RHAPSODY CT

K081889 · Grantadler Corporation · LJT · Nov 12, 2008 · General Hospital

Device Facts

• Record ID: K081889
• Device Name: RHAPSODY CT
• Applicant: Grantadler Corporation
• Product Code: LJT · General Hospital
• Decision Date: Nov 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

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. 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 Story

Subcutaneous, implanted, intravascular infusion port and catheter system; facilitates vascular access for medication, fluids, blood products, and sampling. Device consists of titanium port with high-compression self-sealing silicone septum and flexible, reinforced silicone catheter. Operated by clinicians via percutaneous needle insertion using non-coring Huber needles. Supports power injection of contrast media at rates up to 5 ml/s (19/20G needle) or 2 ml/s (22G needle). Conditionally safe for MRI environments up to 3T. Provides reliable, repeated access; reduces need for frequent venipuncture; enables high-pressure contrast delivery for diagnostic imaging.

Clinical Evidence

Bench testing only. Includes biocompatibility assessment, port leak testing, and power injection performance testing (flow rates and pressure limits). MRI safety testing conducted for 3T environments.

Technological Characteristics

Titanium port; high-compression self-sealing silicone septum (NuSil MED-4780); reinforced silicone catheter (NuSil MED-4780). Double-barbed catheter-to-port connection. Dimensions: 28.3mm x 12.7mm. ETO sterilization. MRI conditional up to 3T.

Indications for Use

Indicated for patients requiring repeated vascular access for medication delivery, nutritional supplementation, fluid/blood administration, or blood sampling. Supports power injection of contrast media when used with compatible non-coring power injectable needles.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

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

Submission Summary (Full Text)

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K081889

(ofa)

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

| Submitter of 510(k): | GrantAdler Corporation<br>1733 Park Street Suite 104<br>Naperville, IL 60563<br>USA | NOV 12 2008 |
|-------------------------|-------------------------------------------------------------------------------------|-------------|
| | Phone: [phone]<br>Fax: [phone] | |
| 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

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# Grant Adler Rhapsody CT Table of Comparison

:

| Test Description | Rhapsody CT | Grant Adler<br>Rhapsody<br>K043178 | Bard<br>Power Port<br>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<br>NuSil MED-4780 | Silicone<br>NuSil MED-4780 | Silicone |
| Materials<br>Catheter | Silicone<br>NuSil MED-4780 | Silicone<br>NuSil MED-4780 | Silicone |
| Dimensional | 28.3mm x 12.7mm | Identical | 32mm x 12.8mm |
| Catheter to Port<br>Connection | Double Barbed<br>Fitting | Double Barbed<br>Fitting | Barbed Fitting |
| Septum Puncture | Needle | Needle | Needle |
| Port Leak Testing | No Leaks | Equivalent | Equivalent |
| Sterilization<br>Information | ETO | ETO | ETO |
| Biocompatibility<br>Assessment | Pass | Pass | Pass |
| Catheter | 7 Fr. up to 52cm | Identical | 8 Fr. up to 45cm |
| Max Power<br>Injection Flow | 5ml/s<br>19 AWG | N/A | 5ml/s<br>19 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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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 [phone]. 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 [phone] or [phone] 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:

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)