RMI DUAL FLUID IRRIGATING SYRINGE

• K Number: K964833
• Device Name: RMI DUAL FLUID IRRIGATING SYRINGE
• Manufacturer: RESEARCH MEDICAL, INC.
• Date Cleared: 1997-02-19 ( 79 days)
• Product Code: KYZ
• Regulation Number: 880.6960

Intended Use

Not Found

Device 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.

Predicate Devices

K881020, K872565

Reference Devices

K881020, K872565

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical function of a syringe and fluid delivery, with no mention of AI or ML.

Therapeutic

No
The device description indicates it is an irrigating syringe used to deliver fluids to a surgical site, which is an operative or assistive function rather than a therapeutic one (i.e., treating or curing a disease).

Diagnostic

No

The device description indicates its purpose is to deliver solutions or fluids onto a surgical site, which is a therapeutic or procedural action, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical medical device consisting of syringes, tubing, a holster, and a stopcock. There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: This section is "Not Found," which is a strong indicator that the device's purpose is not related to diagnosing conditions based on in vitro testing.
• Device Description: The description clearly states the device is an "Irrigating Syringe" used to "deliver two separate solutions or fluids simultaneously onto the surgical site." This is a description of a device used during a surgical procedure, not for testing biological samples outside the body.
• Anatomical Site: The anatomical site is the "surgical site," further reinforcing its use in a surgical setting.
• Performance Studies: The performance studies focus on functional aspects like leak tests, flow tests, and pull tests, as well as comparing its performance to using single syringes or taped-together syringes for fluid delivery. These are not studies related to diagnostic accuracy or the analysis of biological samples.
• Predicate Devices: The predicate devices listed are a "Surgical Sealant Dispenser" and a "Duoflo™ Dispenser." These are devices used for delivering substances during procedures, not for in vitro diagnostic testing.

In vitro diagnostics are devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. The RMI Dual Fluid Irrigating Syringe does not fit this description. It is a surgical tool for delivering fluids directly to a surgical site.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Not Found

Product codes

Not Found

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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): Passed
DFIS Flow Test @ 1.0 CFH (13 units) Passed
DFIS Pull Test -- 5 lbs. minimum Left stopcock / tubing (13 units) All pulled to 17 lbs. or more.
Right stopcock / tubing (13 units) All pulled to 17 lbs. or more.
Gish Fluid Transfer Set, CPVMF36S 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K881020, K872565

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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: [phone] FAX: [phone]
• 2. 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.
• 3. 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: [phone] Fax: [phone]

1

• Duoflo™ Dispenser; 510(k) Number K872565.
  Marketed by : Hemaedies, Inc. 2649 Scahorn Drive Malibu, CA 90265 Phone: [phone]

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
Model
Syringe Volume
Syringe Assembly
Fluid Applicator Tip	DFIS
(2) 10cc
Pre-assembled in PVC holster
Syringe pistons yoke-coupled
Pre-assembled on DFIS
Characteristics
Dual lumen tip configuration
Parallel .039 ID Tecoflex tubing	SA-4310
(2) 10cc
Syringes clipped into assembly
Syringe pistons yoke-coupled
SA-3615 selected representative
Characteristics
Dual lumen tip configuration
20ga. malleable cannula
Sterilization	ETO	Unknown

Table of Comparison