(59 days)
Not Found
No
The summary describes a foam pack for medication administration and hydration, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as administering liquid medication and hydrating for the sinus, which directly addresses a health condition (sinus issues) and provides a therapeutic effect.
No
The device is used for "administration of liquid medication and hydrating for the sinus," which describes a therapeutic or treatment function, not a diagnostic one.
No
The device description "Expandacell Injecto-Pak Foam Pack" clearly indicates a physical, hardware-based medical device (foam pack for medication administration). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "administration of liquid medication and hydrating for the sinus." This describes a device used in vivo (within the body) for treatment and hydration, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description "Expandacell Injecto-Pak Foam Pack" suggests a physical device used for delivery or support within the sinus.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is clearly related to direct patient care within the sinus cavity.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus, nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
0
SMDA SUMMA for Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92
SAFETY AND EFFECTIVENESS OF EXPANDACELL INJECTO-PAK FOAM PACK FOR ADMINISTRATION OF LIQUID MEDICATION AND HYDRATING FOR THE SINUS
No specific medication is mentioned. The physician will choose medication indicated.
This proposed change to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Expandacell Sinus Pack K935724/S1, Expandacell Injecto-Pak, K954845, and the Expandacell Injecto-Pak K960228 have a proven track record that establishes this product line as safe to the post-operative nasal or post-operative sinus surgery patient. The modification of adapting this product for use in the sinus does not change the safety or effectiveness of this device.
The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate devices stated.
The Toxic Shock issue has been addressed in previous 510(k) applications and this product line addresses this issue on its instructions. Appropriate warning and directions are given for symptoms and appropriate care.
Sarah Maxwell Lake
Signature
May 22, 1994
Date
filename: 510KINJS.doc