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 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.

AI/ML Overview

This submission describes the Invisiport™, an implantable infusion port. The acceptance criteria and the study proving it meets these criteria are outlined primarily through a comparison to predicate devices and a statement of compliance with relevant FDA guidance.

1. Table of Acceptance Criteria and Reported Device Performance

The device does not have explicit "acceptance criteria" presented as quantitative thresholds in the provided text for performance outcomes. Instead, substantial equivalence is established by demonstrating that its technical characteristics and performance are comparable to legally marketed predicate devices and that it meets a general standard of efficacy and safety as outlined by FDA guidelines. The table below summarizes the comparison:

Feature	Acceptance Criteria (Inferred from Predicate Devices & Guidance)	Reported Invisiport™ Performance
Indications for Use	Must be equivalent to predicate devices, including for power injection of contrast media.	Equivalent to predicate devices, including power injection compatibility (5 ml/s limit, same as Bard Power Port).
Port Access	Hospital/clinic, licensed healthcare provider.	Same as predicates.
Location of Implant	Peripheral or thoracic (consistent with various predicates).	Peripheral or thoracic. Noted to be the same as PeriPort, GrantAdler Rhapsody, and Port-A-Cath for recommended peripheral implantation site (upper arm).
Design	Septum/port with attachable catheter (based on predicates).	Septum/port with integrated catheter. Comment notes this is "As a convenience to the user," implying it's a design difference, but doesn't state it fails any criteria.
Catheter Length	Within the range of predicate devices (76 cm for PeriPort/PORT-A-CATH, up to 52 cm for GrantAdler, up to 45 cm for Bard Power Port).	53.3 cm. Reported as "Within the range of the predicates."
Catheter ID	Within the range of predicate devices (1.0 mm for PeriPort/PORT-A-CATH, 2 mm for GrantAdler).	1.3 mm. Reported as "Within the range of the predicates."
Catheter OD	Within the range of predicate devices (1.7 mm for PeriPort, 2.33 mm (7 Fr) for GrantAdler, 2.7 mm (8 Fr) for Bard Power Port, 1.9 mm for PORT-A-CATH).	2.0 mm. Reported as "Within the range of the predicates."
Biocompatibility	Material evaluated for biocompatibility.	Made from material evaluated for biocompatibility. (Implied by description and general regulatory requirements).
Self-sealing septum	Must have a self-sealing septum.	Has a self-sealing silicone septum.
Radiopacity	Catheter should be radiopaque.	Open ended radiopaque catheter.
General Performance (Safety & Effectiveness)	Device must pass performance tests according to 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).	The device passed all testing conducted according to relevant FDA guidance. Conclusion states Invisiport™ met "all established acceptance criteria for performance testing" and no new questions of safety or effectiveness are raised.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for performance testing (e.g., number of devices tested for catheter length, ID, OD, or other performance characteristics). The tests are described as being conducted "according to methods presented in FDA Guidance," suggesting laboratory-based performance testing rather than human clinical trials. Thus, the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not relevant here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The study appears to be a technical, laboratory-based performance evaluation against established engineering and material standards, rather than one requiring clinical expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of performance testing described. Adjudication methods are typically employed in studies where expert review is needed to establish ground truth for subjective interpretations (e.g., image analysis, clinical diagnoses).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The submission is a 510(k) premarket notification for a medical device (implantable infusion port), which typically relies on demonstrating substantial equivalence to predicate devices through technical and laboratory performance testing, rather than comparative clinical efficacy studies with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Invisiport™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone" or "algorithm only" performance does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria appears to be derived from:

Predicate Device Specifications: The technical characteristics (e.g., catheter length, ID, OD) are compared directly to ranges or values of legally marketed predicate devices.
FDA Guidance Documents: Performance tests were conducted "according to methods presented in FDA Guidance," implying a benchmark against established regulatory standards and test methodologies for implanted infusion ports. These guidances establish the "truth" for safety and performance metrics (e.g., biocompatibility testing, sterility, mechanical integrity).

8. The Sample Size for the Training Set

This question is not applicable. The Invisiport™ is a physical medical device, not an AI system. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As stated above, there is no training set.

Summary

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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 150Fitchburg, 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 Catheter21 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

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

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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)	PeriPortK934518	GrantAdlerRhapsodyAccess PortK043178,K082126	Bard PowerPortK060812	Smiths MedicalPORT-A-CATHK060036	Comment
Indicationsfor Use	The Invisiport™is indicated forany patientrequiringrepeated accessof the vascularsystem fordelivery ofmedications,nutritionalsupplementation,fluids, blood,blood products,or the samplingof blood, or forpower injectionof contrast whenused with apower-injectableHuber needle orinfusion set.	The PeriPort is atotallyimplantable drugdelivery systemdesigned to giverepeated accessto the venoussystem forinfusions,nutritionalsolutions,medications,fluids, and forthe sampling ofvenous blood.	The GrantAdlerRhapsodyAccess Port andCatheter isindicated for anypatient requiringreliablerepeated accessof the vascularsystem fordelivery ofmedications,nutritionalsupplementation,fluids, blood,blood productsor the samplingof blood.	The PowerPortimplanted port isindicated forpatient therapiesrequiringrepeated accessto the vascularsystem. The portsystem can beused for infusionof medications,I.V. fluids,parenteralnutritionsolutions, bloodproducts, and forthe withdrawalof bloodsamples. Whenused with thePowerLocSafety InfusionSet, thePowerPortdevice isindicated forpower injectionof contrastmedia. Forpower injectionof contrastmedia, themaximumrecommendedinfusion rate is5 ml/s.	PORT-A-CATH-Systems withDual LayerCatheter areindicated whenpatient therapyrequires repeatedvascular accessfor injection orinfusion therapyand/or venousbloodsampling.	The indication for use ofthe Invisiport is the sameas the predicate devices,including powerinjection compatibility.The 5 ml/sec powerinjection of contrastmedia limit is the sameas the Bard Power Port.
Port Access	Hospital/cliniclicensed healthcare provider	Hospital/cliniclicensed healthcare provider	Hospital/cliniclicensed healthcare provider	Hospital/cliniclicensed healthcare provider	Hospital/cliniclicensed healthcare provider	Same
Location ofimplant	Peripheral orthoracic	Peripheral(medial mid armor upper armabove the elbowor antecubitalspace and wellbelow thesubaxillary area)	Peripheral orthoracic	Thoracic	Peripheral(upper arm) orThoracic	SameThe PeriPort, GrantAdlerRhapsody and Port-A-Cath have arecommended peripheralimplantation site (upperarm); the same as theInvisiport.
Design	Septum/portwith integratedcatheter	Septum/portwith anattachable	Septum/portwith anattachable	Septum/portwith anattachable	Septum/portwith anattachable	As a convenience to theuser, the catheter isintegrated with the port.

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Feature	Invisiport™(Under Review)	PeriPortK934518	GrantAdlerRhapsodyAccess PortK043178,K082126	Bard PowerPortK060812	Smiths MedicalPORT-A-CATHK060036	Comment
		catheter	catheter	catheter	catheter	reservoir.
CatheterLength	53.3 cm	76 cm	Up to 52 cm	Up to 45 cm	76 cm	Within the range of thepredicates.
Catheter ID	1.3 mm	1.0 mm	2 mm	Unknown	1.0 mm	Within the range of thepredicates.
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 thepredicates.

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.

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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.

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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

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Indications for Use

510(k) Number (if known): K110 407

Device Name: Invisiport™

Indications for Use:

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

Regulation Number and Section

§ 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.