(232 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid control aspects, with no mention of AI/ML technologies or related performance metrics.
No
The device description indicates its use for "fluid flow directional control and providing access port(s) for administration of solutions," such as "pressure monitoring, intravenous fluid administration and transfusion." These functions are for managing the delivery and monitoring of substances within the body, not for treating a disease or condition itself.
No
The device is described as stopcocks and manifolds for fluid flow control and administration of solutions, such as pressure monitoring and IV fluid administration. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly outlines physical components (stopcock body, handle, connectors, lubricant, swabable port) and mentions being provided sterile or non-sterile, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "fluid flow directional control and providing access port(s) for administration of solutions." This describes a device used for managing fluids within the body or for delivering substances into the body, which is a characteristic of a general medical device, not an IVD.
- Device Description: The description details the physical components of stopcocks and manifolds, which are used for controlling fluid flow in medical settings. There is no mention of analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic, prognostic, or screening information.
- Using reagents or assays.
- Measuring analytes in a sample.
The device's function is purely mechanical and related to fluid management, which falls under the category of general medical devices.
N/A
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.
Product codes
FMG
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.
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
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.
- ISO 16775 Packaging for terminally sterilized medical devices
- ANSI AAMI ST67 Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'
- ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ISO 11137-1 Sterilization of Health Care Products Part 1
- ISO 11137-2 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
- ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
- Pull seal testing completed
- 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 Aging of devices completed prior to testing .
- ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble test)
- Bubble testing of packaging
- 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
- 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
- ISO 80369-20 Thread gauge testing
- Leak testing
- ISO 594-1-go/no go taper block 6% taper
Key Metrics
Microbial Ingress: 24 hours
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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3
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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4
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
and Manifolds | Predicate, Elcam
Stopcocks and Manifolds
K022895 | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Indication 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. | Elcam Stopcocks and
Manifolds are indicated for
fluid flow directional control
and for providing access
port(s) for administration of
solutions. Typical uses
include pressure
monitoring, intravenous
fluid administration and
transfusion. | Same indication-
Difference is regarding
subject device name |
| Design similarities | Stopcocks have a body
and core - the design is
similar in clarity, BPA free.
Female and male
connectors. A small
amount of lubricate is
applied between stopcock
body and handle/core.
Available in variety of | Stopcocks have a body
and core - the design is
similar in clarity, BPA free.
Female and male
connectors. A small
amount of lubricate is
applied between stopcock
body and handle/core.
Available in variety of | Same |
5
| Device configurations
included | configurations. Sam shape
and use luer fittings.
Vented luer caps.
Available as single
stopcocks and manifolds.
3 way 3 port
3 way 4 port
3 way 4 stopcock manifold
with swabable ports | configurations. Sam shape
and use luer fittings.
Vented luer caps. Available
as single stopcocks and
manifolds
3 way 3 port
3 way 4 port
3 way 4 stopcock manifold
with swabable ports | Same |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Design differences | TurnSignal indicator allows
easy identification of which
ports are on/off | No indicator to user –
handle only | Ease of use of TurnSignal
stopcock with flow indicator |
| Materials | HDPE Core, Tritan Body | HDPE Core, Tritan Body | Same |
| Packaging | 3 mil poly/poly pouch | Tyvek or
paper/polyethylene pouch | Similar – both are industry
standard and appropriate
for radiation sterilized
product. |
| Sterilization | Gamma, provided sterile
and bulk non-sterile | Gamma | Same Sterilization method |
| Shelf Life | 1 year | Unknown – some
packaging indicates 1 year | Similar – shelf life testing in
accordance with ISO
11607. |
| Single Use | yes | yes | Same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Microbial Ingress | 24 hours | Unknown | Subject device completed
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 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- 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 ■
6
- 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.