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.

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.

AI/ML Overview

Let's break down the information provided in the K081889 510(k) summary regarding the GrantAdler Rhapsody CT.

It's important to note that this 510(k) submission is for a medical device (implantable port and catheter), not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML devices (like sample sizes for test/training sets, ground truth establishment methods, expert adjudication, MRMC studies, and standalone AI performance) are not applicable here.

The "acceptance criteria" for this type of device are primarily compliance with design specifications, material properties, and functional performance, often benchmarked against predicate devices and relevant industry standards.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided table in the document is a "Grant Adler Rhapsody CT Table of Comparison," which compares the Rhapsody CT device to its predicate devices (Grant Adler Rhapsody K043178 and Bard Power Port K060812). This table effectively serves as a summary of the device's performance against relevant design and functional criteria, demonstrating substantial equivalence to predicates.

Acceptance Criteria (Test Description)	Reported Device Performance (Rhapsody CT)	Justification/Comparison to Predicates
Indications for Use	Power Injection	Has Power Injection indication, similar to Bard Power Port K060812. Expands on previous Rhapsody (K043178) which didn't have this.
Labeling	Equivalent	Equivalent to K043178 and K060812.
Target Population	Equivalent	Equivalent to K043178 and K060812.
Hospital Use	Yes	Consistent with K043178 and K060812.
Design	Port with Septum	Equivalent to K043178 and K060812.
Materials, Port	Titanium	Consistent with K043178 and K060812.
Materials, Septum	Silicone NuSil MED-4780	Consistent with K043178 and comparable to K060812 (general Silicone).
Materials, Catheter	Silicone NuSil MED-4780	Consistent with K043178 and comparable to K060812 (general Silicone).
Dimensional	28.3mm x 12.7mm	Different from K060812 (32mm x 12.8mm) but stated as "Identical" to K043178. Dimensions are typically evaluated for functional equivalence.
Catheter to Port Connection	Double Barbed Fitting	Consistent with K043178, and a variation from K060812 (Barbed Fitting), implying a design difference but functionally equivalent for purpose.
Septum Puncture	Needle	Consistent with K043178 and K060812.
Port Leak Testing	No Leaks	Equivalent to K043178 and K060812. This would be a critical functional acceptance criterion, meaning the device must not leak under tested conditions.
Sterilization Information	ETO (Ethylene Oxide)	Consistent with K043178 and K060812.
Biocompatibility Assessment	Pass	Equivalent to K043178 and K060812. This is a crucial safety acceptance criterion, indicating the materials are safe for implantation.
Catheter	7 Fr. up to 52cm	Different from K060812 (8 Fr. up to 45cm) but stated as "Identical" to K043178. Specific dimensions and French sizes are design parameters.
Max Power Injection Flow	5ml/s 19 AWG	Directly matches K060812 for 19 AWG, and new for this product line. Also specifies 2 ml/s with 22 gauge non-coring power injectable needle in the Intended Use.
Max PI Pressure	Less than 300 psi	Directly matches K060812. This is a critical functional safety acceptance criterion.
MRI Safe	Yes	New feature compared to K043178 ("510k in process") and K060812 ("Unknown"). This required specific testing.

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

For a medical device like this, there isn't a traditional "test set" with "data provenance" in the way one would describe an AI/ML algorithm. Instead, verification and validation testing is performed on the physical device.

Sample Size: The document does not specify the exact number of physical devices tested for each criterion (e.g., how many ports were tested for leaks, or how many underwent material biocompatibility assessments). This information is typically detailed in the full testing reports submitted to the FDA, but not usually in the 510(k) summary. We can infer that enough samples were tested to provide statistical confidence for the claimed performance.
Data Provenance: Not applicable in the context of AI/ML data. The "data" here comes from laboratory testing of manufactured devices.

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

This concept is not applicable to this device. There is no "ground truth" established by experts in the context of image interpretation or diagnosis. Instead, the performance criteria (e.g., "no leaks," "pass biocompatibility," "5 ml/s flow rate at <300 psi") are established through engineering specifications, regulatory standards, and comparison to predicate devices, and then verified through objective physical and chemical testing.

4. Adjudication Method

Not applicable to this device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in diagnostic tasks, which is not relevant for an implantable port.

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

Not applicable. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on human reader performance. This device is an implantable port, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by:

Engineering Specifications: Design limits for pressure, flow rates, dimensions.
Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other device properties.
Predicate Device Performance: The performance of legally marketed predicate devices forms a baseline against which the new device is compared to establish substantial equivalence.
Objective Physical and Chemical Testing: Lab tests demonstrating "no leaks," "pass biocompatibility," "max pressure/flow capabilities," and "MRI safety."

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.

In summary, the K081889 document is a 510(k) premarket notification for a physical medical device (an implantable port and catheter). The "acceptance criteria" and "study" described are focused on demonstrating the device's safety and effectiveness through engineering design, material compatibility, functional performance testing, and substantial equivalence to predicate devices, rather than the statistical performance metrics typical for AI/ML diagnostic software.

Summary

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K081889

(ofa)

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

Submitter of 510(k):	GrantAdler Corporation1733 Park Street Suite 104Naperville, IL 60563USA	NOV 12 2008
	Phone: 800-605-4815Fax: 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:

Device Description:

Predicate Device:

K060812 - Bard Inc - PowerPort™ Implanted Titanium Port with 8 Fr. ChronoFlex® Catheter K043178 - GantAdler Rhapsody Access Port and Catheter

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Kosi889
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....

Grant Adler Rhapsody CT Table of Comparison

Test Description	Rhapsody CT	Grant AdlerRhapsodyK043178	BardPower PortK060812
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	SiliconeNuSil MED-4780	SiliconeNuSil MED-4780	Silicone
MaterialsCatheter	SiliconeNuSil MED-4780	SiliconeNuSil MED-4780	Silicone
Dimensional	28.3mm x 12.7mm	Identical	32mm x 12.8mm
Catheter to PortConnection	Double BarbedFitting	Double BarbedFitting	Barbed Fitting
Septum Puncture	Needle	Needle	Needle
Port Leak Testing	No Leaks	Equivalent	Equivalent
SterilizationInformation	ETO	ETO	ETO
BiocompatibilityAssessment	Pass	Pass	Pass
Catheter	7 Fr. up to 52cm	Identical	8 Fr. up to 45cm
Max PowerInjection Flow	5ml/s19 AWG	N/A	5ml/s19 AWG
Max PI Pressure	Less than 300 psi	N/A	Less than 300 psi
MRI Safe	Yes	510k in process	Unknown

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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.

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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

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Indications for Use

510(k) Number (if known): K081889

Device Name: Rhapsody CT

Indications for Use:

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)

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.