(241 days)
Not Found
No
The device description and intended use focus on the physical components and function of an implantable port, with no mention of AI or ML capabilities.
Yes
The device repeatedly accesses the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, and blood products, which are all therapeutic interventions.
No
The Invisiport™ is used for vascular access for the delivery of substances or sampling of blood, and for power injection of contrast media for imaging. It is a device for therapeutic/interventional use or to facilitate diagnostic imaging, but not a diagnostic device itself as it does not analyze or interpret patient data to make a diagnosis.
No
The device description clearly states that the Invisiport™ consists of physical components like an injection port, septum, catheter, and reservoir, indicating it is a hardware device, not software-only.
Based on the provided information, the Invisiport™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the vascular system for delivering substances (medications, fluids, blood, etc.) and sampling blood from the patient. This is an in-vivo (within the living body) application.
- Device Description: The description details a port and catheter system designed for implantation and direct access to the bloodstream.
- No mention of testing biological samples outside the body: IVD devices are used to examine specimens (like blood, urine, tissue) that have been taken from the human body to provide information about a physiological state, health, or disease. The Invisiport™ facilitates the collection of blood, but it doesn't perform any diagnostic testing on that blood.
- Mentions image processing/contrast media: While it mentions power injection of contrast for imaging, this is a therapeutic/diagnostic imaging procedure performed on the patient, not an in-vitro test of a sample.
Therefore, the Invisiport™ is a medical device used for vascular access, not an IVD.
N/A
Intended Use / Indications for Use
The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.
Product codes
LJT
Device Description
The Invisiport™ consists of an injection port made from material evaluated for hiocompatibility. The Invisiport has a self-sealing silicone septum. An open ended radiopaque catheter is pre-attached to the port. The silicone septum covers a reservoir that can be accessed with a non-coring Huber type needle. Power injection of contrast for imaging examinations can be performed when the port is accessed with a power-injectable Huber needle or infusion set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral or thoracic (for implantation)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital/clinic licensed health care provider
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
To establish the technical equivalency of the Invisiport tests were conducted according to methods presented in FDA Guidance: Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990, Submission and Review of Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile, December 12, 2008 and provided by FDA in review and discussion. The device passed all testing.
Key Metrics
Not Found
Predicate Device(s)
K043178, K060812, K060036, K934518
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
OCT 1 3 2011
5.0 510(k) Summary
This sunmary is provided to support the 510(k) notification for the Invisiport™ manufactured for Stealth Therapenties, Inc.
| Company Name: | Stealth Therapeutics, Inc. |
|---|---|
| Address: | 5520 Nobel Drive, Suite 150 |
| Fitchburg, Wisconsin 53711 | |
| Phone: | (608) 577-4484 |
| Date Summary Prepared: | February 8, 2011 |
| Trade Name: | Invisiport™ |
| Common Name: | Implantable Infusion Port |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter |
| 21 CFR 880.5965, Product Code LJT | |
| Predicate Devices: | K043178, Rhapsody Access Port manufactured by GrantAdler Corporation |
| K060812, PowerPort™ Implantable Titanium Port manufactured by C.R. | |
| Bard, Inc. | |
| K060036, PORT-A-CATH manufactured by Smiths Medical | |
| K934518, PeriPort manufactured by Strato Medical Corp. |
Product Description 5. I
The Invisiport™ consists of an injection port made from material evaluated for hiocompatibility. The Invisiport has a self-sealing silicone septum. An open ended radiopaque catheter is pre-attached to the port. The silicone septum covers a reservoir that can be accessed with a non-coring Huber type needle. Power injection of contrast for imaging examinations can be performed when the port is accessed with a power-injectable Huber needle or infusion set.
5.2 Intended Use of the Device
The intended use of the Invisiport is the same as predicate devices:
The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the
54
1
sampling of blood, or for power injection of contrast media when used with a powerinjectable Huber needle or infusion set.
Summary of Technological Characteristics 5.3
The following table provides a side-by-side comparison the Invisiport™ to the predicate devices being used to support this notification.
