(14 days)
Not Found
No
The summary describes a mechanical needle guide and probe cover kit, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device provides guidance for needle placement during ultrasound procedures, assisting a medical practitioner in performing a procedure, but it does not directly treat or diagnose a disease or condition itself.
No
The device is a needle guide system used to assist a medical practitioner in placing the tip of a needle in a specific structure, not to diagnose a condition or disease. It provides guidance for interventional procedures, not diagnostic information.
No
The device description explicitly states the kit consists of physical, single-use sterile disposables including needle guides, gel, probe covers, and elastic bands. The performance studies also focus on physical characteristics and interactions of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide guidance for a needle during ultrasound-guided procedures to assist in placing the needle tip in a specific structure. This is a procedural aid used in vivo (within the body).
- Device Description: The device consists of physical components like needle guides, gel, probe covers, and elastic bands. These are accessories used with an ultrasound system for a medical procedure.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly intended for use during a medical procedure on a patient, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.
Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides, conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.
A summary of the sterile, single-use ultrasound accessories included in subject device kits is included in the Table below.
| Summary of Sterile, Single-Use Ultrasound Accessories included in Subject Device Kits (Pinpoint™ GT Needle Guide Kits) | ||
|---|---|---|
| Device Description | Shallow Pinpoint™ GT Needle Guide Kit with a 96" Site~Rite® Probe Cover | A set of shallow Pinpoint™ GT Needle Guides (0.5cm, 1.0cm, 1.5cm, and 2.0cm depths), Conductive gel, A 96" 1 mil Site~Rite® Probe Cover, and Elastic bands |
| Deep Pinpoint™ GT Needle Guide Kit with a 96" Site~Rite® Probe Cover | A set of deep Pinpoint™ GT Needle Guides (2.5cm, 3.0cm, and 3.5cm depths), Conductive gel, A 96" 1 mil Site~Rite® Probe Cover, and Elastic bands | |
| Shallow Pinpoint™ GT Needle Guide Kit with a 48" Site~Rite® Probe Cover | A set of shallow Pinpoint™ GT Needle Guides (0.5cm, 1.0cm, 1.5cm, and 2.0cm depths)*, Conductive gel, A 48" 1 mil Site~Rite® Probe Cover, and Elastic bands | |
| Deep Pinpoint™ GT Needle Guide Kit with a 48" Site~Rite® Probe Cover | A set of deep Pinpoint™ GT Needle Guides (2.5cm, 3.0cm, and 3.5cm depths)*, Conductive gel, A 48" 1 mil Site~Rite® Probe Cover, and Elastic bands |
*Indicates a change from the predicate device kits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner
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 were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with internal test protocols to determine appropriate methods for evaluating the performance of the device:
Validation of Pinpoint™ GT Needle Guide Use
- Loading the Needle Guide
- Force to Insert a Needle
- Force to Remove a Needle
Verification Testing of the Pinpoint™ GT Needle Guide Kits and of the Ultrasound Accessories contained therein, including Pinpoint™ GT Needle Guides and 96" 1 mil Site~Rite® Probe Covers
- Needle Guide Depth Accuracy
- Needle Guide Depth Distinction and Material Compatibility
- Needle Guide ID Dimension
- Needle Guide Damage during Needle Insertion
- Needle Guide Removal Force
- Force to Remove a Needle from a Needle Guide
- Needle Retention
- Force to Insert a Needle
- Packaging Integrity
- Kit Component Integrity
- Packaging Minimum Seal Width
- Packaging Sterile Barrier Integrity
Safety & Performance Tests
The following guidance documents and standards were used to determine appropriate methods for evaluating the performance of the device:
- AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- AAMI / ANSI ST72:2011, Bacterial Endotoxins Test Methods, Routine Monitoring, And Alternatives To Batch Testing
- ASTM D4332-14, Standard Practice For Conditioning Containers, Packages, Or Packaging Components For Testing
- ASTM F1980-16, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices
- ISO 10993-1: 2009, Biological Evaluation of Medical Devices; Part 1 - Evaluation and Testing
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-11 Second Edition 2006-08-15, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- ISO 10993-12 Fourth Edition 2012-07-01, Biological Evaluation Of Medical Devices - Part 12: Sample Preparation And Reference Materials
- ISO 11135: 2014. Sterilization of healthcare products Ethylene Oxide - Requirements For Development, Validation And Routine Control Of A Sterilization
- ISO 11607-1 First Edition 2006-04-15, Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
- ISO 11607-2 First Edition 2006-04-15, Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes [Including: Amendment 1 (2014)]
- USP 39-NF34:2016, , Bacterial Endotoxins Test
- USP 39-NF34:2016, , Transfusion And Infusion Assemblies And Similar Medical Devices
The subject device kits, Pinpoint™ GT Needle Guide Kits, met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate device kits.
