(107 days)
No
The document describes a standard vascular access port and catheter, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is described as an access port and catheter for delivering medications, nutritional supplementation, fluids, blood, or blood products, and for sampling blood. It facilitates treatment but does not directly provide therapy itself.
No
The device is described as an "Access Port and Catheter" used for "reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood." This functionality is for administering or collecting substances, not for diagnosing conditions or diseases.
No
The device description explicitly states it is a sterile, single-patient use device made of titanium and silicone, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Function: The grantAdler Rhapsody Access Port and Catheter is a device implanted in the body to provide access to the vascular system for delivering substances or drawing blood. It is a therapeutic or diagnostic access device, not a device that analyzes samples in vitro.
- Intended Use: The intended use clearly describes its function for delivering and sampling within the vascular system, not for analyzing samples outside the body.
Therefore, based on the provided information, this device falls under the category of an implanted medical device for vascular access, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 Rhapsody Port and Catheter are safe to use in an MRI environment.
Product codes
LJT
Device Description
grantAdler Ports and Catheters are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia. The grantAdler port line 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.
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
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)
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
KU82136
NOV 1 3 2008
510(K) SUMMARY (as required by 807.92(c))
| Regulatory Correspondent: | AJW Technology Consultants Inc.
962 Allegro Lane
Apollo Beach, FL 33572
Phone: (813) 645-2855 |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | GrantAdler Corporation
1733 Park Street Suite 104
Naperville, IL 60563
Phone: 800-605-4815 |
| Contact Person: | Michael Loiterman |
| Date of Summary: | July 3, 2008 |
| Trade/Proprietary Name: | Rhapsody MRI |
| Classification Name: | Port & catheter, implanted, subcutaneous, intravascular |
| Product Code: | LJT |
Device Description:
grantAdler Ports and Catheters are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia. The grantAdler port line 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.
Predicate Device:
K043178 - GrantAdler - Rhapsody
Substantial Equivalence:
The Rhapsody MRI mects all established acceptance criteria for performance testing and design verification testing. The components of the Rhapsody MRI are substantially equivalent to the predicate devices as presented in this 510(k). The product is identical to the GrantAdler Rhapsody Access Port with different labeling and testing having been performed to demonstrate its substantial equivalence as a MRI Compatible Device.
1
Intended Use:
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 Rhapsody Port and Catheter are safe to use in an MRI environment.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three lines extending from the bottom of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2008
GrantAdler Corporation C/O Arthur J. Ward, Ph.D. AJW Technology Consultants Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K082126
Trade/Device Name: Rhapsody MRI Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutancous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 3, 2008 Received: August 19, 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
Page 2 -- Dr. Ward
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, pcrmits 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 vours.
Suytie y. Michaud md.
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
XV88d1d6
Indications for Use
510(k) Number (if known):
Devicc Name: Rhapsody MRI
Indications for Use:
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.
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 LINF-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L.K. mD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K082126