(361 days)
Not Found
No
The summary describes a physical medical device (an injection port with a catheter) and a modification involving a change in catheter size. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are bench tests evaluating physical properties.
No
The device is an injection port used for vascular access for delivery of substances or sampling blood, which is a supportive function rather than a direct therapeutic one.
No
The device is an injection port used for delivery of substances or sampling of blood, not for diagnosing conditions.
No
The device description clearly states it is an injection port with an attached catheter, which are physical hardware components. The 510(k) is for a modification to the catheter size, not a software 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 the device as being used for accessing the vascular system for delivery of substances (medications, fluids, blood products, contrast media) and sampling blood from the patient. This is a direct interaction with the patient's circulatory system.
- Device Description: The device is described as an injection port with an attached catheter, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The focus is on accessing and interacting with the patient's body directly.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. This device is a medical device used for direct patient care and treatment.
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 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 predicate device and subject device are injection ports. An open ended radiopaque catheter is preattached to the predicate and subject devices.
This 510(k) pre-market notification supports the addition of a catheter size variation to the predicate device. The modification to the predicate device to create the subject device is a change in the attached catheter. The predicate device attached catheter is substantially a 6 Fr catheter. The subject device attached catheter is a 4.4 Fr catheter. This change affects the attached catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral or thoracic
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
Bench evaluations of potentially affected performance are adequate to support substantial equivalence.
| Test | Summary of Requirement | Result |
|---|---|---|
| 1. Visual | Verify markings on OD with numbers at applicable increments. | Pass |
| 2. Dimensional | Verify critical dimensions. | Pass |
| 3. Clearance Parameters | Verify clearance volume. | Pass |
| 4. Port to Catheter Connection Test | Lateral and Axial (Dry): No leaks after static load. Lateral and Axial (Wet): No leaks after port exposed to wet medium and a static load. Cycle Lateral and Axial: No leaks after cyclic load. Creep: No leaks after minimal load. Load to Failure, Axial and Lateral. | Pass |
| 5. Port Leak Test | Withstand static pressure without leaking for both intermittent and continuous pressure testing. | Pass |
| 6. Power Injection Flow Rate | Verify flow rate under power injection conditions with a set viscosity and flow. | Pass |
Key Metrics
Not Found
Predicate Device(s)
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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Stealth Therapeutics, Inc. c/o Mr. Gary Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589
Re: K141146
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: March 31, 2015 Received: April 2, 2015
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.
1
Page 2 - Mr. Gary 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 (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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina
Kiang-S
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
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Indications for Use
510(k) Number (if known) K141146
Device Name Invisiport
Indications for Use (Describe)
The Invisiport is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, 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.
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)
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K141146
510(k) Summary
This summary is provided to support the 510(k) notification for the subject Invisiport manufactured for Stealth Therapeutics, Inc.
| Contact Name: | Samuel Adams |
|---|---|
| Company Name: | Stealth Therapeutics, Inc. |
| Address: | 101 Nob Hill Road, Suite 100 |
| Madison, WI 53713 | |
| Phone: | (608) 217-2685 |
| Date Summary Prepared: | April 29, 2015 |
| Trade Name: | InvisiportTM |
| Common Name: | Implantable Infusion Port |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter |
| 21 CFR 880.5965, Product Code LJT | |
| Predicate Device: | K110407, InvisiportTM, manufactured for Stealth Therapeutics, Inc. |
Product Description
The predicate device and subject device are injection ports. An open ended radiopaque catheter is preattached to the predicate and subject devices.
This 510(k) pre-market notification supports the addition of a catheter size variation to the predicate device. The modification to the predicate device to create the subject device is a change in the attached catheter. The predicate device attached catheter is substantially a 6 Fr catheter. The subject device attached catheter is a 4.4 Fr catheter. This change affects the attached catheter.
Intended Use of the Device
The intended use of the subject device is the same as the predicate device:
The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, 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.
Summary of Technological Characteristics
The following table provides a side-by-side comparison of the subject device to the predicate device.
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| Table 1: Substantial Equivalence Technical Characteristics | |||
|---|---|---|---|
| Feature | Subject Device | Predicate Device | 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 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. | Same | ||
| Power Injection | Yes | Yes | Same |
| Power Injection | |||
| Input Pressure | |||
| Limit | 300 psi | 300 psi | Same |
| Power Injection | |||
| Flow Rate of | |||
| 11.8 cP fluid | 4.5 ml/sec | 5 ml/sec | Both devices are power |
| injectable at pressures up to 300 | |||
| psi. | |||
| The subject device with a | |||
| 4.4 Fr catheter supports a | |||
| maximum of 4.5 ml/sec power | |||
| injection flow rate of an 11.8 cP | |||
| fluid with a 300 psi power | |||
| injection limit. The predicate | |||
| device with a 6 Fr catheter | |||
| supports a 5 ml/sec power | |||
| injection flow rate of an 11.8 cP | |||
| fluid with a 300 psi power | |||
| injection limit. | |||
| The difference in flow rate is | |||
| due to the power injector's | |||
| ability to support a flow rate | |||
| with an 11.8 cP fluid at 300 psi | |||
| applied pressure. The smaller | |||
| 4.4 Fr catheter supports a lower | |||
| flow rate at this 300 psi pressure | |||
| limit. | |||
| Port Access | Hospital/clinic licensed health care | ||
| provider | Hospital/clinic licensed health care | ||
| provider | Same | ||
| Location of | |||
| implant | Peripheral or thoracic | Peripheral or thoracic | Same |
| Design | Septum/port with integrated catheter | Septum/port with integrated catheter | Same |
| Attached | |||
| Catheter Length | 53.3 cm | 53.3 cm | Same |
| Catheter Diameter | 1.47 mm (4.4 French) | 2.0 mm (6 French) | A smaller diameter catheter |
| variation is available. |
Performance tests to demonstrate substantial equivalency
The risks presented by a smaller catheter diameter have been evaluated. Applicable tests recommended in the FDA Guidance: Guidance on 510(k) Submissions for Implanted Infusion Ports and the tests performed to support substantial equivalence of the predicate device was evaluated. The following table identifies the tests performed on the subject device and results.
5
| Table 1: Subject Device Performance Testing Summary | ||
|---|---|---|
| Test | Summary of Requirement | Result |
| 1. Visual | Verify markings on OD with numbers at applicable increments. | Pass |
| 2. Dimensional | Verify critical dimensions. | |
| 3. Clearance | ||
| Parameters | Verify clearance volume. | |
| 4. Port to Catheter | ||
| Connection Test | Lateral and Axial (Dry): No leaks after static load. | |
| Lateral and Axial (Wet): No leaks after port exposed to wet medium and a static | ||
| load. | ||
| Cycle Lateral and Axial: No leaks after cyclic load. | ||
| Creep: No leaks after minimal load. | ||
| Load to Failure, Axial and Lateral. | Pass | |
| 5. Port Leak Test | Withstand static pressure without leaking for both intermittent and continuous | |
| pressure testing. | Pass | |
| 6. Power Injection | ||
| Flow Rate | Verify flow rate under power injection conditions with a set viscosity and flow. | Pass |
All tests passed with acceptable results on the subject device.
No clinical data are required to confirm substantial equivalence of the subject device. Bench evaluations of potentially affected performance are adequate to support substantial equivalence.
Conclusions
The subject device is a modification of the predicate device and meets all established acceptance criteria for performance testing. The intended use and technology of the subject device is the same as the predicate device.