(174 days)
The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors.
Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection.
Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated.
The provided FDA 510(k) clearance letter for the PowerGlide Pro™ Midline Catheter specifies that no new performance tests, including verification and validation activities, were conducted because the modifications were limited to labeling updates (specifically, changes to the Indications for Use and associated Instructions for Use/labeling), with no changes to the device's design, materials, performance, or risk profile.
Therefore, based on the provided document, the typical information requested for acceptance criteria and study details (such as sample size, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not available as no new studies were deemed necessary due to the nature of the submission. The acceptance criteria essentially rely on the previously established performance of the legally marketed predicate device (K162377), which the subject device is substantially equivalent to.
However, I can extract the comparison table that highlights the differences between the subject device and the predicate device, which implicitly states that the performance criteria for the subject device are considered to be the same as the predicate device due to the lack of design or performance changes.
Here's a summary based on the provided document, addressing the points where information is available or where the document indicates why it's not applicable:
1. A Table of Acceptance Criteria and the Reported Device Performance
Since no new performance studies were conducted for this 510(k) submission, there are no new specific acceptance criteria or reported device performance metrics beyond those previously established for the predicate device. The document explicitly states:
"The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."
The "reported device performance" would therefore implicitly be identical to the predicate device, K162377, for all functional aspects. The acceptance criteria for this submission were that the labeling changes do not introduce new questions of safety or effectiveness and do not introduce any new or significantly modified risks. The document claims this was met for each change.
Summary of Device Comparison (Implicit Acceptance of Predicate Performance)
| Attribute | Predicate Device (K162377) | Subject Device | Comparison / "Acceptance Met" |
|---|---|---|---|
| Indications for Use | "The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors." | "The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro Midline Catheter is suitable for use with power injectors." | "Added mention of adult and pediatric patients. There is no effect on device safety or effectiveness or any significant change in risk. Addressed in Risk Assessment RA82172." |
| Device Description | "Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a single use, sterile intravascular catheters designed to provide access to the patient's vascular system. The device is intended for short term use (<30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen catheter rated for power injection." | "Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection. Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated." | "The Device Description is being updated with minor clarifications based on existing product and existing materials, as well as mentioning that Midline catheters including PowerGlide Pro can be considered in patients with difficult IV access as appropriate. There is no change to the device itself. The mention of patients with difficult IV access does not raise new questions of safety and effectiveness and does not introduce any new or significantly modified risks." |
| Contraindications | "The device is contraindicated whenever:• The presence of device-related infection, bacteremia, or septicemia is known or suspected.• The patient's body size is insufficient to accommodate the size of the implanted device.• The patient is known or is suspected to be allergic to materials contained in the device.• Local tissue factors and/or past treatment will prevent proper device stabilization and/or access." | "The device is contraindicated whenever:• The patient's body size is insufficient to accommodate the size of the implanted device.• The patient is known or is suspected to be allergic to materials contained in the device.• Local tissue factors and/or past treatment will prevent proper device stabilization and/or access." | "Removal of the contraindication does not raise new questions of safety or effectiveness and there are no new or significantly modified risks." |
| Warnings | N/A | "Discontinue use of the PowerGlide Pro Midline Catheter device if it is known to be the source of infection. Otherwise, use clinical judgement regarding device removal." | "Included warning based on existing risks for PowerGlide Pro™, being added to clarify clinician judgement on device removal if identified or suspected as the source of infection. The addition does not raise new questions of safety or effectiveness and does not introduce any new or modified risks." |
| Precautions | N/A | "Select the most appropriate vascular access device based on the necessary and anticipated therapies, patient history and overall vascular health which may include difficult intravascular access, along with the available resources to care for the vascular access device." | "Precaution is being added as a clarification for clinicians based on the device's existing risks, especially for when considering for use in patients with difficult intravascular access. The addition of this precaution does not raise new questions of safety or effectiveness and does not introduce any new or modified risks." |
| Other Attributes | (Length, Diameter, Duration of Use, Primary Components, Means of Insertion, Insertion Site, Materials, Luer Configuration, Lumens, Max Flow Rate, Sterility, Packaging, Intended Use Environment) | (Same as Predicate) | All "Same" - indicating no change in these performance characteristics, therefore acceptance standards remain as previously established for the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set was used as no new performance studies were conducted.
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. No new test set required ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set required 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 device is a medical catheter and does not involve AI assistance or human reader interpretation for its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for this submission. The substantial equivalence is based on the predicate device's established safety and effectiveness.
8. The sample size for the training set
Not applicable. No training set was used as no new algorithm or performance study was conducted.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
FDA 510(k) Clearance Letter - PowerGlide Pro™ Midline Catheter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.01
Silver Spring, MD 20993
www.fda.gov
July 29, 2024
Becton, Dickinson and Company (Bard Access Systems, Inc.)
