(30 days)
No
The device description focuses on mechanical features (check valve, side-notch needle, retraction mechanism) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench tests and simulated clinical use evaluating mechanical function and safety features.
No
The device is used to access veins or arteries and administer fluids, which are procedures rather than therapeutic actions in themselves. It facilitates treatment but does not provide therapy.
No
The device is an intravascular catheter intended to access a vein or artery and administer fluids, not to diagnose a condition or disease. While it has a side-notch for visual confirmation of vessel entry, this is a functional feature for fluid administration, not for diagnosis.
No
The device description clearly details a physical intravascular catheter with various hardware components (needle, hub, check valve, spring, etc.). There is no mention of software as a component of the device.
Based on the provided information, the SUPERCATH 5 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "access a vein or artery and to administer fluids." This describes a device used for direct patient intervention (accessing blood vessels and delivering substances), not for examining specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description focuses on the physical components and function of a catheter for accessing blood vessels and administering fluids. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information about a patient's health status, disease, or condition.
- Using reagents, calibrators, or controls for testing.
The SUPERCATH 5 is clearly described as a device for accessing the circulatory system for therapeutic purposes (administering fluids), which falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FOZ
Device Description
The device is an intravascular catheter known by the trade name SUPERCATH 5 (PROPOSED). It is available in four models, with a check valve, with a side-notch needle, with a check valve and a side-notch needle, and without both a check valve and a notched needle.
The SUPERCATH 5 (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 (PROPOSED) 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 (PROPOSED) catheter hub has a built-in check valve which together with the bealthcare 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 continention of vessel entry. When the introducer needle is inserted into the vein, blood Commination of vesser caside of the and returns down along the inside of the catheter tube.
The SUPERCATH 5 (PROPOSED) is available in 14G, 18G, 20G, 20G, 22G and 24G.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed to ensure the safety and effectiveness of the SUPERCATH 5 (PROPOSED), verify conformity to the recognized standards and demonstrate substantial equivalence to the predicate device(s). All SUPERCATH 5 (PROPOSED) samples were equivale with the ISO and USP standards and demonstrated substantial equivalence to the predicate device(s).
Simulated clinical use testing was performed to test if the sharp needle injury prevention feature of the SUPERCATH 5 (K081953) worked properly under a simulated use clinical environment. 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. No failures were observed in over 500 tests, under different test conditions and five (5) different catheter sizes of the SUPERCATH 5 (PREDICATE).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
No failures were observed in over 500 tests.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
CONFIDENTIAL
SUPERCATH 5 PREMARKET NOTIFICATION 510(k)
DEC 1 7 2009
Section 6- 510(k) Summary
a. Owner/Company name, address TOGO MEDIKIT CO., LTD. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, Miyazaki, 883-0062, Japan
Toshimitsu Hayashi Manager, Quality Assurance Department Phone: 011-81-982-53-8000 Fax: 011-81-982-53-8008 qc@togomedikit.co.jp Email:
b. Contact/Application Correspondent
Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
011-81-3-3818-8577 Phone: 800-714-4641 (USA Toll-free) Fax: fkanai@micinternational.com Email:
c. Date prepared
,
October 5, 2009
d. Name of device
SUPERCATH 5 Trade Name: Intravascular Catheter Common Name: Catheter, Intravascular, Therapeutic, Short-term less than 30 days Classification Name: Classification Regulation: 21 CFR 880.5200
TOGO MEDIKIT CO., LTD. OCTOBER 5, 2009
SECTION 6 6-2 OF 6-6
1
SUPERCATH 5 PREMARKET NOTIFICATION 510(k) CONFIDENTIAL
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 |
The same trade name with the device for the application; 510(k): K081953 SUPERCATH 5 Trade name: Product code: FOZ
f. Description of the device
The device is an intravascular catheter known by the trade name SUPERCATH 5 (PROPOSED). It is available in four models, with a check valve, with a side-notch needle, with a check valve and a side-notch needle, and without both a check valve and a notched needle. (See below Figure 1).
The SUPERCATH 5 (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 (PROPOSED) 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 (PROPOSED) catheter hub has a built-in check valve which together with the bealthcare 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 continention of vessel entry. When the introducer needle is inserted into the vein, blood Commination of vesser caside of the and returns down along the inside of the catheter tube.
The SUPERCATH 5 (PROPOSED) is available in 14G, 18G, 20G, 20G, 22G and 24G.
Image /page/1/Figure/13 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 labeled on the left side of the image, and the needle hub is labeled on the right side of the image.
Introducer needle
Catheter hub
TOGO MEDIKIT CO., LTD. OCTOBER 5, 2009
SECTION 6 6-3 OF 6-6
Figure 1. SUPERCATH 5
2
CONFIDENTIAL
g. Modification description
The SUPERCATH 5 (PROPOSED) contains the following modifications as compared to the SUPERCATH 5 (K081953):
-
- Addition of 14G and 16G sizes.