Risk management, including failure mode and effects analysis (FMEA) of the subject device kits (and the ultrasound accessories included therein) was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of risk management to medical devices.
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.
Not Found
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
C.R. Bard, Inc. Bard Access Systems, Inc % Mr. Christopher Phillips Regulatory Affairs Associate Manager 650 North 5600 West SALT LAKE CITY UT 84116
Re: K171348
Trade/Device Name: Pinpoint™ GT Needle Guide Kits Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: May 5, 2017 Received: May 8, 2017
Dear Mr. Phillips:
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.
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.
1
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" (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.
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.
Michael D. D'Hara
For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Pinpoint™ GT Needle Guide Kits
Indications for Use (Describe)
Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.
Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.
X 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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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image shows the logo for BARD Access Systems. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary 21 CFR 807.92(a)
| General
Provisions | Submitter Name:
Address:
Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116
Christopher M. Phillips
801.522.5000 ext 5965
801.522.5091
05 May 2017 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device Kits | Trade Name:
Common Name:
Regulation Name:
Product Code:
Regulation Number:
Regulatory Class:
Classification Panel: | Pinpoint™ GT Needle Guide Kits
Transducer, Ultrasonic, Diagnostic
Diagnostic Ultrasonic Transducer
ITX
21 CFR 892.1570
Class II
Radiology |
| Predicate
Device Kits | Trade Name:
Common Name:
Regulation Name:
Premarket Notification:
Product Code:
Regulation Number:
Regulatory Class:
Manufacturer:
Classification Panel: | Site~Rite® Needle Guide Kits and Probe Cover Kit
Transducer, Ultrasonic, Diagnostic
Diagnostic Ultrasound Transducer
K042445 (cleared Oct. 19, 2004)
ITX
21 CFR 892.1570
Class II
Bard Access Systems, Inc.
Radiology |
4
Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides, conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.
A summary of the sterile, single-use ultrasound accessories included in subject device kits is included in the Table below.
| | Summary of Sterile, Single-Use Ultrasound Accessories included in
Subject Device Kits (Pinpoint™ GT Needle Guide Kits) | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | Shallow Pinpoint™ GT
Needle Guide Kit with a
96" SiteRite® ProbeRite® Probe Cover*, and Elastic bands |
Cover | A set of shallow Pinpoint™ GT Needle Guides
(0.5cm, 1.0cm, 1.5cm, and 2.0cm depths)*, Conductive gel, A 96" 1 mil Site
| | Deep Pinpoint™ GT
Needle Guide Kit with a
96" SiteRite® ProbeRite® Probe Cover*, and Elastic bands |
Cover | A set of deep Pinpoint™ GT Needle Guides
(2.5cm, 3.0cm, and 3.5cm depths)*, Conductive gel, A 96" 1 mil Site
| | Shallow Pinpoint™ GT
Needle Guide Kit with a
48" SiteRite® ProbeRite® Probe Cover, and Elastic bands |
Cover | A set of shallow Pinpoint™ GT Needle Guides
(0.5cm, 1.0cm, 1.5cm, and 2.0cm depths)*, Conductive gel, A 48" 1 mil Site
| | Deep Pinpoint™ GT
Needle Guide Kit with a
48" SiteRite® ProbeRite® Probe Cover, and Elastic bands |
Cover | A set of deep Pinpoint™ GT Needle Guides
(2.5cm, 3.0cm, and 3.5cm depths)*, Conductive gel, A 48" 1 mil Site
*Indicates a change from the predicate device kits.
| Intended Use | Pinpoint™ GT Needle Guide Kits are intended to be used with SiteRite®Rite®
Ultrasound Systems. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | Pinpoint™ GT Needle Guide Kits are intended to be used with Site
Ultrasound Systems. |
| | Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an
ultrasound beam at a fixed distance below the skin to assist the medical
practitioner in placing the tip of a needle in a specific structure. |
| | Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical
penetration from microbial and other contamination. |
5
Technological Characteristics of the subject device kits. Pinpoint™ GT Needle Guide Kits, are substantially equivalent to the basic design and function to those of the cited predicate device kits. The differences do not alter the intended use of the subject device kits and do not raise new questions of equivalence.
Modifications made to the subject device kits when compared to the predicate device kits are as follows:
- (1) New packaging configuration:
- New packaging configuration for the subject device kits (Pinpoint™ ● GT Needle Guide Kits).
- (2) Modified needle quide offering:
- New subject Pinpoint™ GT Needle Guides will be offered in the ● subject device kits (Pinpoint™ GT Needle Guide Kits). The subject Pinpoint™ GT Needle Guides are modified from the predicate Site
Rite® Needle Guides (which were included in predicate device kits), and include a needle insertion funnel and stabilizing notches. The subject Pinpoint™ GT Needle Guides also utilize different colorant formulations than the predicate SiteRite® Needle Guides, though they are comprised of the same base materials (Low-Density Polyethylene) and the same colorant additive base materials (Linear Low-Density Polyethylene) in the same blend.
