(187 days)
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No
The summary describes a simple aspiration device made of polyurethane and polyethylene, with no mention of software, algorithms, or any technology related to AI/ML.
No
This device is used for diagnostic purposes (to evaluate female pediatric patients with vaginitis and/or possible sexual abuse) by aspirating secretions, not for treating a condition.
Yes
The device is used to aspirate vaginal secretions for evaluation, which implies it's used to gather information for diagnosis.
No
The device description explicitly states it is made from polyurethane and polyethylene, indicating it is a physical device, not software-only.
Based on the provided information, the Pedi Vaginal Aspirator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This typically involves tests performed on the sample itself (e.g., chemical analysis, microscopic examination, genetic testing).
- The Pedi Vaginal Aspirator is a tool used to collect the specimen. Its function is to physically aspirate the vaginal secretions. The diagnostic evaluation happens after the sample is collected, likely in a laboratory setting using other methods.
The device's intended use is to obtain the sample for evaluation, not to perform the evaluation itself. Therefore, it falls under the category of a medical device used for specimen collection, not an IVD.
N/A
Intended Use / Indications for Use
The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse. This device will be made from polyurethane and polyethylene.
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
vaginal
Indicated Patient Age Range
pediatric
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
K9549D3
APR 2 9 1996
6
510(k) Premarket Notification Pedi Vaginal Aspirator Cook OB/GYN
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.
Submitted By:
Tammy Bacon Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 October 24, 1995
Device
Trade Name: Proposed Classification Name: Pedi Vaginal Aspirator Catheter, Pediatric, General & Plastic Surgery
Predicate Devices:
The Pedi Vaginal Aspirator is substantially equivalent to predicate devices in terms of indications for use. Predicate devices include the Bard® Rubber Utility Catheter, Radiopaque manufactured by Bard.
Device Description:
The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse. This device will be made from polyurethane and polyethylene.
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 and physical construction to predicate device meets the requirements for section 510(k) substantial equivalence.