(107 days)
The PowerPICC® SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC® SV catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
The subject PowerPICC® SV catheters are members of Bard Access Systems' PowerPICC® series of power injectable catheters. The PowerPICC® SV catheters are available in 3F single lumen and 4F dual lumen configurations. The catheter extension leg, luer hub and junction are printed with description markings to facilitate proper use of the device. The PowerPICC® SV catheters are provided in sterile kit configurations.
The provided text does not contain information about an AI device or a study comparing human readers with and without AI assistance. The document is a 510(k) summary for a medical device called the PowerPICC® SV Catheter, a peripherally inserted central catheter (PICC). It details the device's characteristics, intended use, indications for use, and a summary of verification and validation activities demonstrating substantial equivalence to predicate devices, but does not involve AI, image analysis, or multi-reader studies.
Therefore, I cannot fulfill most of your request regarding AI-related performance metrics and study details. However, I can extract the general acceptance criteria and the type of study conducted for the physical medical device as described.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reference/Method | Reported Device Performance |
|---|---|---|
| General Performance | - Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995 - ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements - BS/EN/ISO 10555-3:1996/Cor 1:2002, Sterile, single-use intravascular catheters, Part 3. Central venous catheters | "The subject PowerPICC® SV catheters met all predetermined acceptance criteria derived from the above mentioned references." |
| Biocompatibility | - AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile | Implied to meet criteria, as stated "met all predetermined acceptance criteria." |
| Sterilization | - AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results - AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Implied to meet criteria, as stated "met all predetermined acceptance criteria." |
| Design Validation | In-house protocols and design validation activities | "Design validation was conducted on the subject PowerPICC® SV configuration and yielded acceptable results." |
| Risk Management | ISO 14971:2007, Medical Devices - Risk Management for Medical Devices (Failure Modes and Effects Analysis - FMEA) | "No new types of safety or efficacy questions were identified for the subject PowerPICC® SV catheters." (This indicates acceptable risk profile within regulatory norms) |
| Flow Rate (Indications for Use) | Not a test, but stated as part of the intended use parameters. | 3 F Single Lumen: 1 mL/sec 4 F Dual Lumen: 2.5 mL/sec |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Tests were performed on sterilized, finished devices." However, it does not specify the sample size for the test set or the 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. This is a submission for a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth for classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a submission for a physical medical device, not an AI or diagnostic imaging device requiring 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
No MRMC study was done, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance described is for the physical PowerPICC® SV Catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a catheter, "ground truth" generally relates to adherence to physical specifications, material properties, sterility, and functional performance benchmarks (e.g., flow rates, tensile strength, biocompatibility). The document indicates performance was evaluated against "predetermined performance specifications" derived from various international standards (ISO, AAMI/ANSI) and FDA guidance documents. This can be considered the "ground truth" or benchmark against which the device's physical and functional attributes were measured.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a unique design where the letters are interconnected. Below "BARD" is the text "ACCESS SYSTEMS" in a smaller, sans-serif font.
.
:
…
K102159 NOV 1 7 2010
510(k) Summary 21 CFR 807.92(a)
PowerPICC® SV Catheter
| GeneralProvisions | Submitter Name:Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person: | Jessica Agnello | |
| Telephone Number:Fax Number:Date of Preparation: | Regulatory Affairs Specialist(801) 522-5651(801) 522-5425November 4, 2010 | |
| SubjectDevice | Trade Name:Common Name:Classification Name: | PowerPICC® SV CatheterPeripherally Inserted Central Catheter (PICC)Percutaneous, implanted, long-term intravascularcatheterLJS, 21 CFR § 880.5970 Class II |
| PredicateDevices | Trade Name:Classification Name: | Poly Per-Q-Cath® PICC CatheterPercutaneous, implanted, long-term intravascularcatheter |
| Premarket Notification:Manufacturer: | LJS, 21 CFR §880.5970 Class IIK034019, K051991Bard Access Systems, Inc. | |
| Trade Name:Classification Name: | 6F Triple Lumen Poly Per-Q-Cath® PICC CatheterPercutaneous, implanted, long-term intravascularcatheter | |
| Premarket Notification:Manufacturer: | LJS, 21 CFR §880.5970 Class IIK043502, K051991Bard Access Systems, Inc. | |
| Trade Name:Classification Name: | 4F Single Lumen PowerPICC® CatheterPercutaneous, implanted, long-term intravascularcatheter, | |
