(119 days)
No
The device description focuses on the physical components and function of a port access system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
This device is for accessing the vascular system to deliver substances or sample blood, not for directly treating a disease or condition.
No
The device is described as an access system for repeated vascular access for delivery of substances and sampling of blood, not for diagnosing conditions. It facilitates procedures rather than providing diagnostic information itself.
No
The device description clearly states the device is a physical implantable port made of titanium or plastic with a silicone rubber septum and a catheter. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the vascular system or other body sites for the delivery and sampling of substances. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The description details a port and catheter system designed for implantation and direct access to the body. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes.
Therefore, the SmartPort CT Port Access System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The SmartPort CT Series ports are also indicated for power injection of CT contrast media.
The SmartPort CT Series Port Access System is indicated for any pationt requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
The SmartPort CT Series Port Access System is also indicated for power injection of contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20 Ga or 19 Ga power injectable infusion sets.
Product codes
LJT
Device Description
The SmartPort CT Series ports are Titanium or plastic, single or dual ports with a self sealing silicone rubber septum designed to maintain integrity after punctures with a noncoring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.
The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.
The SmartPort CT Series port systems offers models with catheters from 6.6FR to 12FR. The catheters contain radiopacifiers and have depth markings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system or other selected body site
Indicated Patient Age Range
adult patient, any patient
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K905841, K953529, K010189, K032557
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
SEP 2 3 2008
4081472
4.0 510(k) Summary
Date: May 19, 2008
Sponsor of the 510(k)
AngiodDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12801 Establishment Registration number 1319211 Contact: Brian Kunst, Vice President, Regulatory Affairs and Quality Assurance 518-798-1215, x1123
Device Identification:
| Proprietary Name: | SmartPort CT Series Port Access Systems |
|---|---|
| Common Name: | Vascular access port |
| Classification Name: | Subcutaneous, implanted, intravascular infusion port & |
| catheter | |
| Classification Number: | 21 CFR §880.5965 |
| Classification Panel: | General Hospital |
| Product Code: | LJT |
| Regulatory Class: | II |
Legally marketed device to which equivalence is claimed:
| AngioDynamics SmartPort CT MP | 510(k) K072375 |
|---|---|
| AngioDynamics SmartPort CT | 510(k) K062414 |
| Horizon Medical Vortex Ports | 510(k) K905841, K953529, K010189, K032557 |
Intended Use / Indications
The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The SmartPort CT Series ports are also indicated for power injection of CT contrast media.
| Vortex CT 510(k) | Confidential | Page 11 of 39 |
|---|---|---|
| May 19, 2008 |
1
Device Description
The SmartPort CT Series ports are Titanium or plastic, single or dual ports with a self sealing silicone rubber septum designed to maintain integrity after punctures with a noncoring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.
The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.
The SmartPort CT Series port systems offers models with catheters from 6.6FR to 12FR. The catheters contain radiopacifiers and have depth markings.
| Question | YES | NO |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart D)?A | X | |
| Does the device contain components derived from a tissue or other biologic | ||
| source? | X | |
| Is the device provided sterile? | X | |
| Is the device intended for single use? | X | |
| Is the device a reprocessed single use device? | X | |
| Does the device contain a drug? | X | |
| Does the device contain a biologic? | X | |
| Does the device use software? | X | |
| Does the submission include clinical information? | X | |
| Is the device implanted? | X |
| Vortex CT 510(k) | Confidential | Page 12 of 39 |
|---|---|---|
| May 19, 2008 |
2
Device comparison table
| | AngioDynamics
SmartPort CT Series
Vortex Ports | AngioDynamics SmartPort
CT MP | AngioDynamics SmartPort
CT | RITA Medical Systems
(formerly Horizon Medical
Products) |
|----------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------|
| | | K072375 | K062414 | K905841, K953529,
K010189, K032557 |
| Intended use, power
injection | Maximum 3 ml/sec or 5 ml/sec
injection rate of contrast dye
injected at up to 300 psi | Maximum 3 ml/sec injection rate
of contrast dye injected at up to
300 psi. | Maximum 5 ml/sec injection rate
of contrast dye injected at up to
300 psi. | Not indicated for power
injection |
| Design | Port system with attachable
catheter | Port system with attachable
catheter, single. | Port system with attachable
catheter, single. | Port system with attachable
catheter, single or dual. |
| Port Material | Titanium or Plastic | Titanium | Titanium | Titanium or Plastic |
| Catheter Material | Polyurethane or Silicone | Polyurethane | Polyurethane or Silicone | Polyurethane or Silicone |
| Catheter Size | 6.6-12 FR | 5 FR | 7.5-9.6 FR | 6.6-12 FR |
| Shape | Round port system with
tangential outlet | Round port system with tangential
outlet | Round port system with tangential
outlet | Round port system with
tangential outlet |
| Septum Material | Silicone | Silicone | Silicone | Silicone |
| Pressure withstand,
dynamic | 300 PSI | 300 PSI | 300 PSI | Not Rated |
| Needles used for
Access | 19 or 20 Ga power injectable
infusion set | 19 or 20 Ga power injectable
infusion set | 19 or 20 Ga power injectable
infusion set | 19 or 20 Ga infusion set |
Confidential
Vortex CT 510(k)
May 19, 2008
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2008
Mr. Brian Kunst ANGIODYNAMICS, Incorporated 603 Queensbury Avenue Queensbury, New York 12804
Re: K081472
Trade/Device Name: SmartPort CT Series Port Access System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: Il Product Code: LJT Dated: August 27, 2008 Received: August 29, 2008
Dear Mr. Kunst:
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 deviccs 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Kunst
Please be advised that FDA's issuance of a substantial equivalence determination docs 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRHI's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
QRS
Chiu S. Lin. Ph. D Division 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):
| Device Name: | SmartPort CT Series Port Access System | ----- | |
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Indications for Use:
The SmartPort CT Series Port Access System is indicated for any pationt requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
The SmartPort CT Series Port Access System is also indicated for power injection of contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20 Ga or 19 Ga power injectable infusion sets.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Amithen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __