(27 days)
Not Found
No
The summary describes a passive RF coil for MRI, focusing on its physical design, channel count, and access features for interventional procedures. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
The device is a receive-only RF coil used in conjunction with an MRI scanner to produce diagnostic and interventional images, and to aid in MR-guided breast biopsy, localization of lesions, and interventional procedures. It is not designed to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician" and "is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures." The "Device Description" also mentions it offering "diagnostic imaging" and is optimized for "parallel imaging of the chest wall, breast and axillary tissue."
No
The device is a physical RF coil with supporting hardware components (base, coil chambers, plastic housing, positioning accessories) designed for use with an MRI scanner. While it mentions compatibility with "SureLoc software," the primary device described is hardware.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Access Breast Coil is an accessory used with an MRI scanner. Its function is to receive radiofrequency signals from the body during an MRI scan to produce images. It does not analyze samples taken from the body.
- Intended Use: The intended use is to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues. This is an in vivo (within the living body) imaging procedure, not an in vitro diagnostic test.
- Device Description: The description details the physical components of the coil and its role in the MRI process, which is entirely focused on capturing signals from within the patient's body.
Therefore, the Access Breast Coil is a medical device used for in vivo imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
Product codes
MOS
Device Description
Access is a 7-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast and axillary tissue. Access is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.
The design of the Access breast coil focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of breast MRI studies and interventional procedures.
The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.
The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
Features of the Access Breast Coil:
Imaging
- 7-channel phased array design uses multiple elements that surround . the breast tissue
- t Optimized for parallel imaging applications
- Supports both unilateral and bilateral imaging exams .
- Compatible with Siemens 1.5T MRI systems .
- 40 cm field of view .
- Extensive coverage of chest wall and axilla ●
- High SNR t
Ergonomics
- Large apertures to accommodate a major percentage of patient . population
- Ergonomically designed for patient comfort to minimize motion . artifact
- Positioning accessories include a flexible, adjustable headrest, arm . rest and torso pad
- Cushioned head rest with mirror to reduce patient claustrophobic . response
- Padded arm rests for increased patient comfort .
Interventional Access
- Coil design allows lateral, medial and cranial-caudal interventional . access
- Lighting is integrated into the coil for interventional procedures . that demand a well lit area
- Compatible with SureLoc software to support interventional MRI .
Mentions image processing
Optimized for parallel imaging applications
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Breast, chest wall, and axillary tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko52045
AUG 2 4 2005
7
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.
1. Identification of Submitter:
| Submitter: | Confirma, Inc. |
|---|---|
| Address: | 821 Kirkland Avenue |
| Kirkland, WA 98033 | |
| Phone: | 425-576-1226 |
| Fax: | 425-576-9295 |
| Contact: | Patricia A. Milbank |
| Title: | Regulatory Consultant |
| Phone: | 425-894-9733 |
| Fax: | 425-865-9023 |
| Date Prepared: | July 25, 2005 |
2. Identification of Product:
| Trade Name: | Access Breast Coil |
|---|---|
| Regulatory Number: | 21 CFR 892.1000 |
| Regulation Name: | Magnetic Resonance Diagnostic Device |
| Common Name: | Coil, Magnetic Resonance Specialty |
| Regulatory Class: | Class II |
| Product Code: | 90 MOS |
| Manufacturer: | Confirma, Inc. |
|---|---|
| 821 Kirkland Avenue | |
| Kirkland, WA 98033 |
4. Indications for Use
The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
1
5. Device Description:
Access is a 7-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast and axillary tissue. Access is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.
The design of the Access breast coil focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of breast MRI studies and interventional procedures.
The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.
The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
Features of the Access Breast Coil:
Imaging
- 7-channel phased array design uses multiple elements that surround . the breast tissue
- t Optimized for parallel imaging applications
- Supports both unilateral and bilateral imaging exams .
- Compatible with Siemens 1.5T MRI systems .
- 40 cm field of view .
- Extensive coverage of chest wall and axilla ●
- High SNR t
Ergonomics
- Large apertures to accommodate a major percentage of patient . population
- Ergonomically designed for patient comfort to minimize motion . artifact
2
- Positioning accessories include a flexible, adjustable headrest, arm . rest and torso pad
- Cushioned head rest with mirror to reduce patient claustrophobic . response
- Padded arm rests for increased patient comfort .
Interventional Access
- Coil design allows lateral, medial and cranial-caudal interventional . access
- Lighting is integrated into the coil for interventional procedures . that demand a well lit area
- Compatible with SureLoc software to support interventional MRI .
6. Comparison with Legally Marketed Devices
The Access Breast Coil is substantially equivalent to the legally marketed devices listed below:
| Model: | Liberty 9000 Breast Coil |
|---|---|
| Manufacturer: | USA Instruments, Inc. |
| 510 (k) Number: | K000993 |
| Model: | Machnet Bilateral Open Breast Coil |
| Manufacturer: | Machnet BV |
| 510 (k) Number: | K013985 |
| Model: | Biopsy Breast Coil BBC-127 |
| Manufacturer: | MRI Devices Corporation |
| 510 (k) Number: | K041481 |
All of these breast coils are designed as receive-only RF coils and intended for use in conjunction with a magnetic resonance scanner to produce diagnostic images of the breast, chest wall and axillary tissues that can be interpreted by a physician.
The predicate devices are designed for use with various MR scanners. The Access Breast Coil is designed for use with the Siemens 1.5T MR scanner, as is the predicate device marketed by MRI Devices.
The Access Breast Coil is a 7-channel, phased array coil that allows bilateral and unilateral imaging of the breast. All of these breast coils have an open coil design to optimize imaging of breasts of various sizes.
3
The predicate devices allow lateral and medial access to the breast for biopsy The producate devries and in rassisting the Access Breast Coil is designed to allow for lateral, medial and cranial-caudal access to the breast.
7. Conclusions
The Access Breast Coil is substantially equivalent to the identified legally The Access Dreast Oon is eating have been studied and controlled and controlled as marketed devices. - 110 pornent process, including risk analysis, test and part of the product as relephanned verification and validation testing design considerations, and Coil provides images comparable to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of three birds in flight, arranged in a diagonal line. The birds are simple, with curved lines representing their bodies and wings.
AUG 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia A. Milbank Regulatory Consultant Confirma, Inc. 821 Kirkland Avenue, Suite100 KIRKLAND WA 98033
Re: K052045
Trade/Device Name: Access Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: July 27, 2005 Received: July 28, 2005
Dear Ms. Milbank:
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.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you'ls ought maining of substantial equivalence of your device to a legally prematice notification: "Thesults 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 deathe specific access to 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 Also, produs nother general information on your responsibilities under the Act from the 807.77). " Ou may obtain variational 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/industry/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
6
Indication(s) for Use Statement
510(k) Number:
6
To be assigned by FDA
Device Name: Access Breast Coil
Indications for Use:
The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy bardon
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number