K960263 · Cook Urological, Inc. · HFC · Aug 29, 1996 · Obstetrics/Gynecology
Device Facts
Record ID
K960263
Device Name
CERVICAL MUCOUS ASPIRATION CATHETER
Applicant
Cook Urological, Inc.
Product Code
HFC · Obstetrics/Gynecology
Decision Date
Aug 29, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.1050
Device Class
Class 2
Indications for Use
The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility.
Device Story
Catheter used for aspiration of cervical mucous; facilitates infertility evaluation. Device constructed from TFE and nylon. Operated by clinicians in clinical settings to collect samples. Simple manual aspiration mechanism; no complex electronics or software. Provides collected mucous sample for diagnostic analysis; aids clinical decision-making regarding fertility status.
Clinical Evidence
Bench testing only; biocompatibility testing performed on nylon components to ensure safety.
Technological Characteristics
Materials: TFE and nylon. Form factor: Catheter. Principle: Manual aspiration. Sterilization: Standard procedures consistent with existing Cook OB/GYN devices.
Indications for Use
Indicated for patients undergoing evaluation for infertility requiring cervical mucous aspiration.
Regulatory Classification
Identification
An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.
Predicate Devices
Aspirette Endocervical Aspirator (Unimar)
Submission Summary (Full Text)
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AUG 29 1996
K960263
510(k) Premarket Notification
Cervical Mucous Aspiration Catheter
Cook OB/GYN
## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
### Submitted By:
Tammy Bacon
Cook OB/GYN
1100 West Morgan Street
Spencer, Indiana 47460
(812) 829-6500
January 17, 1996
### Device
Trade Name: Cervical Mucous Aspiration Catheter
Proposed Classification Name: Aspirator, Endocervical
### Predicate Devices:
The Cervical Mucous Aspiration Catheter is substantially equivalent to predicate devices in terms of indications for use and design. Predicate devices include the Aspirette Endocervical Aspirator manufactured by Unimar.
### Device Description:
The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility. The Cervical Mucous Aspiration Catheter will be made from TFE and nylon. TFE is widely known and accepted in the medical field, therefore, biocompatibility is assured. Biocompatibility testing has been performed on the nylon and the results show a reasonable assurance of safety and effectiveness.
### Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
