(27 days)
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.
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
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 .
This document describes a 510(k) submission for the "Access Breast Coil" and primarily focuses on establishing substantial equivalence to existing legally marketed devices, rather than a detailed study proving the device meets specific acceptance criteria in the way a new AI/software device would. Therefore, many of the requested data points are not directly available or applicable in the provided text.
Based on the nature of this submission (a medical device coil for MRI), the "acceptance criteria" discussed are largely related to safety, performance comparable to predicate devices, and meeting regulatory standards for a Class II magnetic resonance diagnostic device. The "study" mentioned is more accurately described as a validation process during development and comparison to predicate devices.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device materials are plastic, fire-rated, high impact/tensile strength. No specific performance metrics are given for patient safety other than design features. | "The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength." "Ergonomically designed for patient comfort to minimize motion artifact." |
| Imaging Performance (Diagnostic Capability): Produce diagnostic images comparable to predicate devices. Optimize for parallel imaging, extensive coverage, high SNR. | "7-channel phased array design uses multiple elements that surround the breast tissue." "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." "Coil provides images comparable to the predicate devices." |
| Interventional Access: Allow lateral, medial, and cranial-caudal access comparable to or better than predicate devices. | "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." "The Access Breast Coil is designed to allow for lateral, medial and cranial-caudal access to the breast." |
| Compatibility: Compatible with specified MRI systems. | "Compatible with Siemens 1.5T MRI systems." |
| Substantial Equivalence: Demonstrate equivalence to legally marketed predicate devices. | Declared substantially equivalent to Liberty 9000 Breast Coil (K000993), Machnet Bilateral Open Breast Coil (K013985), and Biopsy Breast Coil BBC-127 (K041481). "The Access Breast Coil is substantially equivalent to the identified legally marketed devices." |
| Regulatory Compliance: Meet general controls and specific regulations for magnetic resonance diagnostic devices. | "The product development process, including risk analysis, test and verification and validation testing, design considerations, and labeling have been studied and controlled and controlled as part of the product as relephanned." (This sentence is slightly garbled but implies a robust development process). "FDA's issuance of a substantial equivalence determination... permits your device to proceed to the market." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of human subject data or image datasets with a defined sample size for performance evaluation. The submission relies on engineering validation, verification, and comparison to predicate devices. There is no mention of a clinical study with a specific sample size of patients or images used to prove the device's diagnostic or interventional performance in a statistical sense beyond what is assumed by comparison to predicate devices. Therefore, sample size for a test set and data provenance (country, retrospective/prospective) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the submission does not detail a formal study involving expert review of a test set. The interpretation of images from the device is stated to be by a "trained physician," but this is a general statement about usage, not a specific ground truth establishment for a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as there is no described test set or expert ground truth establishment and review process that would involve adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for evaluating AI/software performance with human readers. This submission is for an MRI coil, a hardware device, and thus does not involve AI or human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a hardware device (an MRI coil), not an algorithm or software. Therefore, a standalone performance evaluation of an algorithm without human-in-the-loop is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a specific type of ground truth used for a formal performance study in the way one would for evaluating a diagnostic algorithm. The implicit "ground truth" for demonstrating equivalence is that the images produced by the Access Breast Coil are considered "comparable to the predicate devices" when interpreted by a trained physician, which suggests a general equivalence of image quality and diagnostic utility, rather than a specific clinical validation against pathology or outcomes.
8. The sample size for the training set
This information is not applicable/not provided. This is a hardware device, not a machine learning model, so there is no training set in that context.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As a hardware device, there is no training set that requires ground truth establishment.
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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 AvenueKirkland, 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.
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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
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- 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.
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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.
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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.
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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
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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
§ 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.