(49 days)
The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:
| MODEL | INTENDED USE |
|---|---|
| Ultra-Pro II™ Needle Guides | The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. |
| Ultra-Pro 3™ Needle Guides | |
| AccuSITE Transverse Needle Guides | |
| Infiniti™ Needle Guides | |
| Multi-Pro 2000™ Needle Guides | |
| MAGGI II Plus™ Needle Guides |
The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. The guide facilitates directing the device to a target to improve accuracy and repeatability.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided information, the 510(k) summary for the "Ultrasound General Purpose Guidance System" (K093713) does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative performance metrics like accuracy, precision, or sensitivity/specificity.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The primary "acceptance criteria" and "reported device performance" can be inferred as:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence and Verification) |
|---|---|
| Equivalent Intended Use: The device must have the same intended use as legally marketed predicate devices. | The proposed devices (Ultra-Pro II™, Ultra-Pro 3™, AccuSITE Transverse, Infiniti™, Multi-Pro 2000™, MAGGI II Plus™ Needle Guides) have the same intended use: guiding instruments into targeted anatomical locations for percutaneous procedures using diagnostic ultrasound transducers. This is equivalent to the predicate devices (K882383, K071204, K030064). |
| Equivalent Manufacturing Materials: The device must be constructed from materials similar to predicate devices, ensuring comparable safety and efficacy. | "Equivalent... manufacturing materials" is claimed. No specific material details are provided in this summary. |
| Equivalent Operating Principles: The fundamental mechanism by which the device functions must be the same as predicate devices. | "Equivalent... operating principles" is claimed. The description indicates it provides a tool for performing needle-guided procedures, which aligns with the function of similar guides. |
| Equivalent Physical Operational Specifications: The physical characteristics and performance limits of the device must be comparable to predicate devices. | "Equivalent... physical operational specifications" is claimed. |
| Meets Specified Tolerances and Works in Conjunction with Designed Adapter Clip Area: The device must fit and function correctly with its intended adaptors, and operate within design tolerances. (This is the only explicitly mentioned "verification" item, suggesting it's an internal acceptance criterion for manufacturing and design.) | "Verification was performed to ensure that device meets specified tolerances and works in conjunction with specifically designed adapter clip area." |
| Differences have no effect on safety and effectiveness: Any minor differences from predicate devices must not negatively impact the safety or effectiveness of the device. | "These differences have no effect on safety and effectiveness" is stated after a comparison matrix (not included in the provided text). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific sample size for a test set or the provenance of data (e.g., country of origin, retrospective/prospective). This submission is based on a demonstration of substantial equivalence, which often relies on demonstrating that the new device operates similarly to existing, cleared devices, rather than conducting new clinical trials with patient data. The "Performance Testing" section mentions "Verification was performed to ensure that device meets specified tolerances and works in conjunction with specifically designed adapter clip area," but this is a technical/engineering verification, not a clinical study on a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical test set is explicitly described in the provided text, there is no information about the number of experts or their qualifications used to establish a ground truth.
4. Adjudication Method for the Test Set
As no clinical test set is described, there is no information about an adjudication method.
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 comparative effectiveness study was done as this device (Ultrasound General Purpose Guidance System / Needle Guides) is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone algorithm performance study was done. This device is a physical needle guide, not a standalone algorithm.
7. The type of ground truth used
For the engineering/technical verification mentioned ("meets specified tolerances and works in conjunction with specifically designed adapter clip area"), the "ground truth" would be the design specifications and engineering measurements. For the clinical use, the "ground truth" for predicate devices would have been established through prior clinical experience and regulatory clearances that confirmed their safety and effectiveness in guiding instruments.
8. The Sample Size for the Training Set
There is no mention of a training set sample size. This submission is for a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI algorithm, the concept of establishing ground truth for a training set is not applicable.
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K0937/3
510(k) SUMMARY (as required by 807.92(c))
JAN 1 9 2010
Regulatory Correspondent:
AJW Technology Consultants Inc 962 Allegro Lane Apollo Beach, FL 33572 Arthur Ward award@ajwtech.com/awconsltng@aol.com 813-645-2855 813-677-4787
Ultrasound General Purpose Guidance System
Diagnostic Ultrasound Transducers
Submitter of 510(k):
Civco Medical Instruments 102 First Street South Kalona, IA 52247-9589 James Leong James.leong@civco.com
Date of Summary:
Trade/Proprietary Name:
Classification Name:
Product Code:
Intended Use:
The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:
12/21/2009
ITX
| MODEL | INTENDED USE |
|---|---|
| Ultra-Pro II™ Needle Guides | The bracket and disposable guide providephysicians with a tool for performingneedle-guided (or catheter) procedures withthe use of diagnostic ultrasoundtransducers. |
| Ultra-Pro 3™ Needle Guides | |
| AccuSITE Transverse Needle Guides | |
| Infiniti™ Needle Guides | |
| Multi-Pro 2000™ Needle Guides | |
| MAGGI II Plus™ Needle Guides |
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| Device Description: | The bracket and disposable guide providephysicians with a tool for performing needle-guided(or catheter) procedures with the use of diagnosticultrasound transducers. The guide facilitatesdirecting the device to a target to improve accuracyand repeatability. |
|---|---|
K882383 - MAGGI SERIES ULTRA. NEEDLE. BIOPSY/CATHETER GUIDES
K071204 - SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
K030064 - ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
Substantial Equivalence:
Predicate Device:
CIVCO Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K882383. K071204 and K030064. CIVCO claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 8 of this submission. These differences have no effect on safety and effectiveness
Performance Testing:
Verification was performed to ensure that device meets specified tolerances and works in conjunction with specifically designed adapter clip area. All of the appropriate performance testing can be found in Section 12 of this submission.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, capitalized letters. To the left of the text is a symbol that includes a circular border with text and a stylized graphic of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
CIVCO Medical Instruments % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 250 Street NW BUFFALO MN 55313
JAN 1 9 2010
Re: K093713
Trade/Device Name: Ultrasound General Purpose Guidance Systems Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: ITX Dated: January 4, 2010 Received: January 5, 2010
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 indictions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, isting 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, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21, 21 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish find 21 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 Ilsting (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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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/ReportalProblem/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,
Donald J. Trump
Donald J. St.Pierre 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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Indications for Use
510(k) Number (if known):
Device Name: Ultrasound General Purpose Guidance System
Indications for Use:
The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging, instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:
| MODEL | INTENDED USE |
|---|---|
| Ultra-Pro II™ Needle Guides | The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. |
| Ultra-Pro 3™ Needle Guides | |
| AccuSITE Transverse Needle Guides | |
| Infiniti™ Needle Guides | |
| Multi-Pro 2000™ Needle Guides | |
| MAGGI II Plus™ Needle Guides |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off) (Division Sign-Off)
Division of Radiological Previous of CDRH, Office of Device Business (ODD) ( O I )
510(k) Number KD98713
Page 1 of 1
§ 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.