(159 days)
No
The 510(k) summary describes a physical medical device (catheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is indicated for "short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media." The delivery of intravenous therapies is a therapeutic use.
No
Explanation: The device is a catheter designed for providing access to the vascular system for intravenous therapies, blood sampling, and power injection of contrast media. It is a tool for treatment and access, not for diagnosing conditions.
No
The device description clearly states it is a family of peripherally placed midline catheters, which are physical medical devices made of radiopaque polyurethane. The summary also details extensive non-clinical testing related to the physical properties and performance of the catheter hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body.
- Device Function: The primeMIDLINE™ Catheters are designed for accessing the peripheral venous system for administering therapies, drawing blood samples, and injecting contrast media. They are a tool for accessing the body, not for performing tests on samples from the body.
- Intended Use: The intended use clearly describes accessing the vascular system for intravenous therapies, blood sampling, and power injection. These are all procedures performed on the patient, not on a sample in a lab.
- Device Description: The description focuses on the physical characteristics of the catheter and its use in accessing the vascular system.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro testing.
In summary, the primeMIDLINE™ Catheters are a medical device used for accessing the body's vascular system, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
Product codes (comma separated list FDA assigned to the subject device)
PND
Device Description
The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.
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
patients older than 28 days and that weigh more than 10kg
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)
PFM Medical, Inc. conducted a risk analysis per ISO 14971: Medical devices – Application of risk management of medical devices to assess the risk profile of the primeMIDLINE™ catheter. Control mechanisms, including design verification testing, were defined to mitigate the identified risks and to demonstrate that the devices perform as intended. Non-clinical testing included: Visual Inspection, Dimensional Characteristics, Radiopacity, Catheter Collapse, Leak, Priming Volume, Flowrate: Gravity, Tensile Strength, Catheter Elongation, Lifecycle Performance, Static Burst Pressure, Suture Wing Integrity, Luer Testing, and Flowrate: Power Injection.
The primeMIDLINE™ catheters were subjected to biocompatibility testing per ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including: Cytotoxicity, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity, Genotoxicity, Chronic Toxicity, Implantation, Sensitization, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Carcinogenicity, and Hemocompatibility.
Sterilization testing included: Sterilization Validation – Overkill Method, Direct Product Sterility, Bacteriostasis Fungistasis Testing, EO/ECH Residuals, Bioburden / Organism Characterization, and Bacterial Endotoxins / Limulus Amebocyte Lysate.
The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards.
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.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 7, 2018
PFM Medical, Inc. Jessica Jho Regulatory Affairs Consultant 1916 Palomar Oaks Way Suite 150 Carlsbad. California 92008
Re: K173114
Trade/Device Name: primeMidline™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: February 1. 2018 Received: February 5, 2018
Dear Jessica Jho:
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 (OS) 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 mediation-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
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) K173114
Device Name
primeMidline™ Catheters
Indications for Use (Describe)
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for pfmmedical. The logo is composed of the letters "pfm" in blue and the word "medical" in black. The letters "pfm" are in a sans-serif font and are connected to each other. The word "medical" is in a sans-serif font and is separated from the letters "pfm".
