(84 days)
Accuracy In Marking® is a marking device used in conjunction with a transducer during vascular mapping. The device allows the user to mark a vascular area immediately when it is identified during mapping process. The guide path underneath the transducer allows the user to identify the target vessel prior to marking. The product is supplied non-sterile and is intended for single use only.
The marking device is enables the sonographer to mark the "targeted" vessel during vascular mapping. The shadow guide is an adhesive "film" adhered directly underneath the footing of the transducer used as guide on identifying the vessel. The marking device and the "shadow guide" are attached to a transducer using a non-latex adhesive. The device shall be sold non-sterile for single use only. This device is compatible with FDA approved linear and curved linear ultrasonic transducers in the frequency of 4MHz to 12MHz.
The provided 510(k) submission for the "AiM Accuracy In Marking® System" (K053463) does not contain a detailed study report with specific acceptance criteria and performance data in the format typically required for advanced AI/ML medical devices.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Sandel Medical Industries, LLC Skin Marker) based on similarities in function (skin marking) and the simplicity of the "shadow guide" component. The primary "test data" mentioned is to demonstrate that the safety and effectiveness of the transducer's function is not affected by the shadow guide.
Therefore, many of the requested elements for describing acceptance criteria and study details cannot be extracted from this document. However, I can infer what information would be relevant if such a study were present, and provide the limited details available.
Based on the provided document, here's an attempt to answer your questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the "AiM Accuracy In Marking® System." The primary "acceptance" seems to be based on demonstrating that the shadow guide does not adversely affect the safety and effectiveness of the existing ultrasound transducer function, rather than achieving a specific performance metric for aiding vessel marking. The core claim is that its function is "beneficial on identifying the target vessel."
- Reported Device Performance: The document only makes a qualitative statement: "the simplicity of the design as well as test data demonstrates that safety and effectiveness of the function of the transducer is not affected by the shadow guide. The shadow guide's function is beneficial on identifying the target vessel during vascular mapping."
| Performance Metric | Acceptance Criteria (Implied/Inferred) | Reported Device Performance (Qualitative) |
|---|---|---|
| Transducer Safety | No adverse effect on transducer operation | "safety...of the function of the transducer is not affected by the shadow guide" |
| Transducer Effectiveness | No adverse effect on transducer operation | "effectiveness of the function of the transducer is not affected by the shadow guide" |
| Vessel Identification Aid | Aid in identifying target vessels | "The shadow guide's function is beneficial on identifying the target vessel during vascular mapping." and "allows the user to identify the target vessel prior to marking." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers generally to "test data," but does not provide any numerical sample size for cases or participants.
- Data Provenance: Not specified. While the applicant's address is in California, USA, the origin of any "test data" (e.g., country, institution) is not mentioned.
- Retrospective or Prospective: Not specified.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document does not detail how "ground truth" for beneficial vessel identification was established or if any expert evaluation was involved beyond general statements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. Given the lack of detail on the "test data," no adjudication method is described.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not described or referenced. This device is a passive marking accessory, not an AI/ML algorithm requiring a human-in-the-loop performance evaluation in the typical sense.
- Effect Size: Not applicable, as no MRMC study was presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical accessory (shadow guide and marker), not a standalone algorithm. Its function is to be used with a human sonographer and ultrasound transducer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. Based on the description, the "ground truth" for the device's function (identifying target vessels) would likely be based on the sonographer's visual confirmation of the vessel on the ultrasound image and their ability to accurately mark it based on the guide. However, the exact method for establishing this is not detailed in the submission.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical accessory, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is a physical accessory, not an AI/ML device.
Summary Limitations:
The provided 510(k) summary is for a relatively simple accessory device. The requirements for demonstrating substantial equivalence for such devices are often less stringent regarding quantitative performance studies compared to complex AI/ML algorithms. The focus here is on demonstrating that the accessory does not impair the functionality or safety of the primary device (ultrasound transducer) and that its stated purpose (aiding identification and marking) is met in a general sense, without specific numerical performance targets or detailed study methodology being disclosed in this summary.
