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 healthcare worker during reuse of the coil. The latex coil cover is furnished as a non-sterile, single use (patient/procedure), disposable device.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cervix Coil Latex Sheath, based on the provided document:

The device, a "Cervix Coil Latex Sheath," is a Class II device intended to allow the use of an MRI coil in endocavitary exams of the cervix while preventing the transfer of microorganisms, body fluids, and particulate material. It's a non-sterile, single-use, disposable device. The submission focuses on demonstrating substantial equivalence to a predicate device, the CIVCO Latex Ultrasound Transducer Covers (K970515), rather than providing detailed acceptance criteria and a study to meet those criteria in a typical performance study format. The "study" here is essentially the comparison and justification of equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the predicate device, and the "reported device performance" is the claim that the Cervix Coil Latex Sheath shares these characteristics.

Parameter	Predicate Device (CIVCO Latex Ultrasound Transducer Cover, K970515) - Implied Acceptance Criteria	Cervix Coil Latex Sheath - Reported Device Performance
Design	One-piece, open one end, closed other, various dimensional configurations to accommodate ultrasound geometries, externally applied.	One-piece, open one end, closed other with dimensional configurations to accommodate the Hammersmith Endocavitary Cervix Coil, externally applied.
Material	Natural rubber latex, formulation conforms with 21 CFR, 177.2600, manufactured according to cGMP.	Same (Natural rubber latex, formulation conforms with 21 CFR, 177.2600, manufactured according to cGMP).
Manufacturing	Dip-molding, packaging in class 10,000 clean room.	Same (Dip-molding, packaging in class 10,000 clean room).
Safety	Non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic.	Same (Implied to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic due to identical material and manufacturing).
Effectiveness	Sufficient physical and material properties (strength, elasticity), effective barrier to microbial migration.	Same (Implied to have sufficient physical/material properties and be an effective barrier to microbial migration due to identical material and manufacturing).
Intended Use / Indications	Protective cover for diagnostic ultrasound transducers, prevents transfer of microorganisms/body fluids/particulate material during reuse, maintains sterile field (for sterile covers).	Allows use of coil in MR scanning for endocavitary exams of cervix, helps prevent transfer of microorganisms/body fluids/particulate material during reuse.
Device Body Contact Category	Surface devices, intact skin/mucosal membranes/breached surfaces, limited contact (<24 hrs); external communicating devices, blood path indirect/tissue communicating, limited contact (<24 hrs).	Same (Surface devices, intact skin/mucosal membranes/breached surfaces, limited contact (<24 hrs); external communicating devices, blood path indirect/tissue communicating, limited contact (<24 hrs)).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the traditional sense of a performance study with a test set of data. The "test" here is the comparative analysis against the predicate device's established characteristics.
Data Provenance: The document focuses on demonstrating conceptual and material equivalence rather than providing performance data from a specific "test set." The predicate device's data would be considered prior knowledge.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. There isn't a "test set" requiring expert ground truth establishment for this type of submission.

4. Adjudication Method:

Not applicable. No expert adjudication process 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:

Not applicable. This is not an AI/imaging diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device accessory, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the assessment of the Cervix Coil Latex Sheath is the established safety and effectiveness profile of the predicate device, the CIVCO Latex Ultrasound Transducer Cover, as demonstrated through its own testing and market experience. The manufacturer argues that because the new device is "substantially equivalent" in design, material, manufacturing, and intended performance, it inherits the predicate's ground truth for safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set is involved.

Summary

{0}------------------------------------------------

K981406.

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.

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 DeviceCIVCO Latex UltrasoundTransducer Cover (K970515)
Design	One-piece, open on one end,closed on the other end withdimensional configurations toaccommodate theHammersmith EndocavitaryCervix Coil. Cover isexternally applied to the MRcoil.	One-piece, open on one end,closed on the other end withvarious dimensionalconfigurations necessary toaccommodate differences inultrasound geometries. Coversare externally applied toultrasound transducer.
Material	Same.	Natural rubber latex.Formulation conforms with theFDA regulation 21 CFR,Section 177.2600 andmanufactured according tocGMP.
Manufacturing	Same.	• Dip-molding.• Packaging in class 10,000clean room.
Safety	Same.	Testing has demonstrated thatthe materials / devices are:• non-toxic.• non-sensitizing.• non-irritating.• non-hemolytic.• non-pyrogenic.
Effectiveness	Same.	Experience and testing hasshown that the materials:• have sufficient physical andmaterial properties (i.e. strengthand elasticity) for the intendedapplication.• are an effective barrier to theprevention of microbialmigration.
Parameter	Cervix Coil Latex Sheath	Predicate DeviceCIVCO Latex UltrasoundTransducer Cover (K970515)
Intended Use / Indicationsfor Use	The Cervix Coil Latex Sheathallows use of the coil in MRscanning procedures forendocavitary exams of thecervix while helping to preventtransfer of microorganisms,body fluids, and particulatematerial to the patient andhealth care worker duringreuse of the coil. The latexcoil cover is furnished as anon-sterile, single use(patient/procedure), disposabledevice.	Protective cover or sheathplaced over diagnosticultrasound transducer / probe /scanhead instruments. Thecover allows use of thetransducer in scanning andneedle guided procedures forbody surface, endocavitary, andintra-operative diagnosticultrasound, while helping toprevent transfer ofmicroorganisms, body fluids,and particulate material to thepatient and health care workerduring reuse of the transducer(both sterile and non-sterilecovers). The cover alsoprovides a means formaintenance of a sterile field(sterile covers only). CIVCOLatex Transducer Covers arefurnished sterile & non-sterile;single use patient / procedure,disposable.
Device body ContactCategory	Same.	• surface devices, intact skin /mucosal membranes / breachedsurfaces, limited contactduration (< 24 hours).• external communicatingdevices, blood path indirect /tissue communicating, limitedcontact duration (< 24 hours)

1977

(SHEATH)

{2}------------------------------------------------

(SHEATH)

•

。

I - 3

{3}------------------------------------------------

Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

JUL 1 6 1998

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Cleveland, OH 44143

Re:

K981406 Cervix Coil Latex Sheath Dated: April 15, 1998 Received: April 20, 1998 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Keeler:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General 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 result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the 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 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmarn.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

K981406 510(k) Number (if known): _

Cervix Coil Latex Sheath Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oavid C. Seijam
(Division Sign-Off).

Division of Reproductive, Abdominal, EN and Radiological Devi

510(k) Number KAY1406

Prescription Use > (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.