(150 days)
No
The 510(k) summary describes a standard implantable port for vascular access and power injection, with no mention of AI or ML technology in its design, function, or testing.
No.
The device is a port system for accessing the vascular system to infuse medications or withdraw blood, and for power injection of contrast media. It does not directly provide therapy but facilitates its delivery.
No
Explanation: The device is an implantable port used for repeated vascular access for infusion of various substances and withdrawal of blood samples. It is a therapeutic/access device, not a diagnostic one.
No
The device description clearly details a physical, implantable port system with hardware components (port, catheter, septum, etc.) and mentions in vitro testing of these physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for direct patient therapy by providing access to the vascular system for infusion and withdrawal of substances. This is a therapeutic and diagnostic access device, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details an implantable port system designed to be placed within the patient's body for vascular access. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens, detect analytes, or provide diagnostic information based on in vitro testing.
Therefore, the Medcomp® Gen III Power Injectable Port is a medical device used for patient treatment and access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medcomp® Gen III Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. 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.
Product codes
LJT
Device Description
The Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.
Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.
The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port.
Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.
The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
In vitro testing was performed on the Power Injectable. Implantable Infusion Port to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990. Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols.
The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market: Power Injection Simulation, Elongation & Tensile, Priming Volume, Gravity Flow, Stem Break Force, Cap/Base Bond Integrity, Catheter Lock Integrity, Clearance Volume, Needle Insertion/Extraction Force, Reservoir Pressure, Static Burst Pressure.
The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003.
Biocompatibility: Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070003: Medcomp, Power Injectable Implantable Port
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K132177
DEC 12 2013
র ব
Section 5
510(k) SUMMARY
Traditional 510K
Submitter Information:
| Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201
Fax: (215) 256-9191 | |
|----------------------|-----------------------------------------------------------------------------------------------------|--|
| Contact: | Rosanna Severini
Compliance Manager | |
| Date Prepared: | June 28, 2013 | |
| Trade Name: | Medcomp® Gen III Power Injectable Port | |
| Common Name: | Power Injectable, Implantable, Infusion Port | |
| Classification Name: | Subcutaneous, implanted, intravascular infusion port and catheter | |
| C.F.R. Sections | §880.5965
Product Code and Class: LJT, II | |
| Predicate Devices: | K070003: Medcomp, Power Injectable Implantable Port, concurrence date
May 15, 2007. | |
Device Description:
The Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.
Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.
The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port.
Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.
The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.
Indications for Use:
The Medcomp® Gen III Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infission of medications, I.V. Shuts, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable the power injectable infusion port is indicated for power injection of contrast media. 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.
Medcomp® Gen III Power Injectable Port Summary .
1
Comparison to Predicate Devices:
The implanted port is substantially equivalent to the predicate devices in K070003 in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization.
| Port Types | Port Body and Catheter Options | Comparison to Predicate (K070003) |
|---|---|---|
| STANDARD | ||
| PRO-FUSE ® | Purple plastic cap and base. | Inception design of Medcomp Infusion CT Ports. The line began with the Standard Pro-Fuse®. |
| Catheters Offered: | ||
| 9.6F Silicone | ||
| 8F Polyurethane | ||
| Purple plastic cap and base. | ||
| LOW PROFILE | ||
| PRO-FUSE® | ||
| The base is smaller and smaller height than predicate, K070003. | ||
| Silicone Filled Suture Holes available. | ||
| MID-SIZE | ||
| DIGNITY® | Purple plastic cap and base. | |
| Catheters Offered: | ||
| 9.6F Silicone | ||
| 8F Polyurethane | ||
| 6.6F Polyurethane | ||
| 5F Polyurethane | ||
| Silicone Filled Suture Holes available. | ||
| LOW PROFILE | ||
| DIGNITY® | Purple plastic cap and base. | |
| Catheters Offered: | ||
| 8F Polyurethane | ||
| 6.6F Polyurethane | ||
| 5F Polyurethane | ||
| Silicone Filled Suture Holes available. | ||
| MINI | ||
| DIGNITY® | Purple plastic cap and base. | |
| Catheters Offered: | ||
| 8F Polyurethane | ||
| 6.6F Polyurethane | ||
| 5F Polyurethane | ||
| Silicone Filled Suture Holes available. |
The unique characteristic of the Gen 111 implanted port is a universal catherer lock. The new catherer lock is universal in form therefore eliminating the need for insertine which way the lock nust be connected to the port.
. . . . 、、
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. '''' l
Medcomp@ Gen III Power Injectable Port Summary :
: .
2
Bench / Performance Data:
In vitro testing was performed on the Power Injectable. Implantable Infusion Port to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990. Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols.
The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market.
| Power Injection Simulation |
|---|
| Elongation & Tensile |
| Priming Volume |
| Gravity Flow |
| Stem Break Force |
| Cap/Base Bond Integrity |
| Catheter Lock Integrity |
| Clearance Volume |
| Needle Insertion/Extraction Force |
| Reservoir Pressure |
| Static Burst Pressure |
The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003.
Biocompatibility:
Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993.
Technological Characteristics:
Technological similarities between the proposed devices remain the same. The primary difference between the predicate and Gen III implanted port is the universal lock is universal in form and capable of being placed bi-directionally. This provides a unique feature while maintaining the same functional characteristics of the predicate device.
Summary of Substantial Equivalence:
The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices.
3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 12, 2013
Medical Components, Incorporated Ms. Rosanna Severini Regulatory Specialist 1499 Delp Drive HARLEYSVILLE PA 19438
Re: K132177
Trade/Device Name: Medcomp® Gen III 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: November 11, 2013 Received: November 12, 2013
Dear Ms. Severini:
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,
4
Page 2 - Ms. Severini
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 (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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,
Image /page/4/Picture/8 description: The image shows a document with some text and a decorative design. The text includes the name "Tejashri Purohit-Sheth, M.D." followed by "Clinical Deputy Director". The word "FOR" is at the bottom right. The design is on the left side of the text.
Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
、1765年、1994年、1987年、1985年)、1982年の2008年、19
Indications for Use
510(k) Number (if known) K132177
Device Name
Medcomp@ Gen III Power Injectable Port
Indications for Use (Describe)
The Medican po Gen III Power Injectable Por patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-oring power injectable needle.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Richard C. Chapman
Date: 2013.12.12 10:16:39 -05'00' |
| ------------------------------------------------------------------------------ | ----------------------------------------------------------------------------- |
|---|
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
FORM FDA 3881 (9/13)
PSC Publishmig Serviors ( JO1) +4 3-4740 EF