(111 days)
No
The device description and intended use clearly define a simple, passive pad for comfort and gel retention, with no mention of any computational or analytical capabilities.
No
The device provides padding for patient comfort and aids in the retention of coupling media, which are supportive functions rather than direct therapeutic actions.
No
Explanation: The device is described as a pad to facilitate patient comfort and aid in the retention of ultrasonic coupling gel. Its intended use does not involve diagnosing conditions, but rather assisting in the application of an ultrasonic coupling media.
No
The device description clearly states it is a "pad" and a "physical device" temporarily applied to transducers, indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide padding for patient comfort and aid in the retention of coupling media during ultrasound procedures. This is a physical function related to the application of the ultrasound transducer, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a pad applied to the ultrasound transducer. This further reinforces its role as an accessory for the ultrasound procedure itself, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in a sample
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device's function is purely supportive of the ultrasound imaging process, which is a diagnostic imaging modality, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The-Addition provides padding for patient comfort and aids in the retention of coupling media in a defined position.
Product codes
MUI
Device Description
The-Addition is a pad that is temporarily applied to the ultrasound transducer and the toco transducer to facilitate patient comfort and aid in the retention of ultrasonic coupling gel.
The-Addition is provided non-sterile for single use and is disposable.
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)
All necessary verification and validation testing has been performed for The-Addition to assure substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ScanTec Pad K031894, Embrace Gel Pad K072515
Reference Device(s)
Not Found
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
JAN 6 2011
6. 510(k) Summarv
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | OB the-addition, LLC |
|---|---|
| TRADE NAME: | The-Addition |
| COMMON NAME: | Media, Coupling, Ultrasound |
| CLASSIFICATION | |
| NAME: | Diagnostic ultrasonic transducer, 21 CFR, 892.1570 |
| DEVICE | |
| CLASSIFICATION: | Class II |
| PRODUCT CODE | MUI |
PREDICATE DEVICES: ScanTec Pad K031894 Embrace Gel Pad K072515
Substantially Equivalent To:
The-Addition is substantially equivalent in intended use, principal of operation and technological characteristics to the identified predicates.
Description of the Device Subject to Premarket Notification:
The-Addition is a pad that is temporarily applied to the ultrasound transducer and the toco transducer to facilitate patient comfort and aid in the retention of ultrasonic coupling gel.
The-Addition is provided non-sterile for single use and is disposable.
Indication for Use:
The-Addition provides padding for patient comfort and aids in the retention of coupling media in a defined position.
Technical Characteristics:
The-Addition has similar physical and technical characteristics to the predicate devices. The-Addition and the identified predicates all provide for the retention of coupling media in a defined position.
1
Performance Data:
All necessary verification and validation testing has been performed for The-Addition to assure substantial equivalence to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, The-Addition is determined by OB the-addition, LLC, to be substantially equivalent to existing legally marketed devices.
OB the-addition, LLC The-Addition
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. The logo is printed in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
E 2011 JAN
Ms. Rebecca Pine Consultant OB the-addition, LLC 2206 Modoc Road #3 SANTA BARBARA CA 93101
Re: K102683
Trade/Device Name: The-Addition Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: December 2, 2010 Received: December 3, 2010
Dear Ms. Pine:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of
3
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(0) , rims rket 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 Viro 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,
Dan
David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 片102685
Device Name: The-Addition
Indications for Use:
The-Addition provides padding for patient comfort and aids in the retention of coupling media in a defined position.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ X_ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
Page __ of
(Division Sign-Off)
Division of Radiological Devices
Division of Microbiology
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102683