C-PORT - HP POWER INJECTABLE PORT
Device Facts
| Record ID | K091099 |
|---|---|
| Device Name | C-PORT - HP POWER INJECTABLE PORT |
| Applicant | Phs Medical GmbH |
| Product Code | LJT · General Hospital |
| Decision Date | May 22, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5965 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The C-Port™ "Power Injectable" Port (family of products) will be used as a subcutaneously implanted device for delivery of medications, fluids, special fluids such as contrast enhancement fluids or for withdrawal of blood. When used with a power injectable needle infusion set, the C-Port® "Power Injectable" Port is indicated for power injection of contrast media using an 8.0Fr or 9.6Fr catheter. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle.
Device Story
Subcutaneously implanted vascular access device; consists of titanium chamber with silicone membrane and attached catheter. Physician implants port beneath skin; catheter tunneled to superior vena cava. Used for repeated delivery of medications, fluids, contrast media, or blood withdrawal. When paired with power-injectable needle infusion set, enables high-pressure contrast media delivery for CT imaging. Physician accesses port via percutaneous needle puncture of septum. Radiopaque catheter marks assist in tip positioning verification via fluoroscopy. Benefits include reliable, repeated venous access for therapy and diagnostic imaging.
Clinical Evidence
Bench testing only. No clinical data provided. Performance verified through mechanical testing of flow rates, pressure limits, and catheter integrity during power injection.
Technological Characteristics
Titanium chamber; silicone membrane; radiopaque catheter; 8.0Fr or 9.6Fr catheter sizes. Designed for subcutaneous implantation. Manual operation via non-coring Huber needles. No electronic components or software.
Indications for Use
Indicated for patients requiring repeated vascular access for delivery of medications, fluids, contrast media, or blood withdrawal. Used with 8.0Fr or 9.6Fr catheters. Power injection of contrast media limited to 5 ml/s (19/20G needle) or 2 ml/s (22G needle). CT power injections limited to 10 accesses over device life.
Regulatory Classification
Identification
A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Predicate Devices
Submission Summary (Full Text)
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K0910993
Premarket Notification 510(k)
Power Injectable Port and Catheter Kits
Section 10
510(k) Summary
MAY 22 2009
# PHS Medical GmbH Leipziger Str. #246 DE 34260 Kaufungen Germany
# PHS Medical GmbH Premarket Notification 510(k) Summary for the "Power Injectable" C-PortHP Family of Implanted Vascular Access Devices
Part I General Information
- PHS Medical GmbH Submitter name: 1. 3004407880 FDA Establishment Number: 2. 9075683 Owner / Operator Number: Leipziger Str. #246 3. Address: DE 34260 Kaufungen Germany 011-49-5605-94.96.25 4. Phone: 011-49-5605-94.96.99
- Peter Hankel-Shepherd Contact person: Company 6. Donald F. Hults : U.S. Agent 2360 Johnson Road
- Date prepared: 7.
ર.
Fax:
March 2, 2009
214-549-9208
Southlake, TX 76092
- Device trade or proprietary name: 8.
C-PortHe "Power Injectable" Port (family of Vascular Access Devices)
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Power Injectable Port and Catheter Kits
### Device common name or usual name: 9.
Implantable Infusion Ports
### Device classification name: 10.
Port and catheter, implanted, subcutaneous, intravascular ( 85-LJT )
### 11. Device classification:
The device is a Class II Device
### Substantial equivalency: 12.
Claimed against the following device(s):
- C-Port (#K030636, 2003) ●
- Bard Access Systems PowerPort (#K060812, 2006) ●
- MEDCOMP ProFUSET (#K070003, 2007) .
### 13. Type of medical device:
The PHS Medical GmbH family of "Power Injectible" Vascular Access Devices is The PTS Medical Ombrilanily of Townly of Township an attachable catheter for a group of subculaneously implantable ports The C-Port™ "Power Injectable"
application by physicians in indicated therapies. The C-Port"P "Power Injectable" application by physicians in with an appropriate pressure injectable non-coring needle infusion set.
### Description of Device: 14.
### The device is to be used by or on the order of a physician. CAUTION:
The device has a port that is a titanium chamber with a silicone membrane The device nas a port chat be insertion. The port comes in a standard size to enable use with adult patients. A standard profile is preferable so the chamber enable use with adult pationis. Treatment to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into the heart and insert into the rena catheter is fixed to the port with a catheter lock during a larger vossels. The catheter has a senes of radiopaque marks procodire to ith determination when the catheter is inserted into the vena cava. to enable depth dolorhination whole can be cant insertion, and port implantation for A kit is provided to all hirea "sterile, single use". For product supplied as OEM bulk, non-sterile, the product is vacuum-packaged in a double bag format and built, non blonio, the prelabeler to kit and sterilize). Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit intended for sterilization.
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## Indications for use statement and product function: 15.
The C-Port™ "Power Injectable" Port family of Vascular Access Devices will be used as a subcutaneously implanted device where repeated access to the used as a subculariboachy infrica for delivery of medications, fluids, vascular system to the the such as contrast enhancement fluids of for withdrawal of blood.
