(127 days)
No
The summary describes a physical implantable device for vascular access and infusion, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No.
The device is used to facilitate therapeutic interventions (e.g., infusion of medications), but it does not directly provide therapy itself. It is an access device for repeated entry to the vascular system.
No
Explanation: The device is an implantable infusion port used for administering medications, fluids, and collecting blood samples. It facilitates rather than performs diagnostic procedures.
No
The device description clearly details physical components like an injection port, septa, catheter, and base assembly, indicating it is a hardware device.
Based on the provided information, the Dignity® Dual Port is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for patient therapies requiring repeated access to the vascular system for infusion of substances and withdrawal of blood samples. This is a direct interaction with the patient's body for therapeutic and diagnostic sample collection purposes, not for testing samples outside the body.
- Device Description: The description details an implantable device designed to be placed within the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples in vitro (outside the body) to provide diagnostic information. The withdrawal of blood samples is for subsequent testing, which would be performed using separate IVD devices.
Therefore, the Dignity® Dual Port is a medical device used for accessing the vascular system, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port 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 Dignity® Dual 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. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.
The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:
- 9.5F Standard Port Kit (Catalog number MRDP95ADN)
- 9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
- 9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
- 9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic imaging (for identification by letters "CT")
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)
Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device is equivalent to the predicate devices. The performance testing was performed in accordance with the following standards:
- BS EN ISO 10555-1: 2013: Intravascular Catheters Sterile and Single-use Catheters Part 1: General Requirements
- ISO 10555-3: 2013; Intravascular Catheters Sterile and Single-Use -Catheters - Part 3: Central Venous Catheters (General Plastic Surgery/General Hospital)
- BS EN ISO 10993-1; 2009: Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process (Biocompatibility)
- BS EN ISO 11135; Second Edition 2014; Sterilization of health-care products - Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 10555-6: 2015; Intravascular Catheters Sterile and Single-use -Catheters - Part 6: Subcutaneous implanted ports
- ASTM F2213-06: (Reapproved 2011), standard test method for , measurement of magnetically induced torque on medical devices in the magnetic resonance environment. (Materials)
- ASTM F2129-08: Standard test method for conducting cyclic = potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices. (Materials)
- ASTM F2052-14: standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. (Materials)
- ASTM F2503-13: standard practice for marking medical devices and other items for safety in the magnetic resonance environment. (Materials)
MRI Performance Testing:
Power Injection:
19Ga 4.9ml/s
20Ga 4.9ml/s
22Ga 1.9ml/s
Infusion Testing: 1600ml/hr
Catheter Lock Disengagement: 6.9 lb
Needle Insertion:
19Ga 3.8lb
22Ga 3.6 lbs
Gravity Flow: 1760 ml/hr
Biocompatibility:
Materials of the Dignity® Dual Port are equivalent to the cleared, reference devices; Medcomp®, Power Injectable Implantable Infusion Port: Medcomp® Pro-Fuse® (K070003) and Medcomp ® Dignity® Power Iniectable Titanium Port (K120281). Biocompatibility on both reference devices we performed per ISO 10993-1, for a permanent implant device with tissue and both indirect and direct blood contact.
All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993-1.
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.
K090512 C.R. Bard, Inc. PowerPort© duo M.R.I.TM
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.
K070003 Medcomp®, Power Injectable Implantable Infusion Port; Pro-Fuse®, K120281 Medcomp®, Dignity® Power Injectable Titanium Port
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Medcomp (Medical Components) Ms. Courtney Nix Regulatory Associate 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K153238
Trade/Device Name: Dignity Dual Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, implanted, intravascular infusion port and catheter Regulatory Class: II Product Code: LJT Dated: February 9, 2016 Received: February 12, 2016
Dear Ms. Nix:
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.
1
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 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.gov/MedicalDevices/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Dignity® Dual Port
Indications for Use (Describe)
The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port 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 Dignity® Dual 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. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
Type of Use (Select one or both, as applicable)
| Preconstruction Use (Text CA SB 255, 2015, Statute) | Interim Use |
|---|---|
| ------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a pink geometric shape that resembles a stylized letter "M" or a series of interconnected squares. Below the geometric shape, the word "med" is written in pink, followed by "COMP" in gray. The overall design is clean and modern.
