AIM ACCURACY IN MARKING SYSTEM

{0}------------------------------------------------ K053463 Page 1 of 2 2006 MAK 7 # 510(K) SUMMARY AiM Accuracy In Marking® | Date: | December 4, 2005 | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner/Operator: | Georgene Austria<br>5755 Valerie Avenue<br>Woodland Hills, CA 91367 | | Contact Person: | George Austria<br>Owner | | Contract Manufacturer: | Griff Industries<br>19761 Bahama Street<br>Northridge, CA 91324<br>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<br>exempt device under 878.4660 FZZ | | Intended Use and indication<br>for use: | The marking device is enables the sonographer to mark<br>the "targeted" vessel during vascular mapping. The<br>shadow guide is an adhesive "film" adhered directly<br>underneath the footing of the transducer used as guide<br>on identifying the vessel. | | | The marking device and the "shadow guide" are<br>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<br>curved linear ultrasonic transducers in the frequency of<br>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 ________________________________________________________________________________________________________________________________________________________________