Who is the manufacturer of CERVIX COIL LATEX SHEATH?

Philips Medical Systems (Cleveland), Inc. filed the 510(k) submission for CERVIX COIL LATEX SHEATH (K981406).

What is the FDA product code for CERVIX COIL LATEX SHEATH?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CERVIX COIL LATEX SHEATH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CERVIX COIL LATEX SHEATH?

CIVCO Latex Ultrasound Transducer Cover (K970515).

Who can help prepare an FDA 510(k) submission like CERVIX COIL LATEX SHEATH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CERVIX COIL LATEX SHEATH

K981406 · Philips Medical Systems (Cleveland), Inc. · MOS · Jul 16, 1998 · Radiology

Device Facts

Record ID	K981406
Device Name	CERVIX COIL LATEX SHEATH
Applicant	Philips Medical Systems (Cleveland), Inc.
Product Code	MOS · Radiology
Decision Date	Jul 16, 1998
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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.

Device Story

Disposable latex sheath; designed to fit over Picker Hammersmith Endocavitary Cervix Coil; features extension on closed end to allow coil placement without interference. Used in clinical MRI settings; applied by healthcare personnel. Acts as physical barrier to prevent transfer of microorganisms, body fluids, and particulates during endocavitary exams. Benefits patient and staff by facilitating hygienic reuse of MR coil.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established via material property testing (strength, elasticity) and barrier performance validation consistent with predicate device standards.

Technological Characteristics

Material: Natural rubber latex (conforms to 21 CFR 177.2600). Form factor: One-piece, open-ended sheath with specific geometry for Hammersmith Endocavitary Cervix Coil. Manufacturing: Dip-molding in class 10,000 clean room. Non-sterile, single-use disposable.

Indications for Use

Indicated for patients undergoing MR scanning procedures for endocavitary exams of the cervix. Used to prevent cross-contamination between patients and healthcare workers during coil reuse.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

CIVCO Latex Ultrasound Transducer Cover (K970515)

Related Devices

K961029 — KILTEX PROBE COVER · Kiltex Corp. · Jul 25, 1996
K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER · Contour Fabricators, Inc. · Jan 30, 1997
K970515 — GENERAL PURPOSE LATEX TRANSDUCER COVERS · CIVCO Medical Instruments Co., Inc. · Jun 20, 1997
K213087 — Natural Rubber Latex Ultrasound Transducer Probe Covers · Global Protection Corp. · Jun 7, 2022
K974301 — CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER · Clk Intl., Inc. · Feb 6, 1998

Submission Summary (Full Text)

{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. 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 (< 24 hours). • external communicating devices, blood path indirect / tissue communicating, limited contact 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: 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. (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) OR Over-The-Counter Use (Optional Format 1-2-96)