(64 days)
No
The summary describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is indicated for peripheral access for intravenous therapies, blood sampling, and power injection, which are diagnostic and supportive procedures, not therapeutic ones in themselves.
No
Explanation: The device description and intended use clearly state that the CT Midlines are for peripheral venous access for therapies, blood sampling, and power injection of contrast media. There is no mention of it being used to diagnose conditions or process diagnostic images.
No
The device description clearly states it is a physical catheter (CT Midlines) and mentions physical characteristics like French size and lumen configuration. It also describes nonclinical performance tests related to physical properties (flow rate, burst strength).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the peripheral venous system for intravenous therapies, blood sampling, and power injection of contrast media. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic imaging purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into a vein. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a medical device used for accessing the peripheral venous system, specifically a midline catheter with power injection capabilities.
N/A
Intended Use / Indications for Use
The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Product codes
LJS
Device Description
The CT Midlines are designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. The device materials are Thermedics Tecothane TT2095A (30% Barium Sulfate) for the lumen, Markem Black for printing, Dow Pellethane 2363-80A for the hub and suture wing and extensions, Isoplast 2510 (with Titanium Dioxide additives) for the luers, Halkey Roberts Acetal Copolymer for clamps (Purple for single and double lumen), and ABS Lustran 348 for the I.D. ring. The catheters are 20cm in length, open-ended, and feature depth markings every cm. The hub contains the French size, and the I.D. ring on the CT Midline clamp contains the product name and a maximum rate of 7cc/sec. The proposed device is physically identical to the predicate K121094 except for the clamp, which is purple to indicate power injection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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)
Nonclinical Performance Tests:
The following tests were performed to establish the device's equivalence to the relevant predicate device:
- Power Injection Flow Rate
- Max Static Burst
These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection. As the predicate K121094 was not indicated for power injection, the K091953 performance data is discussed in this submission to establish that the proposed device is substantially equivalent in terms of power injection performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Power Injection Flow Rate (4F): Flow Rate (cc/sec)- 4.9, Machine Pressure (psi)- 213, HYDAC Pressure (psi)- 168
- Power Injection Flow Rate (5F): Flow Rate (cc/sec)- 6.9, Catheter Pressure (psi)- 244, HYDAC Pressure (psi)- 181
- MAX STATIC BURST (4F): The average maximum burst pressure was 302±5psi. The range of burst pressures was 292-312 psi.
- MAX STATIC BURST (5F): The average maximum burst pressure was 249±8psi. The range of burst pressures was 241-262 psi.
- AIR LEAKAGE: All versions passed in accordance with ISO 10555-1. Annex D.
- LIQUID LEAKAGE: All versions passed in accordance with ISO 10555-1, Annex C.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: This document is a 510(k) summary for a CT Midline device by MEDCOMP®, dated July 8, 2014. It includes the submitter's information, device name, common name, classification details, and predicate devices. The device is designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations.
The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media.
1
Image /page/1/Picture/0 description: The image shows a logo for medCoMP. The logo consists of a stylized geometric shape above the text "medCoMP". The geometric shape is made up of black lines and white space, forming an abstract design. The text "medCoMP" is in a serif font and is positioned below the geometric shape.
l 499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax: 215-256-1787
Indications for Use:
The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Comparison to Predicate Devices:
The CT Midline is substantially equivalent to the predicate devices in terms of intended use. materials, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.
| Attribute | CT Midline
(Proposed) | Midline (Predicate)
K121094 | Pro-PICCCT
(Predicate) K091953 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS
FOR USE: | The CT Midlines are
indicated for Short-
Term peripheral
access to the
peripheral venous
system for selected
intravenous therapies,
blood sampling, and
power injection of
contrast media. The
maximum
recommended
infusion rate varies
by catheter French
size and is printed on
the catheter. | The Midline
catheters are
indicated for short or
long term peripheral
access to the
peripheral venous
system for selected
intravenous therapies
and blood sampling.
(see
Contraindications)
For blood therapy it
is recommended that
a 4French or larger
catheter is used. | The PRO-PICCCT
catheter is indicated
for short term or
long term peripheral
access to the central
venous system for
intravenous therapy
and power injection
of contrast media
and allows for
central venous
pressure monitoring
when a 20gauge or
larger lumen is
used. For blood
sampling, infusion
or therapies use a
4F or larger
catheter. The
maximum
recommended
infusion rate varies
by catheter French
size and is printed
on the catheter. |
| WHERE USED: | Hospital | Hospital | Hospital |
| STERILITY: | 100% Ethylene Oxide | 100% Ethylene Oxide | 100% Ethylene Oxide |
| BIOCOMPATIBILITY: | Materials are identical to
legally marketed | Legally Marketed
510(k) K121094 | Legally Marketed
510(k) K091953 |
| Attribute | CT Midline
(Proposed) | Midline (Predicate) | Pro-PICC CT
(Predicate) K091953 |
| | K121094 with the
exception of the Acetal
clamp which was cleared
in legally marketed
K091953.
