The ANUTRA Feedback Aspiration Syringe is a piston syringe (control syringe) consisting of a plastic barrel which contains a printed graduated scale (5mL nominal volume) and 6% male Luer Lock connection, a plunger, and a plastic plunger rod. The internal surface of the ANUTRA Feedback Aspiration Syringe barrel is lubricated with polydimethylsiloxane (silicone). The plunger rod design contains a finger ring to allow for ease of use, and tab features with interface with the barrel to provide audible and tactile feedback to the user.

The ANUTRA Feedback Aspiration Syringe is single-use only, non-pyrogenic, and sterilized by gamma irradiation.

AI/ML Overview

The Anutra Feedback Aspiration Syringe's acceptance criteria and performance data are primarily based on demonstrating substantial equivalence to a predicate device (BD Single Use, Hypodermic Syringe, K110771) through a battery of performance tests conforming to international standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with "reported device performance" in a quantitative manner for most tests. Instead, it lists the tests performed on the subject device and implies that the device met the "specified requirements" for these tests, thereby demonstrating substantial equivalence. For some tests, the predicate device also had similar tests performed.

Implied Acceptance Criteria and Performance (based on "Tests Performed on Subject Device")

Test Category / Standard	Specific Test (if detailed)	Implied Acceptance Criteria	Reported Device Performance
ISO 7886-1 (Syringes)	Section 5 (Cleanliness)	Device is clean and free from particulate matter.	Met.
	Section 6 (Limits for Acidity or Alkalinity)	Extracts from the device do not significantly alter pH.	Met. (Performed on both subject and predicate device).
	Section 7 (Limits for Extractable Metals)	Extracts from the device do not exceed specified limits for metals.	Met. (Performed on both subject and predicate device).
	Section 8 (Lubricant)	Lubricant properties meet specified standards.	Met.
	Section 9 (Tolerance on graduated capacity)	Accuracy of graduated volume markings within specified tolerances.	Met.
	Section 10 (Graduated Scale)	Graduated scale is clear, accurate, and durable.	Met.
	Section 11 (Barrel)	Barrel integrity and dimensions meet specifications.	Met.
	Section 12 (Piston/plunger assembly); Annex B	Piston/plunger assembly functions correctly and smoothly.	Met.
	Section 13 (Nozzle)	Nozzle dimensions and integrity meet specifications.	Met.
	Section 14.1 (Dead Space)	Dead space is minimized and within acceptable limits.	Met.
	Section 14.2 (Freedom from air and liquid leakage past piston); Annex B and Annex D	No air or liquid leakage past the piston.	Met. (Specifically, liquid leakage at syringe piston under compression (Annex D) and freedom from air and liquid leakage past piston (Annex B and D) were tested, with the predicate also testing Annex D).
	Annex G (Forces to operate the plunger)	Plunger operation forces are within acceptable range (not too high for user comfort/control, not too low for accidental movement).	Met. (Performed on both subject and predicate device).
	Section 15 (Packaging)	Packaging meets integrity and labeling requirements.	Met.
	Section 16 (Labeling)	Labeling meets specified requirements for content and legibility.	Met.
ISO 594-2 (Luer Connections)	Section 3 (Dimensions and tolerances)	Luer lock dimensions meet standard specifications for compatibility.	Met.
	Section 4.1 (Gauging)	Luer lock fits standard gauges correctly.	Met.
	Section 5.2 (Liquid leakage from fitting assembly under pressure)	No liquid leakage from the Luer lock connection under pressure.	Met.
	Section 5.3 (Air leakage into fitting assembly during aspiration)	No air leakage into the Luer lock connection during aspiration.	Met.
	Section 5.4 (Separation force of fitting assembly)	Connection remains secure under specified separation forces.	Met.
	Section 5.5 (Unscrewing torque of fitting assembly)	Connection can be unscrewed with appropriate torque.	Met.
	Section 5.6 (Ease of assembly)	Connection is easy to assemble.	Met.
	Section 5.7 (Resistance to overriding)	Connection prevents overriding (e.g., cross-threading).	Met.
	Section 5.8 (Stress cracking)	Material maintains integrity under stress.	Met.
Sterile Barrier Packaging Testing	ASTM F2096-11 (Detecting Gross Leaks)	No gross leaks in packaging.	Met.
	ASTM F88-09 (Seal Strength)	Packaging seals exhibit required strength.	Met.
	ASTM F1886/F1886M-09(2013) (Integrity by Visual Inspection)	Packaging seals are visually intact and show no defects.	Met.
General Performance	Syringe package shall be easy to open with gloved hands	Packaging can be easily opened by a user wearing gloves.	Met.
	Syringe shall be able to aspirate and deliver using one hand	Device can be comfortably and effectively operated with one hand.	Met.
	Tactile feedback	The tactile feedback feature functions as intended during aspiration/injection.	Met.
	Finger reach	The finger ring and plunger are ergonomically designed for ease of use.	Met.
Biocompatibility Testing (ISO 10993)	Cytotoxicity by Elution Test (Cytotoxicity)	No cytotoxic effects.	Met. (Summary provided in Section 15 of full submission, not provided here).
	Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity)	No significant irritation or intracutaneous reactivity.	Met. (Summary provided in Section 15 of full submission, not provided here).
	Maximization Test for Delayed Hypersensitivity (Sensitization)	No significant sensitization potential.	Met. (Summary provided in Section 15 of full submission, not provided here).
	Acute Systemic Toxicity (Systemic Toxicity (Acute))	No acute systemic toxicity.	Met. (Summary provided in Section 15 of full submission, not provided here).
	Evaluation of Hemocompatibility: Interaction with Blood (Hemocompatibility/Hemolysis)	Does not cause significant hemolysis or adverse blood interaction.	Met. (Summary provided in Section 15 of full submission, not provided here).

