(30 days)
No reference devices were used in this submission.
No
The summary describes a physical MRI coil and its accessories, focusing on hardware design, materials, and basic performance metrics like SNR and uniformity. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
The device is described as producing "diagnostic images" and facilitating "biopsy and lesion localization procedures," which are diagnostic and interventional rather than therapeutic.
Yes
The device is intended to "produce diagnostic images of the breast anatomy that can be interpreted by a trained physician," explicitly stating its role in diagnosis.
No
The device description clearly details physical hardware components including a phased array coil, compression plates, apertures, and accessories like pads and a head rest. The Grid Holder CX Kit also includes physical components like a biopsy adaptor, grid, and post and pillar device. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The Breast SPEEDER CX and Grid Holder CX are physical devices used in conjunction with an MRI system to acquire images of the breast anatomy and facilitate interventional procedures like biopsies. They do not analyze biological samples.
- Intended Use: The intended use is to produce diagnostic images and permit access for procedures, not to perform diagnostic tests on biological specimens.
- Device Description: The description focuses on the physical components, materials, and how it interacts with the MRI system and the patient's body.
- Performance Studies: The performance studies mentioned are related to biocompatibility, electrical safety, electromagnetic compatibility, and image quality (SNR and uniformity), which are typical for medical devices used in imaging, not IVDs.
Therefore, the Breast SPEEDER CX and Grid Holder CX fall under the category of medical devices used for imaging and interventional procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Breast SPEEDER CX is intended for use with Toshiba 1.5T MRI systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician.
The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Breast SPEEDER CX is a receive-only, eight-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The Breast SPEEDER CX is intended to be used for imaging the breast anatomy. Similar to other breast coils, the Breast SPEEDER CX includes apertures through which the breasts are admitted. The Breast SPEEDER CX includes compression plates which allow compression and immobilization of the breast. Breasts may be imaged individually or simultaneously. The Breast SPEEDER CX also includes the accessories listed in Table 0-1. The accessories consist of pads and a head rest intended to increase patient comfort during scanning.
The Grid Holder CX Kit is an optional kit offered separately and is intended to be used to allow access to the breast for interventional procedures, such as biopsy and lesion localization. When the Grid Holder CX is used with the Breast SPEEDER CX, the lateral coils are replaced with the biopsy adaptor, which is fitted with either a grid or a post and pillar device, both commercially available. Compatible biopsy grids and post and pillar biopsy devices are available from NORAS MRI Products GmbH and include the items listed in Table 0-2. The breast can be accessed and interventional procedures performed from either the lateral or medial directions.
The Breast SPEEDER CX and Grid Holder CX Kit are reusable, noninvasive devices with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
breast anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Biocompatibility Testing: The only patient contact material on the Breast SPEEDER CX and Grid Holder CX is Lexan 940A polycarbonate painted with Polane S polyurethane enamel. Both the polycarbonate and the polyurethane enamel have a history of use in MR applications and other medical devices.
Electrical Safety and Electromagnetic Compatibility: The Breast SPEEDER CX was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33. Surface heating was tested in both plugged in and unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41℃ in either configuration.
Bench Testing: The SNR and uniformity of the Breast SPEEDER CX was analyzed per and found to conform to NEMA MS 9-2008.
Key Results: The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the Breast SPEEDER CX and the bench testing per the NEMA standards demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the Breast SPEEDER CX performs comparably to the predicate device.
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.
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.
No reference devices were used in this submission.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with the outer profile forming the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
QUALITY ELECTRODYNAMICS, LLC. KATHLEEN ARAS DIRECTOR, REGULATORY AND QUALITY AFFAIRS 700 BETA DRIVE, SUITE 100 MAYFIELD VILLAGE OH 44143
Re: K142002
Trade/Device Name: Breast SPEEDER CX and Grid Holder CX Kit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 21, 2014 Received: July 23, 2014
Dear Ms. Aras:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Breast SPEEDER CX
Indications for Use (Describe)
The Breast SPEEDER CX is intended for use with Toshiba 1.5T MRI systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name Grid Holder CX
Indications for Use (Describe)
The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
ਨਾ ਸਿੰਘ ਸ
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
1. Applicant
Quality Electrodynamics, LLC. (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143
2. Contact
Kathleen Aras Director, Requlatory and Quality Affairs (440) 484-2964 kathleen.aras@qualedyn.com
3. Date Prepared
21 July 2014
4. Tradenames
Breast SPEEDER CX
Grid Holder CX Kit
5. Common name
Coil, magnetic resonance, specialty
6. Classification
Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code MOS, Class II)
7. Predicate Device
Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array, Sentinelle Medical, Inc., K060873
No reference devices were used in this submission.
