MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Device Description

MonuMedical TurnSignal® Stopcocks and Manifolds are composed of a stopcock with three port three way and or three port four way body and a handle. Male connectors also include a nut for locking over the female connector or another component. A small amount of lubricant is applied between the stopcock body and handle. The manifolds contain a Halkey Roberts Swabable Port on each stopcock. MonuMedical Stopcocks will be available in a wide variety of configuration for use according to a particular situation and the clinician's preference. Duration of use should not exceed 24 hours and 7 activations of the swabable ports. The devices are provided sterile and non-sterile.

AI/ML Overview

The MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for the administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, and transfusion.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (Non-clinical Testing)	Reported Device Performance
Microbial Ingress (to support 24-hour duration of use)	Microbial Ingress challenge was successfully completed to support a duration of use of 24 hours.
Packaging Sterility (ISO 16775, ANSI AAMI ST67)	Compliance with ISO 16775 (Packaging for terminally sterilized medical devices) and ANSI AAMI ST67 (Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile').
Shipping Performance (ASTM D4169, ASTM D4332)	Compliance with ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems) and ASTM D4332 (Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing).
Sterilization Efficacy (ISO 11137-1, ISO 11137-2)	Compliance with ISO 11137-1 (Sterilization of Health Care Products Part 1) and ISO 11137-2 (Sterilization of health care products Radiation Part 2: Establishing the sterilization dose).
Seal Integrity of Flexible Barrier Materials (ASTM F88, ASTM F1886, ASTM F2096)	Successful Pull seal testing (ASTM F88), Visual inspection per standard (ASTM F1886), and Bubble testing of packaging (ASTM F2096).
Accelerated Aging of Sterile Barrier Systems (ASTM 1980)	Aging of devices completed prior to testing per ASTM F1980.
Biocompatibility (ISO 10993-1)	Testing of cytotoxicity, intracutaneous, sensitization, acute systemic toxicity, hemolysis, and materials mediated pyrogen were completed in compliance with ISO 10993-1.
Small-bore Connectors Performance (ISO 80369-7)	Compliance with ISO 80369-7, including: - Falling drop Positive pressure liquid leakage testing. - Sub atmospheric pressure Air Leakage. - Stress Cracking. - Resistance to Separation from Axial Load. - Resistance to Separation from Unscrewing. - Resistance to overriding.
Thread Gauge Testing (ISO 80369-20)	Compliance with ISO 80369-20.
Leak Testing	Successful leak testing was performed.
Taper Block (ISO 594-1)	Compliance with ISO 594-1 (go/no-go taper block 6% taper).

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the exact sample sizes used for each individual test. However, it indicates "performance testing completed" and "design verification testing" were performed.

The data provenance is from non-clinical bench testing conducted by MonuMedical, LLC. The location of the testing is not specified, but it aligns with the submission from a US-based company (MonuMedical, LLC, Roseville, CA). These tests are typically prospective, designed specifically to evaluate the device's performance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of submission. The performance assessment for material compatibility, sterile barrier integrity, and functional performance of medical devices like stopcocks and manifolds is typically based on adherence to recognized international and national consensus standards (e.g., ISO, ASTM, ANSI AAMI) and their respective test methods, not on expert consensus for "ground truth" in the same way an imaging AI algorithm would be evaluated. The standards themselves define the "ground truth" for acceptable performance.

4. Adjudication method for the test set:

This is not applicable. As stated above, performance is evaluated against established standard test methods and acceptance criteria, not through an adjudication process involving multiple experts for diagnostic accuracy.

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:

This is not applicable. This document describes the substantial equivalence of a physical medical device (stopcocks and manifolds), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance evaluation is irrelevant.

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

This is not applicable. This document describes the substantial equivalence of a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" used for all the performance tests is adherence to established international and national consensus standards and specifications. These standards define the acceptable range of performance for each physical and material characteristic of the device.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for this type of physical medical device. The device itself is manufactured, and its performance is verified through testing, not trained.

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

This is not applicable for the same reasons as #8.

Summary

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October 22, 2019

MonuMedical, LLC % Cheryl Blake Regulatory Affairs 27392 Capricho Mission Viejo, California 92692

Re: K190539

Trade/Device Name: MonuMedical TurnSignal® Stopcocks and Manifolds Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FMG Dated: September 19, 2019 Received: September 23, 2019

Dear Cheryl Blake:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190539

Device Name

MonuMedical TurnSignal® Stopcocks and Manifolds

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K190539 510(k) Summary of Substantial Equivalence

MonuMedical TurnSignal® Stopcocks and Manifolds

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, MonuMedical, LLC. is hereby submitting the 510(k) Summary of Substantial Equivalence for 510(k) prepared October 21, 2019.

