primeMidline Catheters

K192802 · Pfm Medical, Inc. · PND · Oct 28, 2019 · General Hospital

Device Facts

• Record ID: K192802
• Device Name: primeMidline Catheters
• Applicant: Pfm Medical, Inc.
• Product Code: PND · General Hospital
• Decision Date: Oct 28, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The primeMIDLINE™ Catheters are intended to access the vascular system for administration of fluids intravenously, blood sampling, and power injection of contrast media.

Device Story

4F Dual Lumen primeMIDLINE™ Catheter is a peripherally placed, radiopaque polyurethane midline catheter for short-term (<30 days) vascular access. Device includes pre-inserted stiffening stylet; inserted percutaneously via Modified Seldinger Technique. Suitable for power injection of contrast media (max flow rate 4mL/sec). Used in clinical settings by healthcare professionals to administer fluids, sample blood, and deliver contrast media. Output is vascular access; enables therapeutic delivery and diagnostic imaging. Benefits include reliable peripheral venous access for patients meeting weight/age criteria.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional analysis, radiopacity, catheter collapse, leak, priming volume, gravity/power injection flow rates, tensile strength, elongation, lifecycle performance, static burst pressure, suture wing integrity, and luer testing. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemocompatibility, and implantation. All tests met predetermined acceptance criteria.

Technological Characteristics

Radiopaque polyurethane shaft, junction, extension legs, and luer hubs; acetal resin extension leg clamps. Dual lumen (Double D shape). 4F diameter, 20cm length. Open-ended distal configuration. Pre-inserted stiffening stylet. Sterilized via 100% Ethylene Oxide (SAL 10^-6). Complies with ISO 10555-1, ASTM F640-12, and ISO 80369-7.

Indications for Use

Indicated for short term access to the peripheral venous system for intravenous therapies, blood sampling, and power injection of contrast media in patients older than 28 days and weighing more than 10 kg, based on vascular anatomy and procedure appropriateness.

Regulatory Classification

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.

Predicate Devices

• primeMIDLINE™ Catheters (K173114)

Submission Summary (Full Text)

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October 28, 2019

PFM Medical, Inc. Mina Jiang Associate Regulatory Affairs Specialist 1916 Palomar Oaks Way, Suite 150 Carlsbad, California 92008

Re: K192802

Trade/Device Name: primeMidline™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: September 27, 2019 Received: September 30, 2019

### Dear Mina Jiang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192802

Device Name

4F Dual Lumen primeMidline™ Catheter

#### 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 10 kg, 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) | |
|------------------------------------------------------------|---------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary As required by section 807.92

| General Information | |
|------------------------------|--------------------------------------------------------|
| 510(k) Owner: | PFM Medical, Inc. |
| Submitter Address: | 1916 Palomar Oaks Way, Suite 150<br>Carlsbad, CA 92008 |
| Contact Person: | Mina Jiang |
| Telephone Number: | 760.758.8749 |
| Fax Number: | 760.758.1167 |
| Date of Preparation: | October 25, 2019 |
| Subject Device Information | |
| Trade Name: | 4F Dual Lumen primeMIDLINE™ Catheter |
| Premarket Notification: | K192802 |
| Common Name: | Midline Catheter |
| Classification Name: | Intravascular Catheter |
| Product Code: | PND |
| Regulation Number: | 21 CFR §880.5200 |
| Predicate Device Information | |
| Trade Name: | primeMIDLINE™ Catheters |
| Premarket Notification: | K173114 |
| Classification: | PND, 21 CFR §880.5200 |
| Manufacturer: | PFM Medical, Inc. |

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#### Device Description

The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is 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 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

#### Technological Characteristics

The proposed 4F Dual Lumen primeMIDLINE™ Catheter is substantially equivalent to the primeMidline Catheters previously reviewed and cleared under K173114. When compared to the predicate, the proposed 4F Dual Lumen primeMIDLINE™ Catheter has identical intended use, materials, overall design, components, technological characteristics and Indications for Use. The minor differences between the subject 4F DL primeMIDLINE™ catheter 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: 4F Dual<br>Lumen primeMIDLINE<br>Catheter | Predicate Device:<br>primeMIDLINE Catheters | Comparison Discussion |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Manufacturer | PFM Medical, Inc. | PFM Medical, Inc. | This attribute is identical<br>between the subject and<br>predicate device. |
| 510(k) Number | K192802 | K173114 | N/A |
| FDA Product<br>Code | PND | PND | This attribute is identical<br>between the subject and<br>predicate device. |
| Intended Use | The primeMIDLINETM<br>Catheters are intended to<br>access the vascular system for<br>administration of fluids<br>intravenously, blood<br>sampling, and power injection<br>of contrast media. | The primeMIDLINETM<br>Catheters are intended to<br>access the vascular system for<br>administration of fluids<br>intravenously, blood<br>sampling, and power injection<br>of contrast media. | This attribute is identical<br>between the subject and<br>predicate device. |

The following is a summary of the technological characteristics of the 4F Dual Lumen primeMIDLINE™ catheter as compared to the predicate and reference devices:

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# pfmmedical

| Indications for<br>Use | The primeMIDLINE™<br>Catheters are indicated for<br>short term access to the<br>peripheral venous system for<br>selected intravenous<br>therapies, blood sampling and<br>power injection of contrast<br>media. These catheters are<br>indicated for patients older<br>than 28 days and that weigh<br>more than 10 kg, with<br>consideration given to<br>adequacy of vascular anatomy<br>and appropriateness of the<br>procedure. The<br>primeMIDLINE™ Catheters are<br>suitable for use with power<br>injectors. | The primeMIDLINE™<br>Catheters are indicated for<br>short term access to the<br>peripheral venous system for<br>selected intravenous<br>therapies, blood sampling and<br>power injection of contrast<br>media. These catheters are<br>indicated for patients older<br>than 28 days and that weigh<br>more than 10 kg, with<br>consideration given to<br>adequacy of vascular anatomy<br>and appropriateness of the<br>procedure. The<br>primeMIDLINE™ Catheters are<br>suitable for use with power<br>injectors. | This attribute is identical<br>between the subject and<br>predicate device. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Duration of Use | Short term (<30 days) | Short term (<30 days) | This attribute is identical<br>between the subject and<br>predicate device. |
| Duration of Use | Short term (<30 days) | Short term (<30 days) | This attribute is identical<br>between the subject and<br>predicate device. |
| Insertion<br>Method | Percutaneous, using Modified<br>Seldinger Technique and<br>guidewire | Percutaneous, using Modified<br>Seldinger Technique and<br>guidewire | This attribute is identical<br>between the subject and<br>predicate device. |
| Tip Placement<br>Location | Peripheral venous system,<br>with catheter tip terminating<br>prior to the axilla | Peripheral venous system,<br>with catheter tip terminating<br>prior to the axilla | This attribute is identical<br>between the subject and<br>predicate device. |
| Insertion Site | Peripheral | Peripheral | This attribute is identical<br>between the subject and<br>predicate device. |
| | Shaft Tubing<br>Polyurethane<br>Catheter Junction<br>Polyurethane | Shaft Tubing<br>Polyurethane<br>Catheter Junction<br>Polyurethane | |
| Catheter Base<br>Materials | Extension Legs<br>Polyurethane<br>Luer Hubs<br>Polyurethane<br>Extension Leg Clamps<br>Acetal Resin | Extension Leg(s)<br>Polyurethane<br>Luer Hub(s)<br>Polyurethane<br>Extension Leg Clamp(s)<br>Acetal Resin | This attribute is identical<br>between the subject and<br>predicate device. |
| Catheter<br>Proximal<br>Configuration | Luer Connection | Luer Connection | This attribute is identical<br>between the subject and<br>predicate device. |

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# pfmmedical

| Catheter Distal<br>Configuration | Open Ended | Open Ended | This attribute is identical<br>between the subject and<br>predicate device. |
|----------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter<br>Dimensions | 4F Dual Lumen x 20cm length | 3F Single Lumen x 20cm<br>length<br>4F Single Lumen x 20cm<br>length<br>5F Single Lumen x 20cm<br>length<br>5F Dual Lumen x 20cm length | The French size of the<br>catheter is reduced as<br>compared to the 5F DL<br>primeMidline configuration<br>covered under K173114.<br>The reduction in the French<br>size does not raise new<br>questions of safety and<br>effectiveness. The<br>fundamental operating<br>principals, materials and<br>overall design remain the<br>same between the subject<br>and predicate devices. The<br>4F DL primeMidline does<br>not increase the current risk<br>profile of or introduce new<br>risks to the primeMidline<br>family of catheters. |
| Number, Shape<br>of Lumens | Dual Lumen = Double D | Single Lumen = Round<br>Dual Lumen = Double D | Identical to 5F Dual Lumen<br>configuration. |
| Depth<br>Markings | Number every 5 cm and depth<br>mark every cm | Number every 5 cm and depth<br>mark every cm | This attribute is identical<br>between the subject and<br>predicate device. |
| Stylet<br>Configuration | Pre-Inserted<br>Stiffening Stylet | Pre-Inserted<br>Stiffening Stylet | This attribute is identical<br>between the subject and<br>predicate device. |

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# pfmmedical

| Power Injection<br>Maximum Flow<br>Rate | 4F DL: 4mL/sec | 3F SL: 6mL/sec<br>4F SL: 7mL/sec<br>5F SL: 7mL/sec<br>5F DL: 7mL/sec | The subject device has a<br>different flowrate as<br>compared to the predicate<br>devices. This difference<br>does not raise new<br>questions of safety and<br>effectiveness. Clinicians will<br>determine which catheter<br>size, lumen configuration<br>and performance<br>capabilities are appropriate<br>based on patient size and<br>need. The 4F DL<br>primeMidline catheter<br>represents one size and<br>performance option in the<br>family of primeMidline<br>catheters. The differences<br>in flowrate do not increase<br>the current risk profile of or<br>introduce new risks to the<br>primeMidline family of<br>catheters. |
|-----------------------------------------|-------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | 100% Ethylene Oxide, SAL of<br>10-6 | 100% Ethylene Oxide, SAL of<br>10-6 | This attribute is identical<br>between the subject and<br>predicate device. |

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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 4F DL 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 was conducted on the subject device:

| Visual Inspection | Tensile Strength |
|-----------------------------|--------------------------|
| Dimensional Characteristics | Catheter Elongation |
| Radiopacity | Lifecycle Performance |
| Catheter Collapse | Static Burst Pressure |
| Leak | Suture Wing Integrity |
| Priming Volume | Luer Testing |
| Gravity Flowrate | Power Injection Flowrate |

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 F640-12 – Standard Test Methods for Determining Radiopacity for Medical Use
- ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
- FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters
- PFM Medical Internal Standards

Additionally, the primeMIDLINE™ catheters were subjected to applicable 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<br>Reactivity | Acute Systemic Toxicity |
| Material Mediated | Subacute/Subchronic Toxicity |
| Pyrogenicity | |
| Genotoxicity | Carcinogenicity |
| Chronic Toxicity | Hemocompatibility |
| Implantation | Particulate |
| Complement Activation Assay | |

The subject device met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Document 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 4F DL primeMidline Catheter is substantially equivalent to the predicate primeMidline Catheters. Risk identification and validation activities ensure that the risk acceptability criteria have been met, and the risks have been mitigated.