(223 days)
No
The device description focuses on a passive magnetic field and its detection by an ultrasound system to create a virtual image. There is no mention of AI or ML algorithms for image processing, analysis, or decision-making. The performance studies listed are standard tests for medical devices and do not indicate the use of AI/ML.
No: The device is an introducer needle designed to facilitate the placement of other medical devices (like guidewires and catheters), not to directly treat a medical condition.
No
The device is an introducer needle designed to facilitate the placement of a guidewire. While it uses ultrasound to visualize its position, its primary function is for percutaneous access in a medical procedure, not to diagnose a condition or disease.
No
The device description explicitly states it is a "Pinpoint™ GT Safety Introducer Needle" which is a physical medical device containing a magnet. It is designed for percutaneous access and introduces a guidewire. While it interacts with software (Ultrasound Systems with Pinpoint™ GT Technology), the device itself is hardware.
Based on the provided information, the Pinpoint™ GT Safety Introducer Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description focuses on the physical characteristics of the needle and its interaction with an ultrasound system to guide the procedure. It doesn't mention analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or any other biological sample. The device's function is entirely focused on facilitating a medical procedure within the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Pinpoint™ GT Safety Introducer Needle is a surgical/procedural device used for access, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive Device magnetic field that can be detected by Ultrasound Systems equipped with Description Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ GT System creates a virtual image of the needle on the Ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.
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)
Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30. 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:
- ISO 11070: 1998, Sterile, single use intravascular catheter introducer
- · ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment – Part 1: General Requirements
- · ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment – Part 2: Lock Fittings
- ISO 9626: 2001, Stainless steel needle tubing for the manufacturer of medical devices
- BSI BS EN ISO 23908: 2013, Sharps injury protection
- · ISO 7864: 1993, Sterile hypodermic needles for single use
- Guidance Document; Medical Devices with Sharps Injury Prevention Features, August 9, 2005
- Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles, April 1993.
- Guidance Document: Applving Human Factors and Usabilitv Engineering to Optimize Medical Device Design, June 22, 2011
- ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
- ISO 11135:2007, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
- · ISO 6009: 1992, Hypodermic Needles for Single Use- Colour Coding for Identification
The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device.
Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2012, Medical Devices – Risk Management for Medical Devices.
Performance Tests
- Dimensional Analysis
- Assembly Leak
- Hub to Cannula Bond Strength
- Needle Stiffness
- ISO Luer Compliance
- Guidewire Compatibility
- Safety Mechanism Override
- Visual Inspection
- Corrosion
- Usability and Simulated Use
- Blood Flash
- Echogenicity
- Magnet Testing
- Particulate testing (USP )
Biocompatibility Testing:
- · Cytotoxicity
- Sensitization
- Intracutaneous
- Acute Systemic Toxicity
- · Pyrogenicity
- Rabbit Blood Hemolysis
- Unactivated partial Thromboplastin Time Assay
- · Dog Thrombogenicity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
Bard Access Systems, Inc. M.s Amy McManus Regulatory Affairs Specialist II 605 North 5600 West Salt Lake City, UT 84116
Re: K142445
Trade/Device Name: Pinpoint™ GT Safety Introducer Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: March 12, 2015 Received: March 13, 2015
Dear Ms. McManus:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in a bold, sans-serif font, with each letter outlined in black. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font, also in black.
Indications for Use
510(k) Number (if known):
Device Name:
Pinpoint™ GT Safety Introducer Needle
Indications for Use:
The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.
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)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below that, in a smaller, sans-serif font, are the words "ACCESS SYSTEMS."
510(k) Summary 21 CFR 807.92(a)
| | Submitter Name: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 | |
|-----------------------|------------------------------|------------------------------------------------------------------------------|--|
| General
Provisions | Contact Person: | Amy McManus
Regulatory Affairs Specialist II | |
| | Telephone Number: | (801) 522-5724 | |
| | Fax Number: | (801) 522-5425 | |
| | Date of Preparation: | April 10, 2015 | |
| | Trade Name: | Pinpoint™ GT Safety Introducer Needle | |
| Subject
Device | Common Name: | Safety Introducer Needle | |
| | Classification Name: | Catheter Introducer | |
| | Product Code/
Regulation: | DYB/21 CFR §870.1340 | |
| | Predicate Trade Name: | SecureLoc™ Safety Introducer Needle | |
| Predicate Device | Classification Name: | Catheter Introducer | |
| | Premarket Notification: | K050023 | |
| | Manufacturer: | Bard Access System, Inc. | |
| | Reference Device Trade Name: | Soma Access Systems ExactTrack™ I
Procedure Kit | |
| Reference
Device | Classification Name: | Ultrasonic Pulsed Echo Imaging
System | |
| | Premarket Notification: | K113680 | |
| | Manufacturer: | Soma Access Systems LLC | |
Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive Device magnetic field that can be detected by Ultrasound Systems equipped with Description Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ GT System creates a virtual image of the needle on the Ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.
4
| Intended Use | The Pinpoint™ GT Safety Introducer Needle is designed for percutaneous
vasculature access or procedures requiring the placement of a guidewire. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring
percutaneous access to place a guidewire for subsequent placement of
catheters or other medical procedures requiring introducer needle access.
