(194 days)
The Nuvo 9000 Endocavitary Coils are three separate receive-only coils used to obtain diagnostic images of the anus, prostate, and cervix. The coils are designed to be inserted into either the rectum or vagina before imaging. The coils are delivered in a sterile state and are disposable, single-use devices. The indications for use are the same as for standard MR Imaging. The Nuvo 9000 Endocavitary Coils are designed for use with MRI Scanners manufactured by Marconi Medical Systems, Inc. and GE Medical Systems, Inc.
The Nuvo 9000 Endocavitary Coils are three receive only RF Coils designed to provide diagnostic images of the anus, prostate and cervix in Magnetic Resonance Imaging. The Nuvo 9000 Endocavitary Coils are singleuse disposable devices that are delivered and packaged in a sterile state. The Nuvo 9000 Endocavitary Coils are designed for use with Marconi Medical Systems and GE Medical Systems MRI Scanners.
The indications for use are the same as for standard imaging:
The Marconi MRI Scanners and GE MRI Scanners are indicated for use as NMR devices that produce 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 Nuvo 9000 Endocavitary Coils are three separate disposable, receive-only MRI coils. The three separate coils are the prostate probe, the cervical probe, and the anal probe. The Nuvo 9000 Endocavitary Coils provide significant improvement in signal-to-noise ratios (SNR) and image resolution. The coils are designed to be inserted into either the rectum or vagina for imaging and can be used in conjunction with the USA Instruments' Insight Plus 9000 Torso and Pelvis Coil. The shape and dimensions of the three coils are similar to ultrasound probes used in endocavitary applications. The coils are housed in a rigid plastic housing and are connected to an interface box via a cable. An external immobilization device is also provided with the coils to stabilize the coil and limit motion. The physical structure of the coils, and use of an immobilization device, increases patient comfort and ease of positioning.
This document describes the Nuvo 9000 Endocavitary Coils, a Magnetic Resonance Imaging (MRI) accessory cleared through a 510(k) premarket notification (K011683). The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the context of diagnostic accuracy.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include specific quantitative acceptance criteria related to diagnostic performance or accuracy, nor does it report such device performance. The submission for the Nuvo 9000 Endocavitary Coils is a 510(k) summary, which typically demonstrates substantial equivalence to a legally marketed predicate device rather than fulfilling performance criteria of a new diagnostic algorithm.
Instead, the submission focuses on comparing the design, materials, intended use, and safety features of the Nuvo 9000 Endocavitary Coils to existing predicate devices. The "Performance" in this context refers to engineering and safety aspects, not diagnostic image interpretation performance.
| Acceptance Criteria (Not Explicitly Stated for Diagnostic Performance) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Safety and Functional Equivalence: | |
| Intended Use: Imaging anus/prostate (rectal insertion), cervix (vaginal insertion). | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410) and Philips Endocavitary MRI Coils (Philips Medical Systems, K930193). |
| Indications for Use: Identical to routine MRI imaging. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410) and Philips Endocavitary MRI Coils (Philips Medical Systems, K930193). |
| Coil Material: GE Cycolac ABS, Sylvan Technologies PVC. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410). |
| Coil Design: Receive-only. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410) and Philips Endocavitary MRI Coils (Philips Medical Systems, K930193). |
| Decoupling: RF Chokes with Switching Diodes. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410). ----------------------------------------------------------------------------------------------------------- |
| Prevention of RF Burns: No RF transmission, decoupling isolates elements, non-conductive housing. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410) and Philips Endocavitary MRI Coils (Philips Medical Systems, K930193). ----------------------------------------------------------------------------------------------------------- |
| Radio Frequency Absorption: Receive-only coil, no RF power transmission. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410) and Philips Endocavitary MRI Coils (Philips Medical Systems, K930193). ----------------------------------------------------------------------------------------------------------- |
| Formation of Resonant Loops: Decoupling isolates elements, cable length/stiffness prevents looping. | Similar to Hammersmith Endocavitary Coils (Marconi Medical Systems, K981410). ----------------------------------------------------------------------------------------------------------- |
| Image Quality: | The device description states, "The Nuvo 9000 Endocavitary Coils provide significant improvement in signal-to-noise ratios (SNR) and image resolution." However, no specific quantitative criteria or study data are provided to substantiate this claim for regulatory purposes in this summary. The basis for safety and effectiveness is largely equivalence to predicate devices, which are already considered safe and effective for producing diagnostic images. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which in this context are primarily related to safety and substantial equivalence, not diagnostic performance) is a comparison to predicate devices. The entire Section 9, "Safety and Effectiveness," is dedicated to detailing how the Nuvo 9000 Endocavitary Coils are "Similar to" other 510(k) cleared products for various features. This constitutes the "study" for a 510(k) submission where direct clinical performance data is not typically required if substantial equivalence can be demonstrated.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of patient data to evaluate algorithmic performance.
