NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

K122215 · Carticept Medical, Inc. · FRN · Oct 26, 2012 · General Hospital

Device Facts

• Record ID: K122215
• Device Name: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
• Applicant: Carticept Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.

Device Story

Navigator Delivery System (Navigator DS) is an external infusion pump for controlled delivery of medications/fluids. System components: fluid delivery module, daily disposable cassette, per-patient disposable handpiece, tubing set, and wired foot pedal. Optional Ethernet integration with qualified ultrasound units allows simultaneous display of treatment information on ultrasound screens and printing of images on patient records. Operated by clinicians in clinical settings. Modification involves adjusted resistance thresholds to maintain performance equivalence. Device provides controlled fluid delivery to improve procedural accuracy and patient outcomes in intra-articular applications.

Clinical Evidence

No clinical data. Bench testing and hazard analysis performed to validate modified resistance thresholds. Safety and performance demonstrated to be equivalent to predicate.

Technological Characteristics

External infusion pump. Components: fluid delivery module, disposable cassette, handpiece, tubing, foot pedal. Connectivity: Ethernet for ultrasound integration. Design and technological aspects preserved from predicate; modification limited to resistance thresholds.

Indications for Use

Indicated for intermittent delivery of medications and fluids in intra-articular applications.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• NavigatorTM Delivery System (K120830)

Submission Summary (Full Text)

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# 510(k) Summary

SUBMITTER'S INFORMATION

| Owner: | Carticept Medical, Inc. |
|------------------------|--------------------------------------------------------|
| Address: | 6120 Windward Parkway, Suite 220, Alpharetta, GA 30005 |
| Phone: | 770-754-3800 |
| Fax Numbers: | 770-754-3808 |
| Contact Person: | Tanya Eberle, Director, Regulatory Affairs |
| Date Summary Prepared: | July 24, 2012 |

#### DEVICE INFORMATION

| Name of Device: | NavigatorTM Delivery System (Navigator DS) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Infusion Pump, External |
| Classification Name: | Infusion Pump, Class II, 21 CFR 880.5725 (Product Code FRN) |
| Predicate Device(s): | NavigatorTM Delivery System (K120830) |
| Device Description: | The Navigator Delivery System (Navigator DS) consists of a fluid<br>delivery module, a daily disposable cassette, a per-patient<br>disposable handpiece and tubing set, and wired foot pedal.<br>Image integration with qualified ultrasound units occurs by<br>Ethernet cable connection, if desired, allowing simultaneous<br>display of Navigator treatment information on the ultrasound<br>screen and printing of ultrasound images on the patient<br>treatment record. |
| Indication for Use: | The NavigatorTM Delivery System (Navigator DS) is intended for<br>use in the delivery of medication and/or fluids in a controlled<br>manner. The Navigator DS is indicated for use in the<br>intermittent delivery of medications and other fluids in intra-<br>articular applications. |
| Technological<br>Characteristics: | All technological and design aspects of the Navigator DS device<br>are preserved. |
| Comparison to Predicate<br>Device: | The Navigator DS intended use and performance characteristics<br>are not altered by this modification. |

OC

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Performance Data:

Testing of the Navigator DS was carried out, including performance testing. All data demonstrated that the safety and performance of the Navigator DS is not affected by the modification.

A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved.

A Safety Case and Hazard Analysis demonstrated an acceptable risk profile based on design-based risk mitigation and satisfactory performance testing.

Rationale for Substantial Equivalence:

This minor modification falls within the FDA regulations for 510(k) review. The indication for use, intended use, technological characteristics, principles of operation, and performance have not been altered. The modification of resistance thresholds does not raise any new questions of safety or effectiveness and the system has been demonstrated to provide the same level of performance as the predicate device. The Navigator DS with modified resistance thresholds is substantially equivalent to the predicate device (Navigator DS K120830).

Conclusion:

The Navigator DS, as modified by this 510(k), does not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 6 2012

Carticept Medical, Incorporated Ms. Tanya Eberle Director, Regulatory Affairs 6120 Windward Parkway, Suite 220 Alpharetta, Georgia 30005

Re: K122215

Trade/Device Name: Navigator Delivery System (Navigator DS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 1, 2012 Received: October 2, 2012

Dear Ms. Eberle:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Eberle

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. awat

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement

K 122215

510(k) No. (if known):

Device Name:

Navigator™ Delivery System (Navigator DS)

Indications for Use:

The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ali (Ch) 10/26/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KI22215 510(k) Number: _