(28 days)
Not Found
No
The description focuses on the physical characteristics, materials, and performance testing of a catheter, with no mention of AI or ML.
No
The device is described as providing "access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media," not directly administering therapy itself.
No
Explanation: The device is a catheter used for accessing the peripheral venous system for therapies, blood sampling, and contrast media injection. It is a tool for treatment and access, not for diagnosing conditions.
No
The device description clearly states it is a physical catheter made of radiopaque polyurethane, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short term 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 accessing the vascular system and delivering or withdrawing substances.
- Device Description: The description details a "peripherally placed midline catheter" designed to provide "access to the vascular system." This further reinforces its use within the body.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform tests on samples; it facilitates the collection of samples and the delivery of substances.
The device is a medical device, specifically a catheter, but it does not fit the definition of an In Vitro Diagnostic.
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 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.
Product codes
PND
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.
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 10 kg
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 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. Non-clinical testing was conducted on the subject device including: Visual Inspection, Dimensional Characteristics, Radiopacity, Catheter Collapse, Leak, Priming Volume, Gravity Flowrate, Tensile Strength, Catheter Elongation, Lifecycle Performance, Static Burst Pressure, Suture Wing Integrity, Luer Testing, and Power Injection Flowrate. The following standards and FDA guidance documents were utilized: ISO 10555-1:2013, ASTM F640-12, ISO 80369-7:2016, FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, and PFM Medical Internal Standards. Additionally, applicable biocompatibility testing per ISO 10993-1 was performed: Cytotoxicity, Irritation or Intracutaneous Reactivity, Material Mediated, Pyrogenicity, Genotoxicity, Chronic Toxicity, Implantation, Sensitization, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Carcinogenicity, Hemocompatibility, Particulate, and Complement Activation Assay. The subject device met all predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| 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 As required by section 807.92
| General Information | |
|---|---|
| 510(k) Owner: | PFM Medical, Inc. |
| Submitter Address: | 1916 Palomar Oaks Way, Suite 150 |
| 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. |
4
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
Lumen primeMIDLINE
Catheter | Predicate Device:
primeMIDLINE Catheters | Comparison Discussion |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Manufacturer | PFM Medical, Inc. | PFM Medical, Inc. | This attribute is identical
between the subject and
predicate device. |
| 510(k) Number | K192802 | K173114 | N/A |
| FDA Product
Code | PND | PND | This attribute is identical
between the subject and
predicate device. |
| Intended Use | The primeMIDLINETM
Catheters are intended to
access the vascular system for
administration of fluids
intravenously, blood
sampling, and power injection
of contrast media. | The primeMIDLINETM
Catheters are intended to
access the vascular system for
administration of fluids
intravenously, blood
sampling, and power injection
of contrast media. | This attribute is identical
between the subject and
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:
5
pfmmedical
| 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. | 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. | This attribute is identical
between the subject and
predicate device. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Duration of Use | Short term (