(15 days)
No
The document describes a passive receiving coil for an MRI system and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The device is used for imaging and diagnostic purposes, not for treating or rehabilitating a condition.
Yes
The text states, "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This explicitly indicates the device's role in providing diagnostic information.
No
The device description clearly details a physical coil with hardware components (copper tubes, capacitors, PIN diodes, connecting cable, mechanical connections) designed to be used with an MRI system. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The G-scan Cervical Spine Coil is a component of an MRI system. It is a physical coil that is placed around the patient's neck to facilitate the acquisition of MR images of the cervical spine.
- Intended Use: The intended use is for MR imaging of the cervical spine. The output is images, which are then interpreted by a medical expert.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. It interacts directly with the patient's body to generate images based on the magnetic properties of the tissues.
Therefore, the G-scan Cervical Spine Coil falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The G-scan Cervical Spine Coil is to be used in MR imaging of the cervical section of the spine column.
G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.
G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Product codes
90MOS
Device Description
The Cervical Spine Coil is to be used with the MRI system G-scan, cleared via K042236.
This is a solenoidal linear receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's cervical vertebrae; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
The patient's neck is inserted into the coil after the coil itself has been opened by means of nonmagnetic contacts inserted in the coil loops.
The height of the patient's head can be regulated by a suitable mechanism with a lever command. A special cushion is attached to the coil assuring that the patient maintains comfortably his position during the examination.
The mechanical connection between the coil and the patient table is provided through a mechanism that positions the coil at the proper position for a cervical examination.
The coil is equipped with a connecting cable, which must be fitted to the connector on the patient table for proper electrical wiring and for automatic coil model recognition.
The coil resonator is composed of 3 copper tubes each one with two couples of non-magnetic contacts, the three tubes are arranged in a circular path and connected in series and with 3 tuning capacitors groups.
De-coupling between the transmitting and the receiving coil is accomplished via a couple of PIN diodes in a passive circuit. During the RF transmitting pulse, the diodes placed in the receiving coil decoupling circuit are switched on by the pulse and enable a LC parallel resonating circuit, at the working frequency, so that the overall impedance of the coil becomes very high and the parasitic current is minimised.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
cervical section of the spine column; portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip; portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in the use of MR equipment
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
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
510(k) Sammary (1-sean Esaote. Sp A
AUG 1 6 2005
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham, Official Correspondent
7992 Castleway Drive
Indianapolis, IN 46250
| Phone: | (317) 849-1916 x103 |
|---|---|
| Facsimile: | (317) 577-9070 |
| Contact Person: | Carri Graham |
| Date: | July 29, 2005 |
807.92(a)(2)
| Trade Name: | G-scan |
|---|---|
| Common Name: | Coil, Magnetic Resonance Specialty |
| Classification Name(s): | Magnetic Resonance Diagnostic Device |
| Classification Number: | 90MOS |
807.92(a)(3)
Predicate Device(s)
| Esaote | G-scan | K042236 |
|---|---|---|
| -------- | -------- | --------- |
1
S 10(k) Summar. ( r-scan Esacte. Sp A
807.92(a)(4)
Device Description
The Cervical Spine Coil is to be used with the MRI system G-scan, cleared via K042236.
This is a solenoidal linear receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's cervical vertebrae; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
The patient's neck is inserted into the coil after the coil itself has been opened by means of nonmagnetic contacts inserted in the coil loops.
The height of the patient's head can be regulated by a suitable mechanism with a lever command. A special cushion is attached to the coil assuring that the patient maintains comfortably his position during the examination.
The mechanical connection between the coil and the patient table is provided through a mechanism that positions the coil at the proper position for a cervical examination.
The coil is equipped with a connecting cable, which must be fitted to the connector on the patient table for proper electrical wiring and for automatic coil model recognition.
The coil resonator is composed of 3 copper tubes each one with two couples of non-magnetic contacts, the three tubes are arranged in a circular path and connected in series and with 3 tuning capacitors groups.