The "Reported Device Performance" for all listed tests is implicitly "Met" or "Demonstrated to meet the specified requirements" as stated in Section 5.8: "Test results demonstrated that the ANUTRA Feedback Aspiration Syringe is as safe, as effective and performs as well as or better than the legally marketed predicate device (BD Single Use, Hypodermic Syringe)."

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for each individual performance test (e.g., number of syringes tested for leakage, force, etc.).
The data provenance is from performance testing of the manufactured device (Anutra Feedback Aspiration Syringe) and a comparison to a predicate device. It is a prospective evaluation of the new device's performance against established standards. The country of origin of the data is not explicitly stated but would presumably be the testing labs contracted by Anutra Medical, Inc., or Gilero, LLC (based in the US).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This device is a medical device (syringe), not an AI/diagnostic software. Therefore, the concept of "ground truth" established by experts in a diagnostic sense, or based on a "test set" of cases/images with expert interpretations, is not applicable here. The performance evaluation relies on meeting engineering and biocompatibility standards through physical and chemical testing.

4. Adjudication Method for the Test Set

As this is not a diagnostic device or an AI application with human interpretation, an "adjudication method" (like 2+1, 3+1) is not applicable. The test results are objective measurements against specified standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a hardware medical device (syringe), not an AI system or diagnostic tool where MRMC studies involving human readers are performed.

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

Not applicable. This is a physical medical device, not an algorithm. Its standalone performance is assessed through the physical and chemical tests mentioned.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

International Standards: ISO 7886-1 for sterile hypodermic syringes, ISO 594-2 for Luer taper fittings, and ISO 10993 for biocompatibility.
ASTM Standards: For packaging integrity (ASTM F2096, F88, F1886M).
Predicate Device Characteristics: Comparison of technical and performance characteristics to a legally marketed predicate device to establish substantial equivalence.

These standards define the acceptable performance parameters (e.g., limits for acidity, leakage thresholds, force ranges, biocompatibility responses).

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI/machine learning system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with three faces in profile, representing the department's focus on health and well-being.

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

January 8,2015

Anutra Medical Inc. c/o Cameron Perkins 1000 Perimeter Pike, Suite E Morrisville, NC 27560

Re: K143757

Trade/Device Name: Anutra Feedback Aspiration Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Product Code: FMF Regulatory Class: II Dated: December 18, 2014 Received: December 31, 2014

Dear Cameron Perkins:

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.

