(84 days)
Not Found
Not Found
No
The description focuses on a physical marking device and a guide for a transducer, with no mention of AI or ML in the device's function or processing.
No
The device is a marking tool used in conjunction with a transducer for vascular mapping, not for treating or diagnosing a disease or condition. Its purpose is to mark a vascular area, which is a procedural aid rather than a therapeutic intervention.
No
Explanation: This device is described as a "marking device" used in conjunction with a transducer during vascular mapping to mark a vascular area. It does not perform any diagnostic function itself but rather aids in the process of marking an area identified during mapping.
No
The device description explicitly mentions physical components like an adhesive "film" and a marking device that are attached to a transducer. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device's intended use is to mark a vascular area on the patient's skin during vascular mapping using ultrasound. It is a physical marking tool used in conjunction with an imaging procedure.
- Device Description: The description confirms it's a physical marking device and an adhesive guide attached to a transducer. It facilitates the marking process on the patient's body.
- No Analysis of Biological Samples: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status. This device does not interact with or analyze any biological samples.
- Role in the Diagnostic Process: While it's used during a diagnostic procedure (vascular mapping), its function is to physically mark the skin based on the ultrasound image, not to perform a diagnostic test itself.
The device is a tool used to aid in the localization and marking of anatomical structures identified through imaging, which is distinct from performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
ITX, FZZ
Device Description
The AiM Accuracy In Marking® System is an accessory to an ultrasound transducer. It consists of a marking device and a "shadow guide." The shadow guide is an adhesive film that adheres directly underneath the footing of the transducer. Both the marking device and the shadow guide attach to the transducer using a non-latex adhesive. The device is sold non-sterile for single use only and is compatible with FDA approved linear and curved linear ultrasonic transducers operating in the frequency range of 4MHz to 12MHz. When the Shadow Guide is applied to the footprint of a transducer, it creates an acoustic impedance mismatch. The sound wave is completely reflected specifically in the clear areas of the Shadow Guide, producing 2 delineated reference lines in the ultrasound image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Vascular area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Sonographer / 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)
Not Found
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.
Sandel Medical Industries, LLC Skin Marker Class 1 exempt device under 878.4660 FZZ
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
K053463
Page 1 of 2
2006 MAK 7
510(K) SUMMARY AiM Accuracy In Marking®
| Date: | December 4, 2005 |
|---|---|
| Owner/Operator: | Georgene Austria |
| 5755 Valerie Avenue | |
| Woodland Hills, CA 91367 | |
| Contact Person: | George Austria |
| Owner | |
| Contract Manufacturer: | Griff Industries |
| 19761 Bahama Street | |
| Northridge, CA 91324 | |
| FDA 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 1 |
| exempt device under 878.4660 FZZ | |
| Intended Use and indication | |
| for use: | 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. |
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
1
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.
2
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.
3
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
4
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 ________________________________________________________________________________________________________________________________________________________________