TAUTONA INJECTOR DEVICE

K131963 · Tautona Group, LLC · FMF · Oct 22, 2013 · General Hospital

Device Facts

• Record ID: K131963
• Device Name: TAUTONA INJECTOR DEVICE
• Applicant: Tautona Group, LLC
• Product Code: FMF · General Hospital
• Decision Date: Oct 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TauTona Injector Device is a syringe assist device and is intended for use in the administration of sterile materials / autologous adipose tissue under aseptic conditions in accordance with the best judgment of the clinician. The TauTona Injector Device is intended for use with standard syringes / cannulas.

Device Story

Hand-held, sterile, single-use, battery-powered syringe assist device; used by clinicians to inject fluids (sterile materials/autologous adipose tissue) during aesthetic procedures. Device connects to standard off-the-shelf syringes and injection cannulas. Internal components include 12V battery, motor, controller with software, and dispensing trigger. Clinician selects aliquot size via switch; trigger activates motor to apply force to syringe plunger for controlled fluid delivery. Provides consistent injection force compared to manual methods. Used in clinical settings; improves precision of fluid administration.

Clinical Evidence

Bench testing only. Included functional performance testing, comparative testing against predicates, human factors testing, biocompatibility (ISO 10993), sterilization validation (ISO 11135), electrical safety/EMC (IEC 60601), and software validation.

Technological Characteristics

Hand-held, battery-powered (12V) motor-driven syringe pump. Components: PCB controller, trigger, aliquot selector, luer connectors. Single-use, sterile. Software-controlled fluid delivery. Complies with IEC 60601 for electrical safety/EMC and ISO 10993 for biocompatibility.

Indications for Use

Indicated for administration of sterile materials or autologous adipose tissue via standard syringes and cannulas under aseptic conditions by clinicians.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Xpresse Assist / Artiste Device (K083583)
• Tissue Trans Irrigating Syringe (K050797)

Submission Summary (Full Text)

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

| Submitter: | TauTona Group, Inc.<br>4040 Campbell Avenue, Suite 110<br>Menlo Park, CA 94025 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Joe Rimsa<br>Chief Operating Officer, TauTona Group<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | 22 June 2013 |
| Device Trade Name: | TauTona Injector Device |
| Common Name: | Piston Syringe (Syringe Assist Device, Syringe Accessory)<br>Syringe Holder, Adaptor |
| Classification Name: | Syringe, Piston (21 CFR §880.5860) |
| Product Code: | FMF |
| Equivalent Devices: | Xpresse Assist / Artiste Device (K083583, cleared 30 June 2009)<br>Tissue Trans Irrigating Syringe (K050797, cleared 13 July 2005) |

# Section 6: 510(k) Summary (21 CFR § 807.92(c))

#### Device Description:

The TauTona Injector (TTI) Device is a hand-held, sterile, single-use, disposable device and is designed to be used with, off-the-shelf syringes and injection cannulas. The device is used to assist the physician in injection fluids into the body. The clinician connects the TTI device to the pre-filled syringe and a standard re-injection cannula (Size 9, 14G). The device is activated by a trigger mechanism that enables fluid delivery in specific aliquot sizes. The TTI Device is a simple handle that consists of the following components:

- . Pump with an enclosed motor
- Battery pack (12V) .
- . Controller (printed circuit board with software)
- . Dispensing trigger
- . On/off/aliquot size select switch
- . Indicator light
- . Syringe luer connector (female)
- Cannula luer connector (male) .

{1}------------------------------------------------

#### Intended Use / Indications for Use:

The TauTona Injector Device is a syringe assist device and is intended for use in the administration of sterile materials / autologous adipose tissue under aseptic conditions in accordance with the best judgment of the clinician. The TauTona Injector Device is intended for use with standard syringes / cannulas.

## Technological Characteristics:

The TauTona Injector Device is substantially equivalent to the Xpresse Assist / Artiste Device distributed by Nordson Micromedics and the Tissue Trans device distributed by Shippert Medical. Both the subject and predicate devices have similar indications for use, intended uses and operating principles. All three devices are intended to deliver fluids into the body from a prefilled piston syringe. Additionally, both the subject and predicate devices are intended for use with standard off the cannulas for injection of autologous / sterile materials in aesthetic procedures. The Tissue Trans device delivers fluid by applying manual force to a syringe. The TauTona Injector device employs the use of a trigger mechanism to activate a battery powered motor to apply force to a plunger to effect fluid delivery. Similar to the Xpresse Assist / Artiste Device, the TTI Device relies on an energy source to enable fluid delivery. However, the TTI device accomplishes this through a sterile, single-use, hand held battery powered motor as opposed to the Xpress Assist / Artiste Device which relies upon an external source of compressed gas and a power supply to enable fluid delivery. In short, the TauTona Injector is a syringe assist device that is used in the same manner as the predicate devices to assist in injections. The main difference between the predicates and the TauTona Injector Device is the source and control of the force used to drive injections.

#### Non-Clinical Performance Data:

Design verification testing confirmed that the TauTona Injector Device performs according to the stated intended use. Device evaluation consisted of functional testing performed pursuant to TauTona's design verification protocol; comparative testing with the cited predicate devices and human factors testing. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices". The sterilization validation plan complies with the requirements prescribed in ISO 11135 for ethylene oxide sterilization. Electrical safety and electromagnetic compatibility testing was completed pursuant to the requirements outlined in IEC 60601 "Medical Electrical Equipment - General Requirements for Safety". Software validation was conducted pursuant to FDA's Guidance Document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). Packaging and shipping validation studies were conducted pursuant to the applicable ISTA 2A guidelines.

## Summary:

Based on the product technical information, intended use / indications for use and non-clinical performance data provided in this premarket notification, the TauTona Injector Device has been shown to be substantially equivalent to the currently marketed predicate devices. Test data included in this 510(k) submission demonstrate similar performance of the TauTona Injector device as compared to the

{2}------------------------------------------------

predicate devices. The differences between the subject and predicate devices do not raise new types of safety or effectiveness questions.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the serpent winding around a staff.

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

#### October 22, 2013

TauTona Group, LLC C/O Joc Rimsa Chief Operating Officer 4040 Campbell Avenue, Suite 110 Menlo Park, California 94025

Re: K131963

Trade/Device Name: TauTona Injector Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 20, 2013 Received: September 23, 2013

Dear Mr. Rimsa:

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 docs 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.

{4}------------------------------------------------

Page 2 - Mr. Rimsa

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,

Mary St Bunner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K1319633

## Section 5: Indications for Use Statement

510(k) Number if Known: TBD

Device Name: TauTona Injector Device

Indications for Use:

The TauTona Injector Device is a syringe assist device and is Intended for use in the administration of sterile materials / autologous adipose tissue under aseptic conditions in accordance with the best judgment of

the clinician. The TauTona Injector Device Is Intended for use with standard syringes and cannulas.

Prescription Use 图 (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 IF NEEDED)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/12 description: The image shows the FDA logo. The logo is made up of the letters "FDA" in a stylized font. The letters are outlined with multiple lines, giving the logo a three-dimensional appearance. The logo is black and white.

Richard C. Chapman 2013.10.22 13:40:24 -04'00'