| Premarket Notification:Manufacturer: | LJS, 21 CFR §880.5970 Class IIK070996Bard Access Systems, Inc | |
| Trade Name:Classification Name: | 5F Single Lumen PowerPICC® CatheterPercutaneous, implanted, long-term intravascularcatheter, | |
| Premarket Notification:Manufacturer: | LJS, 21 CFR §880.5970 Class IIK033389, K051991Bard Access Systems, Inc |
:5
·
{1}------------------------------------------------
| Trade Name: | 6F Triple Lumen PowerPICC® Catheter | ||||||
|---|---|---|---|---|---|---|---|
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter,LJS, 21 CFR §880.5970 Class II | ||||||
| Premarket Notification: | K053501, K051991 | ||||||
| Manufacturer: | Bard Access Systems, Inc | ||||||
| Trade Name: | PowerLine® Catheters | ||||||
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter,LJS, 21 CFR §880.5970 Class II | ||||||
| Premarket Notification: | K093927 | ||||||
| Manufacturer: | Bard Access Systems, Inc | ||||||
| Trade Name: | Morpheus® CT PICC Catheter | ||||||
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter,LJS, 21 CFR §880.5970 Class II | ||||||
| Premarket Notification: | K072196 | ||||||
| Manufacturer: | AngioDynamics, Inc | ||||||
| Device Description | The subject PowerPICC® SV catheters are members of Bard AccessSystems' PowerPICC® series of power injectable catheters. ThePowerPICC® SV catheters are available in 3F single lumen and 4F duallumen configurations. The catheter extension leg, luer hub and junction areprinted with description markings to facilitate proper use of the device.The PowerPICC® SV catheters are provided in sterile kit configurations. | ||||||
| Intended Use | The PowerPICC® SV catheters are intended for short or long term peripheralaccess to the central venous system for intravenous therapy and bloodsampling. | ||||||
| Indications For Use | The PowerPICC® SV catheter is indicated for short or long-term peripheralaccess to the central venous system for intravenous therapy, blood sampling,power injection of contrast media, and allows for central venous pressuremonitoring. For central venous pressure monitoring, it is recommended that acatheter lumen of 20 gauge or larger be used. | ||||||
| Catheter Size Maximum Flow Rate 3 F Single Lumen 1 mL/sec 4 F Dual Lumen 2.5 mL/sec | |||||||
| Technological Characteristics | Technological characteristics of the subject PowerPICC® SV catheters areequivalent with respect to the basic catheter design and function to those ofthe predicate Poly Per-Q-Cath® Catheters. Technical characteristics basedon the subject device's power injection capabilities are comparable to thepredicate 4F SL PowerPICC® catheter and the Morpheus® CT PICCcatheter. Differences do not raise any new questions regarding safety and |
:
.
the submit the state of the state of the states and
{2}------------------------------------------------
| Safety &PerformanceTests | Verification and validation activities were designed and performed to demonstrate that the subject PowerPICC® SV catheters met predetermined performance specifications. Tests were performed on sterilized, finished devices. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995• ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements• BS/EN/ISO 10555-3:1996/Cor 1:2002, Sterile, single-use intravascular catheters, Part 3. Central venous catheters• AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile• AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results• AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|---|---|
| The subject PowerPICC® SV catheters met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject PowerPICC® SV configuration and yielded acceptable results. | |
| Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2007, Medical Devices - Risk Management for Medical Devices. No new types of safety or efficacy questions were identified for the subject PowerPICC® SV catheters. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPICC® SV catheters met the minimum requirements for its intended use/indications for use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates. |
.
.
.
:
7
.
.
.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol composed of three curved lines that resemble a human figure or abstract design. The logo is black and white and appears to be a scanned or printed image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jessica Agnello Regulatory Affairs Specialist C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116
NOV . 1 7 2010
Re: K102159
Trade/Device Name: PowerPICC® SV Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 4, 2010 Received: November 5, 2010
Dear Ms. Agnello:
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.
{4}------------------------------------------------
Page 2- Ms. Agnello
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
I. Hata for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, general Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
NOV 1 7 2010
510(k) Number (if known):
Device Name:
PowerPICC® SV Catheter
Indications for Use:
The PowerPICC® SV catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
| Catheter Size | Maximum Flow Rate |
|---|---|
| 3 F Single Lumen | 1 mL/sec |
| 4 F Dual Lumen | 2.5 mL/sec |
V Prescription Use (Part 21 CFR §801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR §801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhd C. Chape 11/17/10
Page 1 of 1 (Division Sinn-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Numbar.
4
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”