Biocompatibility
summaries located in
Section 15 page 1. | K121094 | |
| MATERIALS
AND
ADDITIVES: | LUMEN:
Thermedics
Tecothane TT2095A
(30% Barium Sulfate) | LUMEN:
Thermedics
Tecothane TT2095A
(30% Barium
Sulfate) | |
| | PRINTING:
Markem, Black | PRINTING:
Markem, Black | |
| | HUB and SUTURE
WING: Dow
Pellethane 2363-80A | HUB and SUTURE
WING: Dow
Pellethane 2363-80A | |
| | LUERS: Isoplast
2510. Natural White
additives: Titanium
Dioxide. | LUERS: Isoplast
2510. Natural White
additives: Titanium
Dioxide. | CLAMPS: Halkey
Roberts Acetal,
Purple |
| | EXTENSIONS:
Dow Pellethane
2363-80A | EXTENSIONS:
Dow Pellethane
2363-80A | |
| | CLAMPS: Halkey
Roberts Acetal
Copolymer-
Purple - single lumen
Purple- double lumen | CLAMPS: Halkey
Roberts Acetal
Copolymer-
Natural - single
lumen
Natural- double
lumen | |
| | I.D. RING: ABS
Lustran 348 | I.D. RING: ABS
Lustran 348 | |
| | Drawings in Section
11. | Drawings in Section
11. | |
| Design
Specifications | LUMEN and
TAPER LENGTH
AVG.:
Single lumen 4F - | LUMEN and
TAPER LENGTH
AVG.:
Single lumen 4F - | N/A |
Medcomp CT Midline Summary 5-2
2
3
| Attribute | CT Midline
(Proposed) | Midline (Predicate)
K121094 | Pro-PICC CT
(Predicate) K091953 |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | short taper 2.756 inch
(7cm) (Midline) | short taper 2.756 inch
(7cm) (Midline) | |
| | Double 5F – long
taper 3.44 to 5.44
inch. | Double 5F – long
taper 3.44 to 5.44
inch. | |
| | LUMEN I.D./O.D.
AVG.: Proximal to
taper (applies to both
short and long taper)
4F Single: I.D. .045
inch (1.14mm)
O.D. .082
inch (2.08mm)
5F Double*: I.D.
.039 inch (.99mm)
O.D. .092
inch (2.24mm)
- Equivalent
diameter of each
lumen based on D-
lumen cross-section
area. | LUMEN I.D./O.D.
AVG.: Proximal to
taper (applies to both
short and long taper)
4F Single: I.D. .045
inch (1.14mm)
O.D. .082
inch (2.08mm)
5F Double*: I.D.
.039 inch (.99mm)
O.D. .092
inch (2.24mm) - Equivalent diameter
of each lumen based on
D-lumen cross-section
area. | |
| | TIP LUMEN
I.D./O.D. AVG.:
4F Single: I.D. .032
inch (.81mm)
O.D. .052
inch (1.32mm)
5F Double*: I.D.
.031 inch (.79mm)
O.D. .068
inch (1.73mm) - Equivalent
diameter of each
lumen based on D-
lumen cross-section
area. | TIP LUMEN
I.D./O.D. AVG.:
4F Single: I.D. .032
inch (.81mm)
O.D. .052
inch (1.32mm)
5F Double*: I.D.
.031 inch (.79mm)
O.D. .068
inch (1.73mm) - Equivalent diameter
of each lumen based on
D-lumen cross-section
area. | |
| | LUMEN LENGTH:
20cm (midline).
Open ended design.
DEPTH | LUMEN LENGTH:
20cm (midline).
Open ended design.
DEPTH | |
P
Medcomp CT Midline Summary 5-4
4
| | | CT Midline 15
(Proposed) | Midline (Predicate);
K121094 .; I | |
|------------------------|----------------------------|--------------------------------------------|--------------------------------------|--|
| | | MARKING: | MARKING: | |
| | | Number every Scim | Number every Scm | |
| | | and depth mark every | and depth mark every | |
| | | cm. | cm. | |
| | | HUB: With suture | HUB: With suture | |
| | | wing, all models. | wing, all models. | |
| medCoMP | | Contains French size
on hub. | Contains French size
on hub. | |
| 1499 Delp Drive | | | | |
| Harleysville, PA 19438 | | LUER: Easy Grip
design. | LUER: Easy Grip™
design. | |
| | | | | |
| Tel: 215-256-4201 | | EXTENSION | EXTENSION | |
| Fax: 215-256-1787 | | AVG.: Clear with | AVG .: Clear with | |
| | | clamp. | clamp. | |
| www.medcompnet.com | | 4F Single - 19 gauge | 4F Single - 19 gauge | |
| | | 5F Double - 18 | 5F Double - 18 | |
| | | gauge | gauge | |
| | | ALL SINGLE, AND | ALL SINGLE, AND | |
| | | DOUBLE | DOUBLE | |
| | | EXTENSIONS: | EXTENSIONS: | |
| | | I.D .: . 070 inches | I.D . 070 inches | |
| | | O.D .: . 106 inches | O.D .: 106 inches | |
| | | I.D. RING WITHIN | I.D. RING WITHIN | |
| | | CLAMP: On CT | CLAMP: On | |
| | | Midline contains | Midline contains | |
| | | product name and | extension gauge and | |
| | | Max rate of 7cc/sec. | French size with | |
| | | | lumen length. | |
| | | Drawings in Section | Drawings in Section | |
| | | ] l . | l 2. | |
| | MECHANICAL/
PERFORMANCE | AIR LEAKAGE: | | |
| | TESTING: | 4F | | |
| | | All versions passed in accordance with ISO | | |
| | | 10555-1. Annex D. Reference testing | | |
| | | summaries and protocols in Section 18. | | |
| | | SF | | |
| | | All versions passed in accordance with ISO | | |
| | | 10555-1. Annex D. Reference testing | | |
| | | summaries and protocols in Section 18. | | |
| | | LIQUID LEAKAGE: | | |
ﺴﺴ
5
| Attribute | CT Midline
(Proposed) | Midline (Predicate)
K121094 | Pro-PICC CT
(Predicate) K09195- |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All versions passed in accordance with ISO 10555-
1, Annex C. Reference testing summaries and
protocols in Section 18. | | |
| Power Injection
Capability
Testing | POWER INJECTION
FLOW RATE: | | POWER INJECTION
FLOW RATE: |
| | 4F:
V-9131:
Power Injection Flow
Rate / Injection
Pressure (Avg.)