510(k) Summary K173114 As required by section 807.92
| General Information | |
|---|---|
| 510(k) Owner: | |
| Submitter Address: | PFM Medical, Inc. |
| 1916 Palomar Oaks Way, Suite 150 | |
| Carlsbad, CA 92008 | |
| Contact Person: | |
| Telephone Number: | |
| Fax Number: | |
| Date of Preparation: | Jessica Jho, RAC |
| 760.758.8749 | |
| 760.758.1167 | |
| March 6, 2018 | |
| Subject Device Information | |
| Trade Name: | |
| Common Name: | |
| Classification Name: | |
| Product Code: | |
| Regulation Number: | primeMIDLINE™ Catheters |
| Midline Catheter | |
| Intravascular Catheter | |
| PND | |
| 21 CFR §880.5200 | |
| Predicate Device Information | |
| Trade Name: | |
| Premarket Notification | |
| Classification | |
| Manufacturer | PowerMidline Catheter |
| K153393 | |
| PND, 21 CFR §880.5200 | |
| Bard Access Systems | |
| Reference Device Information | |
| Trade Name: | |
| Premarket Notification | |
| Classification: | |
| Manufacturer: | 4F Single Lumen, 5F Single Lumen and 5F Dual Lumen |
| primePICC Catheters | |
| K083873 | |
| L JS, 21 CFR §880.5970 | |
| PFM Medical, Inc. |
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Image /page/4/Picture/9 description: The image shows the logo for PFM Medical. The logo consists of the letters "pfm" in blue, followed by the word "medical" in black. The letters "pfm" are in a sans-serif font, and the word "medical" is in a similar font. The logo is simple and modern, and it is likely used to identify PFM Medical as a company.
Device Description
The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.
Indications for Use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the primeMIDLINE™ Catheters are suitable for use with power injectors.
Technological Characteristics
The proposed primeMIDLINE™ Catheters are substantially equivalent to the Power Midline Catheters, previously reviewed and cleared under K153393. When compared to the proposed primeMIDLINE™ Catheters have equivalent materials, design, components, technological characteristics and Indications for Use statements. The minor differences between the subject primeMIDLINE™ catheters and the predicate device do not change the intended use of the device and they do not raise different questions of safety and effectiveness.
| | Subject Device:
primeMIDLINE™ Catheters | Predicate Device:
PowerMidline Catheters | Reference Device:
4F SL, 5F SL, 5F DL primePICC
Catheters |
|-----------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | PFM Medical, Inc. | Bard Access Systems | PFM Medical, Inc. |
| 510(k) Number | K173114 | K153393 | K083873 |
| FDA Product
Code | Identical to Predicate
Devices | PND | L JS |
| Intended Use | Identical to Predicate/
Reference Devices | The PowerMidline catheter
is intended to access the
vascular system for
administration of fluids
intravenously, blood
sampling, and power
injection of contrast media. | The pimePICC catheters are
intended to access the vascular
system for administration of
fluids intravenously, blood
sampling, and power injection
of contrast media. |
| Duration of Use | Identical to predicate
PowerMidline Catheter | Short term (30 days) |
| Insertion
Method | Identical to Predicate/
Reference Devices | Percutaneous, using
Modified Seldinger
Technique and guidewire | Percutaneous, using Modified
Seldinger Technique and
guidewire |
| | Subject Device:
primeMIDLINE™ Catheters | Predicate Device:
PowerMidline Catheters | Reference Device:
4F SL, 5F SL, 5F DL primePICC
Catheters |
| Tip Placement
Location | Identical to predicate
PowerMidline Catheter | Peripheral venous system,
with catheter tip
terminating prior to the
axilla | Central venous system, lower
1/3 of the Superior Vena Cava
preferred |
| Insertion Site | Identical to Predicate/
Reference Devices | Peripheral | Peripheral |
| | | Shaft Tubing
Polyurethane | Shaft Tubing
Polyurethane |
| | | Catheter Junction
Polyurethane | Catheter Junction
Polyurethane |
| Catheter Base
Materials | Identical to predicate
PowerMidline Catheter | Extension Leg
Polyurethane | Extension Leg
Polyurethane |
| | | Luer Hub
Polyurethane | Luer Hub
Polycarbonate |
| | | Extension Leg Clamp
Acetal Resin | Extension Leg Clamp
Acetal Resin |
| Catheter
Proximal
Configuration | Identical to Predicate/
