(48 days)
Not Found
No
The device description and intended use clearly define it as a physical foam cushion for patient comfort and positioning, with no mention of software, algorithms, or data processing.
No
The device's intended use is for patient comfort and positioning during imaging, not for treating a disease or condition.
No
Explanation: The device is described as providing padding for patient comfort and aid in positioning during radiologic visualization, not for diagnosing medical conditions.
No
The device description explicitly states it is a "radiolucent foam cushion," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that the device is a "radiolucent foam cushion used during radiologic visualization of the breast." Its purpose is to provide comfort and aid in positioning during imaging procedures.
- Lack of Sample Analysis: The device does not interact with or analyze any biological samples from the patient. It is a physical aid used externally during an imaging process.
- Intended Use: The intended use is focused on improving the imaging process itself, not on analyzing biological markers or providing diagnostic information from a sample.
Therefore, the MammoPad falls under the category of a medical device used in conjunction with an imaging modality, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MammoPad is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.
Product codes (comma separated list FDA assigned to the subject device)
IYX, IZH
Device Description
MammoPad is a radiolucent foam cushion used during radiologic visualization of the breast. MammoPad is non-sterile and is a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray or scintillation technology
Anatomical Site
breast
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): 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.
MammoPad® (K003795)
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
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).
0
SEP 1 3 2006
| 4. 510(k) Summary of Safety and Effectiveness | K06 2141 |
|---|---|
| Device Name: | MammoPad Radiolucent Cushion |
| Classification Name: | Accessory to X-Ray Mammographic System (IZH |
| 21 CFR, 892.1710 | |
| Accessory to Scintillation (Gamma) Camera (IYX | |
| 21 CFR, 892.1100 | |
| Device Classification: | Class II (IZH) |
| Class I (IYX) | |
| Predicate devices: | MammoPad® (K003795) |
| Scintimammography Pad Set, PineStar Technology | |
| Scintimammography Pad, Cone Instruments | |
| Manufacturer: | BioLucent, Inc. |
| 6 Journey, Suite 325 | |
| Aliso Viejo, CA 92656 | |
| Establishment Registration | |
| Number: | 2032338 |
| Official Contact: | Sheryl Higgins |
| BioLucent, Inc. | |
| 6 Journey, Suite 325 | |
| Aliso Viejo, CA 92656 | |
| Phone: (949) 349-1380 (x101) |
Intended Use:
MammoPad is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.
Device Description:
MammoPad is a radiolucent foam cushion used during radiologic visualization of the breast. MammoPad is non-sterile and is a single use device.
1
Technological Characteristics/Performance Data Summary
MammoPad is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.
Conclusion:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, MammoPad is determined to be substantially equivalent to an existing legally marketed device
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is black. The text is likely part of a document or presentation.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 3 2006
Ms. Sheryl W. Higgins Director of Engineering BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656
Re: K062141
Trade/Device Name: MammoPad Radiolucent Cushion Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IYX and IZH Dated: July 26, 2006 Received: July 27, 2006.
Dear Ms. Higgins:
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 black and white circular logo. The logo has the letters "FDA" in the center. Above the letters are the numbers "1906-2006". Below the letters is the word "Centennial". There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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/cdrlvindustry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3. Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 06 乙 乙 乙 乙 乙 乙 乙 乙 乙 (
Device Name:
MammoPad Radiolucent Cushion
Indications for Use:
Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number R062141
Confidential