(207 days)
No
The device description and summary of performance studies focus on the physical characteristics and performance of a catheter, with no mention of AI or ML capabilities.
No.
The device is a catheter for intravenous therapies and blood sampling, which are diagnostic and delivery functions, not therapeutic.
No
Explanation: The device is a catheter used for intravenous therapies, blood sampling, and contrast media injection. It is not described as analyzing or interpreting data to diagnose a condition.
No
The device description clearly describes a physical catheter with a lumen, hub, extension, and clamp, indicating it is a hardware medical device.
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 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 delivering substances and drawing blood directly from a vein.
- Device Description: The description details a catheter designed for insertion into a vein, with features like a lumen, extension, luer-lock connector, clamp, and depth marks. These are characteristics of a device used for accessing the circulatory system.
- Anatomical Site: The specified anatomical site is the "peripheral venous system," which is part of the living organism.
- Lack of IVD Indicators: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used on specimens taken from the human body to provide diagnostic information. This device is designed for direct interaction with the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.
Product codes
PND
Device Description
The Arch-Flo™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous system, basilic, cephalic, or median cubital vein
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)
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Arch-Flo™ CT Midline, is equivalent to the predicate device, CT Midline (K141151). The performance testing was performed in accordance with the following standards:
ISO 10555-1: Intravascular Catheter -- Sterile and Single - Use Intravascular Catheters - Part 1: General Requirements, Second edition 2013-06-15. Performance Testing: Air Leakage, Liquid Leakage, Force at Break, Elongation, Gravity Flow, Chemical Exposure, Maximum Burst Pressure, Power Injection Flow Rate, Cyclic Flexure.
11607-1 and 11607-2: Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems Part 2: validation requirements for forming, sealing and assembly processes, First edition 2006-04-15. Performance Testing: Transit Testing (ISTA) Post Aging (ASTM F 1980).
ISO 10555-3: Intravascular Catheters - Sterile And Single-Use Catheters - Part 3: Central Venous Catheters, Second Edition 2013-06-15. Performance Testing: Air Leakage, Liquid Leakage, Gravity Flow.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Max Power Injection Flow: 5cc/sec
Priming Volume: 0.36cc
Gravity Flow: 56 ml/min
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
Medcomp (dba Medical Components, Inc.) Courtney Nix Regulatory Affairs Manager, North America and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K171483
Trade/Device Name: Arch-Flo CT Midline Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: September 1, 2017 Received: November 17, 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.
1
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 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.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina 8 Kiang -S
Tina Kiang, Ph.D. 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
Indications for Use
510(k) Number (if known) K171483
Device Name
Arch-Flo CT Midline
Indications for Use (Describe)
The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.
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 | Traditional 510K | |||
|---|---|---|---|---|
| K171483 | ||||
| 1. | Submitter Information: | |||
| Submitter: | Medical Components Inc. | |||
| (dba Medcomp®) | ||||
| 1499 Delp Drive | ||||
| Harleysville, PA 19438 | ||||
| Tel: (215) 256-4201 | ||||
| Fax: (215) 256-9191 | ||||
| Registration Number: | 2518902 | |||
| Contact: | Courtney Nix | |||
| Cnix@Medcompnet.com | ||||
| Regulatory Affairs Manager, | ||||
| North America and EU | ||||
| Date Prepared: | 05/18/2017 | |||
| 2. | Proposed or Subject Device Information: | |||
| Trade Name: | Arch-Flo™ CT Midline | |||
| Common/Usual Name: | Midline Catheter | |||
| Product Code: | PND | |||
| Regulation Description: | Intravascular Catheter | |||
| C.F.R. Section: | 880.5200 | |||
| Class: | 11 | |||
| Requlation Medical | ||||
| Specialty and Review | ||||
| Panel: | General Hospital | |||
| 3. | Predicate Device Information: | |||
| 510(k) Number: | K141151 | |||
| 510(k) Holder: | Medical Components Inc. (dba Medcomp®) | |||
| Trade Name: | CT Midline | |||
| Common/Usual Name: | Catheter, Intravascular, Therapeutic, Long-Term | |||
| Greater Than 30 Days |
Medcomp®: Arch-Flo™ CT Midline
510(k) Summary
4
| Product Code: | LJS |
|---|---|
| Regulation Description: | Percutaneous implanted, Long-Term intravascular |
| catheter | |
| C.F.R Section: | 880.5970 |
| Class: | II |
| Regulation Medical | |
| Specialty and Review | |
| Panel: | General Hospital |
Note: Midline Intravascular catheters have their own product code now- PND. This is the reason the predicate has a different product code and regulation number.
4. Device Description:
The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
5. Indications for Use:
The Arch-Flo ™ CT Midline is indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media.
