(224 days)
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No
The summary describes a physical aspiration catheter and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for "evaluation of infertility" through "cervical mucous aspiration," which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states "cervical mucous aspiration for the evaluation of infertility," which indicates the device is used to gather information for diagnostic purposes (evaluating infertility).
No
The device description explicitly states it is a "Cervical Mucous Aspiration Catheter" made from TFE and nylon, which are physical materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cervical mucous aspiration for the evaluation of infertility." This describes a procedure to collect a sample from the body.
- Device Description: The device is a "Cervical Mucous Aspiration Catheter" used for the aspiration of cervical mucous. This is a tool for sample collection.
- Lack of Diagnostic Function: The description focuses on the collection of the sample. There is no mention of the device itself performing any analysis, testing, or interpretation of the collected mucous to provide diagnostic information. IVDs are typically used to examine specimens from the body to provide information about a physiological state, disease, or condition.
This device appears to be a sample collection device, which is a different category than an IVD. The evaluation of infertility would likely be performed on the collected cervical mucous using separate IVD tests or laboratory procedures.
N/A
Intended Use / Indications for Use
The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility.
Product codes (comma separated list FDA assigned to the subject device)
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.1050 Endocervical aspirator.
(a)
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.(b)
Classification. Class II (performance standards).
0
K960263
6
AUG 7 9 1996
510(k) Premarket Notification Cervical Mucous Aspiration Catheter Cook OB/GYN
L 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: Proposed Classification Name: Cervical Mucous Aspiration Catheter 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 device meets the requirements for section 510(k) substantial equivalence.