(159 days)
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.
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.
The document provided describes the primeMIDLINE™ Catheters and their substantial equivalence to a predicate device, PowerMidline Catheters. It outlines verification testing performed to demonstrate that the device performs as intended and meets established acceptance criteria.
However, the document does not contain information about a study comparing the device's performance against specific acceptance criteria in the format requested. While it lists various performance testing categories, it does not provide:
- A table of specific quantitative acceptance criteria for each test (e.g., "Tensile Strength should be > X N") and the reported device performance against those criteria.
- Details on sample sizes for a "test set" in the context of device performance, data provenance, or the number/qualifications of experts for ground truth.
- Information on adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance, as these are typically relevant to AI/diagnostic imaging devices, not direct hardware performance.
- The type of ground truth used for performance validation.
- Training set sample size or how ground truth was established for a training set (again, this points more towards AI/ML studies).
Instead, the document states: "The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This is a general statement that the device passed all tests, but without quantifying the criteria or the results.
Therefore, based on the provided text, I cannot complete the table or answer most of the requested questions because the specific data is not available.
Summary of available information:
- Device: primeMIDLINE™ Catheters
- Predicate Device: PowerMidline Catheters (K153393)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Visual Inspection | Met (Statement: "The subject devices met all predetermined acceptance criteria") |
| Dimensional Characteristics | Met (Statement: "...met all predetermined acceptance criteria") |
| Radiopacity | Met (Statement: "...met all predetermined acceptance criteria") |
| Catheter Collapse | Met (Statement: "...met all predetermined acceptance criteria") |
| Leak | Met (Statement: "...met all predetermined acceptance criteria") |
| Priming Volume | Met (Statement: "...met all predetermined acceptance criteria") |
| Flowrate: Gravity | Met (Statement: "...met all predetermined acceptance criteria") |
| Flowrate: Power Injection | Met (Statement: "...met all predetermined acceptance criteria") |
| Tensile Strength | Met (Statement: "...met all predetermined acceptance criteria") |
| Catheter Elongation | Met (Statement: "...met all predetermined acceptance criteria") |
| Lifecycle Performance | Met (Statement: "...met all predetermined acceptance criteria") |
| Static Burst Pressure | Met (Statement: "...met all predetermined acceptance criteria") |
| Suture Wing Integrity | Met (Statement: "...met all predetermined acceptance criteria") |
| Luer Testing | Met (Statement: "...met all predetermined acceptance criteria") |
| Biocompatibility Tests: | |
| Cytotoxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Sensitization | Met (Statement: "...met all predetermined acceptance criteria") |
| Irritation/Intracutaneous Reactivity | Met (Statement: "...met all predetermined acceptance criteria") |
| Acute Systemic Toxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Material Mediated Pyrogenicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Subacute/Subchronic Toxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Genotoxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Carcinogenicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Chronic Toxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Hemocompatibility | Met (Statement: "...met all predetermined acceptance criteria") |
| Implantation | Met (Statement: "...met all predetermined acceptance criteria") |
| Sterilization Validation: | |
| Sterilization Validation – Overkill Method | Met (Statement: "...met all predetermined acceptance criteria") |
| EO/ECH Residuals | Met (Statement: "...met all predetermined acceptance criteria") |
| Direct Product Sterility | Met (Statement: "...met all predetermined acceptance criteria") |
| Bioburden/Organism Characterization | Met (Statement: "...met all predetermined acceptance criteria") |
| Bacteriostasis Fungistasis Testing | Met (Statement: "...met all predetermined acceptance criteria") |
| Bacterial Endotoxins/Limulus Amebocyte Lysate | Met (Statement: "...met all predetermined acceptance criteria") |
Study Information (based on available text):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document states "design verification testing" was conducted but does not provide sample sizes for individual tests or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. The testing described is performance testing of a physical device against standards, not expert-adjudicated diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No. This type of study is for diagnostic tools, typically AI-powered. The device is a physical catheter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- "Predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This refers to objective measurements against established engineering and safety standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML 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 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.
