(144 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of the vascular access device, with no mention of AI or ML.
No.
The device facilitates the administration of drugs and withdrawal of blood but does not provide therapy itself; it is an access device for therapies.
No
This device is designed for repeated access to the vascular system for injections, infusions, blood administration, and blood withdrawal as part of a therapy regimen. Its purpose is therapeutic and facilitative, not diagnostic.
No
The device description clearly states it is composed of physical components like a port reservoir made of titanium or polysulfone, a silicone septum, and a catheter system. It also mentions an implantable kit with tools for placement and implantation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen." This describes a device used in vivo (within the body) for therapeutic and diagnostic sample collection purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details an implantable port and catheter system designed to be placed within the patient's vascular system. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples in vitro, nor does it describe any reagents, calibrators, or controls typically associated with IVD devices.
In summary, the NorPort Family of Implanted Vascular Access Devices is an implantable medical device used for accessing the vascular system, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The NorPort Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
Our device is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium (510 (k)# 871192) or polysulfone (510 (k)# 840788) chamber with a silicone septum and an outlet section. The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity. The port comes in two different sizes to accommodate different body frames. The catheter that is attached to the port is long enough to be inserted in the superior vena cava/right atrium junction to allow for fluid infusion into the heart and large blood vessels.
The NorPort will also be available as part of an implantable kit. The kit contains all the tools needed to aid in catheter placement, insertion and port implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superior vena cava/right atrium junction
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)
The data collected from the non-clinical tests demonstrated that the functionality and performance characteristics of the NorPort vascular port are comparable to the currently marketed vascular ports. The test performed include: catheter to port connection, septum puncture/port leak, patency verification, static burst, and tensile strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Norfolk Medical Vascular Access Port (K830000), PHS C-Port (K091099), Angiodynamics Vortex VX Port Implantable Infusion Port (K081472), Bard PowerPort Implanted Titanium Port Chronoflex with 8 Fr. Catheter (K060812)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
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Norfolk ( Medical
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Section 5
510(k) Summary
Single Lumen Titanium Implanted Port
510 (k) Summary of Safety and Effectiveness Information 21 CFR 807.92
Part I General Information
5.1 Submitter/Sponsor Information
Submitter Name: FDA Establishment Registration Number: Address:
Telephone Number: Fax Number: Contact Person: Date of Preparation: Norfolk Medical Products, Inc.
1450392 7350 N. Ridgeway Skokie, IL 60076 (847) 674-7075 (847) 674-7066 Michael J. Dalton/President August 20, 2010
5.2 Device Name
Device Name:
Trade Name:
Device Common or Usual Name:
Classification Name:
Implanted Drug Delivery Device (Port)
NorPort Family of Ports
Implantable Infusion Ports
LJT- Port & Catheter, Implanted, Subcutaneous, Intravascular 21 CFR 880.5965- Subcutaneous, Implanted, Intravascular Infusion Port and Catheter, Class II
JAN 1 4 2011
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Norfolk ( Medical
7350 N. Ridgeway, Skokie, IL 60076 . 847-674-7075
Predicate Device Name 5.3
Device Name: Premarket Notification:
Device Name: Premarket Notification: PHS Medical GmbH C-Port 510 (k)# 091099, 2009
Bard Power Port Titanium Port w/8Fr 510 (k)# 060812, 2006
Device Name: Premarket Notification:
Device Name: Premarket Notification:
Device Name: Premarket Notification:
Device Name:
Premarket Notification:
Device Name: Premarket Notification:
Device Name: Premarket Notification: Angiodynamycs Vortex® 510 (k)# 081472, 2008
Vascular Medical Access Port, NorPort™ 510 (k)# 830000, 1983
Norfolk Medical, material Titanium 510 (k)# 871192, 1987
Norfolk Medical, change to silicone catheter. 510 (k)# 871209, 1987
Norfolk Medical, change to silicone septum. 510 (k)# 863723, 1986
・・・・・
Norfolk Medical, material polysulfone. 510 (k)# 840788. 1984
5.4 Device Description
Our device is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium (510 (k)# 871192) or polysulfone (510 (k)# 840788) chamber with a silicone septum and an outlet section. The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity. The port comes in two different sizes to accommodate different body frames. The catheter that is attached to the port is long enough to be inserted in the superior vena cava/right atrium junction to allow for fluid infusion into the heart and large blood vessels.
The NorPort will also be available as part of an implantable kit. The kit contains all the tools needed to aid in catheter placement, insertion and port implantation.
