(87 days)
Not Found
No
The device is a simple latex sheath for an MR coil and the description contains no mention of AI or ML.
No.
The device is a disposable sheath designed to provide a barrier for an MR coil and prevent transfer of microorganisms and fluids during reuse, not to directly treat a patient's medical condition or disease.
No
The device is a sheath designed to cover an MR coil used for endocavitary exams of the cervix. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.
No
The device is a physical latex sheath designed to cover an MR coil, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Cervix Coil Latex Sheath is a protective cover for an MR coil used during imaging procedures. Its primary function is to prevent the transfer of microorganisms, body fluids, and particulate material. It does not analyze or process biological specimens.
- Intended Use: The intended use is to facilitate the safe reuse of an MR coil during endocavitary exams of the cervix. This is a procedural aid, not a diagnostic test performed on a specimen.
The device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cervix Coil Latex Sheath allows use of the coil in MR scanning procedures for endocavitary exams of the cervix while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and health care worker during reuse of the coil. The latex coil cover is furnished as a non-sterile, single use (patient/procedure), disposable device.
Product codes
90 MOS
Device Description
The Cervix Coil Latex Sheath has been specifically designed to fit over the Picker Hammersmith Endocavitary Cervix Coil. The sheath has an extension on the closed end that can be depressed into the center of the coil. This allows placement of the cervix within the MR coil ring without interference from the sheath. This disposable sheath prevents transfer of microorganisms, body fluids, and particulate material during reuse of the coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR scanning
Anatomical Site
cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care worker
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
Testing has demonstrated that the materials / devices are: • non-toxic. • non-sensitizing. • non-irritating. • non-hemolytic. • non-pyrogenic.
Experience and testing has shown that the materials: • have sufficient physical and material properties (i.e. strength and elasticity) for the intended application. • are an effective barrier to the prevention of microbial migration.
Key Metrics
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
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
Class II
General Information 1. Classification:
Classification.
Common/Usual Name:
Magnetic Resonance Imaging Coil Cover/Sheath
Magnetic Resonance Imaging (MRI) Accessory
Proprietary Name:
Establishment Registration:
Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965
Cervix Coil Latex Sheath
Performance Standards:
No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
2. Intended Uses
The Cervix Coil Latex Sheath allows use of the coil in MR scanning procedures for endocavitary exams of the cervix while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and health care worker during reuse of the coil. The latex coil cover is furnished as a non-sterile, single use (patient/procedure), disposable device.
Device Description 3.
The Cervix Coil Latex Sheath has been specifically designed to fit over the Picker Hammersmith Endocavitary Cervix Coil. The sheath has an extension on the closed end that can be depressed into the center of the coil. This allows placement of the cervix within the MR coil ring without interference from the sheath. This disposable sheath prevents transfer of microorganisms, body fluids, and particulate material during reuse of the coil.
Safety and Effectiveness র্ব.
This sheath is substantially equivalent in safety and effectiveness to the CIVCO Latex Ultrasound Transducer Covers. The following table has been provided to demonstrate this substantial equivalence.
1
Substantial Equivalence Chart
| Parameter | Cervix Coil Latex Sheath | Predicate Device
CIVCO Latex Ultrasound
Transducer Cover (K970515) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | One-piece, open on one end,
closed on the other end with
dimensional configurations to
accommodate the
Hammersmith Endocavitary
Cervix Coil. Cover is
externally applied to the MR
coil. | One-piece, open on one end,
closed on the other end with
various dimensional
configurations necessary to
accommodate differences in
ultrasound geometries. Covers
are externally applied to
ultrasound transducer. |
| Material | Same. | Natural rubber latex.
Formulation conforms with the
FDA regulation 21 CFR,
Section 177.2600 and
manufactured according to
cGMP. |
| Manufacturing | Same. | • Dip-molding.
• Packaging in class 10,000
clean room. |
| Safety | Same. | Testing has demonstrated that
the materials / devices are:
• non-toxic.
• non-sensitizing.
• non-irritating.
• non-hemolytic.
• non-pyrogenic. |
| Effectiveness | Same. | Experience and testing has
shown that the materials:
• have sufficient physical and
material properties (i.e. strength
and elasticity) for the intended
application.
• are an effective barrier to the
prevention of microbial
migration. |
| Parameter | Cervix Coil Latex Sheath | Predicate Device
CIVCO Latex Ultrasound
Transducer Cover (K970515) |
| Intended Use / Indications
for Use | The Cervix Coil Latex Sheath
allows use of the coil in MR
scanning procedures for
endocavitary exams of the
cervix while helping to prevent
transfer of microorganisms,
body fluids, and particulate
material to the patient and
health care worker during
reuse of the coil. The latex
coil cover is furnished as a
non-sterile, single use
(patient/procedure), disposable
device. | Protective cover or sheath
placed over diagnostic
ultrasound transducer / probe /
scanhead instruments. The
cover allows use of the
transducer in scanning and
needle guided procedures for
body surface, endocavitary, and
intra-operative diagnostic
ultrasound, while helping to
prevent transfer of
microorganisms, body fluids,
and particulate material to the
patient and health care worker
during reuse of the transducer
(both sterile and non-sterile
covers). The cover also
provides a means for
maintenance of a sterile field
(sterile covers only). CIVCO
Latex Transducer Covers are
furnished sterile & non-sterile;
single use patient / procedure,
disposable. |
| Device body Contact
Category | Same. | • surface devices, intact skin /
mucosal membranes / breached
surfaces, limited contact
duration ( (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)