(14 days)
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The E-scan is a magnetic resonance diagnostic device. The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.
The provided 510(k) summary does not contain the detailed information typically required to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device submission. This document pertains to an MRI system (E-Scan) and a new receiving coil, filed in 2001, long before the widespread use and regulatory frameworks for AI/ML in medical devices.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will address what information is available and explain why other fields are missing or not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for E-Scan MRI System (Receiving Coil)
The submission focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating that the addition of a "Multipurpose Flexible Receiving Coil" does not alter the fundamental scientific technology of the cleared device (Esaote E-Scan K001894). The acceptance criteria are implicitly tied to maintaining the safety and effectiveness profile of the predicate device.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain existing diagnostic capabilities of the predicate MR system. | The E-scan, with the Multipurpose Flexible Receiving Coil, is intended for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, and forearm. It produces sectional images displaying internal structure. If interpreted by a medical expert, these images can provide diagnostically useful information. |
| The Multipurpose Flexible Receiving Coil should not negatively impact safety or fundamental technology. | "The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device." The coil is noted to be usable for shoulder and knee, especially for patients with painful or plastered limbs, suggesting improved patient access/comfort. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document does not describe a clinical study or test set in the way an AI/ML validation would. It primarily focuses on the technical characteristics of the new coil and its intended use.
- Data Provenance: Not applicable. There's no mention of specific data used for a test set that would have provenance like country of origin or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The submission states that images, "If interpreted by a medical expert, these images can provide diagnostically useful information," but doesn't detail their role in a specific test for the coil.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. No specific test set or adjudication process 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: No, an MRMC study was not done.
- Effect Size of AI assistance: Not applicable. This submission is for an MRI system and a mechanical coil, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an AI/ML algorithm. The device produces images that "If interpreted by a medical expert, these images can provide diagnostically useful information," clearly indicating human interpretation is part of its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated as part of a formal validation study. For an MRI system, the "ground truth" for image quality and diagnostic utility is typically established by comparing the images produced to established anatomical knowledge, clinical expectations, and the ability of human experts to make diagnoses from them. No specific methodology for establishing such ground truth in the context of this specific submission (for the new coil) is detailed beyond its intended use for diagnostic imaging.
8. The sample size for the training set:
- Sample Size: Not applicable. This is not an AI/ML algorithm that required a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. This is not an AI/ML algorithm that required a training set.
Summary of what can be gleaned about the "study" for this device:
The "study" for this 510(k) submission primarily involved demonstrating that the new Multipurpose Flexible Receiving Coil is consistent with the established safety and effectiveness of the predicate E-Scan MRI system (K001894). The key "performance" claim is that the new coil "improves the system performance and does not alter the fundamental scientific technology of the cleared device," and that it can be used for various anatomical regions, including those that might be challenging with other coils (e.g., painful or plastered limbs). This substantial equivalence argument is based on technical specifications and comparison to existing devices rather than a formal clinical trial or AI/ML validation study.
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510(k) Summar E-Scan Biosound Esaote
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
| Colleen Hittle, Official Correspondent8000 Castleway DriveIndianapolis, IN 46250 | |
|---|---|
| Phone: | (317) 849-1916 |
| Facsimile: | (317) 577-9070 |
| Contact Person: | Colleen Hittle |
| Date: | August 6, 2001 |
| 807.92(a)(2) | |
| Trade Name: | E-Scan |
| Common Name: | Magnetic resonance diagnostic device |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification Number: | 90LNH 90 MOS |
| 807.92(a)(3) |
Predicate Device(s)
| Esaote | E-Scan K001894 |
|---|---|
| -------- | ---------------- |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
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510(k) Summary E-Scan Biosound Esaote
807.92(a)(5)
Intended Use(s)
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, The E-Stan Is Inchood for dagliourist, hand, calf, thigh, arm and forearm The device Knee, ankle, foot, shoulder, cloow, wils, hand, edit, sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-latice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
807.92(a)(6)
Technological Characteristics
The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.
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3 Fork) Summar.
E-Sean
Biosound Esaote
| E-scanWith MultipurposeFlexible ReceivingCoil | Comments |
|---|---|
| Shoulder coil No.1:17.5 x 12.6 x 14.5 cm(w x d x h)Shoulder coil No. 5:16.8 x 7.9 x 15.5 cm(w x d x h)Multipurpose flexible coil:22 x 32.5 x 32.5(short axis x long axis) | The Multipurpose flexible coil substitutescompletely the Hip Coil. For itscharacteristics the flex coil can be used toexam the shoulder and the knee too,especially for patient with painful or inplaster limb.See example for the Flexible body Coil(hip and other regions) – 20x150 cm (wxd)- of the AIRIS HITACHI (K945155) |
Substantial Equivalence Comparison Table
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioSound Esaote, Inc. % Ms. Colleen J. Hittle The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 AUG 2 9 2001
-und Esaote, inc.
- Colleen J. Hittle
_nson Group
Castleway Drive
anolis Indiana 46250
Re: K012728 E-Scan MRI System (Receiving Coil) Dated: August 6, 2001 Received: August 15, 2001 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we device is we nave revel your section 710(s) nothedited with the enclosure) to legally marketed predicate devices marketed in interstate subsancery of the monenent to the notenent of the Medical Device Amendments, or to devices that have been reclassified in commerce with the provisions of the Federal Food, Divg, and Cosmetic Act (Act). You may, therefore, market the device, subject to ation and white 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 succ If your device to classinot (coo no vegulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 800 to 07.1 A substantial.) equality System Regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may Qs illsponolis, all 1 od alle Drag Pramination (Slish futher announcements concerning your device in the Federal Register. Please result it tegulatory action. In addition submission does not affect any obligation you might have under sections $31 through note: and response to your premaine Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
(301) 594-4591 8xx.1xxx 876.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4616 (301) 594-4616 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4654 892.2xxx, 3xxx, 4,xxx, 5xxx (301) 594-4692 Other
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications For Use
510(k) Number (if known):
Kc/2728
Device Name:
E-Scan
Indications for Use:
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, The E-scan is included for dagatosto nacious naments of the device produces transverse, sagittal, soronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation that check the naginette resoluntion properties cle depsity, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter Use
Nancy Choodon
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012728
§ 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.