-
- Modify 22G and 24G introducer needle to include a side-notch to provide rapid visual confirmation of vessel entry.
To evaluate the any effects of the above changes on safety and effectiveness, risk analysis (see Section 18 Risk Analysis) and performance testing (see Section 21 Performance Testing - Bench) were performed. In conclusion the risk analysis and performance testing demonstrated that the above listed modifications did not raise any new safety or effectiveness concerns.
h. Indications for Use
Indication for Use
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.
Statement of substantial equivalence i.
The characteristics of the SUPERCATH 5 (PROPOSED) 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 .
TOGO MEDIKIT CO., LTD. OCTOBER 5, 2009
3
SUPERCATH 5 PREMARKET NOTIFICATION 510(k)
CONFIDENTIAL
| Table 1. Comparison of Factor/Component
Factor/Component | SUPERCATH 5
(PROPOSED) | Insyte Autoguard™
IV Catheter
(K013800) | SUPERCATH 5
(K081953) |
|-------------------------------------------------------------|---------------------------|-----------------------------------------------|--------------------------|
| 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 |
| Ethylene Oxide Sterilized | Yes | Yes | Yes |
| Single Sterile Wrapped | Yes | Yes | Yes |
| Multiple gauge sizes and needle lengths | Yes | Yes | Yes |
| Side-Notch needle | Yes | Yes | No |
Table 1, Comparison of Factor/Comnonent
The SUPERCATH 5 (PROPOSED) has the same intended use and similar technological che Coriences as the "Insyte Autoguard™ IV Catheter" (K013800) and the "SUPERCATH 5" (K081953). Similar components and materials are used in the SUPERCATH 5 (PROPOSED) as in the "SUPERCATH 5" (K081953).
Risk Analysis i.
The SUPERCATH 5 (PROPOSED) was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory. See Section 18 Risk Analysis.
k. Bench Testing
Bench tests were performed to ensure the safety and effectiveness of the SUPERCATH 5 (PROPOSED), verify conformity to the recognized standards and demonstrate substantial equivalence to the predicate device(s). All SUPERCATH 5 (PROPOSED) samples were equivale with the ISO and USP standards and demonstrated substantial equivalence to the predicate device(s).
Simulated Clinical Use l.
Shirdlated Chilital Coo In accordance while is a great go 2005, the sharp needle injury prevention feature of the SUPERCATH 5 (K081953) was tested.
According to the risk analysis (See Section 18 Risk Analysis), the modifications to the SUPERCATH 5 (K081953), of 1) the additional gauge sizes of 14G and 16G and 2) the Sorthernitt > (18001953), or endle of the 22G and 24G, have no effect on the sharp needle Side-noten on the Introducer novel of the SUPERCATH 5 (PROPOSED). Therefore, Togo Mediliti has included the exact same report submitted with the SUPERCATH 5 (K081953). (See Section 23 Performance Testing - Simulated Clinical Use.)
4
SUPERCATH 5 PREMARKET NOTIFICATION 510(k)
CONFIDENTIAL
The purpose of the investigation was to test if the sharp needle injury prevention feature of the SUPERCATH 5 (K081953) 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 (K081953) (PREDICATE) and the SUPERCATH 5 (PROPOSED).
No failures were observed in over 500 tests, under different test conditions and five (5) different catheter sizes of the SUPERCATH 5 (PREDICATE). Thus, the requirement of statistical significance of the safety feature was confirmed for the sharp needle injury prevention feature of the SUPERCATH 5 (PREDICATE).
Therefore, Togo Medikit believes that the same results apply to the identical safety feature of the SUPERCATH 5 (PROPOSED), since the modifications to the SUPERCATH 5 (K081953), of 1) the additional gauge sizes of 14G and 16G and 2) the side-notch on the introducer needle of the 22G and 24G, have no effect on the sharp needle injury prevention feature of the SUPERCATH 5 (PROPOSED) (See Section 18 Risk Analysis.)
m. Conclusion
Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices, Togo Medikit concludes that the SUPERCATH 5 (PROPOSED) is substantially equivalent to the "Insyte Autoguard" IV Catheter" (K013800) and the "SUPERCATH 5" (K081953) and does not raise any new questions regarding safety or effectiveness.
SECTION 6 6-6 OF 6-6
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol to the right, which resembles three human figures connected by flowing lines. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Togo Medikit Company, Limited C/o Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo Bunkyo-Ku, Tokyo 113-0033 JAPAN
DEC 1 7 2009
Re: K093546
Trade/Device Name: SUPERCATH 5 Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 5, 2009 Received: November 17, 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 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.
6
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runner
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
7
Indications for Use
510(k) Number (If known): K093546
Device Name: SUPERCATH 5
Indication for Use
The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The The Borekering o is mondou to de use and for short-term use (less than 30 days), is Sor EKCATI 9-18-dongied 10. "Single in the end to reduce accidental needlesticks.
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)
signature
(Division Sign Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093546