When used with a power injectable needle infusion set, the C-Power when used with a power injocable no power injection of contrast media using an 8.0Fr infocture catheter. For power injection of contrast media, the maximum or 5.01 outhotonfusion rate is 5 ml/s with a 19 or 20 gauge non-coring power recommended infosion rate it o mile mire non-coring power injectable needle.
The C-PortHP "Power Injectable" Port family of ports and catheters provides a simple method for delivery of volumes of specified fluids via a chamber leading to simple meanod for delivery on varge vessel in the body. The catheter is inserted into a large vessel and terminated in the superior vena cava. The port is into a large vessor and tommatou in the clavicle on the patient's right implanted surations or fluids can then be provided as necessary.
### Contraindications or cautions for use: 16.
A complete listing of the possible complications in the implantation and use of the A complete listing of the possible " Ports is listed in the USER'S MANUAL which is supplied with any sterile product. Possible complications in the use of the C-Ported "Power Injectable" Port include, but are not limited to, infection, the O-r oft - riot - riown the device, hematomas, clot formation, thrombosis, catheter erosion, extrusion of the lication, and occlusion. Improper placement of the hagmentation, and chibelizan shown to cause the catheter to be severed from a catheler in the bour has book and the first rib. In the placement of the piriching "check by the superior vena cava, caution should be exercised to be sure that the catheter does not pass between the clavicle and the first rib.
### Methods (ways) of application: 17.
The method of application is to prepare and insert the catheter into the vein (by "The method or application notageous" method) and on into the vena cava. Then the proximal end of the catheter is tunneled subcutaneously to an area of cut the proximal the port is to be placed beneath the skin and secured to the fascial layers of tissue. The catheter is joined to the port and the port is secured to the tissue. All wounds are then closed normally.
Intravenous fluids, medications, blood products, or nutritional fluids may then be intrainsationed by needle puncture of the septum in the port or periodic blood samples may be acquired if appropriate flushing techniques are followed (instructions for this are found in the USER'S MANUAL).
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When used with a power injectable needle infusion set, the C-Port® "Power Injectable" Port is indicated for power injection of contrast media. For power injectable Fort is indication of power injob.org or 9.6Fr catheter, the maximum injection of contract modia, asing on a loth a 19 or 20 gauge non-coning power injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle.
## Special precautions for disposal of the device or emptied packages 18. (container):
The sharps used in the procedure should be disposed of according to institution r ne sharps asou in the pres or empty packages do not require special handling when disposing.
### Information on sterilization method(s): 19.
### For sterile products: a)
All C-Port™ "Power Injectable" Port family products that are intended to be "All O-F one" ower my manufactured by PHS Medical GmbH and are sterilized steme, single ass - Sterilization details for validation, verification, bioburden, by can be found in the section on Risk Assessment (7.0) and Sterilization (8.0) in the PHS Medical GmbH 510(k).
### For non-sterile products: b)
The C-Port™ "Power Injectable" Port may be supplied in bulk, non-sterile format to a contracted OEM customer so they can relabel, kit and sterilize. Each group to a contractor of OEM sale is double-bagged under vacuum, appropriately of ports interiod for Shipment. Any recognized open or damaged packaging laboled, and boxed for clipps in the warranty labeling followed, and the product returned for evaluation and potential repackaging or disposal.
### 20. Validity period:
As long as the package/product is unopened and undamaged the product is As long as the package productions of the components of the C-Port" "Power Injectable" Port family of products do not deteriorate over time.
### Special precautions for handling and transportation: 21.
Keep product dry. Product must be stored in an environment that is temperate (+6°C/+43° F - +35° C/95° F). Do not open the package prior to use.
#### Description of package: 22.
A C-Portle "Power Injectable" Port product (port and catheter) is a basic "cutdown" set with the catheter and port included. The set is packaged in a plastic trav with:
- 1-Huber point needle (straight needle) a)
- b) 1-Vein pick (retraction/introducing device)
- c) 1-Tunneling trocar (atraumatic tip)
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Premarket Notification 510(k)
Power Injectable Port and Catheter Kits
- d) 1-Blunt needle
- e) 1-10 ml Syringe
- 1-Locking mechanism ಗಿ
- g) 1-Patient chart sticker
- h) 1-Directions for Use
The plastic tray is heat sealed in a polyethylene/nylon Tyvek header bag (pouch) and sterilized. If requested, a percutaneous introducer kit is included in the C-Port "Power Iniectable" Port package. This Port/Introducer Set is listed with its own catalog number and must be ordered as such. These sets may be ordered separately or together per physician choice.
The percutaneous introducer kit, or "complete kit" as described in the brochure, contains:
- a) 1-Basic set
- b) 1-"Split-Sheath" introducer
- c) 1-J-Flex Guide Wire with thumb advancer
- d) 1- Introducer needle
In addition, the C-Port" "Power Iniectable" Port "complete kit" is packaged with a User's Manual and Patient Implant stickers.