Reference Devices | Luer Connection | Luer Connection |
| Catheter Distal
Configuration | Identical to Predicate/
Reference Devices | Open Ended | Open Ended |
| | 3F Single Lumen x 20cm | 3F SL x 20cm usable length | 4F Single Lumen x 50cm length |
| Catheter
Dimensions | length
4F Single Lumen x 20cm
length | 4F SL x 20cm useable length | 5F Single Lumen x 55cm length |
| | 5F Single Lumen x 20cm
length
5F Dual Lumen x
20cm length | | 5F Dual Lumen x 55cm length |
| Depth Markings | Identical to predicate/
reference devices | Number every 5 cm and
depth mark every cm | Number every 5 cm and depth
mark every cm |
| Stylet
Configuration | Identical to predicate/
reference devices | Pre-Inserted
Stiffening Stylet | Pre-Inserted
Stiffening Stylet |
| Power Injection
Maximum Flow
Rate | 3F SL: 5mL/sec
4F SL: 7mL/sec
5F SL: 7mL/sec
5F DL: 7mL/sec | 3F SL = 3 mL/sec
4F SL = 7 mL/sec | 5 mL/sec |
| Sterility | Identical to Predicate/
Reference Devices | 100% Ethylene Oxide, SAL
of 10-6 | 100% Ethylene Oxide, SAL of
10-6 |
The following is a summary of the technological characteristics of the primeMIDLINE™ catheters as compared to the predicate and reference devices:
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pfmmedical
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Performance Testing
PFM Medical, Inc. conducted a risk analysis per ISO 14971: Medical devices – Application of risk management of medical devices to assess the risk profile of the primeMIDLINE™ catheter. Control mechanisms, including design verification testing, were defined to mitigate the identified risks and to demonstrate that the devices perform as intended. Below is a listing of non-clinical testing that is included in this submission:
| Visual Inspection | Tensile Strength |
|---|---|
| Dimensional Characteristics | Catheter Elongation |
| Radiopacity | Lifecycle Performance |
| Catheter Collapse | Static Burst Pressure |
| Leak | Suture Wing Integrity |
| Priming Volume | Luer Testing |
| Flowrate: Gravity | Flowrate: Power Injection |
The following standards and FDA guidance documents were utilized in the testing listed above:
- ISO 10555-1:2013, Intravascular Catheters Sterile and Single-Use Catheters ■
- ASTM F640-07 – Standard Test Methods for Determining Radiopacity for Medical Use
- ISO 594-1: 1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 1: General Requirements
- . ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock Fittings
- FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters
- PFM Medical Internal Standards
The primeMIDLINE™ catheters were subjected to the following biocompatibility testing as required per ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process:
| Cytotoxicity | Sensitization |
|---|---|
| Irritation or Intracutaneous | |
| Reactivity | Acute Systemic Toxicity |
| Material Mediated | |
| Pyrogenicity | Subacute/Subchronic Toxicity |
| Genotoxicity | Carcinogenicity |
| Chronic Toxicity | Hemocompatibility |
| Implantation |
7
Performance Testing
The primeMIDLINE™ Catheters are sterilized by 100% Ethylene Oxide Gas with a Sterility Assurance level of 10 °. The following sterilization is applicable to the primeMIDLINE™ Catheters:
| Sterilization Validation –
| Overkill Method | EO/ECH Residuals |
|---|---|
| Direct Product Sterility | Bioburden / Organism |
| Characterization | |
| Bacteriostasis Fungistasis | |
| Testing | Bacterial Endotoxins / Limulus |
| Amebocyte Lysate |
The sterilization testing listed above was conducted in accordance with the following standards:
- l AAMI/ANSI/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
- . ANSI/AAMI/ISO 11737-1: 2006/(R)2011, Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of microorganisms on product
- ANSI/AAMI/ISO 11737-2:2009/(R)2014,Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
- ANSI/AAMI ST72:2011/(R)2016, Bacterial Endotoxin-Test methods, routine monitoring, and alternatives to testing
The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards.
Conclusion
Based on detailed comparison of intended use, technological characteristics and performance testing of the subject and predicate device, the primeMidline Catheters are substantially equivalent to the predicate Power Midline Catheters.