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Norfolk (
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
ર્ડ . ર Indications for Use Statement and Product Function
The NorPort, (Family of Implanted Vascular Access Devices), is a subcutaneously implanted device designed for use when repeated access to the vascular system is the therapy of choice. This device provides the user with an easily located needle insertion point for use whenever introducing fluids or medications into the vascular system or for acquiring periodic blood samples.
The NorPort implantable access device is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen. Additionally, The NorPort is indicated for
use when therapy requires long-term infusion of liquids via an external infusion pump.
5.6 Contraindications or Cautions for Use
A detailed list of possible implantation complications and contraindications of the NorPort family of ports are listed in the "User's Manual" which is supplied with each NorPort Kit. Some of the possible complications due to the implantation of the Norport include, but are not limited to, infection, occlusion, embolization, catheter fragmentation, erosion, extrusion of the device, hematomas, clot formation and thrombosis.
Improper placement of the catheter in the body has been shown to cause the catheter to be cut off from a, "pinching" effect by the clavicle and the first rib. Exercise caution when placing the catheter into the vein and the superior vena cava to ensure that the catheter does not pass between the juncture of the clavicle and the first rib. This "Pinch-off" complication is well documented and a well understood potential complication of the surgical implantation of the Port system.
5.7 Methods of Application
The method of application is to prepare and insert the catheter into the vein (using "cut down" method or "percutaneous" method) and on into the junction of the superior vena cava and the right atrium. Then the proximal end of the catheter is tunneled subcutaneously to an area of cut down where the port is to be placed beneath the skin and secured to the muscle tissue. The catheter is joined to the port and the port is sutured to the muscle. All incisions are sutured normally by the physician.
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Norfolk (C Medical
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Intravenous fluids, medications, blood products, or nutritional fluids may then be administered by needle puncture of the septum in the port or periodic blood samples may be acquired if appropriate flushing techniques are followed. A complete description of the uses of the port is contained in the Instructions for Use/User's Manual in Appendix B.
5.8 Special Precautions for Disposal
Any sharp instrument used in the procedure should be properly disposed of according to the institution policy. Any remaining parts or empty packages do not require special handling when disposing.
5.9 Sterilization Information
The NorPort is provided sterile and is recommended for single use only. In the event that the product becomes contaminated (not by bodily fluids or tissue) prior to use, replace it with sterile product and return the device to Norfolk Medical for repackaging and re-sterilization.
5.10 Validity Period
As long as the package remains unopened and undamaged the product is valid for use. The materials included with the NorPort kit and the NorPort do not degrade over time.
5.11 Special Precautions for Handling and Storage
Product should be stored in a cool and dry place. It should only be open prior to use.
Description of Package (NorPort Kit) 5.12
The NorPort Kit includes a port and catheter and the following inside the sterile package:
- 1 Huber Point Needle (straight needle)
- 1-Vein Pick (retraction/introduction device)
- 1- Tunneling trocar (atraumatic tip)
- 1- Blunt needle
- 1-10 mL syringe
- 1- Locking Mechanism
- 1- Patient chart Sticker
- 1- User's Manual
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Norfolk ( ) Medical
7350 N. Ridgeway, Skokie, IL 60076 . 847-674-7075
The plastic tray is contained within a heat-sealed polyethylene/nylon Tyvek® header bag (pouch) and sterilized. If requested a percutaneous introducer kit is included in the NorPort kit package. This Port/Introducer Kit is listed with its own catalog number. This kit might be ordered separate or as part of the kit as requested by the physician.
The percutaneous introducer kit, or "Full-Kit" as described in the brochure and catalog, contains the following:
- 1- Basic set
- 1- "Split Sheath" percutaneous introducer
- 1- J-Flex guide wire with thumb advancer
- 1- Introducer needle
In addition, the NorPort "Full-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 accordingly to match the item inside the box.
5.13 Labeling
All products are properly labeled on its plastic container with a stick on label containing the following information. Refer to appendix C for sample labels.
- Company Name, Address and Contact Number
- Product Name (Brand Name and Common Name
- Catalog Number
- Catheter Size
- Lot Number
- Units included
- Restricted Device Note: Federal Law restricts this device to sale by or on the order of a physician
- Sterile unopened undamaged package
- For single use only statement
5.14 Instruction for Use
Note: Detailed instructions for use and care of the NorPort are in the "USER'S MANUAL. A simple listing of implant instruction is listed here:
- Before implanting inspect the port thoroughly. Do not use if holes, cracks, or surface contaminations are present.
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Norfolk C Medical
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
-
Flush all air from the port prior to placement using the 20ga Huber point needle and syringe with heparinized saline, which is provided with the kit.