- Data Provenance: Not applicable. The "data" here is descriptive comparison to existing, cleared devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth for diagnostic performance is not established in this type of submission. The safety and effectiveness are established by comparison to already cleared devices that are used by trained physicians to interpret images.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No test set requiring expert adjudication for ground truth was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported for the Nuvo 9000 Endocavitary Coils in this summary. The device is an accessory (coil) for MRI, not an AI diagnostic algorithm.
- Effect Size of AI assistance: Not applicable, as this is not an AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: No, a standalone performance study was not conducted or reported. This device is an MRI accessory, not a standalone diagnostic algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for diagnostic performance. For the purpose of this 510(k), the "ground truth" for safety and basic functionality is simply the established safety and functionality of the predicate devices. The "indications for use" for the images produced by MRI scanners (with these coils) rely on interpretation by a "trained physician," indicating that human expert interpretation is the standard for diagnostic "ground truth."
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is an MRI accessory, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable.
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DEC 1 0 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
KOIL 683
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Nuvo 9000 Endocavitary Coils |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,Aurora, Ohio 44202, USATelephone: 330-562-1000; 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 Nuvo 9000 Endocavitary Coils are threeseparate receive-only coils used to obtain diagnosticimages of the anus, prostate, and cervix. The coilsare designed to be inserted into either the rectum orvagina before imaging. The coils are delivered in asterile state and are disposable, single-use devices.The indications for use are the same as for standardMR Imaging. The Nuvo 9000 Endocavitary Coils aredesigned for use with MRI Scanners manufacturedby Marconi Medical Systems, Inc. and GE MedicalSystems, Inc. |
| 8. Device Description: | The Nuvo 9000 Endocavitary Coils are threeseparate disposable, receive-only MRI coils. Thethree separate coils are the prostate probe, thecervical probe, and the anal probe. The Nuvo 9000Endocavitary Coils provide significant improvementin signal-to-noise ratios (SNR) and image resolution.The coils are designed to be inserted into either therectum or vagina for imaging and can be used inconjunction with the USA Instruments' Insight Plus9000 Torso and Pelvis Coil. The shape anddimensions of the three coils are similar toultrasound probes used in endocavitary applications.The coils are housed in a rigid plastic housing andare connected to an interface box via a cable. Anexternal immobilization device is also provided withthe coils to stabilize the coil and limit motion. Thephysical structure of the coils, and use of animmobilization device, increases patient comfort andease of positioning. |
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9. Safety and Effectiveness
| Nuvo 9000 Endocavitary CoilProduct Features | Comparison to predicate device or other510(k) cleared product |
|---|---|
| Intended Use:Imaging the anus or prostate by insertioninto the rectum, and the cervix by insertioninto the vagina | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410)-Similar to the Philips Endocavitary MRI Coilsmanufactured by Philips Medical Systems, Inc.(K930193) |
| Indications for UseIdentical to routine MRI imaging | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410)-Similar to the Philips Endocavitary MRI Coilsmanufactured by Philips Medical Systems, Inc.(K930193) |
| Coil MaterialGE Cycolac ABSSylvan Technologies PVC | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410) |
| Coil DesignReceive-only design | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410)-Similar to the Philips Endocavitary MRI Coilsmanufactured by Philips Medical Systems, Inc.(K930193) |
| DecouplingRF Chokes with Switching Diodes | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410) |
| Prevention of RF BurnsDoes not transmit RF Power, Decouplingisolates the coil elements from RF fieldsduring RF transmission, Coil elements andcircuitry are enclosed in a non-conductivehousing. | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410)-Similar to the Philips Endocavitary MRI Coilsmanufactured by Philips Medical Systems, Inc.(K930193) |
| Radio Frequency AbsorptionCoil is a receive only coil and does nottransmit RF power | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410)-Similar to the Philips Endocavitary MRI Coilsmanufactured by Philips Medical Systems, Inc.(K930193) |
| Formation of Resonant LoopsDecoupling isolates coil elements from RFfields during RF transmission, Length ofcable and stiffness does not allow permitlooping | -Similar to the Hammersmith Endocavitary Coilsmanufactured by Marconi Medical Systems, Inc.(K981410) |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2001
Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OHIO 44202
Re: K011683
Trade/Device Name: Nuvo 9000 Endocavitary Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: September 17, 2001 Received: September 17, 2001
Dear Mr. Thomas:
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 (PMA), it may be subject to 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. Snogdon
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Nuvo 9000 Endocavitary Coils (Anal, Prostate, and Cervix)
Indications for Use: The Nuvo 9000 Endocavitary Coils are three receive only RF Coils designed to provide diagnostic images of the anus, prostate and cervix in Magnetic Resonance Imaging. The Nuvo 9000 Endocavitary Coils are singleuse disposable devices that are delivered and packaged in a sterile state. The Nuvo 9000 Endocavitary Coils are designed for use with Marconi Medical Systems and GE Medical Systems MRI Scanners.
Anatomic Regions: Anus, Prostate, and Cervix Hvdrogen Nuclei Excited:
The indications for use are the same as for standard imaging:
The Marconi MRI Scanners and GE MRI Scanners are indicated for use as NMR devices that produce 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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011683
§ 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.