| Table 5.3-1: Substantial Equivalence Technical Characteristics | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Feature | Invisiport™ | ||||||||
| (Under Review) | PeriPort | ||||||||
| K934518 | GrantAdler | ||||||||
| Rhapsody | |||||||||
| Access Port | |||||||||
| K043178, | |||||||||
| K082126 | Bard Power | ||||||||
| Port | |||||||||
| K060812 | Smiths Medical | ||||||||
| PORT-A- | |||||||||
| CATH | |||||||||
| K060036 | Comment | ||||||||
| Indications | |||||||||
| for Use | The Invisiport™ | ||||||||
| is indicated for | |||||||||
| any patient | |||||||||
| requiring | |||||||||
| repeated access | |||||||||
| of the vascular | |||||||||
| system for | |||||||||
| delivery of | |||||||||
| medications, | |||||||||
| nutritional | |||||||||
| supplementation, | |||||||||
| fluids, blood, | |||||||||
| blood products, | |||||||||
| or the sampling | |||||||||
| of blood, or for | |||||||||
| power injection | |||||||||
| of contrast when | |||||||||
| used with a | |||||||||
| power-injectable | |||||||||
| Huber needle or | |||||||||
| infusion set. | The PeriPort is a | ||||||||
| totally | |||||||||
| implantable drug | |||||||||
| delivery system | |||||||||
| designed to give | |||||||||
| repeated access | |||||||||
| to the venous | |||||||||
| system for | |||||||||
| infusions, | |||||||||
| nutritional | |||||||||
| solutions, | |||||||||
| medications, | |||||||||
| fluids, and for | |||||||||
| the sampling of | |||||||||
| venous blood. | The GrantAdler | ||||||||
| Rhapsody | |||||||||
| Access Port and | |||||||||
| Catheter is | |||||||||
| indicated for any | |||||||||
| patient requiring | |||||||||
| reliable | |||||||||
| repeated access | |||||||||
| of the vascular | |||||||||
| system for | |||||||||
| delivery of | |||||||||
| medications, | |||||||||
| nutritional | |||||||||
| supplementation, | |||||||||
| fluids, blood, | |||||||||
| blood products | |||||||||
| or the sampling | |||||||||
| of blood. | The 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 | |||||||||
| solutions, blood | |||||||||
| products, and for | |||||||||
| the withdrawal | |||||||||
| of blood | |||||||||
| samples. When | |||||||||
| used with the | |||||||||
| 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. | PORT-A-CATH | ||||||||
| -Systems with | |||||||||
| Dual Layer | |||||||||
| Catheter are | |||||||||
| indicated when | |||||||||
| patient therapy | |||||||||
| requires repeated | |||||||||
| vascular access | |||||||||
| for injection or | |||||||||
| infusion therapy | |||||||||
| and/or venous | |||||||||
| blood | |||||||||
| sampling. | The indication for use of | ||||||||
| the Invisiport is the same | |||||||||
| as the predicate devices, | |||||||||
| including power | |||||||||
| injection compatibility. | |||||||||
| The 5 ml/sec power | |||||||||
| injection of contrast | |||||||||
| media limit is the same | |||||||||
| as the Bard Power Port. | |||||||||
| Port Access | Hospital/clinic | ||||||||
| licensed health | |||||||||
| care provider | Hospital/clinic | ||||||||
| licensed health | |||||||||
| care provider | Hospital/clinic | ||||||||
| licensed health | |||||||||
| care provider | Hospital/clinic | ||||||||
| licensed health | |||||||||
| care provider | Hospital/clinic | ||||||||
| licensed health | |||||||||
| care provider | Same | ||||||||
| Location of | |||||||||
| implant | Peripheral or | ||||||||
| thoracic | Peripheral | ||||||||
| (medial mid arm | |||||||||
| or upper arm | |||||||||
| above the elbow | |||||||||
| or antecubital | |||||||||
| space and well | |||||||||
| below the | |||||||||
| subaxillary area) | Peripheral or | ||||||||
| thoracic | Thoracic | Peripheral | |||||||
| (upper arm) or | |||||||||
| Thoracic | Same | ||||||||
| The PeriPort, GrantAdler | |||||||||
| Rhapsody and Port-A- | |||||||||
| Cath have a | |||||||||
| recommended peripheral | |||||||||
| implantation site (upper | |||||||||
| arm); the same as the | |||||||||
| Invisiport. | |||||||||
| Design | Septum/port | ||||||||
| with integrated | |||||||||
| catheter | Septum/port | ||||||||
| with an | |||||||||
| attachable | Septum/port | ||||||||
| with an | |||||||||
| attachable | Septum/port | ||||||||
| with an | |||||||||
| attachable | Septum/port | ||||||||
| with an | |||||||||
| attachable | As a convenience to the | ||||||||
| user, the catheter is | |||||||||
| integrated with the port. |
2
| Feature | Invisiport™
(Under Review) | PeriPort
K934518 | GrantAdler
Rhapsody
Access Port
K043178,
K082126 | Bard Power
Port
K060812 | Smiths Medical
PORT-A-
CATH
K060036 | Comment |
|--------------------|-------------------------------|---------------------|--------------------------------------------------------------|-------------------------------|----------------------------------------------|----------------------------------------|
| | | catheter | catheter | catheter | catheter | reservoir. |
| Catheter
Length | 53.3 cm | 76 cm | Up to 52 cm | Up to 45 cm | 76 cm | Within the range of the
predicates. |
| Catheter ID | 1.3 mm | 1.0 mm | 2 mm | Unknown | 1.0 mm | Within the range of the
predicates. |
| Catheter OD | 2.0 mm | 1.7 mm | 2.33 mm (7 Fr) | 2.7 mm (8 Fr) | 1.9 mm | Within the range of the
predicates. |
Performance tests to demonstrate substantial equivalency: 5.4
To establish the technical equivalency of the Invisiport tests were conducted according to methods presented in FDA Guidance: Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990, Submission and Review of Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile, December 12, 2008 and provided by FDA in review and discussion. The device passed all testing.
5.5 Conclusion
The Invisiport™ met all established acceptance criteria for performance testing. The intended use and technology of the Invisiport are equivalent to the predicate devices. No new questions of safety or effectiveness are raised.
3
Image /page/3/Picture/0 description: The image shows a partial view of the Department of Health & Human Services logo. The left side of the logo shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. To the right of the text is a symbol consisting of three stylized lines, which are thicker at the top and taper towards the bottom.
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
Stealth Therapeutics, Incorporated C/O Mr. Gary J. Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
OCT. 13 2011
Re: K110407
Trade/Device Name: Invisiport™ Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 6, 2011 Received: October 7, 2011
Dear Mr. Syring:
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 - Mr. Syring
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 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 yours.
Anthony O. m
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
5
Indications for Use
510(k) Number (if known): K110 407
Device Name: Invisiport™
Indications for Use:
The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rily C. Chyn 10/14/14
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110407
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