(246 days)
Not Found
No
The device description focuses on mechanical features for safety and fluid administration, with no mention of AI or ML. The performance studies evaluate mechanical function and user interaction, not algorithmic performance.
No.
The primary purpose of the SUPERCATH 5 is to access blood vessels for fluid administration, not to treat a specific disease or condition. While it enables therapeutic actions (administering fluids), it is not, in itself, a therapeutic device.
No
The device is an intravascular catheter designed to access a vein or artery and administer fluids, not to diagnose a condition.
No
The device description clearly details a physical, intravascular catheter with mechanical components (check valve, coiled spring, button) and different sizes (18G, 20G, 22G, 24G). There is no mention of any software component.
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 provide diagnostic information.
- Device Description: The description focuses on the physical components and function of a catheter designed for accessing blood vessels and administering fluids. It does not mention any components or processes related to analyzing biological samples.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. Its purpose is purely procedural (access and administration).
IVD devices are specifically designed to examine specimens such as blood, urine, or tissue in vitro to provide information for diagnosis, monitoring, or screening. The SUPERCATH 5 does not fit this description.
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. 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.
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
healthcare 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
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.
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.
Key Metrics
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
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
1
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 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.
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
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.
SUPERCATH 5 (K081953)
2
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.
3
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.
4
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.
5
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
te
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
6
Indications for Use
510(k) Number (If known): 408/953
Device Name: SUPERCATH 5
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.
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 |
|---|---|
| ---------------- | --------- |