Who is the manufacturer of INVISIPORT?

Stealth Therapeutics, Incorporated filed the 510(k) submission for INVISIPORT (K110407).

What is the FDA product code for INVISIPORT?

LJT. It is classified under 21 CFR 880.5965 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for INVISIPORT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INVISIPORT?

Rhapsody Access Port (K043178); PowerPort™ Implantable Titanium Port (K060812); PORT-A-CATH (K060036); PeriPort (K934518).

Who can help prepare an FDA 510(k) submission like INVISIPORT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INVISIPORT

K110407 · Stealth Therapeutics, Incorporated · LJT · Oct 13, 2011 · General Hospital

Device Facts

Record ID	K110407
Device Name	INVISIPORT
Applicant	Stealth Therapeutics, Incorporated
Product Code	LJT · General Hospital
Decision Date	Oct 13, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5965
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Invisiport™ is an implantable infusion port system consisting of a reservoir with a self-sealing silicone septum and a pre-attached, open-ended radiopaque catheter. Used in hospital or clinic settings by licensed healthcare providers, the device is implanted peripherally or in the thoracic region. The reservoir is accessed percutaneously using a non-coring Huber needle. For power injection of contrast media, a power-injectable Huber needle or infusion set is required. The system facilitates repeated vascular access, reducing the need for frequent venipuncture and providing a reliable route for therapeutic infusions and blood sampling.

Clinical Evidence

Bench testing only. Performance testing was conducted in accordance with FDA Guidance on 510(k) Submissions for Implanted Infusion Ports (1990) and sterility information guidelines (2008). The device passed all performance testing.

Technological Characteristics

Implantable infusion port with self-sealing silicone septum and pre-attached radiopaque catheter. Materials evaluated for biocompatibility. Designed for peripheral or thoracic implantation. Compatible with power injection of contrast media up to 5 ml/s. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring repeated vascular access for medication delivery, nutritional supplementation, fluid/blood product administration, blood sampling, or power injection of contrast media using a compatible Huber needle or infusion set.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

Rhapsody Access Port (K043178)
PowerPort™ Implantable Titanium Port (K060812)
PORT-A-CATH (K060036)
PeriPort (K934518)

Reference Devices

Rhapsody Access Port (K082126)

Submission Summary (Full Text)

{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 Page 1 of 1

INVISIPORT

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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INVISIPORT

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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