8. Device Description
The Breast SPEEDER CX is a receive-only, eight-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The Breast SPEEDER CX is intended to be used for imaging the breast anatomy.
5
Similar to other breast coils, the Breast SPEEDER CX includes apertures through which the breasts are admitted. The Breast SPEEDER CX includes compression plates which allow compression and immobilization of the breast. Breasts may be imaged individually or simultaneously.
The Breast SPEEDER CX also includes the accessories listed in Table 0-1. The accessories consist of pads and a head rest intended to increase patient comfort during scanning.
| QED Part Number | Description | Qty |
|---|---|---|
| 3003080 | Comfort pad | 1 |
| 3003081 | Sternum pad | 1 |
| 3003084 | Medial pad | 2 |
| 3003082 | Transition pad | 1 |
| 3003079 | Head rest pad | 1 |
| 2000588 | Head rest | 1 |
| 3003225 | Compression Plate | 2 |
| 3003085 | Breast Riser CX (optional) | 1 |
Table 0-1: Breast SPEEDER CX Accessories
The Grid Holder CX Kit is an optional kit offered separately and is intended to be used to allow access to the breast for interventional procedures, such as biopsy and lesion localization. When the Grid Holder CX is used with the Breast SPEEDER CX, the lateral coils are replaced with the biopsy adaptor, which is fitted with either a grid or a post and pillar device, both commercially available. Compatible biopsy grids and post and pillar biopsy devices are available from NORAS MRI Products GmbH and include the items listed in Table 0-2. The breast can be accessed and interventional procedures performed from either the lateral or medial directions.
6
| Part Number | Description |
|---|---|
| 117143 | NORAS Height Adjustable Grid, |
| Lateral, Re-usable | |
| 112235 | NORAS Grid Lateral, Disposable |
| 112238 | NORAS Grid Medial, Disposable |
| 117884 | NORAS Pillar and Post Adapter, |
| Re-usable | |
| 117139 | NORAS Vertically Curved Slat |
| Plate, Re-usable | |
| 111301 | NORAS Horizontally Curved Slat |
| Plate, Re-usable |
The Breast SPEEDER CX and Grid Holder CX Kit are reusable, noninvasive devices with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
9. Indications for Use
The Breast SPEEDER CX is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician.
The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.
The Indications for Use statements for the Breast SPEEDER CX and Grid Holder CX are not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both Indications for Use statements indicate that the device is intended to be used in conjuction with an MR system to produce images of the breast, that the images can be interpreted by a trained physician, and that when used with additional equipment, the device permits access to the breast anatomy for biopsy and localization procedures. The Indications for Use statements differ in that the Indications for Use statement for the predicate device encompasses both the imaging and breast access aspects of the device whereas, since the Breast SPEEDER CX and Grid Holder CX are sold separately, the subject's Indication for Use statement has been separated into two parts that address the
7
imaging and breast access aspects specific to the two products separately.
Summary of Technological Characteristics Compared to the 10. Predicate Device
The Breast SPEEDER CX and the Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array are both 8-channel, receive-only, phased array RF coils intended to be used with a 1.5T MR system to provide images of the breast. When the Grid Holder CX is used with the Breast SPEEDER CX, both devices allow access to the breast for biopsy and localization procedures.
At a high level, the subject and predicate devices are based on the following same technological elements:
- RF coils intended to provide images of the breast anatomy ●
- . Compatible with 1.5T MR systems
- . 8-channel, receive-only, phased array coil design
- Active PIN diode switching blocking circuitry. Passive blocking circuitry.
- Supports a patient in a prone position, with apertures through which the breasts are admitted
- Includes compression plates which allow compression and ● immobilization of the breast.
- . Allows access to the breast for biopsy and localization procedures
The following technological differences exist between the subject and predicate devices:
- MR system compatibility (Toshiba (subject) versus GE (predicate))
11. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The only patient contact material on the Breast SPEEDER CX and Grid Holder CX is Lexan 940A polycarbonate painted with Polane S
8
polyurethane enamel. Both the polycarbonate and the polyurethane enamel have a history of use in MR applications and other medical devices. For example, these materials were patient contact materials in the devices cleared through 510(k) numbers K122638 and K140998.
Electrical Safety and Electromagnetic Compatibility
The Breast SPEEDER CX was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Surface heating was tested in both plugged in and unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41℃ in either configuration.
Bench Testing
The SNR and uniformity of the Breast SPEEDER CX was analyzed per and found to conform to NEMA MS 9-2008.
12. Conclusion
The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the Breast SPEEDER CX and the bench testing per the NEMA standards demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the Breast SPEEDER CX performs comparably to the predicate device.