(207 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called "Arch-Flo CT Midline." This document primarily focuses on establishing substantial equivalence to a predicate device through comparison and performance testing. It does not contain information about acceptance criteria and studies related to the performance of an AI/algorithm-based device.
The device in question is an "Intravascular Catheter," which is a traditional medical device, not an AI or software-based application. Therefore, the specific questions regarding AI device performance (like the number of experts for ground truth, MRMC studies, standalone performance with AI, training set details, etc.) are not applicable to the content provided.
However, I can extract the general "acceptance criteria" (or performance data) for the physical device based on the bench/performance data and comparison to the predicate device.
Here's the information that can be extracted, interpreted based on the context of a traditional medical device submission:
1. A table of acceptance criteria and the reported device performance:
The document describes performance data for the Arch-Flo CT Midline and compares it to the predicate device, CT Midline (K141151). The "acceptance criteria" are implied by the standards the device was tested against and by demonstrating similar or superior performance to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Standards/Predicate) | Proposed Device (Arch-Flo CT Midline) Performance | Predicate Device (CT Midline) Performance |
|---|---|---|---|
| Max Power Injection Flow | 5cc/sec (matching predicate) | 5cc/sec | 5cc/sec |
| Priming Volume | Comparable to predicate | 0.36cc | 0.41cc |
| Gravity Flow | Comparable to predicate | 56 ml/min | 31.5 ml/min |
| Air Leakage | Meets ISO 10555-1 and ISO 10555-3 requirements | Tested and met | Implied met as predicate |
| Liquid Leakage | Meets ISO 10555-1 and ISO 10555-3 requirements | Tested and met | Implied met as predicate |
| Force at Break | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Elongation | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Chemical Exposure | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Maximum Burst Pressure | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Cyclic Flexure | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Sterilization (SAL) | 10^-6 (ANSI/AAMI/ISO 11135-1:2014) | SAL is 10^-6 | Not specified |
| ETO Residual Level | < sterilant residual limits per ISO 10993-7 | <= sterilant residual limits | Not specified |
| Pyrogenicity (LAL) | Non-pyrogenic (ANSI/AAMI ST72:2011) | Non-pyrogenic | Not specified |
| Endotoxin | Max 20 EU/device (ANSI/AAMI ST72:2011) | Max 20 EU/device | Not specified |
| Biocompatibility | Meets ISO 10993-1, -10, -11, -4, -3, -5, -6, ASTM F 756-08, ASTM F 619-03 | Tested and met for all relevant endpoints | Not specified |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a specific number of devices for each test. The document mentions "performance testing" was performed according to various ISO and ASTM standards. These standards typically define the sample sizes required for validation studies.
- Data Provenance: The testing was "bench / performance data / non-clinical testing" conducted by the manufacturer, Medcomp®. There is no mention of country of origin for data (as it's bench testing, not patient data) or whether it was retrospective or prospective (which applies to patient studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The device is a physical intravascular catheter. Its performance is evaluated through objective physical and chemical tests against established international standards (e.g., ISO, ASTM) and comparison to a predicate device, not by expert interpretation of data points in the way an AI model would be validated.
4. Adjudication method for the test set:
Not applicable, as the evaluation is based on objective measurements and comparison to standards, not human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a traditional medical device, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a traditional medical device.
7. The type of ground truth used:
The "ground truth" used for this device is based on:
- International Standards: e.g., ISO 10555-1, ISO 11607-1, ISO 10555-3, ANSI/AAMI/ISO 11135-1, AAMI TIR 28, ANSI/AAMI ST72, ISO 10993 series, ASTM F 756-08, ASTM F 619-03.
- Predicate Device Performance: The performance of the legally marketed predicate device (CT Midline K141151) serves as a benchmark for substantial equivalence.
- Objective Measurements: Physical and chemical measurements (e.g., flow rates, volumes, material properties, sterility levels) are the "ground truth" for compliance.
8. The sample size for the training set:
Not applicable. This is a traditional medical device, not an AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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.
