(254 days)
Not Found
No
The device description and performance studies focus on the physical components, materials, and standard performance testing of an IV catheter, with no mention of AI or ML capabilities.
No.
The device is used to administer fluids or sample blood, which are diagnostic and supportive functions, not a direct therapeutic treatment of a disease or condition.
No
The device is an IV catheter used for administering fluids or sampling blood, which are therapeutic and collection purposes, not for diagnosing conditions.
No
The device description explicitly lists multiple physical components (protective needle cover, catheter hub, catheter tube, etc.) and describes a physical insertion process, indicating it is a hardware device.
Based on the provided information, the MedSource CathMED IV Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "sample blood or administer fluids intravenously." This describes a procedure performed directly on a patient for therapeutic or diagnostic purposes (sampling blood), not for testing a sample in vitro (outside the body).
- Device Description: The description details a physical device designed for insertion into a vein. It focuses on components like the catheter, needle, and hub, which are used for accessing the bloodstream.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples in vitro, or any other elements typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. The MedSource CathMED IV Catheter is a device used in vivo (within the body) to facilitate these processes (sampling blood or administering fluids), but it doesn't perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
The MedSource CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Product codes
FOZ
Device Description
The MedSource CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Each MedSource CathMED IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, Teflon catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The MedSource CathMED IV Catheter components combine for an ergonomic design.
The device inserts a catheter intravenously by inserting a sharp needle with an over-theneedle catheter. Once the needle and catheter have been passed into a vein the catheter can be advance off the needle is the needle is removed while the catheter remains in the vein for short term use to sample blood or administer fluids.
The MedSource CathMED IV Catheter gauges are color coded for positive identification and range from 14G to 24G
ORANGE = 14G
GREY = 16G
GREEN = 18G
PINK = 20G
BLUE = 22G
YELLOW = 24G
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
any patient population
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)
Performance testing included:
- ISO 10555-5: Intravascular catheters Sterile and single-use catheters Part 5: ● Over-needle peripheral catheters
- ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: ● General requirements
- ISO 594-1Conical fittings with a 6% (Luer) taper for syringes, needles and certain ● other medical equipment. - Part 1: General requirements
- . ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
Biocompatibility: A signed statement of conformance was included in place of testing as the testing from the predicate device was referenced.
- . USP Particulate Matter in Injections
Sterility:
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices
Conclusion: Based on the indication for use, technological characteristics and performance testing, the differences between the MedSource CathMED IV Catheter and the predicate did not raise concern for safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 7, 2020
MedSource Labs Emilie Andrews Quality Technician 8600 Shelby Court Chanhassen, MN 55317
Re: K193278
Trade/Device Name: MedSource CathMED IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: July 13, 2020 Received: July 13, 2020
Dear Emilie Andrews:
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 mediation-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 Payal Patel Assistant Director, General Hospital 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193278
Device Name MedSource CathMED IV Catheter
Indications for Use (Describe)
The MedSource CathMed IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
| 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
510 K-Summary- K193278
Date of Prepared: August 6, 2020
A. Submitter:
MedSource International, LLC 8600 Shelby Court Chanhassen, MN 55317
B. Contact Person:
Emilie Andrews, Quality and Regulatory Affairs 8600 Shelby Court Chanhassen. MN 55317 Phone: 952-472-0131
C. Proposed Device:
Product Code: FOZ Trade Name: MedSource CathMED IV Catheter Common Name: Intravascular catheter Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Regulatory Reference: 21 CFR §880.5200 Review Panel: General Hospital Classification: Class II
D. Predicate:
510(K): K131555 Product Code: FOZ Trade Name: MedSource IV Safety Catheter Common Name: Intravascular catheter Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30Days Regulatory Reference: 21 CFR §880.5200 Review Panel: General Hospital Classification: Class II
E. Indications for Use:
The MedSource CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
4
F. Device Description:
The MedSource CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Each MedSource CathMED IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, Teflon catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The MedSource CathMED IV Catheter components combine for an ergonomic design.
The device inserts a catheter intravenously by inserting a sharp needle with an over-theneedle catheter. Once the needle and catheter have been passed into a vein the catheter can be advance off the needle is the needle is removed while the catheter remains in the vein for short term use to sample blood or administer fluids.