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)K143757
Device Name

ANUTRA Feedback Aspiration Syringe

Indications for Use (Describe)

The ANUTRA Feedback Aspiration Syringe is intended for use by healtheare professionals for general purpose fluid aspiration/injection.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EFF

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5.0 510(k) Summary

5.1. Submitter Information

Company Name:	Anutra Medical, Inc.
Company Address:	1000 Perimeter Pk, Suite E Morrisville, NC 27560 USA
Company Phone:	844-268-8721
Company Fax:	844-268-8721
Contact Person:	Cameron PerkinsAnutra Medical, Inc.Phone: 844-268-8721Fax: 844-268-8721Email: cameron@anutramedical.com
Prepared By:	Kristin BenokraitisDirector of Quality and OperationsGilero, LLC4022 Stirrup Creek Drive Suite 300Durham, NC 27703Phone: 919-595-8223Fax: 919-595-8221Email: kristinb@gilero.com
Date SummaryPrepared:	December 18, 2014

Device Identification 5.2.

Trade/Proprietary Name:	ANUTRA Feedback Aspiration Syringe
Common Name:	Control Syringe
Classification Name:	Piston Syringe21CFR 880.5860, Class II
Classification Panel	General Hospital
Product Code:	FMF (Syringe, piston)

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5.3. Predicate Device

The ANUTRA Feedback Aspiration Syringe is substantially equivalent to the following predicate device:

Device	Manufacturer	510(k)	Date Cleared
BD Single Use,Hypodermic Syringe	Becton, Dickinson andCompany	K110771	May 13, 2011

5.4. Device Description

The ANUTRA Feedback Aspiration Syringe is single-use only, non-pyrogenic, and sterilized by gamma irradiation.

ર.ડ. Intended Use

The ANUTRA Feedback Aspiration Syringe is intended for use by healthcare professionals for general purpose fluid aspiration/injection.

5.6. Predicate Device Comparison - Technical Characteristics

Equivalency of technical characteristics is demonstrated through a direct comparison of the ANUTRA Feedback Aspiration Syringe and the predicate device listed in the table below.

TechnicalCharacteristic	Subject Device:ANUTRA FeedbackAspiration Syringe	Predicate Device:BD Single Use, HypodermicSyringe (K110771)
Barrel	Yes	Yes
Plunger Rod	Yes	Yes
Plunger	Yes	Yes
Luer Configuration	Luer Lock	1mL – Luer Slip3mL and 5mL – Luer Lock
Nominal FluidVolume	5mL	1mL, 3mL and 5mL
Lubrication	Polydimethylsiloxane(silicone)	Unknown, device assumed tobe lubricated
Sterilization Method	Gamma irradiation	Ethylene oxide or gammairradiation

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The predicate device is a piston syringe. The ANUTRA Feedback Aspiration Syringe is a type of piston syringe (specifically, a control syringe). The intended use for the ANUTRA Feedback Aspiration Syringe is the same as its predicate device, the BD Single Use, Hypodermic Syringe (K110771).

Barrel

The volume of fluid contained within the both the ANUTRA Feedback Aspiration Syringe and the predicate device is indicated by graduation marks printed on the outside of the barrel. The ANUTRA Feedback Aspiration Syringe has a plastic barrel with a 5mL nominal fluid volume. A 5mL variant of the predicate device contains the same nominal volume.

Luer Configuration

Both the subject device and the predicate device are offered in a male Luer Lock configuration. The predicate device is also available in a Slip Luer configuration (1mL only).

Nominal Fluid Volume

The nominal fluid volume for both the subject device and the predicate device is 5mL. The predicate device is also available in other fluid volumes.

Lubrication

The internal surface of the ANUTRA Feedback Aspiration Syringe is coated with a polydimethylsiloxane (silicone). The predicate device 510(k) summary does not specify whether or not the predicate device is lubricated, however based on an inspection of the predicate device, it is believed to be lubricated.

