(99 days)
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Open Breast Coil with Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Open Breast Coil with Biopsy Plates is designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System.
The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil. The coil consists of three sections: 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 ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Open Breast coil with Biopsy plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
The provided text describes a 510(k) premarket notification for a medical device called the "Open Breast Coil with Biopsy Plates." This document is a summary of safety and effectiveness, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with detailed acceptance criteria and performance metrics typically found in clinical trials for new technologies.
Therefore, the requested information for acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fully provided from the given document. The document states that the device is similar to a previously cleared device (Liberty 5000 Breast Coil with Disposable Biopsy Plate manufactured by USA Instruments, Inc. - K022007) and its indications for use are the same as for standard MR imaging. This implies that the device is expected to perform comparably to established MRI technology and its predicate.
Here's an attempt to address the points based on the available information, noting where information is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided document, K050128-21, is a Summary of Safety and Effectiveness for a 510(k) submission. For this type of submission, the primary aim is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than to independently prove its performance against a set of specific, quantifiable acceptance criteria through novel studies. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device.
The study described is a comparison of the modified device's features to those of the predicate device, emphasizing their similarities to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence claim, explicit "acceptance criteria" against specific performance metrics (e.g., sensitivity, specificity, image quality scores) are not detailed in this document. Instead, the "acceptance criteria" are implied to be the established safety and effectiveness profile of the predicate device and standard MRI imaging. The "reported device performance" is essentially that the new device shares similar characteristics and intended use with the predicate, thereby being safe and effective for its intended purpose.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate K022007 and Standard MRI) | Reported Device Performance (as described in the document) |
|---|---|
| Safety: | |
| * No RF burns | - "Does not transmit RF power; decoupling isolates the coil elements from RF fields during RF transmission; coil elements and circuitry are enclosed in a non-conductive housing." - Similar to predicate. |
| * Limited Radio Frequency Absorption (SAR) | - "Coil is a receive-only coil and does not transmit RF power: power deposition during imaging is limited by SAR algorithm." - Similar to predicate. |
| * Prevention of resonant loop formation | - "Decoupling isolates coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping." - Similar to predicate. |
| * Biocompatibility of materials | - Coil Enclosure Material: Polyurethane Plastic, ABS Plastic, Polycarbonate and Delrin. (Implied to be safe and similar to predicate materials). |
| Effectiveness (Imaging Capability): | |
| * Ability to produce MR images of breast and auxiliary tissue | - "The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue." - "Designed to offer optimized imaging capabilities." - Intended use and Indications identical to predicate and routine MRI. |
| * Compatibility with specified MRI scanner | - "Designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System." (This is a specific compatibility criterion that must be met.) |
| * Allows access for biopsy procedures | - "The biopsy plate allows access to the breast anatomy during biopsy procedures." - "Designed to offer... maximum lateral access to each breast for biopsy procedures." - This feature is a direct part of the device design and intended use, similar to the predicate's "Disposable Biopsy Plate." |
| * Maintains comparable image quality to predicate and standard MRI. | - The document does not explicitly present image quality metrics but by stating "Similar to Liberty 5000 Breast Coil with Disposable Biopsy Plate manufactured by USA Instruments, Inc. (K022007)" across multiple design features, it implies comparable performance given the same underlying MRI physics and receiver coil technology. The indication for use being "the same as for standard MR Imaging" also implies meeting established imaging effectiveness standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not reported in this document. Substantial equivalence claims often rely on engineering analysis, component comparisons, and adherence to design specifications rather than clinical test sets with patient data. If any testing involved physical measurements or bench tests, the "sample size" would relate to the number of units tested, but this is not specified.
- Data Provenance: Not applicable/not reported. No patient data, country of origin, or retrospective/prospective nature of a study is mentioned. The comparison is against the design and performance characteristics of a previously cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Qualifications: Not applicable/not reported. As there is no clinical test set with patient images requiring expert interpretation for ground truth, this information is not relevant to this document.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not reported. No test set for clinical performance is described.
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:
- MRMC Study/Effect Size: No. This device is a passive MRI coil accessory, not an AI-powered diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a hardware component (MRI coil), not an algorithm or software. It does not have "standalone" algorithmic performance.