This catheter may be inserted via the basilica, cephalic, or median cubital vein,
6. Comparison to Predicate Devices:
Arch-Flo™ CT Midline is substantially equivalent to the predicate device, CT Midline (K141151), in terms of indications of use, intended use, anatomical location, design, performance, labeling, and method of sterilization.
The difference or changes between the Arch-Flo™ CT Midline and the predicate, CT Midline (K141151), is the radius arched tip, catheter length, luer and hub colorant. The differences in technological characteristics do not raise different questions of safety and effectiveness.
The yellow luer and hub, along with the printing, are intended to distinguish that the catheter is a Midline.
Medcomp®: Arch-Flo™ CT Midline 510(k) Summary
5
| Device | Proposed Device:
Arch-Flo™ CT Midline
(Proposed) | Predicate Device:
CT Midline (K141151) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Arch-Flo™ CT Midline
Catheter is indicated for
Short-Term peripheral
access to the peripheral
venous system for selected
intravenous therapies,
blood sampling, and power
injection of contrast media.
This catheter may be
inserted via the basilic,
cephalic, or median cubital
vein | 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.
This catheter may be
inserted via the basilic,
cephalic, or median cubital
vein. |
| Design | Catheter:
OD 4F
Extension:
I.D .070 ± .002
O.D .106 ± .002 | Catheter:
OD 4F
OD 5F
Extension:
I.D .070 ± .002
O.D .106 ± .002 |
| Catheter
Length | 10 cm | 20 cm |
| Lumen
Marking | Number every 5cm and
depth mark every cm. | Number every 5cm and
depth mark every cm |
| Tip Design | Radius Arch Tip | Box |
| Dimensions
or Lengths | 4F X 10 cm | 4F X 20 cm
5F X 20 cm |
| Materials | Hub (Yellow): Pellethane
Lumen (White):
Tecothane w/ 20% BaSO4
Extensions (Clear) and
Luer (Yellow) Sub-Asm:
Isoplast
Tubing Clamp (Purple):
Acetal | Hub (White): Pellethane
Lumen (White) :
Tecothane w/ 30% BaSO4
Extension (Clear) and
Luer (Natural) Sub Asm:
Isoplast
Double:
Extension (Clear) and
Luer (Red) Sub-ASM:
Isoplast
Tubing Clamp (Purple):
Acetal |
Table 5.1: 510(K) Summary: Design Comparison Matrix
6
| Small ID Ring: ABS | Small ID Ring: ABS | |
|---|---|---|
| French Size | 4F | 4F and 5F |
| Lumen Configuration | Single | Single and Double |
| Sterilization Method | ETO | ETO |
| Performance | Max Power Injection Flow: | |
| 5cc/sec |
Priming Volume:
0.36cc
Gravity Flow:
56 ml/min | Max Power Injection Flow:
5cc/sec
Priming Volume:
0.41cc
Gravity Flow:
31.5 ml/min |
7. Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Arch-Flo™ CT Midline, is equivalent to the predicate device, CT Midline (K141151). The performance testing was performed in accordance with the following standards:
| Standard | Standard Title | Revision/Date | Performance
Testing |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10555-1 | Intravascular Catheter --
Sterile and Single - Use
Intravascular Catheters -
Part 1: General
Requirements | Second edition
2013-06-15 | Air Leakage, Liquid
Leakage, Force at
Break, Elongation,
Gravity Flow,
Chemical
Exposure,
Maximum Burst
Pressure, Power
Injection Flow
Rate, Cyclic
Flexure |
| 11607-1 and
11607-2 | Packaging for terminally
sterilized medical devices -
Part 1: requirements for
materials, sterile barrier
systems and packaging
systems
Part 2: validation
requirements for forming,
sealing and assembly
processes | First edition
2006-04-15 | Transit Testing
(ISTA)
Post Aging (ASTM
F 1980) |
| ISO 10555-3 | Intravascular Catheters -
Sterile And Single-Use
Catheters - Part 3: Central
Venous Catheters | Second
Edition 2013-
06-15 | Air Leakage, Liquid
Leakage, Gravity
Flow |
Medcomp®: Arch-Flo™ CT Midline 510(k) Summary
7
Sterilization:
| Sterilization Validation: | ANSI/AAMI/ISO 11135-1:2014; AAMI TIR 2
8:2009/(R) 2013 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility Assurance Level: | SAL is 10-6. |
| Description of Validation Method:
Sterilization Method: | The product is sterilized by 100% Ethylene
Oxide (EO) Gas1 in a fixed chamber. |
| ETO Residual Level: | In accordance with AAMI/ANSI/ISO 10993-7:2008,
Biological Evaluation of Medical Devices – Part 7:
Ethylene Oxide Sterilization Residuals, the maximum
allowable limits for EO and ECH was less than or
equal to the sterilant residual limits per ISO 10993-7
for a prolonged exposure device (>24 h 24 hours