Abigail Ryder
Senior Regulatory Affairs Specialist
605 S 5600 W
Salt Lake City, Utah 84116
Re: K240359
Trade/Device Name: PowerGlide Pro™ Midline Catheter
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: June 26, 2024
Received: June 28, 2024
Dear Abigail Ryder:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K240359 - Abigail Ryder Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
David Wolloscheck, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices,
and Human Factors
Page 3
K240359 - Abigail Ryder Page 3
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K240359
Device Name
PowerGlide Pro™ Midline Catheter
Indications for Use (Describe)
The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
K240359. 510(k) Summary
| General Provisions | |
|---|---|
| Submitter Name: | Bard Access Systems, Inc. (BD) |
| Submitter Address: | 605 North 5600 WestSalt Lake City, Utah 84116 |
| Contact Person: | Abigail RyderSenior Regulatory Affairs Specialist |
| Telephone Number: | 801.522.5000 |
| Date of Preparation: | July 29th, 2024 |
| Subject Device: | |
|---|---|
| Trade Name: | PowerGlide Pro™ Midline Catheter |
| Common Name: | Intravascular Catheter |
| Classification Name: | catheter, intravascular, therapeutic, short-term less than 30 days |
| Class: | Class II |
| Regulation Number: | 880.5200 |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
| Predicate Device | |
|---|---|
| Trade Name: | PowerGlide Pro™ Midline Catheter |
| Common Name | Intravascular Catheter |
| Classification Name: | catheter, intravascular, therapeutic, short-term less than 30 days |
| Class: | Class II |
| Regulation Number: | 880.5200 |
| Premarket Notification Number: | K162377 |
| Device Description | |
|---|---|
| Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection. |
Page 6
| Indications for Use | |
|---|---|
| The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro Midline Catheter is suitable for use with power injectors. |
| Technological Characteristics | |
|---|---|
| Technological characteristics of the subject PowerGlide Pro™ Midline Catheter are substantially equivalent with respect to design and function to those of the cited predicate device. | |
| The key modification made to the subject device when compared to the predicate device is the mention of The PowerGlide™ Pro Midline catheters may be considered for patients with difficult intravascular access (DIVA) as clinically indicated; addition of mention of use in adult and pediatric populations in the indications for use; and removal of a contraindication. As a result, the Instructions for Use (IFU) were updated to reflect the modification, the indications for use were updated, and the contraindication of the device for use in patients with infection was also removed. There are no other differences between the subject and predicate devices. The following table provides a comparison between the subject and predicate device: |
| Attribute | Predicate DevicePowerGlide Pro™ Midline Catheter(K162377) | Subject DevicePowerGlide Pro™Midline Catheter | Comparison |
|---|---|---|---|
| Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Same |
| Classification | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Same |
| 510(k) Status | K162377 | Subject of this Premarket Notification | - |
| Indications for Use | The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of | The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro Midline Catheter is suitable for use with power injectors. | Added mention of adult and pediatric patients. There is no effect on device safety or effectiveness or any significant change in risk. Addressed in Risk Assessment RA82172. |
Page 7
| Attribute | Predicate DevicePowerGlide Pro™ Midline Catheter(K162377) | Subject DevicePowerGlide Pro™Midline Catheter | Comparison |
|---|---|---|---|
| the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors. | |||
| Device Description | Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a single use, sterile intravascular catheters designed to provide access to the patient's vascular system. The device is intended for short term use (<30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen catheter rated for power injection. | Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection.Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated. | The Device Description is being updated with minor clarifications based on existing product and existing materials, as well as mentioning that Midline catheters including PowerGlide Pro can be considered in patients with difficult IV access as appropriate. There is no change to the device itself. The mention of patients with difficult IV access does not raise new questions of safety and effectiveness and does not introduce any new or significantly modified risks. |
| Contraindications | The device is contraindicated whenever:• The presence of device-related infection, bacteremia, or septicemia is known or suspected. | The device is contraindicated whenever:• The patient's body size is insufficient to accommodate the size of the implanted device. | Removal of the contraindication does not raise new questions of safety or effectiveness and there are no new or |
Page 8
| Attribute | Predicate DevicePowerGlide Pro™ Midline Catheter(K162377) | Subject DevicePowerGlide Pro™Midline Catheter | Comparison |
|---|---|---|---|
| • The patient's body size is insufficient to accommodate the size of the implanted device.• The patient is known or is suspected to be allergic to materials contained in the device.• Local tissue factors and/or past treatment will prevent proper device stabilization and/or access. | • The patient is known or is suspected to be allergic to materials contained in the device.• Local tissue factors and/or past treatment will prevent proper device stabilization and/or access. | significantly modified risks. | |
