(68 days)
The Site-Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel
The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.
The needle guides are intended to 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. This device is intended for use with pediatrics and adults.
The Site~Rite Prevue* Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (e.g., USB flash drive).
Bard Access Systems, Inc.'s, Pinpoint* Gel Cap is a sterile, single use accessory for use with the SiteRite Prevue* Ultrasound System. The device is intended for use as an ultrasound coupling medium. This device attaches to the ultrasound transducer and contains a hydrogel pad that interfaces directly with the transducer face and the patient's skin to provide an acoustic coupling pathway. The device contains a feature that accommodates attachment of the Pinpoint* Needle Guide. A removable lid protects the hydrogel pad during transit and while the clinician is attaching the device on the SiteRite Prevue* ultrasound transducer.
The Pinpoint* Needle Guide is a sterile, single use accessory for use with ultrasound. The device is intended to 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 the needle in a specific structure. The Pinpoint* Needle Guide attaches to the Pinpoint* Gel Cap which attaches to the ultrasound probe. Each needle guide accommodates multiple vein depths.
The provided text describes the Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap, and Pinpoint* Needle Guide, and states that they met pre-determined acceptance criteria for substantial equivalence to predicate devices. However, the document does not explicitly detail specific quantitative acceptance criteria or a dedicated study proving the device meets those criteria with statistical significance. Instead, it focuses on demonstrating technological equivalence and compliance with general safety and performance standards.
Based on the provided information, I can formulate the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) that were met by the device for its intended use. Instead, the acceptance criteria appear to be qualitative, revolving around meeting general safety and performance standards and demonstrating technological equivalence to predicate devices.
The table below summarizes the technical characteristics reported for the Pinpoint* Gel Cap in comparison to a predicate ultrasound gel, which served as part of the "Non-Clinical Comparative Testing" to demonstrate substantial equivalence, rather than a direct measure of the final device's clinical performance against pre-defined acceptance criteria.
| Test Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate) | Pinpoint* Gel Cap Performance (Reported Value) | Aquasonic 100 Ultrasound Trans. Gel Performance (Predicate - Reported Value) |
|---|---|---|---|
| Sound Velocity (m/s) | Within acceptable range for ultrasound coupling media, comparable to predicate. | 1502 | 1558 |
| Acoustic Impedance (MRayls) | Within acceptable range for ultrasound coupling media, comparable to predicate. | 1.526 | 1.641 |
| Attenuation 5 MHz (dB/(cm MHz)) | Within acceptable range for ultrasound coupling media, comparable to predicate. | 0.0657 | 0.0792 |
Key takeaway: The document states, "The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate devices." However, these "pre-determined acceptance criteria" are not explicitly listed in quantitative terms for the final device's performance in clinical applications like "Adult Cephalic" or "Peripheral Vessel." The detailed performance data provided is limited to the acoustic properties of the Pinpoint* Gel Cap compared to another gel, used to establish technological equivalence, not direct clinical performance.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the device. The "Non-Clinical Comparative Testing" for the gel cap involves technical measurements, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention a test set requiring expert ground truth establishment for clinical performance. The evaluation focused on technical specifications and comparison to predicate devices, which typically do not involve expert interpretation of images for ground truth in this context.
4. Adjudication Method for the Test Set:
Since no clinical test set requiring expert interpretation is described, there is no information provided on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human readers improving with AI vs. without AI assistance. The device is an ultrasound system with accessories, not an AI-assisted diagnostic tool as typically understood in MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not describe a standalone (algorithm only) performance study. The device is an ultrasound imaging system with manual operation, not an AI algorithm.
7. Type of Ground Truth Used:
For the "Non-Clinical Comparative Testing" of the Pinpoint* Gel Cap, the "ground truth" was established by direct physical measurement of acoustic properties (sound velocity, acoustic impedance, attenuation) using standard laboratory methods. For the overall device, the ground truth for substantial equivalence was based on compliance with harmonized standards (IEC, NEMA, ISO) and comparison of technological characteristics to existing predicate devices. No clinical ground truth (e.g., pathology, outcomes data) is mentioned in relation to a specific performance study for the device itself.
8. Sample Size for the Training Set:
The document does not mention a training set. This device is an ultrasound imaging system, and its evaluation did not involve machine learning or AI models that would require a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth would have been established.
