The Encore™ Neutral is intended for single patient use in intravenous and blood administrations and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use.

The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does not have to be changed subsequent to use with a low pressure power injector.

Device Description

The Encore™ Neutral is a luer activated needleless IV Connector that is disposable and for single patient use. It includes the following features:

. smooth swabbable surface
. tight seal integrity with no gaps or openings
straight-through fluid pathway resulting in zero dead space ●
100% effective blood clearing
neutral fluid displacement ●
. low priming volume
saline-only flush option
. no clamping sequence or positive pressure syringe technique required

The Encore™ Neutral is a sterile single-use device which is provided individually packaged. The Encore™ Neutral is also provided bulk non-sterile, to be further processed (packaged and sterilized) by another manufacturer.

The Encore™ Neutral is available with an optional protective end cap attached to the male luer of the device.

The Encore™ Neutral is compatible with ISO 594 compliant male luer slip devices and male luer lock devices.

The Encore™ Neutral is composed of medical grade materials that are not made with Bisphenol A (BPA), di-2-ethylhexyl phthalate, diethylhexyl phthalate (DEHP) or natural rubber latex. The materials used have been subjected to and have passed biocompatibility testing per the latest ISO 10993 standards.

The Encore™ Neutral is MR Safe as it does not contain metallic, magnetic or metal components.

The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The device does not have to be changed subsequent to use with a low pressure power injector. When used with a low pressure power injector, the Encore™ Neutral must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

AI/ML Overview

This document describes the Encore™ Neutral device, an intravenous (IV) connector, and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific performance acceptance criteria in the manner you've requested (e.g., using a test set, ground truth, expert adjudication, etc.). The document focuses on regulatory approval (510(k)) based on substantial equivalence to an existing marketed device.

Here's an analysis based on the information provided, highlighting what is and is not present:

Summary of Acceptance Criteria and Device Performance (Limited Information)

The document states that "All testing met the predetermined acceptance criteria." However, the specific quantitative acceptance criteria and the corresponding reported device performance values are generally not provided in a detailed table format within this regulatory submission. For most items, it only lists the "performance test conducted" without numerical criteria or results.

Acceptance Criteria (Inferred/Abstract)	Reported Device Performance
Smooth swabbable surface	Verified
Tight seal integrity with no gaps	Verified
Straight-through fluid pathway	Verified
100% effective blood clearing	Verified
Neutral fluid displacement	Verified
Low priming volume	Verified
Saline-only flush option	Verified
No clamping sequence/positive pressure	Verified
Sterility Assurance Level (SAL) 10-6	Verified
Compatibility with ISO 594 luer devices	Verified
Biocompatibility per ISO 10993	Verified
Specific Performance Tests:
Activation Force	Met predetermined criteria
Flow Rate at Gravity	Met predetermined criteria
Fluid Displacement	Met predetermined criteria
Multiple Activations	Met predetermined criteria
Back Pressure	Met predetermined criteria
Extended Access (Snap Back)	Met predetermined criteria
High pressure (static conditions)	Met predetermined criteria
Power Injection (325 psi, 10 mL/sec)	Met predetermined criteria
Microbial Ingress (up to 7 days/300 activations)	Verified up to 7 days or 300 activations
Mechanical Hemolysis (Injection/Aspiration)	Met predetermined criteria
Blood Clearing	Met predetermined criteria

Detailed Information as Requested:

A table of acceptance criteria and the reported device performance
- As shown in the table above, the document lists performance tests and states that "All testing met the predetermined acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test (e.g., "activation force must be >X and <Y N") nor the specific numerical results of those tests (e.g., "activation force was Z N").
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the exact sample sizes used for each performance test. It mentions "All testing was conducted on the final finished sterile device."
- The data provenance (country of origin, retrospective/prospective) is not stated.
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)
- This question is not applicable to this type of device and study. The testing described involves physical, chemical, and microbiological performance evaluations, not diagnostic interpretation requiring expert medical review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the reasons stated above.
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
- This question is not applicable. This is a medical device for intravenous access, not an AI-assisted diagnostic tool or an imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. There is no algorithm involved.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the performance tests would be the established physical, chemical, and engineering standards defined by the cited ISO and ASTM standards, as well as internal procedures. For example, for sterility, the ground truth is a Sterility Assurance Level (SAL) of 10-6. For biocompatibility, it's compliance with ISO 10993 standards.
The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is the product being tested.
How the ground truth for the training set was established
- This question is not applicable for the reasons stated above.

