The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

Device Description

The device is an intravascular catheter known by the trade name SUPERCATH 5. It is available in two models, with a check valve and without a check valve. The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The SUPERCATH 5 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finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture.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 to prevent needlestick injury. The SUPERCATH 5 is available in 18G, 20G, 22G and 24G.

AI/ML Overview

The provided document describes the safety and effectiveness testing for the SUPERCATH 5, an intravascular catheter with a sharp needle injury prevention feature.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Metal introducer needle completely retracts into the plastic needle hub after firmly pressing the safety button. (Critical for sharp needle injury prevention)	"No failures were observed in over 500 tests, under different test conditions and five (5) different catheter sizes of the SUPERCATH 5." This indicates 100% success rate in the simulated use study for the needle retraction mechanism.
Compliance with ISO and USP standards (General safety and effectiveness)	"All samples were compliant with the ISO and USP standards."

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

Sample Size for the Test Set: "No failures were observed in over 500 tests" for the needle injury prevention feature. This indicates at least 500 tests were performed.
Data Provenance: The study was conducted by TOGO MEDIKIT CO., LTD., a Japanese company. The document does not specify the country of origin for the data collection itself, but it implies it was part of their internal testing for FDA submission. The study was a "simulated use clinical environment," suggesting prospective data collection for this specific evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Eight (8) healthcare professional volunteers.
Qualifications of Experts: They were described as "health care professional volunteers who routinely use this type of catheter in their clinical practice." Specific qualifications like "radiologist with 10 years of experience" are not provided, but their routine use of such catheters implies relevant experience.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The primary evaluation parameter was a direct observation of whether the metal introducer needle completely retracted. Since "no failures were observed," it implies a clearpass/fail outcome where no adjudication among multiple observers was necessary for discrepant findings, or if multiple observers were present, they all agreed on the absence of failure.

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

This document does not describe an MRMC comparative effectiveness study involving AI or human readers. The device is an intravascular catheter with a safety feature, not an AI-powered diagnostic tool. Therefore, these metrics are not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This document does not describe a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the sharp needle injury prevention feature, the ground truth was direct observation by healthcare professionals in a simulated clinical environment. The success criterion was the physical complete retraction of the needle, which is an objective measurement verified by "expert" users. For compliance with ISO and USP standards, the ground truth was adherence to published technical specifications and testing protocols.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is a physical medical device and not a machine learning model. Therefore, this metric is not applicable.

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

As no training set (in the context of machine learning) was used or described, this information is not applicable.

Summary

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K081953

sual 1 2 2005

RESPONSE TO FDA LETTER DATED AUGUST 29, 2008

CONFIDENTIAL TOGO MEDIKIT CO., LTD.

Section 6- 510(k) Summary

Owner/Company name, address a. TOGO MEDIKIT CO., LTD. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, Miyazaki, 883-0062, Japan

Makoto Ishimura Manager, Quality Assurance Department 011-81-982-53-8000 Phone: Fax: 011-81-982-53-8008 qc@togomedikit.co.jp Email:

b. Contact/Application Correspondent

Fumiaki Kanai, Ph.D. President and CEO MIC International (4th Floor) 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

Phone: 011-81-3-3818-8577 011-81-3-3818-8577 Fax: Email: fkanai@micinternational.com

c. Date prepared

January 30, 2009

d. Name of device

Trade Name: SUPERCATH 5 Common Name: Intravascular Catheter Catheter, Intravascular, Therapeutic, Short-term less than 30 days Classification Name: Classification Regulation: 21 CFR 880.5200

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K08/953

CONFIDENTIAL TOGO MEDIKIT CO., LTD.

e. Predicate devices

The SUPERCATH 5 is substantially equivalent to the following legally marketed devices:

510(k):	K013800
Trade name:	Insyte Autoguard™ IV Catheter
Product code:	FOZ
510(k):	K050114
Trade name:	SUPERCATH Z3V
Product code:	FOZ

f. Description of the device

The device is an intravascular catheter known by the trade name SUPERCATH 5. It is available in two models, with a check valve and without a check valve.

The SUPERCATH 5 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 to prevent needlestick injury.

The SUPERCATH 5 is available in 18G, 20G, 22G and 24G.

