NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

K112067 · Carticept Medical, Inc. · FRN · Sep 16, 2011 · General Hospital

Device Facts

• Record ID: K112067
• Device Name: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
• Applicant: Carticept Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Sep 16, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 include fluid delivery module, daily disposable cassette, per-patient disposable handpiece/tubing set, and wired foot pedal. Device integrates with qualified ultrasound units (SonoSite M-Turbo/M-MSK) via Ethernet cable to display treatment information on ultrasound screen and print images to patient records. Operated by clinicians in clinical settings. Integration allows simultaneous visualization of treatment data and ultrasound imaging; does not alter core pump functionality. Benefits include improved documentation and procedural workflow through image integration.

Clinical Evidence

No clinical data. Bench testing only, including software validation, electrical testing of connected devices, and simulated use testing. Safety Case and Hazard Analysis performed.

Technological Characteristics

External infusion pump. Components: fluid delivery module, disposable cassette, disposable handpiece/tubing, wired foot pedal. Connectivity: Ethernet interface for ultrasound integration. Software: image integration/display functionality. Sterilization: not specified.

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

• Navigator™ Delivery System (K101994)

Reference Devices

• SonoSite M-Turbo and M-MSK (K082098)

Submission Summary (Full Text)

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# K112067

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## 510(k) Summary

SEP 1 6 2011

### 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 18, 2011 |

## DEVICE INFORMATION

| Name of Device: | Navigator™ Delivery System (Navigator DS) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Infusion Pump, External |
| Classification Name: | Infusion Pump, Class II, 21 CFR 880.5725 (Product Code<br>FRN) |
| Predicate Device(s): | Navigator™ Delivery System (K101994) |
| | Diagnostic Ultrasound Accessory<br>SonoSite M-Turbo and M-MSK, part of the Maxx Series<br>(K082098) |
| Device Description: | The Navigator Delivery System (Navigator DS) consists of a<br>fluid delivery module, a daily disposable cassette, a per-<br>patient disposable handpiece and tubing set, and wired foot<br>pedal. Image integration with qualified ultrasound units<br>occurs by Ethernet cable connection, if desired, allowing<br>simultaneous display of Navigator treatment information on<br>the ultrasound screen and printing of ultrasound images on<br>the patient treatment record. Qualified ultrasound imaging<br>units include the SonoSite M-Turbo and SonoSite M-MSK,<br>(configuration part numbers L05323 and L05600,<br>respectively). |
| Indication for Use: | The Navigator™ Delivery System (Navigator DS) is intended<br>for use in the delivery of medication and/or fluids in a<br>controlled manner. The Navigator DS is indicated for use in<br>the intermittent delivery of medications and other fluids in<br>intra-articular applications. |
| Technological<br>Characteristics: | All technological and design aspects of the Navigator DS<br>device are preserved. Image integration allows<br>simultaneous display of Navigator DS treatment images on |

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| | the ultrasound screen and printing of ultrasound screen<br>images in the patient treatment record. Independent<br>functionality of the Navigator DS device and qualified<br>ultrasound units is preserved. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate<br>Devices: | The Navigator DS with the added feature of image<br>integration raises no new questions of safety or<br>effectiveness. The Navigator DS intended use and<br>performance characteristics are not changed by this added<br>feature. |
| Performance Data: | Testing of the Navigator DS with image integration capability<br>was carried out, included software validation, electrical<br>testing of the connected devices, and simulated use testing.<br>All data demonstrated that the safety and performance of the<br>Navigator DS is not affected by the added ability to interface<br>with ultrasound accessories. |
| | A Clinical Evaluation was determined not to be required as<br>the device design, intended use and indication for use are<br>preserved. |
| | A Safety Case and Hazard Analysis demonstrated an<br>acceptable risk profile based on design-based risk mitigation<br>and satisfactory performance testing. |
| Rationale for Substantial<br>Equivalence: | This minor modification allowing imaging integration falls<br>within the FDA regulations for 510(k) review. The Navigator<br>DS with image integration capability is substantially<br>equivalent to the predicate device (Navigator DS K101194). |
| Conclusion: | The Navigator DS, as modified by this 510(k), does not raise<br>any new issues regarding safety or effectiveness, and<br>therefore is suitable for commercial sale. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

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

SEP 16 2011

Re: K112067

Trade/Device Name: Navigator Delivery System (or Navigator DS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: July 18, 2011 Received: July 19, 2011

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/Safetv/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 vours.

Nh for

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

510(k) No.
(if known):

`K112067`

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 AND/OR Over-the-Counter Use*_*_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ___ of

(Part 21 CFR 801 Subpart D)

Rli C. A
9/14/11

(21 CFR 801 Subpart C)

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

510(k) Number: K112067