HEMO-CATH 10F, HEMO-CATH 12.5F

K113487 · Medical Components, Inc. · MSD · Mar 9, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K113487
• Device Name: HEMO-CATH 10F, HEMO-CATH 12.5F
• Applicant: Medical Components, Inc.
• Product Code: MSD · Gastroenterology, Urology
• Decision Date: Mar 9, 2012
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternative insertion sites include subclavian vein as required.

Device Story

Hemo-Cath® is a 12.5 French double-lumen silicone catheter designed for long-term or temporary vascular access. It features a cuff for long-term implantation and is available in various lengths (15cm to 40cm), including pre-curved options. The device is inserted percutaneously by a clinician, typically into the internal jugular vein. It facilitates blood flow for hemodialysis, hemoperfusion, or apheresis. The catheter includes a soft pliable hub with a suture wing, color-coded clamps, and luer connectors to prevent air/fluid communication. The radiopaque silicone construction allows for visualization. By providing reliable venous access, the device enables extracorporeal blood treatment, benefiting patients with renal failure or those requiring apheresis.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ISO 10555-1, ISO 10555-3, and ISO 594-2. Evaluations included air leakage, liquid leakage, priming volume, flow versus pressure, force at break, recirculation, chemical exposure, accelerated aging, and mechanical hemolysis. Biocompatibility testing met ISO 10993 requirements.

Technological Characteristics

12.5 French double-lumen catheter; radiopaque silicone construction; cuff for long-term fixation; soft pliable hub with suture wing; color-coded clamps and luer connectors. Complies with ISO 10555-1, ISO 10555-3, and ISO 594-2 standards. Sterilization method not specified.

Indications for Use

Indicated for adult patients requiring long-term or temporary vascular access for hemodialysis, hemoperfusion, or apheresis therapy via percutaneous insertion, primarily in the internal jugular vein or alternatively the subclavian vein.

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-Cath® (K893439)
• Hemo-Cath® (K091953)
• Hemo-Cath® (K981125)
• Hemo-Cath® (K030270)
• Hemo-Cath® (K010306)

Submission Summary (Full Text)

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K113487 Page 1 of 2

MAR - 9 2012

## 510(k) Summarv

Hemo-Cath® Summary of Safety and Effectiveness Prepared November 22, 2011

| Attachment 8<br>General Information | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------|
| Submitter: | MEDCOMP®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Phone: [phone]<br>Fax: [phone] |
| Contact: | Jean Callow<br>Regulatory Specialist |
| Device Trade Name: | Hemo-Cath® |
| Common Name: | Hemodialysis Catheter, Implanted |
| Classification Name: | MSD - Blood access device and accessories |
| CFR Reference: | 21 CFG 876.5540, Class III |
| Classification Panel: | Gastroenterology / Urology |

#### Predicate Devices:

Device Trade Name: Common Name: Classification Name: CFR Reference: Classification Panel: Premarket Notification: Hemo-Cath® Hemodialysis Catheter, Implanted LJF -Blood access device and accessories 21 CFR 876.5540, Class III Gastroenterology / Urology K893439, concurrence date June 13, 1989 K091953, concurrence date September 16, 2009 K981125, concurrence date February 26, 1999 K030270, concurrence date April 14, 2003 K010306, concurrence date October 3, 2001

Performance Standards: Performance standards have not been established by FDA under section 514 of the Federal Food, Drug, and Cosmetic Act.

## Indications for Use:

Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy

It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternative insertion sites include subclavian vein as required.

### Device Description:

Medcomp Hemo-Cath® 510(k) Summary

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K113487. Pge 2 of 2

- 12.5French double lumen design with cuff for long-term implant.
- Variety of lumen lengths: 15cm, 18cm, 24cm, 32cm, 32cm and 40cm.
- 12.5F with a pre-curved lumen in a 28cm and 32cm length.
- Radiopaque silicone material
- Lumen is connected to the extension via a soft pliable hub with a suture winq .
- Red and blue clamps and red and blue luers are provided on the extension tube to ● prevent air/fluid communications
- . The hub contains the device name and French size, clamp I.D. Rings are printed with the priming volume.

## Safety and Performance Tests

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the Hemo-Cath were previously cleared for similar applications by Medcomp, Inc.

Performance testing of the Hemo-Cath was conducted in accordance with the following international standards:

- ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General . Reguirements
- ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
- ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and . Certain Other Medical Equipment - Part 2: Lock Fittings

Subject product testing has yielded acceptable safety and performance outcomes.

Testing performed: Air Leakage Liquid Leakage Priming Volume Flow verse Pressure Force at Break Recirculation Chemical Exposure Accelerated Aging Mechanical Hemolysis

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the Split Cath® III is substantially equivalent to the cited predicate devices.

## Summary of Substantial Equivalence

Based on the indications for use and safety and performance testing, the Hemo-Cath meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilizations for use to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Jean Callow Regulatory Specialist MEDCOMP (MEDICAL COMPONENTS) 1499 Delp Drive HARLEYSVILLE PA 19438

MAR - 9 2012

Re: K113487

Trade/Device Name: Hemo-Cath® Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: February 7, 2012 Received: February 8, 2012

Dear Ms. Callow:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 the kit nave thing 100(k) of the act), or were on the market prior to May 28, 1976, the enactment date process (Occiten >><(n) of the works. 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 (1.c., ammission) and farmer proveral 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 11 your de fiel 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.

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);

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Page 2 - Ms. Jean Callow

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains 5cc Lidocaine: HCL 1% , which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing This drug, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your be FDA finding of substantial equivalence of your device to a legally prematicate 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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference Compiration at [phone]. Thise, production of the regeneral information on your to prematice nonneanen Act from the Division of Small Manufacturers, International and responsibilities and its toll free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

L. Harris Taylor, Ph.D.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K113487

Device Name: Hemo-Cath®

Indications for Use:

Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy.

It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternative insertion sites include subclavian vein as required.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(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)

Herbert Lewin

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices K113487
510(k) Number

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