A. Submitter

MonuMedical, LLC 3017 Douglas Boulevard, Suite 300 Roseville, CA 95661

Establishment Registration: Not yet Registered

Applicant Correspondent

Cheryl Blake Regulatory Consultant 27392 Capricho Mission Viejo, CA 92692 cherylblake@cox.net 949-285-3517

B. Device Name

Regulatory Class:

Panel:

Proprietary Name:	MonuMedical TurnSignal® Stopcocks and Manifolds
	Part Number	Description
	S133000	3-Port 3-Way Stopcock sterile
	S134000	3-Port 4-Way Stopcock sterile
	S434012	4 Stopcock Manifold (3-Port 4-Way Stopcock) Sterile
	B133000	3-Port 3-Way Stopcock Bulk non sterile
	B134000	3-Port 4-Way Stopcock Bulk non sterile
	B434012	4 Stopcock Manifold (3-Port 4-Way Stopcock) Bulk non sterile
Common Name:	Stopcocks and manifolds
Classification Name:	Intravascular Administration Set
Regulation Number:	880.5440
Product Code:	FMG

General Hospital

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C. Predicate Device(s)

Device Name:	Elcam Medical ACAL Stopcocks and Manifolds
Company Name:	Elcam Medical ACAL
	Kibbutz BarAm,
	Merom HaGalil 1386000
	Israel
510(k):	K022895

D. Device Description

E. Intended Use / Indications for Use

F. Substantial Equivalence

The MonuMedical TurnSignal® Stopcocks and Manifolds are substantially equivalent to the Elcam Stopcocks and manifolds cleared under 510K K022895.

The MonuMedical TurnSignal® Stopcocks and Manifolds are the same indications for used, principle of operation, shape, sterilization method as the predicate device.

Feature	TurnSignal Stopcocksand Manifolds	Predicate, ElcamStopcocks and ManifoldsK022895	Comparison
Indication for Use	MonuMedical TurnSignal®Stopcocks and Manifoldsare indicated for fluid flowdirectional control andproviding access port(s) foradministration of solutions.Typical uses includepressure monitoring,intravenous fluidadministration andtransfusion.	Elcam Stopcocks andManifolds are indicated forfluid flow directional controland for providing accessport(s) for administration ofsolutions. Typical usesinclude pressuremonitoring, intravenousfluid administration andtransfusion.	Same indication-Difference is regardingsubject device name
Design similarities	Stopcocks have a bodyand core - the design issimilar in clarity, BPA free.Female and maleconnectors. A smallamount of lubricate isapplied between stopcockbody and handle/core.Available in variety of	Stopcocks have a bodyand core - the design issimilar in clarity, BPA free.Female and maleconnectors. A smallamount of lubricate isapplied between stopcockbody and handle/core.Available in variety of	Same

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Device configurationsincluded	configurations. Sam shapeand use luer fittings.Vented luer caps.Available as singlestopcocks and manifolds.3 way 3 port3 way 4 port3 way 4 stopcock manifoldwith swabable ports	configurations. Sam shapeand use luer fittings.Vented luer caps. Availableas single stopcocks andmanifolds3 way 3 port3 way 4 port3 way 4 stopcock manifoldwith swabable ports	Same
Design differences	TurnSignal indicator allowseasy identification of whichports are on/off	No indicator to user –handle only	Ease of use of TurnSignalstopcock with flow indicator
Materials	HDPE Core, Tritan Body	HDPE Core, Tritan Body	Same
Packaging	3 mil poly/poly pouch	Tyvek orpaper/polyethylene pouch	Similar – both are industrystandard and appropriatefor radiation sterilizedproduct.
Sterilization	Gamma, provided sterileand bulk non-sterile	Gamma	Same Sterilization method
Shelf Life	1 year	Unknown – somepackaging indicates 1 year	Similar – shelf life testing inaccordance with ISO11607.
Single Use	yes	yes	Same
Biocompatibility	ISO 10993-1	ISO 10993-1	Same
Microbial Ingress	24 hours	Unknown	Subject device completedmicrobial ingress testing

G. Non-clinical Performance Testing

Non-clinical bench testing demonstrated the MonuMedical TurnSignal® Stococks and Manifolds are substantially equivalent to the predicate with regard to intended use, materials, technology, and performance. Design verification testing, demonstrates performance related to product label claims.

Microbial Ingress challenge was completed to support duration of use of 24 hours. o
ISO 16775 Packaging for terminally sterilized medical devices O
ANSI AAMI ST67 Sterilization of health care products-Requirements and guidance for selecting a O sterility assurance level (SAL) for products labeled 'sterile'
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems O
ASTM D4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components O for Testing
o ISO 11137-1 Sterilization of Health Care Products Part 1
ISO 11137-2 Sterilization of health care products Radiation Part 2: Establishing the sterilization o dose
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials o · Pull seal testing completed
O ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
- Visual inspection per standard .
ASTM 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices O Aging of devices completed prior to testing .
ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal O Pressurization (Bubble test)
- Bubble testing of packaging

o ISO 11607 Packaging for terminally sterilized medical devices
- ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
  - Testing of cytotoxicity, intracutaneous, sensitization, acute systemic toxicity, hemolysis, and materials mediated pyrogen were completed.
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications O
- Falling drop Positive pressure liquid leakage testing .
- Sub atmospheric pressure Air Leakage ■

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Stress Cracking י
. Resistance to Separation from Axial Load
. Resistance to Separation from Unscrewing
트 Resistance to overriding
O ISO 80369-20 Thread gauge testing
O Leak testing
ISO 594-1-go/no go taper block 6% taper o

H. Conclusion

Through the performance testing completed Monumedical has demonstrated that the MonuMedical TurnSignal® Stopcocks and Manifolds are substantial equivalent to the predicate device Elcam Stopcocks and manifolds cleared under 510K K022895.

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.