(74 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use as a sizing tool.
No
The device is intended to assist in evaluation of appropriate prosthesis volume, not to treat or diagnose a condition.
No
Explanation: The device is described as assisting in the evaluation of appropriate mammary prosthesis volume. This is a planning or sizing aid, not a diagnostic tool used to identify the nature or cause of a disease or condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, the Specialty Surgical Products Mammary Sizer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation." This describes a device used in vivo (on the patient's body) to aid in a surgical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Mammary Sizer does not involve testing biological samples.
- Lack of IVD-related information: The provided information does not mention any aspects typically associated with IVDs, such as sample types, analytical methods, or diagnostic results.
Therefore, the Mammary Sizer is a surgical accessory used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.
Product codes
MRD
Device Description
Mammary Sizer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mammary
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
SEP 8 1398 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. T. Jan Varner President and CEO Specialty Surgical Products, Inc. 302 North First Street Hamilton, Montana 59840
Re: K982258 Trade Name: Mammary Sizer Regulatory Class: II Product Code: MRD Dated: June 12, 1998 Received: June 26, 1998
Dear Mr. T. Jan Varner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. T. Jan Varner
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Mammary Sizer
Indications For Use:
The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.
(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 General Restorative Devices | |
| 510(k) Number | K982258 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
: