(194 days)
No
The description focuses on the physical design and function of receive-only MRI coils, which are hardware components for signal acquisition, not software or algorithms for image processing or analysis. There is no mention of AI, ML, or any form of computational analysis of the acquired data within the device itself.
No.
The device is used to obtain diagnostic images and aid in diagnosis, not to provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used to "obtain diagnostic images" and that the images "yield information that can be useful in the determination of a diagnosis."
No
The device description clearly states that the Nuvo 9000 Endocavitary Coils are physical coils housed in a rigid plastic housing, connected by a cable, and include an external immobilization device. These are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Nuvo 9000 Endocavitary Coils are used inside the body (in vivo) to acquire images using Magnetic Resonance Imaging (MRI). They are a component of the MRI system, not a device that analyzes biological samples.
- Intended Use: The intended use is to obtain diagnostic images of specific anatomical sites (anus, prostate, cervix) for interpretation by a trained physician. This is a diagnostic imaging procedure, not an in vitro diagnostic test.
The device description and intended use clearly indicate that this is an imaging accessory used within the body for diagnostic purposes, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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 single-use 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.
Product codes
90 MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Anus, prostate, and cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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, USA | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been |
| issued under Section 514 of the Food, Drug and | |
| Cosmetic Act. | |
| 7. Intended Use: | 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. | |
| 8. Device Description: | 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. |
:
1
9. Safety and Effectiveness
| Nuvo 9000 Endocavitary Coil
Product Features | Comparison to predicate device or other
510(k) cleared product |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:
Imaging the anus or prostate by insertion
into the rectum, and the cervix by insertion
into the vagina | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410)
-Similar to the Philips Endocavitary MRI Coils
manufactured by Philips Medical Systems, Inc.
(K930193) |
| Indications for Use
Identical to routine MRI imaging | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410)
-Similar to the Philips Endocavitary MRI Coils
manufactured by Philips Medical Systems, Inc.
(K930193) |
| Coil Material
GE Cycolac ABS
Sylvan Technologies PVC | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410) |
| Coil Design
Receive-only design | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410)
-Similar to the Philips Endocavitary MRI Coils
manufactured by Philips Medical Systems, Inc.
(K930193) |
| Decoupling
RF Chokes with Switching Diodes | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410) |
| Prevention of 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 the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410)
-Similar to the Philips Endocavitary MRI Coils
manufactured by Philips Medical Systems, Inc.
(K930193) |
| Radio Frequency Absorption
Coil is a receive only coil and does not
transmit RF power | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410)
-Similar to the Philips Endocavitary MRI Coils
manufactured by Philips Medical Systems, Inc.
(K930193) |
| Formation of Resonant Loops
Decoupling isolates coil elements from RF
fields during RF transmission, Length of
cable and stiffness does not allow permit
looping | -Similar to the Hammersmith Endocavitary Coils
manufactured by Marconi Medical Systems, Inc.
(K981410) |
:
2
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.
3
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
4
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