1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax. 215-256-1787 www.medcompnet.com
| Section 5 | | 510(k) SUMMARY
K153238 | Traditional 510K |
|-----------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------|
| A. | Submitter Information: | | |
| | Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201, x2244
Fax: (215) 256-9191 | |
| | Contact: | Courtney Nix
Regulatory Associate
Cnix@medcompnet.com | |
| | Date Prepared: | March 11, 2016 | |
| B. | Trade Name: | Dignity® Dual Port | |
| | Common Name: | Power Injectable, Implantable, Infusion Port | |
| | Product Code : | LJT - Subcutaneous, Implanted, Intravascular Infusion
Port and Catheter | |
| | C.F.R. Section: | 21 CFR 880.5965, Class II | |
| | Classification Panel: | General Hospital | |
| C. | Predicate Devices: | K090512 C.R. Bard, Inc. PowerPort© duo M.R.I.TM
Implanted Port with 9.5 Fr, Dual Lumen ChronoFlex®
Catheter, class II 880.5956 | |
| D. | Reference Devices: | K070003 Medcomp®, Power Injectable Implantable
Infusion Port; Pro-Fuse®, class II 880.5965 | |
| | | K120281 Medcomp®, Dignity® Power Injectable
Titanium Port, class II 880.5965 | |
| E. | Purpose for Submission: | Expansion of Medcomp®'s Dignity® product line to
include an in-line dual reservoir point with injection
capabilities. | |
The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port
4
Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo features a stylized, geometric design in pink, resembling a house or an abstract letter 'M'. Below the geometric shape, the word "medCOMP" is written in a stylized, italicized font, also in pink.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.
The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:
- 9.5F Standard Port Kit (Catalog number MRDP95ADN)
- 9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
- 9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
- 9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)
Indications for Use: G.
The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port 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 Dignity® Dual 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. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
H. Comparison to Predicate Devices:
The Dignity® Dual Port is substantially equivalent to the predicate device, C.R. Bard PowerPort© (K090512), in terms of intended use, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.
The Dignity® Dual power injectable implantable infusion port, is equivalent to the Medcomp® references devices, Medcomp® Pro-Fuse® (K070003) and Medcomp® Dignity® Power Injectable Titanium Port (K120281), in materials.
The difference between the reference device, Dignity® Power Injectable Titanium Port (K120281), and the Dignity® Dual Port assembly is that the Dignity® Dual Port has a polysulfone cap, base, two silicone septa and a titanium insert, while the titanium port is comprised of a one piece titanium housing and silicone septum. The Dignity® Dual Port utilizes a titanium insert to connect the distal reservoir to the catheter. Both ports use the same grade of titanium.
The difference between the Dignity® Dual Port and the predicate, Bard Access Systems, PowerPort™ duo M.R.I™ Implanted Port (K090512), is that the PowerPort™ duo M.R.I™ is a side-by-side reservoir design, whereas the Dignity® Dual Port has an in-line reservoir design.
5
Image /page/5/Picture/0 description: The image shows a logo with a geometric design in pink and the word "medCOMP" in a combination of pink and gray. The geometric design consists of a stylized shape resembling an incomplete square with rounded corners, positioned above two curved shapes that mirror each other. The word "medCOMP" is written in lowercase, with "med" in pink and "COMP" in gray.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Table 1: 510(K) Summary: Design Comparison Matrix
| Device | Proposed Dignity® Dual Port
(K153238) | C.R. Bard PowerPort®
(K090512) | Substantially
Equivalent
Comparison |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Design | Double lumen open ended
Dual reservoir
Power injection | Double Lumen
Dual reservoir
Power Injection | Equivalent |
| Dimensions | Bases Fits within:
41mm x 12mm
Internal Volume:
0.7ml and 0.6 ml
Depth Marking every 1cm | Bases Fits within:
29mm x 39mm
Internal Volume:
0.6 ml each reservoir
Depth Marking every 1cm | Equivalent |
| Indications
for use | The Dignity® Dual Port is a
power injectable implantable
infusion port that is indicated for
patient therapies requiring
repeated access to the vascular
system. The Dignity® Dual Port
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 Dignity®
Dual 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.
The maximum recommended
infusion rate is 2 ml/s with a 22
gauge non-coring power
injectable needle. | PowerPort™ Implanted 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 soltuions,
blood products, and for the
withdrawal of blood samples.
When used with a PowerLoc™
Safety Infusion Set, The
PowerPort™ device is indicated
for power injection of contrast
media. For power injection of
contrast media, the maximum
recommended infusion rate is 5
ml/s.