Plunger Rod & Plunger

Both the subject device and the predicate device have a plastic plunger rod and a synthetic rubber plunger; the plunger is attached to the plunger rod with snap-fit retention features. The ANUTRA Feedback Aspiration Syringe plunger rod contains features which provide audible and tactile feedback when the plunger is advanced or retracted, and a finger ring for ease of use and handling the device. The predicate device has a flat push-button on the end of its plunger rod. The mechanism for delivery of fluid is the same for both the subject device and predicate devices.

Sterilization Method

The ANUTRA Feedback Aspiration Syringe is sterilized using gamma irradiation. The predicate device can be sterilized by either gamma irradiation or ethylene oxide.

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Materials

The ANUTRA Feedback Aspiration Syringe is constructed of the following polymeric components:

. Barrel: Polypropylene copolymer
Plunger Rod: Polypropylene copolymer ●
Plunger: Synthetic (polyisoprene) rubber ●
Lubrication: Polydimethylsiloxane (silicone) ●

The subject device has been tested and meets the biological requirements outlined in ISO 10993-1. A summary of these test results is provided in Section 15 -Biocompatibility.

5.7. Predicate Device Comparison - Performance Characteristics

The performance data supplied with this submission demonstrates that the ANUTRA Feedback Aspiration Syringe meets the specified requirements and is substantially equivalent to the predicate device.

The predicate device (BD Single Use, Hypodermic Syringe) provided an overview of testing completed in the 510(k) Summary (K110771). These tests were used to compare the subject device and the predicate device performance.

Tests Performed on Subject Device and Predicate Device (as indicated in the predicate device 510(k) Summary):

· ISO 7886-1
- Section 6 (Limits for Acidity or Alkalinity) o
- Section 7 (Limits for Extractable Metals) o
- Annex D Liquid leakage at syringe piston under compression O
- Annex G Forces to operate the plunger о

Tests Performed on Subject Device:

ISO 7886-1 .
- o Section 5 (Cleanliness)
- Section 8 (Lubricant) o
- Section 9 (Tolerance on graduated capacity) O
- Section 10 (Graduated Scale) O
- Section 11 (Barrel) O
- Section 12 (Piston/plunger assembly); Annex B O
- Section 13 (Nozzle) O
- Section 14.1 (Dead Space) O
- Section 14.2 (Freedom from air and liquid leakage past piston); O Annex B and Annex D
- Section 15 (Packaging) о
- Section 16 (Labeling) O

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ISO 594-2
- o Section 3 (Dimensions and tolerances)
- Section 4.1 (Gauging) O
- Section 5.2 (Liquid leakage from fitting assembly under pressure) O
- Section 5.3 (Air leakage into fitting assembly during aspiration) O
- Section 5.4 (Separation force of fitting assembly) O
- Section 5.5 (Unscrewing torque of fitting assembly) O
- Section 5.6 (Ease of assembly) O
- Section 5.7 (Resistance to overriding) O
- Section 5.8 (Stress cracking) o
Sterile Barrier Packaging Testing ●
- o ASTM F2096 11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- O ASTM F88-09 Standard Test Method for Seal Strength of Flexible Barrier Materials
- o ASTM F1886 / F1886M 09(2013) Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
. General performance
- Syringe package shall be easy to open with gloved hands o
- Syringe shall be able to aspirate and deliver using one hand O
- Tactile feedback O
- o Finger reach
Biocompatibility Testing (ISO 10993) ●
- Cytotoxicity by Elution Test (Cytotoxicity) O
- Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity) о
- Maximization Test for Delayed Hypersensivity (Sensitization) O
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) O
- Evaluation of Hemocompatibility: Interaction with Blood O (Hemocompatibility/Hemolysis)

5.8. Conclusion

Test results demonstrated that the ANUTRA Feedback Aspiration Syringe is as safe, as effective and performs as well as or better than the legally marketed predicate device (BD Single Use, Hypodermic Syringe).

Based on comparisons of the device's intended use, technology and performance characteristics, the ANUTRA Feedback Aspiration Syringe is substantially equivalent to the indicated predicate device. Any differences between the ANUTRA Feedback Aspiration Syringe and the predicate device have no significant influence on safety or effectiveness.

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).