15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET

K071422 · Rex Medical · MSD · Aug 22, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071422
• Device Name: 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
• Applicant: Rex Medical
• Product Code: MSD · Gastroenterology, Urology
• Decision Date: Aug 22, 2007
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemo-Stream™ True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis.

Device Story

Hemo-Stream™ True Over the Wire Dialysis Catheter is an implanted vascular access device for chronic hemodialysis and apheresis. It features a 15.5F catheter with three kidney-shaped arterial lumens and one round venous lumen, designed to achieve high flow rates at low arterial pressures. The device includes a catheter cuff for tissue in-growth and an offset tip for arterial/venous separation. It is inserted using a provided 16F dilator and tunneling tool. The device is intended for use by healthcare professionals in clinical settings. By providing reliable vascular access, it facilitates the extracorporeal blood treatment necessary for patients with renal failure or other conditions requiring apheresis, potentially improving patient outcomes through efficient blood flow management.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and non-clinical performance testing, including functional testing per ISO 10555-1 and biocompatibility testing per ISO 10993.

Technological Characteristics

Implanted vascular access catheter; 15.5F O.D.; 20% Barium Sulfate radiopaque material; 3 kidney-shaped arterial lumens, 1 round venous lumen; 1.125" tip separation; injection molded one-piece hub; latex-free injection sites; non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring chronic hemodialysis and apheresis.

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

• Hemo-Stream™ Hemodialysis Catheter Set (K023847)
• Vaxcel Plus Dialysis Catheter (K040736)
• Vaxcel Dialysis Catheter (K012365)

Submission Summary (Full Text)

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Special 510(k): Device Modification Hemo-Stream Hemodialysis Catheter

Image /page/0/Picture/3 description: The image shows the logo for REX MEDICAL. The logo is in black and white. The word "REX MEDICAL" is written in a bold, sans-serif font. A curved line extends from the top left of the "R" to the bottom right of the "L", creating a semi-circular shape around the text.

AUG 2 2 2007

# 1100 East Hector Street, Suite 245, Conshohocken, PA 19428

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

## Submitter's Identification: 1.

Rex Medical, LP 1100 East Hector Street Suite 245 Conshohocken, PA 19428

Contact: Mr. Walter H. Peters Quality Manager

Date Summary Prepared: April 30, 2007

## Name of the Device: 2.

Hemo-Stream™ True Over the Wire Dialysis Catheter

## Predicate Device Information: 3.

- 1) K023847, Hemo-Stream™ Hemodialysis Catheter Set
- 2) K040736, Vaxcel Plus Dialysis Catheter
- 3) K012365, Vaxcel Dialysis Catheter

## 4. Device Description:

The Rex Medical Hemo-Stream™ True Over the Wire Dialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.

The Hemo-Stream™ True Over the Wire Dialysis Catheter will be available in lengths of 24, 28, 32, 36 and 40cm.

The device is used in exactly the same manner as the predicate devices and other substantially equivalent 510(k) cleared devices.

#### 5. Intended Use:

The Hemo-Stream™ True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis.

## 6. Comparison to Predicate Devices: See next page

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KC 71422 page d'or?