(From 510(k) Summary
K090512) | Equivalent |
| Catheter
Size | 9.5F Double Lumen ChoronFlex
Polyurethane Catheter | 9.5F Double Lumen ChoronFlex
Polyurethane Catheter | Equivalent |
| Sterilization | ETO
ANSI/AAMI/ISO 11135-1:2007
SAL 10-6 | ETO
Reference Not Sited in
published 510(k) Summary | Equivalent |
| Power
Injectable | Power Injectable
Rate: 5 ml/s | Power Injectable
Rate: 5 ml/s | Equivalent |
| Materials | Thermoplastic Polymer
Silicone
Polyurethane
Titanium
Polycarbonate | Plastic
Silicone
Polyurethane | Equivalent to
References
Devices;
Medcomp®
Pro-Fuse®
(K070003)
and
Medcomp ®
Dignity® |
| | | | |
| MRI
Performance
Testing | MRI Conditional
Power Injection:
19Ga 4.9ml/s
20Ga 4.9ml/s
22Ga 1.9ml/s
Infusion Testing: 1600ml/hr
Catheter Lock Disengagement:
6.9 lb
Needle Insertion:
19Ga 3.8lb
22Ga 3.6 lbs
Gravity Flow:
1760 ml/hr | MRI Conditional
Power Injection:
19Ga 4.9ml/s
20Ga 4.9ml/s
22Ga 1.9ml/s
Infusion Testing: 1700ml/hr
Catheter Lock
Disengagement:
10 lbs
Needle Insertion:
19Ga 2.88lb
22Ga 2.05 lbs
Gravity Flow:
1680 ml/hr | Injectable
Titanium Port
(K120281)
Equivalent
Equivalent |
6
Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building. Below the shape, the word "medCOMP" is written in a stylized font, with "med" in red and "COMP" in gray.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
l,
Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device is equivalent to the predicate devices. The performance testing was performed in accordance with the following standards:
- BS EN ISO 10555-1: 2013: Intravascular Catheters Sterile and Single-use Catheters Part 1: General Requirements
- ISO 10555-3: 2013; Intravascular Catheters Sterile and Single-Use -Catheters - Part 3: Central Venous Catheters (General Plastic Surgery/General Hospital)
- BS EN ISO 10993-1; 2009: Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process (Biocompatibility)
- BS EN ISO 11135; Second Edition 2014; Sterilization of health-care products - Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 10555-6: 2015; Intravascular Catheters Sterile and Single-use -Catheters - Part 6: Subcutaneous implanted ports
- ASTM F2213-06: (Reapproved 2011), standard test method for , measurement of magnetically induced torque on medical devices in the magnetic resonance environment. (Materials)
- ASTM F2129-08: Standard test method for conducting cyclic = potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices. (Materials)
- ASTM F2052-14: standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment. (Materials)
- ASTM F2503-13: standard practice for marking medical devices and other items for safety in the magnetic resonance environment. (Materials)
7
Image /page/7/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a pink geometric shape that resembles a stylized letter "M" or a house. Below the shape, the word "medCOMP" is written in a combination of pink and gray letters.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Biocompatibility:
J.
Materials of the Dignity® Dual Port are equivalent to the cleared, reference devices; Medcomp®, Power Injectable Implantable Infusion Port: Medcomp® Pro-Fuse® (K070003) and Medcomp ® Dignity® Power Iniectable Titanium Port (K120281). Biocompatibility on both reference devices we performed per ISO 10993-1, for a permanent implant device with tissue and both indirect and direct blood contact.
The Dignity® Dual Port is comprised of a polysulfone cap (with silicone filled suture holes, or open suture holes), two silicone septa, and a polysulfone base assembly with a titanium tube that provides a channel from the stem to the distal reservoir. The reservoir is plastic (polysulfone). The Dignity® Dual catheter locking assembly (makrolon/pellethane) locks the chronoflex lumen to the plastic stem of the Dignity® Dual Port. The materials that the Dignity® Dual Port is constructed of are the same as those cleared in the Power Injectable Implantable Infusion Port Pro-Fuse ™ (K070003), and the same formulation of titanium as cleared in the Dignity® Power Injectable Titanium Port (K120281). Therefore, as mentioned above, Medcomp® intends to use approved Medcomp® devices, Medcomp® Pro-Fuse® (K070003) and Medcomp® Dignity® Power Injectable Titanium Port (K120281), for biocompatibility testing results per ISO 10993-1, for a permanent implant device with tissue and both indirect and direct blood contact. Hence, all biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993-1 and a summary of prior testing is contained in section 15.
Summary of Substantial Equivalence: K.
In conclusion, the proposed device, The Dignity® Dual power injectable implantable infusion port, is equivalent to the predicate device, C.R. Bard PowerPort© (K090512), in intended use, design, function, and performance. The proposed device. The Dignity® Dual power injectable implantable infusion port, is equivalent to the Medcomp® references devices, Medcomp® Pro-Fuse® (K070003) and Medcomp® Dignity® Power Injectable Titanium Port (K120281), in materials.
The proposed device, The Dignity® Dual power injectable implantable infusion port, meets the performance criteria of design verification as specified by ISO standards. quidance documents and internal test protocols. The proposed device is substantially equivalent to the indicated legally marketed predicate and reference devices as defined in paragraph above.