| Warnings | N/A | Discontinue use of the PowerGlide Pro Midline Catheter device if it is known to be the source of infection. Otherwise, use clinical judgement regarding device removal. | Included warning based on existing risks for PowerGlide Pro™, being added to clarify clinician judgement on device removal if identified or suspected as the source of infection. The addition does not raise new questions of safety or effectiveness and does not introduce any new or modified risks. |
| Precautions | N/A | Select the most appropriate vascular access device based on the necessary and anticipated therapies, patient history and overall vascular health which may include difficult intravascular access, along with the available resources to care for the vascular access device. | Precaution is being added as a clarification for clinicians based on the device's existing risks, especially for when considering for use in patients with difficult intravascular access. The addition of |
Page 9
| Attribute | Predicate DevicePowerGlide Pro™ Midline Catheter(K162377) | Subject DevicePowerGlide Pro™Midline Catheter | Comparison |
|---|---|---|---|
| this precaution does not raise new questions of safety or effectiveness and does not introduce any new or modified risks. | |||
| Commercial Name | PowerGlide Pro™ Intravascular Catheter | PowerGlide Pro™ Intravascular Catheter | Same |
| Catheter Dimensions | Length: 8 and 10 cmDiameter: 18, 20, 22* Gauge*22Ga is 8cm length only | Length: 8 and 10 cmDiameter: 18, 20, 22* Gauge*22Ga is 8cm length only | Same |
| Durations of Use | Short term (<30 days) | Short term (<30 days) | Same |
| Primary Device Components | NeedleGuidewireCatheter | NeedleGuidewireCatheter | Same |
| Means of Insertion | Percutaneous, over a guidewire | Percutaneous, over a guidewire | Same |
| Insertion Site | Peripheral | Peripheral | Same |
| Primary Device Components and Materials | CatheterShaft:Polyether Polyurethane with Barium SulfateLubricantSiliconeCatheter TipPolyurethane, ColorantLuer Hub:Polyurethane, Colorant, InkStrain Relief:Polyether Polyurethane, | CatheterShaft:Polyether Polyurethane with Barium SulfateLubricantSiliconeCatheter TipPolyurethane, ColorantLuer Hub:Polyurethane, Colorant, InkStrain Relief:Polyether Polyurethane, Barium | Same |
Page 10
| Attribute | Predicate DevicePowerGlide Pro™ Midline Catheter(K162377) | Subject DevicePowerGlide Pro™Midline Catheter | Comparison |
|---|---|---|---|
| Barium Sulfate, ColorantsNeedleShaft:Stainless SteelLubricant:SiliconeHub:Polycarbonate, Colorant, AdhesiveNeedle SafetyHousing:PolycarbonateInternal Safety Mechanism:Silicone, Stainless SteelGuidewireNitinolGuidewire "Push Off"/Guidewire CouplerAcetal Resin, PTFE Lubricant, ColorantCatheter Handle (Wings)Base Material (all sizes):Polystyrene, ColorantsBlood Control MechanismBiomedical Grade SiliconeHousing (Top and Bottom)Top Housing:Polycarbonate, White ColorantBottom Housing:Polycarbonate | Sulfate, ColorantsNeedleShaft:Stainless SteelLubricant:SiliconeHub:Polycarbonate, Colorant, AdhesiveNeedle SafetyHousing:PolycarbonateInternal Safety Mechanism:Silicone, Stainless SteelGuidewireNitinolGuidewire "Push Off"/Guidewire CouplerAcetal Resin, PTFE Lubricant, ColorantCatheter Handle (Wings)Base Material (all sizes):Polystyrene, ColorantsBlood Control MechanismBiomedical Grade SiliconeHousing (Top and Bottom)Top Housing:Polycarbonate, White ColorantBottom Housing:Polycarbonate |
Page 11
| Attribute | Predicate DevicePowerGlide Pro™ Midline Catheter(K162377) | Subject DevicePowerGlide Pro™Midline Catheter | Comparison |
|---|---|---|---|
| Needle/Catheter Protective CoverPolypropylene | Needle/Catheter Protective CoverPolypropylene | ||
| Catheter Proximal Configuration | Luer Connection | Luer Connection | Same |
| Catheter Distal Configuration | Open Ended | Open Ended | Same |
| Number of Lumens | Single Lumen | Single Lumen | Same |
| Power Injection Maximum Flow Rate | 18 Gauge = 7 mL/s max20 Gauge = 5 mL/s max22 Gauge = 2 mL/s max | 18 Gauge = 7 mL/s max20 Gauge = 5 mL/s max22 Gauge = 2 mL/s max | Same |
| Sterility | Provided Sterile | Provided Sterile | Same |
| Packaging Configuration | Basic ConfigurationIntermediate ConfigurationMax Barrier Configuration | Basic ConfigurationIntermediate ConfigurationMax Barrier Configuration | Same |
| Intended Use Environment | The typical environment for the placement, access, and use of PowerGlide Pro™ Midline Catheters may include:• Imaging Centers• Infusion Centers• Hospital/Hospital Ward• Physician's Office/Clinic• Home Health Care• ICU/Critical Care Ward• Emergency Department• OR | Same | Same |
Page 12
| Performance Tests | |
|---|---|
| As part of Bard Access Systems, Inc.'s design controls, a risk analysis was conducted to assess the impact of the proposed subject device labeling modifications. The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation. |
| Summary of Substantial Equivalence | |
|---|---|
| The modification to the indications for use and resulting modifications to the product instructions for use and labeling has no impact on the intended use, technological characteristics, or risk profile of the subject device because there are no changes to the design or performance of the predicate device. Therefore, the subject PowerGlide Pro™ Midline Catheter is substantially equivalent to the predicate PowerGlide Pro™ Midline Catheter. |
§ 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).