In conclusion: The provided document is a 510(k) summary for a medical device (IV connector) seeking market clearance based on substantial equivalence. It describes a series of non-clinical performance and biocompatibility tests conducted to demonstrate that the device meets safety and effectiveness requirements relative to a predicate device and relevant standards. While it states that all predetermined acceptance criteria were met, it does not provide the specific numerical details of those criteria or the test results, nor does it involve the type of clinical or AI-related study design (experts, ground truth adjudication, MRMC, training/test sets for algorithms) that your questions typically address.

Summary

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

June 15, 2017

RyMed Technologies, LLC Ms. Anna McCutchen Director of Ouality Assurance and Regulatory Affairs 6000 W. William Cannon Drive B300 Austin, Texas 78749

Re: K162826

Trade/Device Name: Encore™ Neutral Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: May 19, 2017 Received: May 23, 2017

Dear Ms. Anna McCutchen:

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 (OS) 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,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting 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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Indications for Use

510(k) Number (if known) K162826

Device Name Encore™ Neutral

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for RyMed Technologies, LLC. The logo consists of a black square containing a white clover on the left, followed by the text "RyMed" in a bold, sans-serif font. Below "RyMed" is the text "TECHNOLOGIES, LLC" in a smaller, sans-serif font. The logo is simple and professional, with a clear emphasis on the company name.

510(k) Summary

Summary provided per [21 CFR 807.92]- K162826

Date: June 9, 2017

Common Name:

Submitter's Information:	RyMed Technologies, LLC6000 W. William Cannon DriveBuilding B, Suite 300Austin, TX 78749512-301-7334

Contact:	Anna McCutchenDirector of Quality Assurance and Regulatory AffairsPhone: (512) 301-7334 x 303Fax: (512) 301-7338E-mail: amccutchen@rymedtech.com
Device Name/ Trade Name:	Encore™ Neutral

Needleless IV Connector

Device Classification: Regulation Number: 880.5440, Class II Intravascular Administration Set Classification Product Code: FPA Panel: General Hospital Predicate Device: 510(k) Number: K991653 Device Name: InVision-Plus® Injection Ports Classification Product Code: FPA Regulation Number: 880.5540, Class II Applicant: RyMed Technologies, LLC

Description of the Device

The Encore™ Neutral is a luer activated needleless IV Connector that is disposable and for single patient use. It includes the following features:

. smooth swabbable surface
. tight seal integrity with no gaps or openings
straight-through fluid pathway resulting in zero dead space ●
100% effective blood clearing
neutral fluid displacement ●
. low priming volume
saline-only flush option
. no clamping sequence or positive pressure syringe technique required

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The Encore™ Neutral is available with an optional protective end cap attached to the male luer of the device.

The Encore™ Neutral is compatible with ISO 594 compliant male luer slip devices and male luer lock devices.

The Encore™ Neutral is MR Safe as it does not contain metallic, magnetic or metal components.

Indication for Use

Substantial Equivalence

The Encore™ Neutral is substantially equivalent to the predicate device having similar indications for use, technological characteristics, and performance. Below is a device comparison between the Encore™ Neutral and the predicate device. In addition, RyMed Technologies, LLC has successfully conducted microbial ingress testing for up to 7 days or 300 activations, and sterilization, shelf life and packaging validations.

