(51 days)
Not Found
No
The summary describes a conventional film-based mammography system with mechanical and design modifications, and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for descriptions of training/test sets and performance studies typically associated with AI/ML devices.
No
The device is described as an x-ray system used to produce radiographs for diagnostic purposes, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states the device is "intended to be used to produce radiographs of the human breast" and "can be equipped with accessories to fulfil different diagnostic needs," clearly indicating its use in diagnosis.
No
The device is explicitly described as a "mammography x-ray system" and a "conventional mammography x-ray system utilizing films and cassettes," indicating it is a hardware device that produces radiographs.
No, 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. These tests are performed outside of the body.
- Device Function: The Planmed Sophie Nuance Classic is a mammography x-ray system. Its function is to produce images (radiographs) of the human breast using x-rays. This is an in vivo (within the living body) imaging procedure, not an in vitro test on a sample.
The description clearly states its purpose is to produce radiographs of the human breast, which is a form of medical imaging performed directly on the patient.
N/A
Intended Use / Indications for Use
The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.
Product codes
90 IZH
Device Description
The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human 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)
K904953, K923471, K951883, K962105, K973493, K983659, K991826, K013656, K021945
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
NOV 1 9 2004
Image /page/0/Picture/1 description: The image shows the word "Planned" in large, bold, white letters against a black background. Below the word "Planned" are the words "ENCLOSURE 12" and "P. 12-1" in a smaller font size. The words "ENCLOSURE 12" and "P. 12-1" are also in black.
510K) SUMMARY
K04 2671
DATE
November 16, 2004
PRODUCT, CLASSIFICATION NAME
Trade name: Planmed Sophie Nuance Classic Common name: Mammographic x-ray system Classification: 90 IZH, Class II Regulation number: 892.1710
MANUFACTURER
Planmed Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 300 Fax: +358 20 7795 555 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)
Planmed USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2200 Fax: (630) 894 4271 Contact person : Bob Pienkowski
INTENDED USE
The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.
PRODUCT DESCRIPTION
The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.
SUBSTANTIAL EQUIVALENCE
We consider this product to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:
Planmed Sophie # K904953
1
Image /page/1/Picture/0 description: The image shows the word "Planned" in large, bold, white letters against a black background. Below the word "Planned" are the words "ENCLOSURE 12" and "P. 12-2" in a smaller font size. The text is centered.
| # K923471 | Planmed Sophie with Cytoguide |
|---|---|
| # K951883 | Planmed Sophie modification |
| # K962105 | Planmed Sophie Classic |
| # K973493 | Planmed Sophie Classic with Cytoguide |
| # K983659 | Planmed Sophie modification |
| # K991826 | Planmed Sophie with Maxview |
| # K013656 | Planmed Sophie modification |
| # K021945 | Planmed Sophie with Digiguide |
The comparison of characteristics supports substantial equivalence. Planmed Sophie Nuance Classic is as safe and effective as the predicate devices.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Planmed Ov % Mr. Bob Pienkowski Managing Director Planmed USA, Inc. 100 North Gary Avenue, Suite A ROSELLE IL 60172
Re: K042671 Trade/Device Name: Planmed Sophie Nuance Classic Regulation Number: 21 CFR 892.1710 Regulation Name: Mammograhpic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: September 17, 2004 Received: September 29, 2004
Dear Mr. Pienkowski:
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 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and your he FDA finding of substantial equivalence of your device to a legally premated notificated on " 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 If you don't openite 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 00 : 7 // 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/dsma/dsmamain.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):_K042671
Device Name: Planmed Sophie Nuance Classic
Indications For Use:
The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
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)
David C. Hodgson
(Division Sign-Off) Division of Reproductive and Radiological Devic 510(k) Number
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