De-coupling between the transmitting and the receiving coil is accomplished via a couple of PIN diodes in a passive circuit. During the RF transmitting pulse, the diodes placed in the receiving coil decoupling circuit are switched on by the pulse and enable a LC parallel resonating circuit, at the working frequency, so that the overall impedance of the coil becomes very high and the parasitic current is minimised.
807.92(a)(5)
Intended Use(s)
The G-scan Cervical Spine Coil is to be used in MR imaging of the cervical section of the spine column.
G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.
G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-latice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
The indications for use of the G-scan MRJ system with the Cervical Spine Coil are the same as those for the G-scan previously cleared via K 042236.
2
Technological Characteristics
The technological characteristics of the Cervical Spine Coil are similar to the characterisities of the predicate device linear receiving coils.
presided device intear received ally adapted to the examined area for increasing the Signal-to-Noise Ratio.
| Characteristics | G-scan
K042236 | Modified
G-scan |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cervical Spine Coil | Linear Receiving Coils:
- Shoulder coil 1: 22.4 x 21.6 x 12.6 cm
(h x w x d) external; 14.5 x 17.5 x 12.6 cm (h x w x d) internal - Flexible coil 6: 4.0 x 33.0 x 28.5 cm (h x w x d) maximum external
- Thoracic 8 - Lumbar Spine coil: 4.5 x 32.2 x 28.4 cm (h x w x d) maximum external
DPA Receiving Coils:
- Knee coil 2: 22.5 x 21.0 x 18.3 cm (h x w x d) external; 14.3 x 16.0 x 18.3 cm (h x w x d) internal
- Hand coil 3: 17.8 x 17.5 x 20 cm (h x w x d) external; 11.9 x 7.2 x 20 cm (h x w x d) internal
- Foot/Ankle coil 4: 22.0 x 19.2 x 28.5 cm (h x w x d) external; 14.6 x 10.0 x 28.5 cm (h x w x d) internal
- Shoulder coil 7: 21.5 x 30.0 x 21.8 cm (h x w x d) maximum external | Linear Receiving Coils:
- Shoulder coil 1: 22.4 x 21.6 x 12.6 cm
(h x w x d) external; 14.5 x 17.5 x 12.6 cm (h x w x d) internal - Flexible coil 6: 4.0 x 33.0 x 28.5 cm (h x w x d) maximum external
- Thoracic 8 – Lumbar Spine coil: 4.5 x 32.2 x 28.4 cm (h x w x d) maximum external
- Cervical Spine Coil 9: 26.4 x 32.1 x 36.6 cm (h x w x d) maximum external; 17.5 x 15.1 x 5.0 cm (h x w x d) internal
DPA Receiving Coils:
- Knee coil 2: 22.5 x 21.0 x 18.3 cm (h x w x d) external; 14.3 x 16.0 x 18.3 cm (h x w x d) internal
- Hand coil 3: 17.8 x 17.5 x 20 cm (h x w x d) external; 11.9 x 7.2 x 20 cm (h x w x d) internal
- Foot/Ankle coil 4: 22.0 x 19.2 x 28.5 cm (h x w x d) external; 14.6 x 10.0 x 28.5 cm (h x w x d) internal
- Shoulder coil 7: 21.5 x 30.0 x 21.8 cm (h x w x d) maximum external |
Substantial Equivalence Comparison Table
3
Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of a bird or eagle in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle, framing the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Esaote, S.p.A. % Ms. Carri Graham Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250
AUG 1 6 2005
Re: K052077
Trade/Device Name: G-scan Cervical Spine Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: July 29, 2005 Received: August 1, 2005
Dear Ms. Graham:
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.
4
This letter will allow you to begin marketing your device as described in your Section 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:
| 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 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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
Enclosure
5
Indications for Use
510(k) Number (if known): Kos 20 77
Device Name: G-scan Cervical Spine Coil
Indications for Use:
The G-scan Cervical Spine Coil is to be used in MR imaging of the cervical section of the spine column.
G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.
G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Prescription Use X (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 C. Brogdon
Page 1 of 1
(Division Sigh Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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