The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate
patient population. |
| Technological
Characteristics | Technological characteristics of the subject Pinpoint™ GT Safety Introducer
Needle are substantially equivalent with respect to basic design and function
to those of the predicate, Bard Access Systems, Inc.'s SecureLoc™ Safety
Introducer Needle. The differences are not critical to the intended use of the
device and do not raise any new questions regarding safety or effectiveness. |
5
| Table1– Subject Device Attribute and Technology Comparison Table | |||
|---|---|---|---|
| Device Attribute | Subject: | ||
| PinpointTM GT Safety Introducer Needle | Primary Predicate: | ||
| Introducer Needle | |||
| SecureLocTM | Reference Device: | ||
| Magnet Tracking System | |||
| (Needle Technology | |||
| ExactTrackTM Procedure Kit | |||
| (AKA AxoTrackTM)) | |||
| Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Soma Access Systems LLC. |
| Needle | |||
| Components | Needle tip: | ||
| -Echogenic | |||
| -A Bevel | Needle tip: | ||
| -Available as Echogenic and | |||
| non-echogenic | |||
| -Modified B Bevel | Needle tip: | ||
| -Bevel type is not publically | |||
| available | |||
| Open ended luer locking hub | |||
| Bevel Indicator | |||
| Incorporated active safety mechanism | |||
| Passive Magnet | Open ended luer locking hub | ||
| Bevel Indicator | |||
| Incorporated active safety | |||
| mechanism | Hub | ||
| Bevel Indicator | |||
| Does not contain a safety mechanism | |||
| Passive Magnet | |||
| Needle Dimensions | • Length: 7 cm | ||
| • Diameter: 21 gauge | • Length: 5.08 -8.89 cm | ||
| • Diameter: 18, 19 and 21 gauge | • Length: Information not publically | ||
| available | |||
| • Diameter: 18 gauge | |||
| Needle-shield | |||
| (Safety | |||
| Mechanism) | |||
| feature description | The PinpointTM GT Safety Introducer | ||
| Needle includes an active safety guard | |||
| mechanism. The safety guard is manually | |||
| activated by the user sliding the | Needle includes an active safety | ||
| guard mechanism. The safety guard | |||
| is manually activated by the user. | |||
| The user sliding the mechanism | Device does not contain a safety | ||
| mechanism. | |||
| Table1- Subject Device Attribute and Technology Comparison Table | |||
| Device Attribute | Subject: | ||
| PinpointTM GT Safety Introducer Needle | Primary Predicate: | ||
| Introducer Needle | |||
| SecureLocTM | Reference Device: | ||
| Magnet Tracking System | |||
| (Needle Technology | |||
| ExactTrackTM I Procedure Kit | |||
| (AKA AxoTrackTM)) | |||
| mechanism down the needle cannula and | |||
| over the needle tip. As the safety | |||
| mechanism passes over the needle tip | |||
| the safety locks into place, securing and | |||
| covering the tip. | down the needle cannulation and | ||
| over the needle tip; as the | |||
| mechanism passes over the needle | |||
| tip the safety locks into place, | |||
| securing and covering the tip. | The data was gathered from publicly | ||
| available resources. See Attachment | |||
| 4 for all resources used. | |||
| Guidewire | |||
| Compatibility | 21 Ga Needle | ||
| Same as Primary Predicate | |||
| GW OD ≤ 0.018" | 21 Ga Needle | ||
| GW OD ≤ 0.018" | 18 Ga Needle | ||
| GW OD ≤ 0.035" (0.89 mm) |
6
7
Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30. 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:
- ISO 11070: 1998, Sterile, single use intravascular catheter introducer
- · ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment – Part 1: General Requirements
- · ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment – Part 2: Lock Fittings
- ISO 9626: 2001, Stainless steel needle tubing for the manufacturer of medical devices
- BSI BS EN ISO 23908: 2013, Sharps injury protection
- · ISO 7864: 1993, Sterile hypodermic needles for single use
- Guidance Document; Medical Devices with Sharps Injury Prevention Features, August 9, 2005
- Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles, April 1993.
- Guidance Document: Applving Human Factors and Usabilitv Engineering to Optimize Medical Device Design, June 22, 2011
- ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
- ISO 11135:2007, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
- · ISO 6009: 1992, Hypodermic Needles for Single Use- Colour Coding for Identification
The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device.
Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2012, Medical Devices – Risk Management for Medical Devices.
Performance Tests
8
Performance Testing- Bench:
- Dimensional Analysis
- Assembly Leak
- Hub to Cannula Bond Strength
- Needle Stiffness
- ISO Luer Compliance
- Guidewire Compatibility
- Safety Mechanism Override
- Visual Inspection
- Corrosion
- Usability and Simulated Use
- Blood Flash
Performance
- Tests
- Echogenicity
- Magnet Testing
- Particulate testing (USP )
Biocompatibility Testing:
- · Cytotoxicity
- Sensitization
- Intracutaneous
- Acute Systemic Toxicity
- · Pyrogenicity
- Rabbit Blood Hemolysis
- Unactivated partial Thromboplastin Time Assay
- · Dog Thrombogenicity
Summary of Substantial Equivalence
Based on the intended use, technological characteristics, and safety and performance testing, the subject Pinpoint™ GT Safety Introducer Needle met the requirements that are considered sufficient for its intended use and is as safe and as effective as predicate device cited.