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510(k) Summary 21 CFR 807.92
Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| Contact Person: | Kerrie HamblinSenior Regulatory Affairs SpecialistBard Access Systems, Inc.kerrie.hamblin@crbard.com801.522.5000 ext 4909801.522.5425 fax | |
| Date of Preparation: | 17 May 2012 | |
| Subject Device | Trade Name: | Site~Rite Prevue* Ultrasound System |
| Classification Name: | IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging SystemITX 21 CFR 892.1570 Diagnostic Ultrasonic TransducersClass II, Radiology | |
| PredicateDevices | Trade Name: | Site~Rite Vision* Ultrasound System |
| Classification Name: | IYN 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging SystemIYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging SystemITX 21 CFR 892.1570 Diagnostic Ultrasonic TransducersLLZ 21 CFR 892.2050 Picture Archiving and Communications System | |
| Premarket Notification: | K100402, concurrence date 05 March 2010 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Trade Name: | Site~Rite* 6 Ultrasound System | |
| Classification Name: | IYO 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging SystemITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers | |
| Premarket Notification: | K071204, concurrence date 18 May 2007 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Subject Device | Trade Name: | Pinpoint* Gel Cap |
| Classification Name: | MUI 21 CFR 892.1570 Diagnostic Ultrasonic TransducerClass II, Radiology | |
| Predicate Devices | Trade Name: | Embrace™ Gel Pad |
| Classification Name: | MUI 21 CFR 892.1570 Diagnostic Ultrasonic Transducer | |
| Premarket Notification: | K072515, concurrence date 20 September 2007 | |
| Manufacturer: | Orison Corporation | |
| Trade Name: | ScanTac™ Pad | |
| Classification Name: | MUI 21 CFR 892.1570 Diagnostic Ultrasonic Transducers | |
| Premarket Notification: | K031894, concurrence date 18 July 2003 | |
| Manufacturer: | SONOTECH, Inc. | |
| Subject Device | Trade Name: | Pinpoint* Needle Guide |
| Classification Name: | ITX 21 CFR 892.1570 Diagnostic Ultrasonic TransducerClass II, Radiology | |
| Predicate Device | Trade Name: | Site |
| Classification Name: | ITX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers | |
| Premarket Notification: | K042445, concurrence date 19 October 2004 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Device Description -Site~Rite Prevue*Ultrasound System | The Site~Rite Prevue* Ultrasound System is a portable device that features real-time 2Dultrasound imaging. Additional features include compact size, simple user interface, and variouscalculations. The system may incorporate various accessories, including an upright stand, A/Cadapter, needle guide/gel cap kits, etc. The system includes USB support for storage deviceswith no external power connections (e.g., USB flash drive). | |
| Device Description -Pinpoint* Gel Cap | Bard Access Systems, Inc.'s, Pinpoint* Gel Cap is a sterile, single use accessory for use withthe Site | |
| Device Description -Pinpoint* Needle Guide | The Pinpoint* Needle Guide is a sterile, single use accessory for use with ultrasound. Thedevice is intended to provide guidance for a needle to intersect an ultrasound beam at a fixeddistance below the skin to assist the medical practitioner in placing the tip of the needle in aspecific structure. The Pinpoint* Needle Guide attaches to the Pinpoint* Gel Cap whichattaches to the ultrasound probe. Each needle guide accommodates multiple vein depths. | |
| Indications forUse / IntendedUse - Site-RitePrevue*UltrasoundSystem,Pinpoint* GelCap andPinpoint* NeedleGuide | The Site-Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of thehuman body. Specific clinical applications include:• Adult Cephalic• Neonatal Cephalic• Pediatric• Peripheral VesselThe gel cap is intended for use as an ultrasound coupling medium for use with the Site-RitePrevue* Ultrasound System. The device is intended for use with pediatrics and adults.The needle guides are intended to provide guidance for a needle to intersect an ultrasoundbeam at a fixed distance below the skin to assist the medical practitioner in placing the tip of aneedle in a specific structure. This device is intended for use with pediatrics and adults. | |
| TechnologicalCharacteristics | Technological characteristics of the subject Site-Rite Prevue* Ultrasound System, Pinpoint* GelCap and Pinpoint* Needle Guide are equivalent with respect to the basic design and function to thatof the predicate devices, Site-Rite Vision* Ultrasound System, Site~Rite* 6 Ultrasound System,Embrace™ Gel Pad, ScanTac™ Pad, and Site-Rite* Needle Guide Kits and Site-Rite* Probe CoverKit respectively. | |
| Safety &PerformanceTests | Verification and validation activities were designed and performed to demonstrate that thesubject Site-Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* NeedleGuide met predetermined performance specifications. The following standards in conjunctionwith in-house protocols were used to determine appropriate methods for evaluating theperformance of the device: | |
