(74 days)
To be obtained following 510(k) clearance
No
The summary describes a physical accessory for marking anatomical features and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is indicated for diagnostic ultrasound procedures to mark anatomical features, not to treat any condition.
Yes
The "Intended Use / Indications for Use" states that it is "indicated for diagnostic ultrasound procedures". While the device itself is a "skin-marking attachment," its intended use is within the context of a diagnostic procedure to "mark anatomical features."
No
The device description explicitly states it is a "skin-marking attachment," indicating a physical hardware component.
Based on the provided information, the Sonomark® accessory is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "mark anatomical features" during diagnostic ultrasound procedures. This is a physical action performed on the patient's skin, not a test performed on a sample taken from the body.
- Device Description: It's described as a "skin-marking attachment." This further reinforces its function as a physical marker.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Sonomark® accessory's function is external and procedural, not analytical of biological samples.
N/A
Intended Use / Indications for Use
This accessory device is intended to be used for skin marking when used with various diagnostic ultrasound transducers.
Product codes
90-ITX,ITX
Device Description
The Sonomark® accessory to Diagnostic Ultrasound Transducers is a skin-marking attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Reference Device(s)
To be obtained following 510(k) clearance
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(K) number is : K�ط 15 كل
Description:
The Sonomark® accessory to Diagnostic Ultrasound Transducers is a skin-marking attachment.
Substantial Equivalence:
Substantial equivalence has been demonstrated between the Sonomark® accessory, the AiM Accuracy in Marking® System (510(k) No.: K053463).
Intended Use:
This accessory device is intended to be used for skin marking when used with various diagnostic ultrasound transducers.
| Manufacturer: | Medical Products Manufacturing, Inc.
(MPM) and Innovative Manufacturing
Company (IMC) |
|-------------------------|---------------------------------------------------------------------------------------------|
| Address: | 1775 Gunnison
Delta, CO 81416 |
| Corresponding Official: | Theron E. Johnson |
| Title: | President & CEO |
| Address: | 11495 - 3800 Road
Paonia, CO 81428 |
| Telephone | 970-527-7879 |
| Initial Distributor: | Same as Manufacturer |
| Device Name: | Sonomark® |
| Common Name | Accessory to a Linear Diagnostic Ultra-
sound Transducer |
1
| K061560 | |
|---|---|
| Classification: | Regulatory Class: II, Review Category: Tier |
| II | |
| Diagnostic Ultrasound Transducer | |
| FR Number: 892.1570 | |
| Product Code: 90-ITX | |
| Establishment Registration No.: | To be obtained following 510(k) clearance |
| 514 Performance Standard: | None |
| Special Controls: | None for accessory device |
| Prescription Status: | Accessory to Prescription Device |
| Manufacturing Location: | 1775 Gunnison |
| Delta, CO 81416 | |
| Sterilization Site: | Not applicable |
| Reason for Submission: | Notification of intent to market accessory |
| device in US | |
| Submission Track: | Not applicable for accessory device |
Indications for Use
The Sonomark® accessory to linear diagnostic ultrasound transducers is indicated for diagnostic ultrasound procedures to mark anatomical features.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 8 2006
Mr. Theron E. Johnson CEO & President Medical Products Manufacturing, Inc. and Innovative Manufacturing Company 11495 - 3800 Road PAONIA CO 81428
Re: K061560
Trade/Device Name: Sonomark® Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Codes: ITX Dated: May 24, 2006 Received: June 5, 2006
Dear Mr. Johnson:
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.
Image /page/2/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA".
noting Public J
3
Page 2 -
!
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 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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy 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
510(k) Number (if known):
Sonomark®
Device Name:
Indications For Use:
The Sonomark accessory to linear diagnostic ultrasound transducers is indicated for diagnostic ultrasound procedures to mark anatomical features.
Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR
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 Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Page 1 of