The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke. The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.

AI/ML Overview

The provided text describes a medical device, the RMI Dual Fluid Irrigating Syringe, and its testing for safety and effectiveness. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.

The document focuses on the device itself and its manufacturing, biocompatibility, and basic functional performance, comparing it to predicate devices. It does not involve any AI components, image analysis, or diagnostic capabilities that would typically be evaluated with metrics like those commonly used for AI in healthcare (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Specifically, the following information is missing or not applicable based on the provided text:

A table of acceptance criteria and the reported device performance: While there is a "Table of Tests and Results" for functional parameters (leak, flow, pull), these are for the physical device, not for an AI algorithm's performance against clinical acceptance criteria.
Sample sized used for the test set and the data provenance: No test set for an AI algorithm is mentioned. The sample sizes for functional tests (e.g., 13 units for leak/flow tests) refer to physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no AI algorithm requiring ground truth from experts.
Adjudication method for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the functional tests, the "ground truth" is simply the physical measurement or observation (e.g., "Passed" leak test).
The sample size for the training set: Not applicable as there's no AI algorithm.
How the ground truth for the training set was established: Not applicable.

The document primarily covers:

Product Description: RMI Dual Fluid Irrigating Syringe.
Component Materials: List of materials in contact with fluids.
Predicate Device Identification: Micromedics, Inc. Surgical Sealant Dispenser (SSD) and Duoflo™ Dispenser.
Summary of Biocompatibility: Various tests (skin irritation, sensitization, cytotoxicity, systemic toxicity, hemocompatibility, pyrogenicity, muscle implantation, Ames test) and their results, all indicating acceptable biocompatibility for medical device use.
Functional/Performance Information:
- Functional Testing: Leak tests, flow tests, and pull tests on stopcocks/tubing with reported results (e.g., "Passed," "all pulled to 17 lbs. or more").
- Performance Testing: States the device is substantially equivalent in performance to two separate 10cc syringes or two taped-together syringes in delivering fluids simultaneously and in an equal 1:1 ratio.
Comparison to Predicate Device (Micromedics SA-4310): Tabular comparison of characteristics like model, syringe volume, assembly, applicator tip configuration, and sterilization method.

Summary

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

大964833

FEB 19 1997

Attachment II.A.

SMDA Summary of Salety and Effectiveness Information

In compliance with requirements of the Sale Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:

1. Product: RMI Dual Fluid Inigating Syringe Manufactured by: Research Medical, Inc. 6864 South 300 West Midvale, UT 84047
  Phone: (801) 562-0200 FAX: (801) 562-1122
1. Description: The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke.
  The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.
1. Component Materials: The RMI Dual Fluid Irrigating Syringe is composed of the following fluid contacting components and materials:

Component	Materials
(2) 10cc SLP LL BD#301030 syringes	Standard Becton Dickinson
(2) Three-way stopcocks	Polycarbonate
(2) Parallel fluid pathway lines	Tecoflex tubing
(2) Gish Fluid Transfer Set, CPVMF36S	PVC tubing, PVC female luer-lock, polycarbonate male luer-lock, and ABS end caps

4 . Predicate Device Identification: A claim of substantial equivalence of the RMI Dual Fluid Irrigating Syringe is made to the following predicate devices:
- Micromedics, Inc. Surgical Sealant Dispenser (SSD); 510(k) Number K881020. [Also marketed as the Micromedics Fibrijet Delivery System]

Marketed by : Micromedics, Inc. 1285 Corporate Center Drive #150 Eagan, Minnesota 55121 Phone: (612) 452-1977 Fax: (612) 452-1787

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

Duoflo™ Dispenser; 510(k) Number K872565.
Marketed by : Hemaedies, Inc. 2649 Scahorn Drive Malibu, CA 90265 Phone: (213) 454-4757

ડ . Summary of Biocompatibility:

