(133 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a catheter, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is a catheter used for peripheral access for intravenous therapies, blood sampling, and power injection, which are diagnostic or supportive procedures, not therapeutic interventions in themselves.
No
The device is a catheter designed for peripheral venous access for infusions, blood sampling, and power injection of contrast media, not for diagnosing conditions.
No
The device description clearly describes a physical catheter made of polyurethane with a lumen, hub, extensions, clamps, and luer connectors. It is a hardware device for accessing the peripheral venous system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media." This describes a device used in vivo (within the body) for administering substances and collecting samples, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into a vein. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information based on testing performed outside the body.
Therefore, the CT Midline is a medical device used for accessing the peripheral venous system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PND
Device Description
The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.
The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.
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
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)
No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
Medical Components, Inc. (dba Medcomp) Courtney Nix Regulatory Affairs Manager. North America and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K170770
Trade/Device Name: CT Midline Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: July 5, 2017 Received: July 6, 2017
Dear Courtney Nix:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (21 CFR 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.
Tara A. Ryan -S
for Lori Wiggins Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) N/A - Unknown
Device Name 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Section 6 | 510(k) SUMMARY | Traditional 510K | |||
|---|---|---|---|---|---|
| A. | Submitter Information: | ||||
| Submitter: | Medcomp® | ||||
| 1499 Delp Drive | |||||
| Harleysville, PA 19438 | |||||
| Tel: (215) 256-4201, x 2285 | |||||
| Fax: (215) 256-9191 | |||||
| Registration Number: | 2518902 | ||||
| Contact: | Courtney Nix | ||||
| Cnix@Medcompnet.com | |||||
| Regulatory Affairs Manager: North America and EU | |||||
| Date Prepared: | 03/13/2017 | ||||
| в. | Proposed or Subject Device Information: | ||||
| Trade Name: | CT Midline | ||||
| Device: | Midline Catheter | ||||
| Product Code: | PND | ||||
| Regulation Description | Intravascular Catheter | ||||
| C.F.R. Section: | 880.5200 | ||||
| Class: | ll | ||||
| Regulation Medical | |||||
| Specialty and Review | |||||
| Panel: | General Hospital | ||||
| B. | Predicate Device Information: | ||||
| 510(k) Number: | K141151 | ||||
| 510(k) Holder: | Medcomp® | ||||
| Trade Name: | CT Midline | ||||
| Device: | Catheter, Intravascular, Therapeutic, Long-Term | ||||
| Greater Than 30 Days | |||||
| Product Code: | LJS | ||||
| Medcomp®: CT Midline | |||||
| Section 6: 510(k) Site Summary | 6-1 |
4
Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a stylized geometric shape in pink, resembling a house or an arrow pointing upwards. Below the shape, the word "med" is written in pink, lowercase letters, followed by "COMP" in gray, uppercase letters. The overall design is clean and modern.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Requlation Description:
Percutaneous, implanted, long-term intravascular catheter
880.5970 C.F.R Section:
Class:
D.
E.
11
Requlation Medical Specialty and Review Panel: General Hospital
Purpose for Submission:
The purpose of this submission is to remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised.
Device Description:
The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.
The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.
G. 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.
H. Intended 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.
- -Comparison to Predicate Devices:
Medcomp®: CT Midline Section 6: 510(k) Site Summary
5
Image /page/5/Picture/0 description: The image shows the MedComp logo. The logo features a stylized, geometric shape in pink, resembling a simplified house or building outline. Below the shape, the word "med" is written in pink, followed by "COMP" in gray, indicating the company name.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
The proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization. All technology, including features, materials, and principles of operation are identical to what was cleared in K141151, CT Midline. The only difference between the predicate and the proposed device is a revision to the instructions for use (labeling). This revision is to remove a contraindication. The revision to the labeling does not change the intended use of the device, both revisions are in are in alight with the Journal of Infusion Nursing.
The difference or changes between the proposed CT Midline and the predicate, CT Midline (K141151), is that the revision to the instructions for use, below is a comparison matrix demonstrating substantial equivalence.
Table 5.1: 510(K) Summary: Design Comparison Matrix
| Device | Proposed Device:
CT Midline | Predicate Device:
CT Midline (K141151) | Substantially
Equivalent
Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Dimensions
or Lengths | Lumen: 4F Single and 5F
Double
Lumen Length: 20cm | Lumen: 4F Single and 5F
Double
Lumen Length: 20cm | Identical, no
change |
| 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 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. | Identical, no
change |
| Sterilization
Method | ETO | ETO | Identical, no
change |
| Materials
and
Processes | LUMEN: Tecothane
HUB and SUTURE WING:
Pellethane
LUERS: Isoplast
EXTENSIONS: Pellethane
CLAMPS: Acetal
Purple: single lumen
Purple: double lumen
I.D. RING: Lustran | LUMEN: Tecothane
HUB and SUTURE WING:
Pellethane
LUERS: Isoplast
EXTENSIONS: Pellethane
CLAMPS: Acetal
Purple: single lumen
Purple: double lumen
I.D. RING: Lustran | Identical, no
change |
| Performance
Testing | Power Injection:
5cc/sec (4F) | Power Injection:
5cc/sec (4F) | Identical, no
change |
Medcomp®: CT Midline Section 6: 510(k) Site Summary 6-3
6
Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a pink geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in pink, while "COMP" is written in gray. The logo appears to be for a medical company.
K.
L
- 1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
7cc/sec (5F)
7cc/sec (5F)
Bench / Performance Data / Non-Clinical Testing:
No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151).
Biocompatibility:
Biocompatibility was performed on the CT Midline in accordance with ISO 10993-1. According to ISO 10993-1 the final, finished 5F Double lumen CT midline was tested as an implant device with blood contact and prolonged contact duration (greater than 24 hours less than 30 days). Biocompatibility was performed on the finished and sterilized device in accordance with ISO 10993-12:2012. Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials, and 21CFR. Part 58 - Good Laboratory Practices for Nonclinical Laboratory Studies by a contracted laboratory that is ISO 17025 certified.
- Summary of Substantial Equivalence:
The proposed CT Midline is substantially equivalent to the predicate device, CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization. The only difference between the predicate and the proposed device is a revision to the instructions for use (labeling). This revision is to remove a contraindication.
The proposed device, CT Midline, meets the performance criteria of design verification as specified by ISO standards, quidance documents and internal test protocols. The proposed device is substantially equivalent to the indicated legally marketed predicate as defined in paragraph above.