(142 days)
Not Found
No
The device description focuses on mechanical features for safety and fluid administration, with no mention of AI or ML terms or functionalities.
No
The device is described as an intravascular catheter intended to access a vein or artery and administer fluids, which is a diagnostic or access function, not a therapeutic treatment of a condition. Its needle-stick prevention feature is a safety design, not a therapeutic function.
No
The device is described as an intravascular catheter intended to access veins or arteries and administer fluids, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical intravascular catheter with a hub, valve, and introducer needle, indicating it is a hardware device.
Based on the provided information, the SUPERCATH Z3V intravascular catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "access vein or artery and to administer fluids." This describes a device used in vivo (within the living body) for therapeutic or diagnostic procedures involving the circulatory system.
- Device Description: The description details a catheter designed for insertion into blood vessels and features related to safe insertion and fluid administration. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The provided information does not mention any such use or interaction with patient specimens outside the body.
Therefore, the SUPERCATH Z3V is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FOZ
Device Description
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.
The catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the introducer needle is withdrawn following blood vessel puncture.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.
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
Not Found
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
Not Found
Key Metrics
Not Found
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
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:
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.
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.
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.
34
1
35
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three diagonal lines representing the three branches of government. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
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.
3
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
4
April 22, 2005
Supercath Z3V Premarket Notification
INDICATIONS FOR USE
510(K) NUMBER (If known):
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)
OR
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