- New subject Pinpoint™ GT Needle Guides will be offered in the ● subject device kits (Pinpoint™ GT Needle Guide Kits). The subject Pinpoint™ GT Needle Guides are modified from the predicate Site
- (3) Additional probe cover offering:
- In addition to the predicate 48" 1 mil Site
Rite® probe cover (which ● were included in predicate device kits), new subject 96" 1 mil SiteRite® Probe Cover will be offered in the subject device kits (Pinpoint™ GT Needle Guide Kits). The subject 96" 1 mil SiteRite® Probe Cover is modified from the predicate 48" long, 1 mill SiteRite® Probe Cover, and includes dimensional changes along with a different material formulation.
- In addition to the predicate 48" 1 mil Site
- (4) Labeling updates:
- The Indications for Use statement for the subject device kit has been ● clarified from that of the predicate device kits to reflect Pinpoint™ GT and Site~Rite® branding, and
- An IFU and labels were generated for the subject device kits with ● content modified from the predicate device kits' IFU and labels, to provide clarity and to ensure safe and effective use of the subject device kit.
The differences identified above between the subject and predicate device kits do not alter the intended use of the subject device kits and do not raise any new questions of equivalence.
Technological Characteristics
6
Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with internal test protocols to determine appropriate methods for evaluating the performance of the device:
Validation of Pinpoint™ GT Needle Guide Use
- Loading the Needle Guide ●
- Force to Insert a Needle
- Force to Remove a Needle
Verification Testing of the Pinpoint™ GT Needle Guide Kits and of the Ultrasound Accessories contained therein, including Pinpoint™ GT Needle Guides and 96" 1 mil Site~Rite® Probe Covers
- Needle Guide Depth Accuracy ●
- Needle Guide Depth Distinction and Material Compatibility
- Needle Guide ID Dimension ●
- Needle Guide Damage during Needle Insertion ●
- Needle Guide Removal Force
- Force to Remove a Needle from a Needle Guide ●
- Needle Retention ●
- Force to Insert a Needle ●
- Packaging Integrity ●
- Kit Component Integrity ●
- Packaging Minimum Seal Width ●
- Packaging Sterile Barrier Integrity ●
Safety & Performance Tests
The following guidance documents and standards were used to determine appropriate methods for evaluating the performance of the device:
- AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of ● Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- AAMI / ANSI ST72:2011, Bacterial Endotoxins Test Methods, Routine ● Monitoring, And Alternatives To Batch Testing
- ASTM D4332-14, Standard Practice For Conditioning Containers, ● Packages, Or Packaging Components For Testing
- . ASTM F1980-16, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices
- ISO 10993-1: 2009, Biological Evaluation of Medical Devices; Part 1 -● Evaluation and Testing
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: ● Ethylene Oxide Sterilization Residuals
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of ● Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-11 Second Edition 2006-08-15, Biological Evaluation Of ● Medical Devices - Part 11: Tests For Systemic Toxicity
- ISO 10993-12 Fourth Edition 2012-07-01, Biological Evaluation Of Medical Devices - Part 12: Sample Preparation And Reference Materials
- ISO 11135: 2014. Sterilization of healthcare products Ethylene Oxide ● - Requirements For Development, Validation And Routine Control Of A Sterilization
7
| Safety &
Performance
Tests | ISO 11607-1 First Edition 2006-04-15, Packaging For Terminally
Sterilized Medical Devices - Part 1: Requirements For Materials,
Sterile Barrier Systems And Packaging Systems [Including:
Amendment 1 (2014)] ISO 11607-2 First Edition 2006-04-15, Packaging For Terminally
Sterilized Medical Devices - Part 2: Validation Requirements For
Forming, Sealing And Assembly Processes [Including: Amendment 1
(2014)] USP 39-NF34:2016, , Bacterial Endotoxins Test USP 39-NF34:2016, , Transfusion And Infusion Assemblies
And Similar Medical Devices The subject device kits, Pinpoint™ GT Needle Guide Kits, met all
predetermined acceptance criteria derived from the above listed tests and
demonstrated substantially equivalent performance as compared to the cited
predicate device kits.
Risk management, including failure mode and effects analysis (FMEA) of the
subject device kits (and the ultrasound accessories included therein) was
conducted in accordance with BS EN ISO 14971:2012, Medical Devices –
Application of risk management to medical devices. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the intended use, technological characteristics, and performance
testing, the subject device kits, Pinpoint™ GT Needle Guide Kits, meet the
requirements that are considered sufficient for their intended use and
demonstrate substantial equivalence to the cited predicate device kits. |