The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

Device Description

The catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the introducer needle is withdrawn following blood vessel puncture. The introducer needle is retracted into the telescope casing to prevent needle stick injury.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Supercath Z3V intravascular catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria in the way one might expect for a novel diagnostic or AI-driven device.

Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm) are not applicable or not provided in this type of submission. This document highlights a regulatory pathway based on showing similarity to already approved devices, not necessarily a de novo clinical validation study with specific performance metrics.

Here's the information that can be extracted from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of intended use and technological characteristics. The "performance" is implicitly deemed acceptable if it matches or is sufficiently similar to the predicate devices. There are no explicit quantitative acceptance criteria or reported device performance metrics in the provided text.

Factor	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated in comparison)
Same Intended Use	Must be "Yes"	Yes
Polyurethane Catheter	Must be "Yes"	Yes
Radiopaque Catheter	Must be "Yes"	Yes
Flashback Visualization	Must be "Yes"	Yes
Needle stick Injury Prevention Feature	Must be "Yes"	Yes
Hemostatic Valve	Can be "Yes" or "No" (technological difference allowed if not raising new safety/effectiveness questions)	Yes
EtO Sterilized	Must be "Yes"	Yes
Single Sterile Wrapped	Must be "Yes"	Yes
Multiple gauge Sizes and Needle Lengths	Must be "Yes"	Yes

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

Sample Size for Test Set: Not applicable. This is not a study that involved a test set of data in the context of diagnostic performance. The substantial equivalence is based on device design, materials, and intended use comparison.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.

4. Adjudication method for the test set

Not applicable.

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. This device is an intravascular catheter, not an AI-driven diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The Supercath Z3V aims to show it is equivalent.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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Supercath Z3V Premarket Notification

Attachment 8

JUN 9 - 2005

KOSO 114
Page 1 of 2

April 22, 2005

510(K) SUMMARY

a. Company Name, Address:

TOGO MEDIKIT CO., LTD. 17148-6 Oaza-Hichiya Aza-Kamekawa, Hyuga-shi, Miyazaki-Ken, Japan 883-0062

b. Contact:

Kozo Nagayama, Director, Product Quality Center

c. Date Prepared:

August 2, 2004

d. Name of Device

Trade Name: SUPERCATH Z3V Common Name: Intravascular catheter Classification Name: Catheter, Intravascular (short-term)

e. Predicate Devices:

This device is substantially equivalent to "PROTECTIV PLUS Safety IV Catheter" (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773).

f. Description of the Device:

g. Statement of Substantial Equivalence:

The SUPERCATH Z3V is substantially equivalent to the PROTECTIV PLUS Safety IV Catheter (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773. See Comparison Table 1.

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Table 1

Factor	Supercath Z3V	PROTECTIV
Same Intended Use	Yes	Yes
Polyurethane Catheter	Yes	Yes
Radiopaque Catheter	Yes	Yes
Flashback Visualization	Yes	Yes
Needle stick Injury Prevention Feature	Yes	Yes
Hemostatic Valve	Yes	No
EtO Sterilized	Yes	Yes
Single Sterile Wrapped	Yes	Yes
Multiple gauge Sizes and Needle Lengths	Yes	Yes

h. Conclusion

The SUPERCATH Z3V has the same intended use and similar technological characteristics as the PROTECTIV PLUS Safety IV Catheter (K030571) and similar component materials of prior Supercath models cleared by FDA. Thus, The SUPERCATH Z3V is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 - 2005

Mr. Kozo Nagayama Director, Regulatory Affairs and Quality Assurance Togo Medikit Company Limited 17148 Oaza-Hichiya Aza Kamekawa Miyazaki-Ken Hyuga-Shi, 883-0062 JAPAN

Re: K050114

Trade/Device Name: Supercath Z3V Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 16, 2005 Received: May 17, 2005

Dear Mr. Nagayama:

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 – Mr. Nagayama

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sayte y. Michie Oms.

Chiú Lin, Ph.D. 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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April 22, 2005

Supercath Z3V Premarket Notification

INDICATIONS FOR USE

510(K) NUMBER (If known):

K050114

Supercath Z3V Device Name:

Indications for Use:

Indications for Use:
The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to The SUPERCATH ZSV Intravascular catherer is interests to short-term use (less than 30 administer fitulds. The SUPERCATT ZSV is designed to thended to reduce accidental needlesticks.

Prescription Use

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Please do not write below this line - Continue on other page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ana 2smm

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

510(k) Number: K050114

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).