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Characteristics for Substantial Equivalence (SE) Determination
Characteristic	Predicate Device (K991653)	Encore™ Neutral (subject device)
FDA Regulation	21 CFR 880.5440Intravascular Administration SetClass IIClassification Product Code: FPA	21 CFR 880.5440Intravascular Administration SetClass IIClassification Product Code: FPA
Indicationsfor Use	Intended for single patient use inintravenous and blood administration andaspiration without the need for needles,thus eliminating the potential for needle-stick injuries during use.	Intended for single patient use inintravenous and blood administration andaspiration without the need for needles,thus eliminating the potential for needle-stick injuries during use.Device may be used with low pressurepower injectors having a maximumpressure of 325 psi and a maximum flowrate of 10 mL/sec. The subject device doesnot have to be changed subsequent to usewith a low pressure power injector.
Design	The predicate device is a luer activatedneedleless IV ConnectorThe predicate device is disposable and forsingle patient use.The predicate device consists of a straight-through fluid pathway with zero residualvolume (dead space), a smooth surface andis non-hemolytic (aspiration and injection).	The subject device is a luer activatedneedleless IV ConnectorThe subject device is disposable and forsingle patient use.The subject device consists of a straight-through fluid pathway with zero residualvolume (dead space), a smooth surface andis non-hemolytic (aspiration and injection).
Materials ofConstruction	The predicate consists of the followingmedical grade material types:Polycarbonate, polyethylene, polyisoprene,silicone rubber	The subject device consists of thefollowing medical grade material types:Copolyester, MABS polymer, siliconerubber
Sterilization	The product Sterility Assurance Level(SAL) is 10-6Method: Gamma and/or Ethylene Oxide	The product Sterility Assurance Level(SAL) is 10-6Method: Gamma

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Comparison

The following differences exist between the subject device and predicate device:

The subject device indications for use includes use with power injection procedures
The materials to construct the devices differ
The subject device is validated for Gamma sterilization while the predicate device may be Gamma or Ethylene Oxide sterilized

The differences in the indications for use for the subject device device do not alter the intended use of the subject device. Both the subject device and predicate device are intended for intravenous and blood administration and aspiration.

The material differences between the subject device and predicate device do not adversely affect the safety and effectiveness of the subject device. All materials are medical grade and have passed biocompatibility testing.

Non-Clinical Data- Performance Testing

RyMed Technologies, LLC performed design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predict device. All testing was conducted on the final finished sterile device.

The following standards were utilized in evaluating the functionality of the Encore ™ Neutral:

. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements
. ISO 594-2:1998 Second Edition, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment- Part 2 Lock Fittings (General Plastic Surgery/General Hospital)
ASTM F1608-16, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
AAMI/ANSI/ISO 11137-1: 2006/(R)2010, Sterilization of Health Care Products- Radiation- Part 1: . Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
AAMI/ANSV/ISO 11137-2:2013. Sterilization of Health Care Products- Radiation- Part 2: Establishing ● the Sterilization Dose

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The following performance tests were conducted according to internal procedures. All testing met the predetermined acceptance criteria and support the substantial equivalence determination:

Activation Force ●
Flow Rate at Gravity ●
Fluid Displacement
Multiple Activations ●
Back Pressure ●
Extended Access (Snap Back) ●
High pressure (static conditions)
Power Injection 10 mL/sec with maximum pressure of 325 psi ●
Microbial Ingress
Mechanical Hemolysis- Injection and Aspiration
Blood Clearing ●

Biocompatibility

The materials of construction for the subject device were evaluated according to ISO 10993-1:2009 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. All testing was conducted on the final finished sterile device. RyMed Technologies, LLC performed testing according to the following parts of the ISO 10993 Standard:

. ISO 10993-4:2002, Biological Evaluation of Medical Devices- Part 4: Selection of Tests for Interaction with Blood
ISO 10993-5:2009, Biological Evaluation of Medical Devices- Part 5: Tests for InVitro Cytotoxicity ●
ISO 10993-10:2010, Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11:2006-, Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity ●

Conclusion

It is concluded that based on performance data and biocompatibility testing conducted on the subject device along with the same intended use and similarities in indications for use and technological characteristics that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.