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.

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.

AI/ML Overview

The provided text is for a 510(k) summary for a medical device called "Rhapsody MRI," which is an implanted port and catheter. This document focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its MRI compatibility. Therefore, the "acceptance criteria" and "study" described are related to verifying this compatibility, not the performance of an AI algorithm.

Based on the provided text, here's a breakdown of the requested information, interpreted in the context of a medical device submission rather than an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
MRI Compatibility	The Rhapsody MRI meets all established acceptance criteria for performance testing and design verification testing related to MRI compatibility.
Substantial Equivalence	The product is identical to the GrantAdler Rhapsody Access Port with different labeling and testing performed to demonstrate its substantial equivalence as an MRI Compatible Device.
Intended Use (General)	Indicated for reliable repeated access of the vascular system for fluid/medication delivery and blood sampling. Safe to use in an MRI environment.

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

The document does not explicitly state a "sample size" for a specific test set in the way one would for an AI/ML study (e.g., number of images or patients). Instead, it refers to "performance testing and design verification testing" related to MRI compatibility. This likely involved a set of physical devices being subjected to various MRI conditions to assess their safety and function.

Sample Size: Not specified in terms of numerical units like "patients" or "cases." The context suggests a set of physical devices tested.
Data Provenance: Not specified, but likely refers to internal testing conducted by the manufacturer (GrantAdler Corporation). It is not retrospective or prospective in the clinical study sense; rather, it's product testing.

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

This concept of "experts establishing ground truth" is not directly applicable in the context of this device's submission. The "ground truth" here is the physical interaction of the device with an MRI environment, and its safe and effective function. This would be established through engineering and electromagnetic compatibility testing standards, not expert subjective review.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data, typically in diagnostic imaging studies where there's subjectivity. Here, the assessment is based on objective measurements and adherence to engineering standards for MRI compatibility.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device approval, not an AI/ML algorithm submission. An MRMC study is designed to evaluate the impact of an AI algorithm on human reader performance, which is not relevant for this device.

6. Standalone Performance Study (Algorithm Only)

No. This refers to a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Physical and electronic measurements: Demonstrating the device's behavior in an MRI field (e.g., heating, artifact generation, displacement).
Adherence to recognized standards: Likely ISO, ASTM, or similar standards for MRI compatibility of implanted devices.
Functional performance: Ensuring the port and catheter continue to function as intended after exposure to MRI.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

KU82136

NOV 1 3 2008

510(K) SUMMARY (as required by 807.92(c))

Regulatory Correspondent:	AJW Technology Consultants Inc.962 Allegro LaneApollo Beach, FL 33572Phone: (813) 645-2855
Submitter of 510(k):	GrantAdler Corporation1733 Park Street Suite 104Naperville, IL 60563Phone: 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:

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.

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Intended Use:

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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.

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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

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XV88d1d6

Indications for Use

510(k) Number (if known):

Devicc Name: Rhapsody MRI

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 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

Page 1 of 1

510(k) Number: K082126

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.