(434 days)
Not Found
No
The summary describes a mechanical device for accessing blood vessels during dialysis, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is a fistula catheter used to access a vein or artery for connection to a blood circuit during kidney dialysis. While it facilitates the dialysis process, the catheter itself is not performing therapeutic action but rather providing access for a therapeutic procedure.
No
Explanation: The device description states its purpose is to access a vein or artery and connect a patient to a hemodialysis machine. This is a therapeutic and access function, not a diagnostic one.
No
The device description clearly states it is a "fistula catheter" and describes physical components like a "catheter hub," "hemostatic valve," and "metallic introducer needle," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access a vein or artery for blood circuit connection during kidney dialysis and to minimize needlesticks. This is a direct interaction with the patient's circulatory system for therapeutic purposes (dialysis), not for examining specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a catheter and needle system for accessing blood vessels. This aligns with a medical device used for direct patient intervention, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, etc.) or providing diagnostic information based on such analysis.
Therefore, the Supercath V fistula catheter is a medical device used for accessing the circulatory system for dialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Supercath V fistula catheter is intended to access a vein or artery while connected to a blood circuit during kidney dialysis. The Supercath V is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.
Product codes
FIE
Device Description
The SUPERCATH V fistula catheter is part of any hemodialysis system that connects the patient to the machine and provides access to the patient's blood.
This device is designed for single use and the catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the metallic introducer needle is withdrawn following blood vessel puncture. The metallic introducer needle is retracted into the extendable needle casing to prevent needlestick 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Supercath V Premarket Notification
August 4, 2005 Page 1/2
Attachment 8- 510(k) Summary
510(k) SUMMARY
OCT 2 7 2006
a. Submitter's Name and 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 4, 2005
d. Name of device
Trade Name: SUPERCATH V Common Name: Fistula Needle Classification Name: Blood access device and accessories
e. Predicate devices
This device is substantially equivalent to "PROTECTIV PLUS Safety IV Catheter" (K030571), Togo Medikit's Supercath A.V. Fistula (K854773) and Supercath Z3V (K050114).
f. Device description
The SUPERCATH V fistula catheter is part of any hemodialysis system that connects the patient to the machine and provides access to the patient's blood.
This device is designed for single use and the catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the metallic introducer needle is withdrawn following blood vessel puncture. The metallic introducer needle is retracted into the extendable needle casing to prevent needlestick injury.
1
Supercath V Premarket Notification
August 4, 2005 Page 2/2
g. Substantial equivalence
The SUPERCATH V is substantially equivalent to the PROTECTIV PLUS Safety IV Catheter (K030571) and Togo Medikit's Supercath A.V. Fistula (K854773) and Supercath Z3V (K050114). See Comparison Table 1 below.
| 1.
Table
| AND & A |
|---|
| ------------------------ |
| Factor | Supercath V | PROTECTIV
PLUS | Supercath
A.V. Fistula | Supercath
Z3V |
|-----------------------------------------|-------------|-------------------|---------------------------|------------------|
| Same Intended Use | Yes | No | Yes | No |
| Needlestick Injury Prevention Feature | Yes | Yes | No | Yes |
| Hemostatic Valve | Yes | No | No | Yes |
| EtO Sterilized | Yes | Yes | Yes | Yes |
| Single Sterile Wrapped | Yes | Yes | Yes | Yes |
| Multiple gauge Sizes and Needle Lengths | Yes | Yes | Yes | Yes |
h. Conclusion
The SUPERCATH V has the same intended use as Togo Medikit's Supercath A.V. Fistula (K854773) and similar technological characteristics as the PROTECTIV PLUS Safety IV Catheter (K030571) and the Supercath Z3V (K050114). Similar component materials are used as in prior Supercath models cleared by FDA. Therefore we affirm that the SUPERCATH V is substantially equivalent to the predicate devices listed herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 2 7 2006
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
Fumiaki Kanai, Ph.D. President and CEO MIC International 4-2-1 Yushima Bunkyou-ku, Tokyo 113-0034 JAPAN
K052267 Trade/Device Name: Supercath V Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: FIE Dated: August 25, 2006 Received: August 28, 2006
Dear Dr. Kanai:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(K) promation the equivalent (for the indications for referenced above and have decemined the devices marketed in interstate comments or to devices that use stated in the enclosure) to legally man totoal Device Amendments, or to devices that prior to May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMA). You may have been reclassified in accordance with the provisition (PMA). You may,
Act (Act) that do not require approval of a premarket approval appiestion of the general Act (Act) that do not require approval of a provisions of the Act. The general therefore, market the device, subject to the general vone seguiredion, listing of devices, good
controls provisions of the Act include requirements for annual registration controls provisions of the Act merded requirement against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into crated in Existing major regulations affecting your Approval), it may be subject to such adultions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title Al-Sades Hooses device can be found in the Code of Peacharies your device in the Federal Register.
Image /page/2/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. In the center of the logo are the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three dots are arranged horizontally below the word "Centennial". The text around the circle is difficult to read.
d Promoting Public Halth
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of any I edital statutes and regarations and using, but not limited to: registration and listing (21 comply with an the Act s requiremones, moreaning, which and manufacturing practice requirements as set CFK Part 807), labeling (21 OFR Part 820), government (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin narketing your device as described in your Section 510(k) I his letter wifi anow you to begin manteinig , " substantial equivalence of your device to a legally premiation. The PDF miding of cassification 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 If you desire specific advice for your of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prease note the regalation other general information on your responsibilities under (2107 N Fart 607.97). Promise 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Supercath V Premarket Notification
INDICATIONS FOR USE
510(k) NUMBER (If known): K052267
Supercath V Device Name:
Indications for Use:
The Supercath V fistula catheter is intended to access a vein or artery while connected to a blood circuit during kidney dialysis. The Supercath V is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.
(Please do not write below this line - Continue on other page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use
David H. Seamon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) Number
2 of 2 (Attachment 9)