# Special 510(k): Device Modification
Hemo-Stream Hemodialysis Catheter

| Attribute | Rex Medical Hemo-<br>Stream ™ True Over<br>the Wire Dialysis<br>Catheter (Subject<br>Device) | Rex Medical Hemo-<br>Stream™<br>Hemodialysis<br>Catheter Set<br>(K023847 - Predicate) | Vaxcel Plus<br>Hemodialysis Catheter<br>Set (K040736 -<br>Predicate) | Vaxcel Hemodialysis<br>Catheter Set (K012365 -<br>Predicate) |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------|
| Catheter Type | Implanted Vascular<br>Access | Implanted Vascular<br>Access | Implanted Vascular<br>Access | Implanted Vascular<br>Access |
| Intended Use | Hemodialysis and<br>Apheresis | Hemodialysis and<br>Apheresis | Hemodialysis and<br>Apheresis | Hemodialysis and<br>Apheresis |
| Lumen<br>Configuration | 3 Kidney Shaped<br>Arterial Lumens, 1<br>Round Venous Lumen | 4 Oval Arterial<br>Lumens<br>1 Square Venous<br>Lumen | 1 "D" Arterial Lumen<br>1 "D" Venous Lumen | 1 "D" Arterial Lumen<br>1 "D" Venous Lumen |
| Catheter O.D. | 15.5F | 16F | 16F Proximal/14.5F Distal | 16F Proximal; 14F Distal |
| Arterial/Venous<br>Access Lumens | Yes | Yes | Yes | Yes |
| Color Coded<br>Female Luers | Red: Arterial, Blue:<br>Venous | Red: Arterial, Blue:<br>Venous | No | Red: Arterial; Blue:<br>Venous |
| Color Coded<br>Clamp on<br>Extensions | No | Red: Arterial, Blue:<br>Venous | No | Red: Arterial; Blue:<br>Venous |
| Rotating Suture<br>Wing on Cath.<br>Hub | No | Yes | Yes | Yes |
| Catheter Cuff for<br>Tissue In-<br>Growth | Yes | Yes | Yes | Yes |
| Radiopaque<br>Catheter Lumen | 20% Barium Sulfate | 20% Barium Sulfate | Radiopaque, unknown<br>loading | Radiopaque, unknown<br>loading |
| Offset Tip for<br>Arterial / Venous<br>Separation | 1.125" Separation | 1" Separation | 0.675" Separation | 0.675" Separation |
| Hub junction for | Injection Molded, One | Integrated clamshell | Insert Molded hub to form | Insert Molded hub to form |
| catheter lumen /<br>extension tubing | Piece Hub | hub covering sealed<br>junctions | connection of extension<br>tubing to lumens | connection of extension<br>tubing to lumens |
| Dilator Provided<br>for Catheter<br>Insertion | 16F Rex Dilator | 18F Cook Coons<br>Dilator | 15F Tear-Away<br>Introducer Sheath | 14F Tear-Away<br>Introducer Sheath |
| Tunneling Tool<br>provided for<br>Catheter<br>Insertion | Tunneling Tool<br>w/integrated Handle | Tunneling Tool<br>w/integrated Handle | Trocar device with barbs<br>to attach to the catheter<br>tip | Trocar device with barbs<br>to attach to the catheter<br>tip |
| Injection Sites<br>supplied with<br>Catheter | Qty. 2: Latex Free<br>Injection Sites<br>Provided | Qty. 2: Latex Free<br>Injection Sites<br>Provided | Qty: 2: Injection Sites<br>(material composition not<br>known) | Qty: 2: Injection Sites<br>(material composition not<br>known) |
| Priming Volume<br>Printed on<br>Female Luers | No | Yes | Yes | Yes |
| Catheter<br>Identification and<br>Reference size<br>printed on<br>Catheter Hub | Yes | Yes | Yes | No |

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# 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

Comparative functional testing to the predicated devices was performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. Material testing also included ISO 10993 Biocompatibility Testing. Testing results revealed the subject device to be substantially equivalent to the predicate devices.

## Discussion of Clinical Tests Performed: 8.

Not applicable as there are no new indications for use which must be supported bv clinical data.

## 9. Conclusions:

The subject device, the Hemo-Stream™ True Over the Wire Dialysis Catheter, has the same intended use as the predicate devices, Hemo-Stream ™ Hemodialysis Catheter Set (K023847), the Vaxcel Plus Dialysis Catheter (K040736) and the Vaxcel Dialysis Catheter (K012365). Bench testing and nonclinical testing supplied within our submission demonstrates that there are not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness. Therefore, the Hemo-Stream™ TM True Over the Wire Dialysis Catheter is substantially equivalent to the predicate devices, the Hemo-Stream™ Hemodialysis Catheter Set (K023847), the Vaxcel Plus Dialysis Catheter (K040736) and the Vaxcel Dialysis Catheter (K012365).

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Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rex Medical, LP c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd. Suite 200 GREAT NECK NY 11021

AUG 2 2 2007

Re: K071422

Trade/Device Name: Hemo-Stream" True Over the Wire Dialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: August 3, 2007 Received: August 10, 2007

Dear Ms. Goldstein-Falk:

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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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# Page 2 - Ms. Susan Goldstein-Falk

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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Doyce M. Whay fincs

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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Exhibit B

# Indications For Use

Page 1 of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Hemo-Stream™ True Over the Wire Dialysis Catheter

Indications For Use:

The Hemo-Stream™ True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The Counter Use (Optional Format 1-2-96)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jvthan

ivision Sign-Off ivision of Reproductive, Abdominal and Radiological Devices 510(k) Number