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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
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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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| 510(k) SUMMARY | Traditional 510K | |||
|---|---|---|---|---|
| K171483 | ||||
| 1. | Submitter Information: | |||
| Submitter: | Medical Components Inc.(dba Medcomp®)1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201Fax: (215) 256-9191 | |||
| Registration Number: | 2518902 | |||
| Contact: | Courtney NixCnix@Medcompnet.comRegulatory 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 MedicalSpecialty and ReviewPanel: | 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-TermGreater Than 30 Days |
Medcomp®: Arch-Flo™ CT Midline
510(k) Summary
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| Product Code: | LJS |
|---|---|
| Regulation Description: | Percutaneous implanted, Long-Term intravascularcatheter |
| C.F.R Section: | 880.5970 |
| Class: | II |
| Regulation MedicalSpecialty and ReviewPanel: | 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
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| Device | Proposed Device:Arch-Flo™ CT Midline(Proposed) | Predicate Device:CT Midline (K141151) |
|---|---|---|
| Indicationsfor Use | The Arch-Flo™ CT MidlineCatheter is indicated forShort-Term peripheralaccess to the peripheralvenous system for selectedintravenous therapies,blood sampling, and powerinjection of contrast media.This catheter may beinserted via the basilic,cephalic, or median cubitalvein | The CT Midlines areindicated for Short-Termperipheral access to theperipheral venous systemfor selected intravenoustherapies, blood sampling,and power injection ofcontrast media.This catheter may beinserted via the basilic,cephalic, or median cubitalvein. |
| Design | Catheter:OD 4FExtension:I.D .070 ± .002O.D .106 ± .002 | Catheter:OD 4FOD 5FExtension:I.D .070 ± .002O.D .106 ± .002 |
| CatheterLength | 10 cm | 20 cm |
| LumenMarking | Number every 5cm anddepth mark every cm. | Number every 5cm anddepth mark every cm |
| Tip Design | Radius Arch Tip | Box |
| Dimensionsor Lengths | 4F X 10 cm | 4F X 20 cm5F X 20 cm |
| Materials | Hub (Yellow): PellethaneLumen (White):Tecothane w/ 20% BaSO4Extensions (Clear) andLuer (Yellow) Sub-Asm:IsoplastTubing Clamp (Purple):Acetal | Hub (White): PellethaneLumen (White) :Tecothane w/ 30% BaSO4Extension (Clear) andLuer (Natural) Sub Asm:IsoplastDouble:Extension (Clear) andLuer (Red) Sub-ASM:IsoplastTubing Clamp (Purple):Acetal |
Table 5.1: 510(K) Summary: Design Comparison Matrix
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| 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/secPriming Volume:0.36ccGravity Flow:56 ml/min | Max Power Injection Flow:5cc/secPriming Volume:0.41ccGravity 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 | PerformanceTesting |
|---|---|---|---|
| ISO 10555-1 | Intravascular Catheter --Sterile and Single - UseIntravascular Catheters -Part 1: GeneralRequirements | Second edition2013-06-15 | Air Leakage, LiquidLeakage, Force atBreak, Elongation,Gravity Flow,ChemicalExposure,Maximum BurstPressure, PowerInjection FlowRate, CyclicFlexure |
| 11607-1 and11607-2 | Packaging for terminallysterilized medical devices -Part 1: requirements formaterials, sterile barriersystems and packagingsystemsPart 2: validationrequirements for forming,sealing and assemblyprocesses | First edition2006-04-15 | Transit Testing(ISTA)Post Aging (ASTMF 1980) |
| ISO 10555-3 | Intravascular Catheters -Sterile And Single-UseCatheters - Part 3: CentralVenous Catheters | SecondEdition 2013-06-15 | Air Leakage, LiquidLeakage, GravityFlow |
Medcomp®: Arch-Flo™ CT Midline 510(k) Summary
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Sterilization:
| Sterilization Validation: | ANSI/AAMI/ISO 11135-1:2014; AAMI TIR 28:2009/(R) 2013 |
|---|---|
| Sterility Assurance Level: | SAL is 10-6. |
| Description of Validation Method:Sterilization Method: | The product is sterilized by 100% EthyleneOxide (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 maximumallowable limits for EO and ECH was less than orequal to the sterilant residual limits per ISO 10993-7for a prolonged exposure device (>24 h <30 days): EO≤4 mg first 24 hours and ECH ≤9 mg first 24 hours. |
| Pyrogen Test Method(LAL): | Tested in accordance with ANSI/AAMI ST72:2011Bacterial Endotoxin-Test methods, routine monitoring,and alternatives to testing the product is Non-pyrogenic. |
| Endotoxin: | Tested in accordance with ANSI/AAMI ST72:2011Bacterial Endotoxin-Test methods, routine monitoring,and alternatives to testing the maximum level is 20EU/device. |
8. Biocompatibility:
Biocompatibility was performed for the Arch-Flo™ CT Midline per ISO 10993-1 for a blood implant device with prolonged exposure (i.e. > 24 hours < 30 days). The biological endpoints and reference standard are as follows:
- Sensitization/Irritation: ●
- o ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
- . Acute Systemic Toxicity:
- ISO 10993-11: 2006 Biological Evaluation of Medical Devices Part 11: O Tests for Systemic Toxicity
- . Pyrogenicity (Materials Mediated) :
- o ISO 10993 11 2006 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
- . Hemocompatibility:
- ISO 10993-4: 2002 Amended 2006 Biological Evaluation of Medical Devices o - Part 4: Selection for tests for interactions with blood
- ASTM F 756-08, Standard Practice for Assessment of Hemolytic Properties o of Materials, 2008
Medcomp®: Arch-Flo™ CT Midline 510(k) Summary
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- o ASTM F 619-03, Standard Practice for Extraction of Medical Plastics, 2008.
- Genotoxicity:
- o ISO 10993-3 : 2003 Biological Evaluation of Medical Devices Part 3 : Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . Cytotoxicity:
- o ISO 10993 -5: 2009 Biological Evaluation of Medical Devices Part 10: Tests for in Vitro Cytotoxicity
- . Implantation:
- o ISO 10993-6 : 2016 Biological Evaluation of Medical Devices Part 6: Tests for local effects after implantation
9. Summary of Substantial Equivalence:
In conclusion, the proposed device, Arch-Flo™ CT Midline, is considered substantially equivalent to the predicate device, CT Midline (K141151) as demonstrated through non-clinical testing performed.
§ 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).