mentioned in section "i. Performance data" (page 9) refers to engineering and biological performance tests for the catheter device itself, such as:
- Biocompatibility testing (e.g., hemocompatibility, according to ISO 10993-1).
- Catheter burst pressure test (according to ISO 10555-1).
- Vent fitting test for the needle hub (according to ISO 10555-5).
- Flow rate test (according to ISO 10555-1).
- Ease of assembly performance testing for the plunger (according to ISO 594-2).
- Tensile strength testing for the cap.
- Sterilization validation (according to ISO 11135) and shelf-life testing.
These tests are standard for medical device safety and functionality but are not related to the acceptance criteria or study design for an AI-powered diagnostic device as requested in the prompt.
In summary, the provided text does not contain the information required to answer the prompt because it pertains to the regulatory submission for a physical medical device (an intravascular catheter) and its engineering performance, not an AI/diagnostic software or algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2019
TOGO MEDIKIT Co., Ltd. % Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo Bunkyo-ku, Tokyo 113-0033 JAPAN
Re: K190001
Trade/Device Name: Supercath 5 Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 15, 2019 Received: August 19, 2019
Dear Izumi Maruo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Nikhil Thakur Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190001
Device Name Supercath 5
Indications for Use (Describe)
The Supercath 5 is intended to access a vein or attery and to administer fluids and/or blood. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo with a globe-like grid pattern in the background. In the foreground, there is a stylized human figure with arms outstretched, forming a 'P' shape with its body. The figure is positioned in front of the globe, creating a sense of global reach or connection.
TOGO MEDIKIT CO., LTD.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008
Page 1 of 8
510(k) Summary - K190001
Owner/Company name, address a.
TOGO MEDIKIT CO., LTD. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, Miyazaki, 883-0062, Japan
Daisuke Nagamizu Manager, Regulatory Affairs Section, Quality Assurance Department Phone: 011-81-982-53-8000 Fax: 011-81-982-53-8008 qc@togomedikit.co.jp Email:
b. Contact/Application Correspondent
Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
011-81-3-3818-8577 Phone: Fax: 011-81-3-3818-8573 Email: maruo@mici.co.jp
c. Date prepared
September 18, 2019
d. Name of device
| Trade Name: | Supercath 5 |
|---|---|
| Common Name: | Catheter, Intravascular, Therapeutic, Short-term less than 30days |
| Regulation Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Regulation Class: | II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
Hereinafter, the Proposed Device is called as "Supercath 5 (Proposed)" in this submission because predicate devices have the same trade name.
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Image /page/4/Picture/0 description: The image shows a logo with a globe-like structure made of intersecting lines, resembling a grid. Inside the globe, there is a stylized human figure with arms outstretched, as if embracing the world. The logo is presented in grayscale, giving it a simple and clean appearance.
TOGO MEDIKIT CO., LTD.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008
e. Predicate and reference devices
Predicate devices
The Supercath 5 (Proposed) has two predicate devices because those two devices altogether cover the sizes which the Supercath 5 (Proposed) includes.
Predicate Device for gauges 14G, 16G, 18G, 20G, 22G, and 24G
| Trade Name: | Supercath 5 |
|---|---|
| 510(k) Number: | K140419 |
| Common Name: | Catheter, Intravascular, Therapeutic, Short-term less than 30 days |
| Regulation Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Regulation Class: | II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
Hereinafter "Supercath 5 (K140419)" in this submission. This predicate device is primary predicate.
| Predicate Device for 26G | |
|---|---|
| Trade Name: | Supercath 5 |
| 510(k) Number: | K172496 |
| Common Name: | Catheter, Intravascular, Therapeutic, Short-term less than30 days |
| Regulation Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Regulation Class: | II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
Hereinafter "Supercath 5 (K172496)" in this submission.
| Reference Devices | |
|---|---|
| Trade Name: | Supercath 6 |
| 510(k) Number: | K160592 |
| Common Name: | Catheter, Intravascular, Therapeutic, Short-term less than 30 days |
| Regulation Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Regulation Class: | II |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
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f. Description of the device
The Supercath 5 (Proposed) is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 (Proposed) is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.
