TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

K190539 · Monumedical, LLC · FMG · Oct 22, 2019 · General Hospital

Device Facts

• Record ID: K190539
• Device Name: TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
• Applicant: Monumedical, LLC
• Product Code: FMG · General Hospital
• Decision Date: Oct 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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 Story

MonuMedical TurnSignal® Stopcocks and Manifolds are intravascular administration accessories used for fluid flow control and access. The device consists of a stopcock body, a handle, and male/female luer connectors; some configurations include Halkey Roberts swabable ports. A flow indicator on the handle allows clinicians to visually identify which ports are open or closed. The device is used in clinical settings by healthcare providers to manage IV lines, pressure monitoring, and transfusions. It functions as a manual flow-switching mechanism. The primary benefit is improved ease of use and clarity regarding flow direction compared to standard stopcocks. The device is intended for single-use, with a maximum duration of 24 hours and 7 activations for swabable ports.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included microbial ingress (24-hour duration), biocompatibility (cytotoxicity, sensitization, acute systemic toxicity, hemolysis, pyrogenicity), packaging integrity (ASTM F88, F1886, F2096, ISO 11607), and mechanical performance (ISO 80369-7, ISO 80369-20, ISO 594-1) to verify design and safety.

Technological Characteristics

Materials: HDPE core, Tritan body. Principle: Manual fluid flow directional control via stopcock handle. Connectivity: Luer fittings (ISO 80369-7, ISO 594-1). Sterilization: Gamma radiation. Form factor: Single stopcocks and manifolds (3-port 3-way, 3-port 4-way, 4-stopcock manifold). Features: Integrated flow indicator, Halkey Roberts swabable ports.

Indications for Use

Indicated for fluid flow directional control and access port(s) for solution administration, including pressure monitoring, IV fluid administration, and transfusion in patients requiring intravascular access.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Elcam Medical ACAL Stopcocks and Manifolds (K022895)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 [e-mail] 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

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.

#### E. Intended Use / Indications for Use

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.

### 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 Stopcocks<br>and Manifolds | Predicate, Elcam<br>Stopcocks and Manifolds<br>K022895 | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Indication for Use | MonuMedical TurnSignal®<br>Stopcocks and Manifolds<br>are indicated for fluid flow<br>directional control and<br>providing access port(s) for<br>administration of solutions.<br>Typical uses include<br>pressure monitoring,<br>intravenous fluid<br>administration and<br>transfusion. | Elcam Stopcocks and<br>Manifolds are indicated for<br>fluid flow directional control<br>and for providing access<br>port(s) for administration of<br>solutions. Typical uses<br>include pressure<br>monitoring, intravenous<br>fluid administration and<br>transfusion. | Same indication-<br>Difference is regarding<br>subject device name |
| Design similarities | Stopcocks have a body<br>and core - the design is<br>similar in clarity, BPA free.<br>Female and male<br>connectors. A small<br>amount of lubricate is<br>applied between stopcock<br>body and handle/core.<br>Available in variety of | Stopcocks have a body<br>and core - the design is<br>similar in clarity, BPA free.<br>Female and male<br>connectors. A small<br>amount of lubricate is<br>applied between stopcock<br>body and handle/core.<br>Available in variety of | Same |

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| Device configurations<br>included | configurations. Sam shape<br>and use luer fittings.<br>Vented luer caps.<br>Available as single<br>stopcocks and manifolds.<br>3 way 3 port<br>3 way 4 port<br>3 way 4 stopcock manifold<br>with swabable ports | configurations. Sam shape<br>and use luer fittings.<br>Vented luer caps. Available<br>as single stopcocks and<br>manifolds<br>3 way 3 port<br>3 way 4 port<br>3 way 4 stopcock manifold<br>with swabable ports | Same |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Design differences | TurnSignal indicator allows<br>easy identification of which<br>ports are on/off | No indicator to user –<br>handle only | Ease of use of TurnSignal<br>stopcock with flow indicator |
| Materials | HDPE Core, Tritan Body | HDPE Core, Tritan Body | Same |
| Packaging | 3 mil poly/poly pouch | Tyvek or<br>paper/polyethylene pouch | Similar – both are industry<br>standard and appropriate<br>for radiation sterilized<br>product. |
| Sterilization | Gamma, provided sterile<br>and bulk non-sterile | Gamma | Same Sterilization method |
| Shelf Life | 1 year | Unknown – some<br>packaging indicates 1 year | Similar – shelf life testing in<br>accordance with ISO<br>11607. |
| Single Use | yes | yes | Same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Microbial Ingress | 24 hours | Unknown | Subject device completed<br>microbial 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

- 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.