-
The selected site for the reservoir body should be over a bony structure and in a location that is 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 highly recommended to verify proper placement of the catheter tip in the junction of the superior vena cava/high right atrium.
-
Take special care not to serrate the catheter tip or occlude it during the catheter placement process. Leave sufficient slack upon placement so the patient movement does no 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 to shallow. A depth of approximately 5mm under the skin surface is recommended as the optimal placement of 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 barbed 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 the connection 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 NorPort by x-ray, fluoroscopy, or by imaging technique of choice.
-
After each use, always leave the NorPort filled with a heparinized saline solution in a concentration recommended by your institution.
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Image /page/6/Picture/0 description: The image shows the words "Norfolk Medical" in a bold, serif font. There is a logo between the two words that is a black heart shape with a white outline of a stethoscope on the left side. The letters "TM" are in the bottom right corner of the heart.
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
A copy of the Instructions for User's Manual is attached in Appendix B, which contains detailed instructions.
5.14 Technological Characteristics Summary
The following Summary Information refers to the Norfolk Medical NorPort and catheter.
Is the new device compared to Marketed Device?
- Yes, the Norfolk Medical NorPort and catheter are compared to legally marketed predicate devices.
Does the new device have the same indications for use statement?
- Yes, the Norfolk Medical NorPort and catheter have the same indications for use statement to legally marketed predicate devices.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. in deciding, impact on safety and effectiveness may be considered)?
- No, the differences do not alter the intended use of the port.
Does the new device have the same technological characteristics, e.g. design, materials, etc?
- No, not in all regards.
The NorPort implanted Port has some minor differences from the predicate devices, however, the fundamental scientific technology of the port/catheter has not changed.
Could the new characteristics affect safety and effectiveness?
- No, there are no new significant characteristics that would affect safety and effectiveness in the new device.
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Norfolk C Medical
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes,
FDA, Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990 was used to as a reference for the performance testing. BS EN ISO 10555-1:2009, Sterile, single-use intravascular catheters Part 1:General requirements, was used as a testing reference.
ISO 11135-1:2007, Sterilization of health care products -Ethylene oxide- Part 1, Requirements for development, validation and routine control of a sterilization process for medical devices. Specifies requirements for the development. validation and routine control of an ethylene oxide sterilization process for medical devices.
Are performance data available to assess effects of new characteristics?
Yes, verification testing was performed according to protocols based on the above referenced guidance document recommendation and additional standards.
Do performance data demonstrate equivalence?
Yes, performance data gathered in the design verification testing demonstrated that the NorPort family of products is substantially equivalent to the predicate devices mentioned in this submission.
ર.15 Non-Clinical Data
The data collected from the non-clinical tests demonstrated that the functionality and performance characteristics of the NorPort vascular port are comparable to the currently marketed vascular ports. The test performed include: catheter to port connection, septum puncture/port leak, patency verification, static burst, and tensile strength.
5.16 Conclusion
The NorPort family of products meets all established acceptance criteria for performance testing and design verification testing. Based on the FDA's decision tree, the NorPort and its components is substantially equivalent to their respective
8
Image /page/8/Picture/0 description: The image shows the words "Norfolk Medical" in a bold, serif font. There is a logo between the two words that is a stylized heart shape. The letters are black on a white background. There is a trademark symbol on the bottom of the heart.
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
predicates: Norfolk Medical Vascular Access Port (K830000), the PHS C-Port (K091099), the Angiodynamics Vortex VX Port Implantable Infusion Port (K081472), and the Bard PowerPort Implanted Titanium Port Chronoflex with 8 Fr. Catheter (K060812).
9
Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three wavy lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael J. Dalton President Norfolk Medical Products, Incorporated 7350 N. Ridgeway Skokie, Illinois 60076
JAN 1 4 2011
Re: K102385
Trade/Device Name: NorPort (Family of Implanted Vascular Access Devices) Port and Catheter, Implanted, Subcutaneous, Intravascular-LJT Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: January 5, 2011 Received: January 6, 2011
Dear Mr. Dalton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. No. of Children College
cerning your device
ements concerning you
10
Page 2- Mr. Dalton
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); 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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Section 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): MA K 102385
Device Name:
NorPort (Family of Implanted Vascular Access Devices) Port and Catheter, Implanted, Subcutaneous, Intravascular-LJT
Indications for Use:
The NorPort Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ald C. Chapman 1/12/11
0238
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of AneSthoolor 37
Infection Control, Dental Devices
510(k) Number: _