Flow Rate (cc/sec)- 4.9
Machine Pressure (psi)-
213
HYDAC Pressure (psi)-
168 | | 4F:
4Fx50cm Single
Power Injection Flow
Rate / Injection
Pressure (Avg.)
Flow Rate (cc/sec)-
3.9
Machine Pressure
(psi)- 183 |
| | 5F:
V-9077:
Power Injection Flow
Rate / Injection
Pressure (Avg.)
Flow Rate (cc/sec)- 6.9
Catheter Pressure (psi)-
244
HYDAC Pressure (psi)-
181 | | 5F:
5Fx55cm Double
Power Injection
Flow Rate / Injection
Pressure (Avg.)
Flow Rate (cc/sec)-
4.9
Machine Pressure
(psi)- 212 |
| | MAX STATIC BURST: | | MAX STATIC
BURST: |
| | 4F:
V-9043:
The average maximum
burst pressure was
302±5psi. The range of
burst pressures was 292-
312 psi. | | 4F:
The average maximum
burst pressure was
288±4psi. The range
of burst pressures was
279-293 psi. All
samples burst along
the lumen. |
| | 5F:
V-9073:
The average maximum
burst pressure was
249±8psi. The range of
burst pressures was 241-
262 psi. | | 5F:
The average maximum
burst pressure was
269±4psi. The range
of burst pressures was
262-278 psi. All
samples failed by
rupture of the lumen. |
Comparison to Predicate Devices (cont.):
6
Image /page/6/Picture/0 description: The image shows a logo with a geometric design above the word "medCOMP." The geometric design consists of a stylized shape, possibly representing a stylized letter or symbol, with a combination of black and white areas creating a sense of depth. The word "medCOMP" is written in a serif font, with the letters in lowercase except for the "COMP" part, which is in uppercase. There is a period at the end of the word.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4207
Fax: 215-256-1787
The proposed device is substantially equivalent to the predicate devices because the data demonstrates the proposed device matches the power injection indication and performance of the predicate K091953 while being otherwise identical to the K121094 predicate device.
Performance Standards:
Performance standards have not been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act.
Nonclinical Performance Tests:
The following tests were performed to establish the device's equivalence to the relevant predicate device:
- o Power Injection Flow Rate
- � Max Static Burst
These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection. As the predicate K121094 was not indicated for power injection, the K091953 performance data is discussed in this submission to establish that the proposed device is substantially equivalent in terms of power injection performance.
Biocompatibility:
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.
Technological Characteristics:
The principles of operation are the same as the predicate devices, with the exception that the proposed device is indicated for power injection of contrast media. Fundamentally, the proposed device is physically identical to the predicate K 121094 aside from the clamp, which is now colored purple to indicate power injection. The purpose of this submission is to establish that the proposed device can be properly indicated for power injection as supported by the provided data. There are no new questions raised regarding the safety or effectiveness of the device.
Summary of Substantial Equivalence:
The proposed device meets the performance criteria of design verification as specified by ISOstandards, guidance documents and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed device is substantially equivalent to the logally marketed predicate devices.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2014
Medical Components, Inc. Timothy Holwick International Principal Regulatory Associate 1499 Delo Drive Harleysville, PA 19438
Re: K141151
Trade/Device Name: CT Midline Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: May 5, 2014 Reccived: May 6, 2014
Dear Mr. Holwick:
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 10 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. 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.
8
Page 2 - Mr. Holwick
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141151
Device Name
Medcomp CT Midline
Indications for Use (Describe)
The CT Midlines are indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
.
Digitally signed by Richard C. Chapman -S Date: 2014.07.08 11:11:27 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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