The MedSource CathMED IV Catheter gauges are color coded for positive identification and range from 14G to 24G
ORANGE = 14G GREY = 16G GREEN = 18G PINK = 20G BLUE = 22G YELLOW = 24G
G. SUMMARY OF COMPARISON TABLE OF PROPOSED DEVICE and PREDICATE
The proposed device is substantially equivalent to the predicate device the MedSource Safety Catheter (K131555).
| Comparison
Point | Submission Device
MedSource CathMED IV
Catheter | Predicate Device
MedSource IV Safety
Catheter (K131555) | Discussion | Comments |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | | | | |
| Indications for
Use | The MedSource
CathMED IV Catheter is
indicated to sample blood
or administer fluids
intravenously. The
MedSource IV Catheter
may be used for any
patient population with
consideration given to
adequacy for the vascular
anatomy appropriateness
for the solution being
administered and | The MedSource IV Safety
Catheter is indicated to
sample blood or administer
fluids
intravenously. The
MedSource IV Safety
Catheter may be used for
any patient population
with consideration given to
adequacy for the vascular
anatomy appropriateness
for the
solution being | Same | |
| | duration of the therapy. | administered and duration
of the therapy. | | |
| Intended Use | The MedSource
CathMED IV Catheter is
indicated to sample blood
or administer fluids
intravenously. The
MedSource CathMED IV
Catheter may be used for
any patient population
with consideration given
to adequacy for the
vascular anatomy
appropriateness for the
solution being
administered and
duration of the therapy. | The MedSource IV Safety
Catheter is indicated to
sample blood or administer
fluids intravenously. The
MedSource IV Safety
Catheter may be used for
any patient population with
consideration given to
adequacy for the vascular
anatomy appropriateness
for the solution being
administered and duration
of the therapy. | Same | |
| Distal End
configuration | Beveled | Beveled | Same | |
| Proximal End
configuration | Cupper | Cupper | Same | |
| Needle Stick
Prevention
Feature | Not present | Push-button needle
shielding | Different | Absent in the
submission
device.
A warning was
added to the
labeling of this
product that a
Needle Stick
Prevention
Feature is not
present in this
device.
This does not
affect the safety
and
effectiveness of
the device. |
| Catheter
Length
Catheter O.D.
Needle Gauge | Gauge Length OD
mm mm | Gauge Length OD
mm mm | Different | one new Gauge
Length "20G
length 33 mm
OD 1.1 mm" |
| | 24G | 19 | 0.7 | |
| | 24G | 19 | 0.7 | |
| | 22G | 25 | 0.9 | |
| | 22G | 25 | 0.9 | |
| | 20G 33 1.1
20G 25 1.1
18G 45 1.3
16G 45 1.8
14G 45 2.1 | 20G 25 1.1
18G 25 1.3
16G 30 1.7
14G 45 2.1 | Same | added to the
submission
device.
This was added
to expand the
size availability
for patient care.
This does not
affect the safety
and
effectiveness of
the device. |
| Sterilization | Terminal Ethylene Oxide
(EtO gas) | Terminal Ethylene Oxide
(EtO gas) | Same | |
| | Materials | | | |
| Catheter | Polyurethane (PUR)
/ (PTFE)
Polytetrafluoroethylene | Polyurethane (PUR)
/ (PTFE)
Polytetrafluoroethylene | Same | |
| Needle | Stainless Steel | Stainless Steel | Same | |
| Catheter Body | K-Resin | K-Resin | Same | |
| Catheter
Holder | Polyacetal (POM) | Polyacetal (POM) | Same | |
| Needle Hub | K-Resin | K-Resin | Same | |
| Activation
Lever | Absent | Polyacetal (POM) | Different | Absent in the
submission
device.
A warning was
added to the
labeling of this
product that a
Needle Stick
Prevention
Feature is not
present in this
device.
This does not
affect the safety
and
effectiveness of |
| | | | | the device. |
| Flashback
Chamber | PUR/PTFE | PUR/PTFE | Same | |
| Hydrophobic
Filter | Stainless Steel | Stainless Steel | Same | |
| Materials | K-Resin | K-Resin | Same | |
| Sterilization
method | EtO | EtO | Same | |
5
6
7
H. Performance Data:
I. Performance Testing:
- ISO 10555-5: Intravascular catheters Sterile and single-use catheters Part 5: ● Over-needle peripheral catheters
- ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: ● General requirements
- ISO 594-1Conical fittings with a 6% (Luer) taper for syringes, needles and certain ● other medical equipment. - Part 1: General requirements
- . ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
II. Biocompatibility
There were no changes to the material that impacted the biocompatibility of the device. A signed statement of conformance was included in place of testing as the testing from the predicate device was referenced.
- . USP Particulate Matter in Injections
III. Sterility
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices
I. Conclusion:
In summary, based on the indication for use, technological characteristics and performance testing, the differences between the MedSource CathMED IV Catheter and the predicate did not raise concern for safety and effectiveness. Therefore, we conclude that the subject device is substantially equivalent to the legally marketed predicate device.