(133 days)
Not Found
No
The summary describes a vascular access port and its associated kit, focusing on materials, intended use for fluid delivery and blood sampling, and MRI compatibility. There is no mention of any computational or analytical functions that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as an access port for delivering medications, fluids, and blood products, or for sampling blood. It facilitates treatment and diagnosis but does not directly provide therapy.
No
The device is described as a port line intended to facilitate access to the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or for blood sampling, and for power injection of contrast media. These are therapeutic or access functions, not diagnostic ones.
No
The device description explicitly states the device is manufactured of titanium and silicone, which are hardware components. The intended use also describes a physical port line and catheter.
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 used to access the vascular system for the delivery of substances (medications, fluids, blood products, etc.) and the sampling of blood. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The device is described as an implanted port and catheter made of titanium and silicone. This is a medical device designed for implantation and direct interaction with the patient's circulatory system.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Rhapsody port line does not involve any testing or analysis of samples in vitro.
The device is a vascular access port, which is a type of implanted medical device used for long-term access to the bloodstream.
N/A
Intended Use / Indications for Use
The Grant Adler Rhapsody port line is intended to facilitate reliable and repeated acces of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. Access is performed by percutaneous needle insertion, using only non-coring, Huber needles. When used with a power injectable needle, Rhapsody CT is indicated for power injection of contrast media. For power injection of contrast media, the maxum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with 22 gauge non-coring power injectable needle. The Rhapsody CT has been tested and is conditionally safe to use in an MRI environment up to 3T. The Port is normally included in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.
Product codes
LJT
Device Description
The Rhapsody CT is supplied as a sterile device, and is intended for single patient use only. The port is available as a single model and is manufactured of the highest quality titanium. It also incorporates a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. The Port is normally inclused in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital Use
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
Not Found
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.
0
(ofa)
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | GrantAdler Corporation
1733 Park Street Suite 104
Naperville, IL 60563
USA | NOV 12 2008 |
|-------------------------|-------------------------------------------------------------------------------------|-------------|
| | Phone: 800-605-4815
Fax: 773-442-0992 | |
| Contact Person: | Michael Loiterman | |
| Date of Summary: | 11/4/08 | |
| Trade/Proprietary Name: | Rhapsody CT | |
| Classification Name: | Port & catheter, implanted, subcutaneous, intravascular | |
| Product Code: | LJT | |
Intended Use:
The Grant Adler Rhapsody port line is intended to facilitate reliable and repeated acces of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. Access is performed by percutaneous needle insertion, using only non-coring, Huber needles. When used with a power injectable needle, Rhapsody CT is indicated for power injection of contrast media. For power injection of contrast media, the maxum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with 22 gauge non-coring power injectable needle. The Rhapsody CT has been tested and is conditionally safe to use in an MRI environment up to 3T.
Device Description:
The Rhapsody CT is supplied as a sterile device, and is intended for single patient use only. The port is available as a single model and is manufactured of the highest quality titanium. It also incorporates a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. The Port is normally inclused in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.
Predicate Device:
K060812 - Bard Inc - PowerPort™ Implanted Titanium Port with 8 Fr. ChronoFlex® Catheter K043178 - GantAdler Rhapsody Access Port and Catheter
1
Kosi889
2sf2
- ....
Grant Adler Rhapsody CT Table of Comparison
:
| Test Description | Rhapsody CT | Grant Adler
Rhapsody
K043178 | Bard
Power Port
K060812 |
|--------------------------------|----------------------------|------------------------------------|-------------------------------|
| Indications for Use | Power Injection | No Power Injection | Power Injection |
| Labeling | Equivalent | Equivalent | Equivalent |
| Target Population | Equivalent | Equivalent | Equivalent |
| Hospital Use | Yes | Yes | Yes |
| Design | Port with Septum | Equivalent | Equivalent |
| Materials, Port | Titanium | Titanium | Titanium |
| Materials, Septum | Silicone
NuSil MED-4780 | Silicone
NuSil MED-4780 | Silicone |
| Materials
Catheter | Silicone
NuSil MED-4780 | Silicone
NuSil MED-4780 | Silicone |
| Dimensional | 28.3mm x 12.7mm | Identical | 32mm x 12.8mm |
| Catheter to Port
Connection | Double Barbed
Fitting | Double Barbed
Fitting | Barbed Fitting |
| Septum Puncture | Needle | Needle | Needle |
| Port Leak Testing | No Leaks | Equivalent | Equivalent |
| Sterilization
Information | ETO | ETO | ETO |
| Biocompatibility
Assessment | Pass | Pass | Pass |
| Catheter | 7 Fr. up to 52cm | Identical | 8 Fr. up to 45cm |
| Max Power
Injection Flow | 5ml/s
19 AWG | N/A | 5ml/s
19 AWG |
| Max PI Pressure | Less than 300 psi | N/A | Less than 300 psi |
| MRI Safe | Yes | 510k in process | Unknown |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 12 2008
GrantAdler Corporation C/O Arthur J. Ward, Ph.D. AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K081889
Trade/Device Name: Rhapsody CT Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 4, 2008 Received: November 5, 2008
Dear Dr. Ward:
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.
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.
3
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); 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 (CDRH'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,
Sulfite G. Michael MD
FOR DR. CHUE UN
FOR 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
4
Indications for Use
510(k) Number (if known): K081889
Device Name: Rhapsody CT
Indications for Use:
The Grant Adler Rhapsody port line is intended to facilitate reliable and repeated acces of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. Access is performed by percutaneous needle insertion, using only non-coring, Huber needles. When used with a power injectable needle, Rhapsody CT is indicated for power injection of contrast media. For power injection of contrast media, the maxum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with 22 gauge non-coring power injectable needle. The Rhapsody CT has been tested and is conditionally safe to use in an MRI environment up to 3T. The Port is normally included in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.
Cina Vina
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Ky31889
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)