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K053463
Page 1 of 2
2006 MAK 7
510(K) SUMMARY AiM Accuracy In Marking®
| Date: | December 4, 2005 |
|---|---|
| Owner/Operator: | Georgene Austria5755 Valerie AvenueWoodland Hills, CA 91367 |
| Contact Person: | George AustriaOwner |
| Contract Manufacturer: | Griff Industries19761 Bahama StreetNorthridge, CA 91324FDA Registration # 2031528 |
| Device Trade Name: | AiM Accuracy In Marking® System |
| Common Name: | Accessory to an Ultrasound Transducer |
| Classification Name: | Class II, 90ITX and Accessories |
| Regulatory Reference: | 892.1570 |
| Predicate Device: | Sandel Medical Industries, LLC Skin Marker Class 1exempt device under 878.4660 FZZ |
| Intended Use and indicationfor use: | The marking device is enables the sonographer to markthe "targeted" vessel during vascular mapping. Theshadow guide is an adhesive "film" adhered directlyunderneath the footing of the transducer used as guideon identifying the vessel. |
| The marking device and the "shadow guide" areattached to a transducer using a non-latex adhesive. | |
| The device shall be sold non-sterile for single use only. | |
| This device is compatible with FDA approved linear andcurved linear ultrasonic transducers in the frequency of4MHz to 12MHz. |
Principle of Operation: Transducer Shadow Guide
Transducer
Ultrasound transducers emit mechanical sound waves which are transmitted into human tissue through a coupling medium. As the sound wave propagates through the tissue, a portion of the sound wave is reflected and a portion of the sound wave is transmitted
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dependent upon the acoustic properties of the tissue it encounters. Tissues with significant disparities in acoustic properties create a tissue interface that promotes a strong reflection of the sound wave due to an acoustic impedance mismatch. The reflected sound wave termed echo is detected by the transducer and the echo signal is processed electronically by the ultrasound system.
Shadow Guide
When the Shadow Guide is applied to the footprint of a transducer, the Shadow Guide creates an acoustic impedance mismatch as the sound wave propagates from the footprint of the transducer to the Shadow Guide. The sound wave is completely reflected specifically in the clear areas of the Shadow Guide producing 2 delineated reference lines in the ultrasound image.
Summary of Similarities and Differences:
Similarities:
The following are similarities between Sandel Medical Industries Skin Marker and AiM Marking device
- Both devices are skin markers o
- Both devices are single use only o
- Both devices use the same ink (gentian violet) 0
- Both devices are Class 1 exempt devices o
Differences
The following are differences between Sandel Medical Skin marker and AiM Marking Device
- The shape of the devices are different o
- The internal components are different O
- The AiM Marking device includes a shadow guide for identifying target vessels. o
- The AiM Marking device shall be sold non-sterile while skin markers are available o sterile and non sterile
Conclusion:
The proposed marking device is comparable to the predicate device (Skin Marker). Although there is no identified predicate device for the shadow guide, the simplicity of the design as well as test data demonstrates that safety and effectiveness of the function of the transducer is not affected by the shadow guide. The shadow guide's function is beneficial on identifying the target vessel during vascular mapping.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
mar 7 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Georgene Austria Official Correspondent 5755 Valerie Avenue WOODLAND HILLS CA 91367 Re: K053463
Trade/Device Name: Accuracy In Marking® Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX and FZZ Dated: December 4, 2005 Received: December 20, 2005
Dear Ms. Austria:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 revulations 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); 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.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
T. Nancy C. Brigdon
Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement
Applicant: Georgene Austria
510(k) Number: K053463
Device Name: Accuracy In Marking®
Indication For Use
Accuracy In Marking® is a marking device used in conjunction with a transducer during *vascular mapping. The device allows the user to mark a vascular area immediately when it is identified during mapping process. The guide path underneath the transducer allows the user to identify the target vessel prior to marking.
The product is supplied non-sterile and is intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The Counter Use __
Nancy Brazdon
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.