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 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) .

AI/ML Overview

The provided text describes the TauTona Injector Device, a syringe assist device. However, it does not contain the specific details regarding acceptance criteria for device performance or a detailed study proving the device meets these criteria in the format requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria. While it mentions "Design verification testing" and "comparative testing," it does not present the outcomes of these tests in a quantifiable manner or against specific thresholds.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here's an attempt to answer the questions based on the available information, with clear indications where information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (If stated)	Reported Device Performance
Not explicitly stated in the document for specific performance metrics. The overall acceptance criterion is likely "substantially equivalent" to predicate devices for intended use, operating principles, and safety/effectiveness profile.	"Design verification testing confirmed that the TauTona Injector Device performs according to the stated intended use." "Test data included in this 510(k) submission demonstrate similar performance of the TauTona Injector device as compared to the predicate devices." (No quantitative performance metrics or specific thresholds are provided.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document refers to "Design verification testing," "comparative testing with the cited predicate devices," and "human factors testing," but no details on the origin or nature (retrospective/prospective) of the data are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. This type of device (piston syringe/syringe assist device) typically relies on engineering and functional testing rather than expert-established ground truth for image interpretation or diagnosis.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable to the type of testing described (functional, comparative, human factors).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images, often with or without AI assistance. The TauTona Injector Device is a mechanical assist device, not an imaging or diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable for this device. The TauTona Injector Device is a mechanical "human-in-the-loop" device by its very nature, designed to assist a physician in injecting fluids. It does not have an "algorithm-only" or "standalone" mode in the context of AI performance. The software validation mentioned refers to the internal control software, not a diagnostic algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: Not explicitly stated in terms of expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic devices. For this device, "ground truth" would likely be defined by engineering specifications and functional requirements (e.g., precise aliquot delivery, consistent force, biocompatibility compliance, electrical safety standards). These are verified through various tests like "functional testing," "biocompatibility testing," "sterilization validation," "electrical safety and electromagnetic compatibility testing," and "software validation."

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that typically requires a "training set" for diagnostic performance.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/machine learning model.

Summary of what the document does indicate about performance and testing:

Testing Types Mentioned:
- Functional testing
- Comparative testing with predicate devices
- Human factors testing
- Biocompatibility testing (ISO 10993)
- Sterilization validation (ISO 11135)
- Electrical safety and electromagnetic compatibility testing (IEC 60601)
- Software validation (per FDA Guidance Document)
- Packaging and shipping validation (ISTA 2A guidelines)
Conclusion: The device performs according to its intended use and demonstrates "similar performance" to predicate devices, thus establishing substantial equivalence without raising new safety or effectiveness questions.

Summary

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Submitter:	TauTona Group, Inc.4040 Campbell Avenue, Suite 110Menlo Park, CA 94025
Contact:	Joe RimsaChief Operating Officer, TauTona GroupTelephone: 650.331.2450Fax: 650.331.2451Email: joerimsa@tautonagroup.com
Date Summary Prepared:	22 June 2013
Device Trade Name:	TauTona Injector Device
Common Name:	Piston Syringe (Syringe Assist Device, Syringe Accessory)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)Tissue Trans Irrigating Syringe (K050797, cleared 13 July 2005)

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

Device Description:

. 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) .

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Intended Use / Indications for Use:

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

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

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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.

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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 (800) 638-2041 or (301) 796-7100 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

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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'

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
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.(b)
Classification. Class II (performance standards).