The maximum flow rate and maximum pressure setting for each catheter size are listed in the table shown as follows. The maximum flow rate may vary due to differences in injector characteristics, injectate viscosity and temperature, and other variables.
| Gauge | Length | MaximumFlow Rate(mL/sec) | MaximumPressure(psi) | |
|---|---|---|---|---|
| (in) | (mm) | |||
| 22G | 1 | 25 | 7 | 300 |
| 22G | 1 1/4 | 31 | 7 | 300 |
| 20G | 1 | 25 | 9 | 300 |
| 20G | 1 1/4 | 31 | 9 | 300 |
| 20G | 2 | 50 | 9 | 300 |
| 18G | 1 1/4 | 31 | 12 | 300 |
| 18G | 2 | 50 | 12 | 300 |
Table 1. The maximum flow rate and the maximum pressure setting
The Supercath 5 (Proposed) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub.
The Supercath 5 (Proposed) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows up and through the side-notch and returns down along the inside of the catheter tube.
The Supercath 5 (Proposed) is available in 14G, 16G, 18G, 20G, 22G, 24G and 26G.
g. Indications for Use Statement
The Supercath 5 is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 is designed for single use and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22-gauge catheters may be used with power injectors at a maximum pressure of 300 psi.
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Image /page/6/Picture/0 description: The image shows a logo with a globe-like background. In the center of the globe is a stylized human figure with arms raised. The figure is white, and the globe is made up of a grid pattern.
TOGO MEDIKIT CO., LTD.
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008
Page 4 of 8
h. Comparative Information
The Supercath 5 (Proposed) was modified from the Supercath 5 (K140419) and the Supercath 5 (K172496). The primary difference in the Supercath 5 (proposed) is the indications for use statement includes administration of blood and 18-22 gauge catheters may be used with power injectors. These changes do not affect the intended use of the device compared to the predicates.
Technological characteristics
The similarities of the subject device to the predicate devices are:
- Same catheter material (Polyurethane)
- Radiopaque
- Flashback Visualization
- Side-Notch Needle ●
- Same Needlestick Injury Prevention Feature ●
- Check Valve
- Ethylene Oxide Sterilized ●
- Single Sterile Wrapped ●
- Multiple Gauge Sizes and Needle Lengths ●
The Supercath 5 (Proposed) contains following modifications as compared to the predicate devices:
- Change of material formulation of the plug, the wing, the plunger, the cap, and the protector
- The adjustable attachment on the tip of the grip is not used for all models
- Addition of a packing part for blood on the needle hub for all models ●
- Addition of power injection to 18G, 20G, and 22G ●
- Addition of administration of blood in the Indications for Use ●
Performance testing was done to support the modifications of the subject device
Followings are comprehensive comparison table for the proposed, predicate, and reference devices:
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Image /page/7/Picture/0 description: The image shows a logo featuring a stylized human figure within a globe. The figure is composed of simple lines and shapes, suggesting a person with arms raised. The globe is represented by a grid pattern, giving it a three-dimensional appearance. The logo is in grayscale and appears to be a symbol for an organization or concept related to global humanity.
TOGO MEDIKIT CO., LTD
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
Table 2 Comparison table between the Supercath 5 (Proposed), the predicate and the reference devises
| Item | Supercath(Proposed) | Predicate Devices | Reference Device | SubstantialEquivalenceAnalysis | |
|---|---|---|---|---|---|
| 5 | Supercath(K140419) | 5Supercath(K172496) | 5Supercath(K160592) | 6 | |
| Indications for UseStatement | The Supercath 5 isintended to access avein or artery and toadminister fluidsand/or blood. TheSupercath 5 isdesigned for singleuse, and is designedto minimizeinadvertentneedlesticks and toreduce accidentalneedlesticks. The 18- 22 gauge cathetersmay be used withpower injectors at amaximum pressureof 300 psi. | The Supercath 5 isintended to access avein or artery and toadminister fluids.The Supercath 5 isdesigned for singleuse and forshort-term use (lessthan 30 days), isdesigned tominimizeinadvertentneedlesticks and toreduce accidentalneedlesticks. | The Supercath 5 isintended to access avein or artery and toadminister fluids.The Supercath 5 isdesigned for singleuse, and is designedto minimizeinadvertentneedlesticks and toreduce accidentalneedlesticks. | The Supercath 6 isintended to access avein or artery and toadminister fluids.The Supercath 6 isdesigned for singleuse and forshort-term use (lessthan 30 days), isdesigned tominimizeinadvertentneedlesticks and toreduce accidentalneedlesticks. The 18- 22 gauge cathetersmay be used withpower injectors at amaximum pressureof 300 psi. | Substantiallyequivalent.For detail aboutsubstantialequivalenceanalysis forIndications for Usestatement, pleasesee above. |
| Needlestick injuryprevention feature | The metallic introducer needle is retracted into the needle hub when the activation buttonon the needle hub is pressed. | Same | |||
| Flashbackvisualization | Yes | Yes | Yes | Same. | |
| Side-notch needle*1 | Yes | Yes | Yes | Same |
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Image /page/8/Picture/0 description: The image shows a logo that appears to be for an organization or company. The logo features a stylized human figure standing within a globe-like structure. The figure is abstract, with a large head and arms raised, giving the impression of someone reaching upwards or outwards. The globe is represented by a grid of lines, suggesting a network or global connection.
