← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K052045 # ACCESS BREAST COIL (K052045) _Confirma, Inc. · MOS · Aug 24, 2005 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K052045 ## Device Facts - **Applicant:** Confirma, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Aug 24, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended 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. ## Device Story Access Breast Coil is a 7-channel, phased array, receive-only RF coil for use with Siemens 1.5T MRI scanners. Device captures MR signals from breast, chest wall, and axillary tissues; transforms signals into diagnostic and interventional images. Features open design with integrated lighting to facilitate lateral, medial, and cranial-caudal interventional access. Includes patient positioning accessories (headrest, armrest, torso pad) to enhance comfort and minimize motion artifacts. Operated by clinicians in a clinical setting; output viewed by physicians to guide biopsies and localize lesions. Benefits include improved imaging access and patient ergonomics during interventional MRI procedures. ## Clinical Evidence Bench testing only. No clinical data provided. Device performance validated through risk analysis, design verification, and validation testing to ensure image quality comparable to predicate devices. ## Technological Characteristics 7-channel phased array, receive-only RF coil. Materials: rigid plastic housing (fire-rated, high impact/tensile strength). Form factor: bilateral open design with large apertures. Connectivity: compatible with Siemens 1.5T MRI systems. Integrated lighting for interventional procedures. Positioning accessories: headrest, armrest, torso pad. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Liberty 9000 Breast Coil ([K000993](/device/K000993.md)) - Machnet Bilateral Open Breast Coil ([K013985](/device/K013985.md)) - Biopsy Breast Coil BBC-127 ([K041481](/device/K041481.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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}------------------------------------------------ K052045 # 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K052045](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K052045) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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