Image /page/1/Figure/11 description: The image shows a diagram of a catheter tube and needle hub. The catheter tube is a thin, hollow tube that is inserted into a vein or artery to administer fluids or medications. The needle hub is the part of the catheter that connects to the syringe or IV line. The catheter tube is on the left side of the image, and the needle hub is on the right side of the image.

Introducer needle

Catheter hub

Figure 1. SUPERCATH 5

g. Indications for Use

Indication for Use

SUPERCATH 5 (K081953)

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K081953

RESPONSE TO FDA LETTER DATED AUGUST 29, 2008

CONFIDENTIAL TOGO MEDIKIT CO., LTD.

h. Statement of substantial equivalence

The characteristics of the SUPERCATH 5 are similar to those of the predicate devices described in Item e above. The similarities are:

Same Intended Use
Same Catheter Material (Polyurethane) .
. Radiopaque
. Flashback Visualization
Needle Stick Injury Prevention Feature .
. Check Valve
◆ Ethylene Oxide Sterilized
Single Sterile Wrapped .
Multiple Gauge Sizes and Needle Lengths .

Factor/Component	SUPERCATH 5	Insyte Autoguard™IV Catheter(K013800)	Supercath Z3V(K050114)
Same Intended Use	Yes	Yes	Yes
Polyurethane Catheter	Yes	Yes	Yes
Radiopaque Catheter	Yes	Yes	Yes
Flashback Visualization	Yes	Yes	Yes
Needle Stick Injury Prevention Feature	Yes	Yes	Yes
Check Valve	Yes	No	Yes(hemostatic valve)
Ethylene Oxide Sterilized	Yes	Yes	Yes
Single Sterile Wrapped	Yes	Yes	Yes
Multiple gauge sizes and needle lengths	Yes	Yes	Yes
Used with power injectors up to 300 psi	No	Yes	No

Table 1. Comparison of Factor/Component

The SUPERCATH 5 has the same intended use and similar technological characteristics as the "Insyte Autoguard" IV Catheter" (K013800) and the "SUPERCATH Z3V" (K050114). Similar components and materials are used in the SUPERCATH 5 as in prior SUPERCATH models cleared for marketing by FDA.

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K081453

CONFIDENTIAL TOGO MEDIKIT CO., LTD.

i. Bench Testing

Bench tests were performed to ensure the safety and effectiveness of the SUPERCATH 5, conform to the recognized standards and to demonstrate substantial equivalence to the predicate device(s). All samples were compliant with the ISO and USP standards.

Simulated Clinical Use i.

In accordance with FDA's guidance "Medical Devices with Sharps Injury Prevention Features", Document issued on: August 9, 2005, the sharp needle injury prevention feature of the SUPERCATH 5 was tested.

The purpose of the Study was to test if the sharp needle injury prevention feature of the SUPERCATH 5 worked properly under a simulated use clinical environment. As per recommendation under the "Guidance", eight (8) health care professional volunteers who routinely use this type of catheter in their clinical practice were recruited.

The primary evaluation parameter was to test if the metal introducer needle completely retracted into the plastic needle hub after firmly pressing the safety button. This mechanism is the sharp needle injury prevention feature of the SUPERCATH 5.

No failures were observed in over 500 tests, under different test conditions and five (5) different catheter sizes of the SUPERCATH 5. Thus, the requirement of statistical significance of the safety feature was confirmed for the sharp needle injury prevention feature of the SUPERCATH 5.

k. Conclusion

Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices, TOGO MEDIKIT CO., LTD concludes that the SUPERCATH 5 is substantially equivalent to the "Insyte Autoguard™ IV Catheter" (K013800) and the "SUPERCATH Z3V" (K050114) and does not raise any new questions regarding safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract depiction of an eagle with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2009

Togo Medikit Company, Limited C/o Fumiaki Kanai, Ph.D. President and CEO MIC International 4/1/17 Hongo Bunkyo-Ku, Tokyo 113-0035 JAPAN

Re: K081953

Trade/Device Name: SUPERCATH 5 Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 30, 2009 Received: February 3, 2009

Dear Dr. Kanai:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -Dr. Kanai

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Pearson

Ginette Y. Michaud, M.D. Acting 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

510(k) Number (If known): 408/953

Device Name: SUPERCATH 5

Indication for Use

Prescription Use
(Per 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)

(Division Sign-Off)
---------------------	--

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	Y081953
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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).