TOGO MEDIKIT CO., LTD
17148-6, Aza Kamekawa, Oaza Hichiya, Hyuga City
Miyazaki Prefecture 883-0062, Japan
TELEPHONE: +81-982-53-8027
FACSIMILE: +81-982-53-8008
| Item | Supercath(Proposed) | Predicate Devices | Supercath(K140419) | Supercath(K172496) | Reference Device | Supercath(K160592) | SubstantialEquivalenceAnalysis |
|---|---|---|---|---|---|---|---|
| Radiopaque | Yes | Yes | Yes | Same | |||
| Adjustableattachment*2 | No | Yes | No | Please see *2 | |||
| Additional packingpart for blood on theneedle hub*3 | Yes | No | No | Performance data | |||
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | Same | |||
| Packaging | Blister | Blister | Blister | Same. | |||
| Use with PowerInjectors (18G, 20G,22G) | Yes | No | No | Yes | Performance Data | ||
| Multiple gaugesizes and needlelength | Yes (14G, 16G, 18G,20G, 22G, 24G, and26G) | Yes (14G, 16G, 18G,20G, 22G, and 24G) | 26G | The two predicatedevices altogethercover the sizeswhich the Supercath(Proposed)includes. | |||
| Material of cathetertube | Polyurethane | Polyurethane | Polyurethane | Same. |
*! Side-notch needle is the introducer needle with a side-noth, to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows upward into the side-notch alown along the inside of the catheter tube. This does not affect the intended use of the device.
*2: The adjustable attachment is used just when manufacturing the Supercath 5 (K140419). The attachment the tip of the introducer needle and the tip of the catheter. This does not affect the intended use of the device.
*3: The packing part on the needle hub improves the prevention of the device. This does not affect the intended use of the device.
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Image /page/9/Picture/0 description: The image shows a logo with a stylized human figure standing inside a globe. The human figure is white, and the globe is made up of intersecting lines, giving it a grid-like appearance. The logo is simple and abstract, focusing on the concept of humanity within a global context.
i. Performance data
Evaluations of the modifications in support of the substantial equivalence determination is shown below;
1. Biocompatibility testing
The Supercath 5 (Proposed) contacts patient's skin and blood and is categorized as an External communicating. Circulating blood contact device with a Prolonged contact duration in accordance with ISO 10993-1:2009 and referencing FDA guidance entitled "Use of International Standard ISO 10993- 1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The nature of contact with the body and the category of the Supercath 5 (Proposed) are identical to those of the predicate devices.
Biocompatibility testing was leveraged from the sponsor's own predicate devices (K140419 and K172496).
The addition of administration of blood in the Indications for Use is supported by the Hemocompatibility testing (hemolysis, complement system, coagulation, platelets, and thrombosis) performed on the sponsor's own reference device (K160592).
- Power injection test
Catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when tested according to ISO 10555-1:2013.
- Vent fitting test for the needle hub
The needle hub with the packing part is impervious to liquid infiltration when subjected to positive pressure in accordance with ISO 10555-5:2013.
-
- Flow rate test
The flow rate through catheter meets allowable limits when tested according to ISO 10555-1:2013.
- Flow rate test
- Ease of assembly performance testing for the plunger
The plunger passes through the check valve when tested according to ISO 594-2:1998 section 5.6.
- Tensile strength testing for the cap
The tensile strength of the cap meets acceptable minimum force until breakage when tested according to in-house standard.
- Sterilization validation in accordance with ISO 11135:2014 and shelf-life testing were conducted.
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Image /page/10/Picture/0 description: The image shows a logo with a globe-like structure in the background. In the foreground, there is a stylized human figure with arms outstretched, superimposed over the globe. The figure appears to be made of interconnected lines or segments, giving it a modern and abstract look. The overall design is simple and monochromatic, with a focus on the interconnectedness of the human figure and the global sphere.
The results of testing above did not raise any new questions of safety or effectiveness.
j. Conclusion
Based on the Indications for Use, technological characteristics, and performance testing, Togo Medikit concludes that the Supercath 5 (proposed) is substantially equivalent to the predicate devices.
§ 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).