A Primary Skin Irritation Evaluation was conducted. Under conditions of the test, ● the Test Article extract did not produce a skin irritation and passed the CFR primary skin irritation.
. The Guinea Pig Maximization (Magnusson/Kligman Method) was performed. Under conditions of the test, the Test Article, extracted in normal saline, was a class I (weak) sensitizer in guinea pigs using the Magnusson/Kligman Guinea Pig Maximization test. A response of I is not considered to reflect significant sensitization
. The Cytotoxicity Test (MEM Elution Test) was performed. Under conditions of the test, the Test Article is not cytotoxic.
. The Cytoxicity Test (Agar Overlay Test) was performed. Under conditions of the test, the Test Article is not cytotoxic. All components met the USP guidelines with a grade of 2 or lower.
. The Acute Systemic Toxicity Test (USP Systemic Toxicity Evaluation) was conducted. Under conditions of the test, there was no reaction of the mice to the Test Article when observed at intervals for a period of 72 hours following treatment.
. The Hemocompatibility (Hemolysis Test) for blood compatibility was conducted. Under conditions of the test, the Test Article had 0.20% Hemolysis. Experience with this test on a wide range of samples indicates that less than 5% hemolysis should not be considered significant. The 5% level is based on the reproducibility and ruggedness of the assay.
The Hemocompatibility (Thrombogenicity Test) was performed to quantitate the thrombogenic potential of the Test Article. Under conditions of the test, the average clouing time for the negative control sample was 137.3 seconds. The average clotting time for the Test Article was 129.5 seconds. Summarized, the test sample did demonstrate shortened clotting time (thrombogenic risk was detected.)
The Material Mediated Pyrogenicity Test (Limulus Test) was performed. Under conditions of the test, the Test Article is not pyrogenic.
USP muscle implantation tests (Seven Day Muscle Implant Evaluation) were performed on various components of the Test Article. Under conditions of the test, all tested components of the Test Article met the requirements of the 7 day USP musele implant test.
The Salmonella Typhimurium Reverse Mutation Assay (AMES Test) was performed. Under conditions of the test, extract of the Test Article tested against five strains did not meet the criteria for a potential mutagen.

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

Functional/Performance and Comparative Information 6.

A. Summary of Functional Testing of the RMI Dual Fluid Irrigating Syringe:

Table of Tests and Results

Parameter

Results

DFIS Leak Test @ 2 PSI (13 units): DFIS Flow Test @ 1.0 CFH (13 units) DFIS Pull Test -- 5 lbs. minimum Left stopcock / tubing (13 units) Right stopcock / tubing (13 units) Gish Fluid Transfer Set, CPVMF36S

Passed Passed

All pulled to 17 lbs. or more. All pulled to 17 lbs. or more. Meets all IQA acceptance criteria

B. Summary of Performance Testing of the RMI Dual Fluid Irrigating Syringe:

Performance [functionality] testing shows that the RMI Dual Fluid Irrigating Syringe (DFIS) is substantially equivalent in performance to: (1) two single 10cc syringes, one syringe held in each hand; and (2) two 10cc syringes taped together held in one hand. The testing showed that the DFIS not only delivers fluids simultaneously, but in an equal l:1 ratio.

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

C. Summary of Comparison of RMI Dual Fluid Irrigating Syringe (DFIS) to
ﮨﺴ

Characteristic	Research Medical, Inc.	Micromedics
ModelSyringe VolumeSyringe AssemblyFluid Applicator Tip	DFIS(2) 10ccPre-assembled in PVC holsterSyringe pistons yoke-coupledPre-assembled on DFISCharacteristicsDual lumen tip configurationParallel .039 ID Tecoflex tubing	SA-4310(2) 10ccSyringes clipped into assemblySyringe pistons yoke-coupledSA-3615 selected representativeCharacteristicsDual lumen tip configuration20ga. malleable cannula
Sterilization	ETO	Unknown

Table of Comparison

Regulation Number and Section

§ 880.6960 Irrigating syringe.

(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.