Each kit is packaged in an external fiberboard box. Each box is labeled appropriately to match the item inside the box.
#### 23. Labeling:
Each product is labeled on its plastic container with a stick-on label containing the following information:
Company Name, Location, Contact Number Product Name by Brand Name and Common Name Model No. Size of catheter Lot Number registration Units/package indicator Restricted Device: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician Sterile in unopened undamaged package For single use only Package contains information as noted in item 22 above
### 24. Instructions:
Detailed instructions for use and care of the C-Port® "Power Injectable" Port are in the USER'S MANUAL. A simple listing of implant instructions is noted here:
Before implanting inspect the port. Do not use if holes, cracks, or surface contaminants are visible.
Flush all air from the port prior to placement using the 20ga. Huber point needle and syringe with heparinized saline.
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Premarket Notification 510(k)
Power Injectable Port and Catheter Kits
The selected site for the reservoir body should be over a bony structure and in a location both convenient and comfortable for the patient. Place the catheter into the vein using the "cut-down" technique or by using a
percutaneous introducer. Place the tip of the catheter in an area of high blood flow when placing it
in the venous system. Fluoroscopy is recommended to verfiy proper placement of the catheter tip in the superior vena cava.
Take care not to serrate the catheter tip or occlude it during the catheter placement process. Leave sufficient slack upon placement so patient movement does not stress the catheter.
Position the pocket for the reservoir so that the suture line is not directly over the port. Do not place the port too deep or too shallow. A depth of approximately 5mm under the skin surface is recommended as the optimal placement depth.
Cut the catheter to the proper length and moisten all components with saline.
Slide the catheter lock over the catheter.
Slide the catheter over the buibed outlet tube (pin connector) of the reservoir. Slide the catheter lock and catheter forward until the catheter and the outlet tube are completely covered.
Test by gently tugging on the catheter.
Secure the port to the underlying fascia with at least three non-absorbable sutures.
After suturing has been satisfactorily completed, flush the incision with an appropriate antibiotic to ensure a sterile pocket.
Before closure, check patency and flow through the C-PortHP "Power Injectable" Port by x-ray, fluoroscopy, or by an imaging technique of choice.
After each use, always leave C-Port" "Power Injectable" Port filled with a heparinized saline solution in a concentration recommended by your institution.
If the C-Port™ "Power Injectable" Port is to be used for "power injection" of special fluids, a power injectable needle infusion set must be used. The C-Porthe "Power Injectable" Port is intended to be used with an 8.0Fr or 9.6Fr catheter. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19 or 20 gauge non-coring power injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three overlapping wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
## Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PHS Medical GmbH C/o Mr. Donald F. Hults DFH Associates 2360 Johnson Road Southlake, Texas 76092
MAY 2 2 2009
Re: K091099
Trade/Device Name: C-PortHB "Power Injectable" Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: March 23, 2009 Received: April 16, 2009
Dear Mr. Hults:
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 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
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Page 2- Mr. Hults
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runser
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kng1099 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: C-Port*R "Power Injectable" Port (family of Implanted Vascular Access Devices) Access Devices]
Port and catheter, Implanted, Subcutaneous, Intravascular - Intravascular
Indications for Use:
The C-Port™ "Power Injectable" Port (family of products) will be used as a The C-Fort subculaneously implanted user for delivery of medications, fluids, special system is the therapy of onoloo for as not withdrawal of blood.
When used with a power injectable needle infusion set, the C-Port" "Power when used with a power injection of contrast media using an mjectable - For is marcator power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge nonmaximum reconimended infactor function is 22 gauge non-coring power injectable needle.
Prescription Use X (Part 21 CFR-801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR-801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurence of CDRH, Office of Device Evaluation (ODE)
seal
ivision Sign-Off) ivision of Anesthesiology, General Hospital ifection Control, Dental Devices
η(k) Number: 68009
(Optional Format 3-10-98)
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510(k) Number (if known): ____
Device Name: C-Port4P "Power Injectable" Port (family of Implanted Vascular Access Devices) Access Devices]
Port and catheter, Implanted, Subcutaneous, Intravascular - July
Indications for Use:
The C-Port® "Power Injectable" Port (family of products) will be used as a The O4 ort system is the therapy of choice for delivery of medications, fluids, special fluids such as contrast enhancement fluids or for withdrawal of blood.
When used with a power injectable needle infusion set, the C-Port® "Power Injectable" Port is indicated for power injection of contrast media using an 11/2018 Fr catheter. For power injection of contrast media, the o.or of o.or road.net infusion rate is 5 ml/s with a 19 or 20 gauge nonmaximum recomment in a medie or 2 ml/s with a 22 gauge non-coring power injectable needle.
For CT diagnostic procedures, it is recommended that the number of CT "power injections" be limited to a maximum number of ten (10) accesses over the life of the device.
Prescription Use (Part 21 CFR-801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR-801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
s. are for
Division of Anesthesiology, General Hospital infection Control, Dental Devices
(Optional Format 3-10-98)
510(k) Number: K091099
4