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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 (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
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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 150Carlsbad, CA 92008 |
| Contact Person:Telephone Number:Fax Number:Date of Preparation: | Jessica Jho, RAC760.758.8749760.758.1167March 6, 2018 |
| Subject Device Information | |
| Trade Name:Common Name:Classification Name:Product Code:Regulation Number: | primeMIDLINE™ CathetersMidline CatheterIntravascular CatheterPND21 CFR §880.5200 |
| Predicate Device Information | |
| Trade Name:Premarket NotificationClassificationManufacturer | PowerMidline CatheterK153393PND, 21 CFR §880.5200Bard Access Systems |
| Reference Device Information | |
| Trade Name:Premarket NotificationClassification:Manufacturer: | 4F Single Lumen, 5F Single Lumen and 5F Dual LumenprimePICC CathetersK083873L JS, 21 CFR §880.5970PFM 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 primePICCCatheters | |
|---|---|---|---|
| Manufacturer | PFM Medical, Inc. | Bard Access Systems | PFM Medical, Inc. |
| 510(k) Number | K173114 | K153393 | K083873 |
| FDA ProductCode | Identical to PredicateDevices | PND | L JS |
| Intended Use | Identical to Predicate/Reference Devices | The PowerMidline catheteris intended to access thevascular system foradministration of fluidsintravenously, bloodsampling, and powerinjection of contrast media. | The pimePICC catheters areintended to access the vascularsystem for administration offluids intravenously, bloodsampling, and power injectionof contrast media. |
| Duration of Use | Identical to predicatePowerMidline Catheter | Short term (<30days) | Short term (<30days) or longterm (>30 days) |
| InsertionMethod | Identical to Predicate/Reference Devices | Percutaneous, usingModified SeldingerTechnique and guidewire | Percutaneous, using ModifiedSeldinger Technique andguidewire |
| Subject Device:primeMIDLINE™ Catheters | Predicate Device:PowerMidline Catheters | Reference Device:4F SL, 5F SL, 5F DL primePICCCatheters | |
| Tip PlacementLocation | Identical to predicatePowerMidline Catheter | Peripheral venous system,with catheter tipterminating prior to theaxilla | Central venous system, lower1/3 of the Superior Vena Cavapreferred |
| Insertion Site | Identical to Predicate/Reference Devices | Peripheral | Peripheral |
| Shaft TubingPolyurethane | Shaft TubingPolyurethane | ||
| Catheter JunctionPolyurethane | Catheter JunctionPolyurethane | ||
| Catheter BaseMaterials | Identical to predicatePowerMidline Catheter | Extension LegPolyurethane | Extension LegPolyurethane |
| Luer HubPolyurethane | Luer HubPolycarbonate | ||
| Extension Leg ClampAcetal Resin | Extension Leg ClampAcetal Resin | ||
| CatheterProximalConfiguration | Identical to Predicate/Reference Devices | Luer Connection | Luer Connection |
| Catheter DistalConfiguration | 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 | |
| CatheterDimensions | length4F Single Lumen x 20cmlength | 4F SL x 20cm useable length | 5F Single Lumen x 55cm length |
| 5F Single Lumen x 20cmlength5F Dual Lumen x20cm length | 5F Dual Lumen x 55cm length | ||
| Depth Markings | Identical to predicate/reference devices | Number every 5 cm anddepth mark every cm | Number every 5 cm and depthmark every cm |
| StyletConfiguration | Identical to predicate/reference devices | Pre-InsertedStiffening Stylet | Pre-InsertedStiffening Stylet |
| Power InjectionMaximum FlowRate | 3F SL: 5mL/sec4F SL: 7mL/sec5F SL: 7mL/sec5F DL: 7mL/sec | 3F SL = 3 mL/sec4F SL = 7 mL/sec | 5 mL/sec |
| Sterility | Identical to Predicate/Reference Devices | 100% Ethylene Oxide, SALof 10-6 | 100% Ethylene Oxide, SAL of10-6 |
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 IntracutaneousReactivity | Acute Systemic Toxicity |
| Material MediatedPyrogenicity | Subacute/Subchronic Toxicity |
| Genotoxicity | Carcinogenicity |
| Chronic Toxicity | Hemocompatibility |
| Implantation |
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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 / OrganismCharacterization |
| Bacteriostasis FungistasisTesting | Bacterial Endotoxins / LimulusAmebocyte 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.
§ 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).