| IEC 60601-1:1988/1991/1995 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety, 1988; Amendment 1, 1991-11,Amendment 2, 1995 | |
| IEC 60601-1-2:2007 | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Compatibility -Requirements and Tests | |
| IEC 60601-2-37:2008 | Medical Electrical Equipment - Part 2-37: ParticularRequirements for the Basic Safety and EssentialPerformance of Ultrasonic Medical Diagnostic andMonitoring Equipment | |
| NEMA UD 2:2004 | Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment | |
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing within a Risk Management Process | |
| ISO 11607-1:2006 | Packaging for Terminally Sterilized Medical Devices | |
| ISO 11607-2:2006 | Packaging for Terminally Sterilized Medical Devices | |
| ISO 11137-1:2006/(R) 2010 | Sterilization of health care products - Radiation - Part 1:Requirements for development, validation, and routinecontrol of a sterilization process for medical devices | |
| ISO 11137-2:2006 | Sterilization of health care products - Radiation - Part 2:Establishing the sterilization dose |
*Site-Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc.
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Bard Access Systems, Inc. K120882 - Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide Traditional 510(k) Premarket Notification
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Bard Access Systems, Inc. K120882 - Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide Traditional 510(k) Premarket Notification
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*Site~Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc.
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ISO 11137-3:2006/(R)2010
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspect
The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate devices.
| Non-ClinicalComparativeTesting | Test Characteristic | Pinpoint* Gel Cap | Aquasonic 100Ultrasound Trans. Gel |
|---|---|---|---|
| Sound Velocity (m/s) | 1502 | 1558 | |
| Summary ofAcoustic Testing(mean values) | Acoustic Impedance (MRayls) | 1.526 | 1.641 |
| Attenuation 5 MHz (dB/(cmMHz)) | 0.0657 | 0.0792 |
Substantial Equivalence
testing, the subject SiteRite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide, met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate devices, SiteRite Vision* Ultrasound System, SiteRite* 6 Ultrasound System, Embrace™ Gel Pad, ScanTac™ Pad, and SiteRite* Needle Guide Kits and Site~ Rite* Probe Cover Kits respectively. .
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
CR Bard, Inc. % Mr. Mark Job Owner/Reviewer Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
MAY 3 0 2012
Re: K120882
Trade/Device Name: Site~Rite Prevue*, Pinpoint* Gel Cap and Pinpoint* Needle Guide Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: May 17, 2012 Received: May 18, 2012
Dear Mr. Job:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Bard Access Systems, Inc.
Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap and Pinpoint* Needle Guide Traditional 510(k) Premarket Notification .
Indications for Use
510(k) Number (if known):
Device Names:
Site~Rite Prevue*, Pinpoint* Gel Cap and Pinpoint* Needle Guide
Indications for Use:
The Site~Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
- ·Adult Cephalic ·Neonatal Cephalic ·Pediatric ·Peripheral Vessel
The gel cap is intended for use as an ultrasound coupling medium for use with the Site~Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.
The needle guides are intended to 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. This device is intended for use with pediatrics and adults.
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K. | K120882 |
|---|---|
| ------- | --------- |
*Site~Rite Prevue and Pinpoint are trademarks and/or registered trademarks of C.R. Bard, Inc.
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (abdominal,thoracic, and vascular) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| Small Organ (breast, thyroid,parathyroid, testicles,prostate, uterus, ovary) | ||||||||
| Fetal Imaging& Other | Neonatal Cephalic | N | ||||||
| Adult Cephalic | N | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-Esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral Vessel | N | ||||||
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form - Site~Rite Prevue* Ultrasound System
N = new indication; P = previously cleared by FDA; E = added under this appendix
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- Examples of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)
- Examples of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120882
- Pinpoint, Site-Rite, Site-Rite Prevue, and Site-Rite Vision are trademarks and/or registered trademarks of C.R. Bard. Inc.
279
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.