7. The type of ground truth used:
- Type of Ground Truth: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device (K022007) and the principles of standard MRI imaging. The manufacturer is asserting that the new device, due to its similar design and intended use, will perform equivalently without introducing new risks.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/not reported. No machine learning or AI component is described there that would require a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable/not reported, as there is no training set for an algorithm.
In summary, the document fulfills the requirements for a 510(k) submission by demonstrating substantial equivalence through a detailed comparison of the new device's features and intended use to those of a predicate device. It does not contain information about clinical studies with specific performance metrics, patient sample sizes, or expert adjudication, as would be expected for a novel diagnostic algorithm or a device requiring new clinical evidence of effectiveness.
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K050128-21
r
SUMMARY OF SAFETY AND EFFECTIVENESS
.
| 1. Device Name: | Magnetic Resonance Image Accessory |
|---|---|
| 2. Proprietary Name: | Open Breast Coil with Biopsy Plates |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,Aurora, Ohio 44202, USATelephone: 330-995-8572; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Open Breast Coil with Biopsy Plates is a phasedarray, receive-only MRI coil, used for obtaining MRimages of the breast and auxiliary tissue. The biopsyplate allows access to the breast anatomy duringbiopsy procedures. No biopsy needles are includedwith, or packaged with the Open Breast Coil withBiopsy Plates. The indications for use are the sameas for standard MR Imaging. The Open Breast Coilwith Biopsy Plates is designed for use with the 0.3TAiris-Elite MRI scanner manufactured by HitachiMedical System. |
| 8. Device Description: | The Open Breast Coil with Biopsy Plates is a phasedarray, receive-only MRI coil. The coil consists ofthree sections: a supporting base and two insulatingcoil chambers, one for each breast. Each of thehollow coil chambers houses two coil elements thatare insulated from the patient by a ridged plastichousing. The coil housing is made of plasticmaterials, which are fire rated and have high impactand tensile strength. The Open Breast coil withBiopsy plates is designed to offer optimized imagingcapabilities and maximum lateral access to eachbreast for biopsy procedures. |
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9. Safety and Effectiveness
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| Modified Device Features | Comparison to Baseline Device |
|---|---|
| Intended Use: Breast imaging fordiagnostic purposes. The coil has abiopsy plate that allows access to thebreast. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Indications for Use: Identical to routineMRI imaging. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Coil Enclosure Material: PolyurethanePlastic, ABS Plastic, Polycarbonate andDelrin. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Coil Design: Receive-only phased arraydesign. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Decoupling: RF Chock with SwitchingDiode. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Prevention of RF Burns: Does nottransmit RF power; decoupling isolatesthe coil elements from RF fields duringRF transmission; coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Radio Frequency Absorption: Coil is areceive-only coil and does not transmitRF power: power deposition duringimaging is limited by SAR algorithm. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
| Formation of Resonant Loop:Decoupling isolates coil elements fromRF fields during RF transmission; lengthof cable and stiffness does not permitlooping. | -Similar to Liberty 5000 Breast Coil with DisposableBiopsy Plate manufactured by USA Instruments,Inc. (K022007) |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines extending from the eagle's head.
Food and Drug Administration 9200 Côrporate Boulevard Rockville MD 20850
Mr. David S. Brown Manager, QA/RA USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K050728 Trade/Device Name: Open Breast Coil with Biopsy Plates Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: MOS Dated: June 6, 2005 Received: June 10, 2005
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have icenced your bettler. been) programially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosate) to regally mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the chavinent 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 do fiot require approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the generation, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUN 2 8 2005
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your de roo be subject to such additional controls. Existing major regulations affecting your / Ipplo vary, it ifal 70 od ot 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 I Toase of determination that your device complies with other requirements of the Act or any I Dri has made a advertising administered by other Federal agencies. You must comply with all the I carrar suiteres and regulating, 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) (21 CFF CFR 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 hils letter witi anow you to organization of substantial equivalence of your device to a legally prematice notification: - The sification 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 desire specific ac no 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, proase note the regulation on your responsibilities under the Act from the 807.77). Tou may ooum ourers, 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/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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Page 1 of 1
510(k) Number (if known):_ ズクイップし
Device Name: Open Breast Coil with Biopsy Plates
Indications for Use: The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in quidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
Anatomic Regions: Breast Anatomy Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use(Per 21 CFR 801.109) | |
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| Over-The-Counter Use(Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K050728 |
§ 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.