SUPERCATH V

K052267 · Togo Medikit Co., Ltd. · FIE · Oct 27, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K052267
• Device Name: SUPERCATH V
• Applicant: Togo Medikit Co., Ltd.
• Product Code: FIE · Gastroenterology, Urology
• Decision Date: Oct 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Supercath V is a single-use fistula catheter for hemodialysis; provides vascular access for blood circuit connection. Features include a metallic introducer needle for vessel puncture and a catheter hub with a built-in hemostatic valve; valve assists compression hemostasis upon needle withdrawal. Includes a safety mechanism where the metallic needle retracts into an extendable casing post-puncture to prevent needlestick injuries. Operated by healthcare professionals in clinical settings. Output is the established vascular access point for dialysis machines. Benefits include reduced risk of accidental needlestick injuries for clinicians and facilitated hemostasis for patients.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Single-use fistula catheter; includes metallic introducer needle and integrated hemostatic valve. Features extendable needle casing for safety. Sterilized via Ethylene Oxide (EtO). Available in multiple gauge sizes and needle lengths.

Indications for Use

Indicated for patients requiring vascular access for hemodialysis. Used to access veins or arteries for connection to a blood circuit.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• PROTECTIV PLUS Safety IV Catheter (K030571)
• Supercath A.V. Fistula (K854773)
• Supercath Z3V (K050114)

Submission Summary (Full Text)

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Supercath V Premarket Notification

K052267

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.

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Supercath V Premarket Notification

K052267

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.<br>Table<br>AND & A |
|------------------------|
|------------------------|

| Factor | Supercath V | PROTECTIV<br>PLUS | Supercath<br>A.V. Fistula | Supercath<br>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.

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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

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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

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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 [phone] or [phone]

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

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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)