(23 days)
Not Found
No
The device description focuses on the material and physical properties of a nasal and sinus packing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a packing material used to absorb fluids and provide pressure after surgery or for nosebleeds; it does not claim to treat or cure a disease or condition, which is characteristic of a therapeutic device.
No
Explanation: The device is a nasal and sinus packing designed to absorb fluids and provide pressure after surgery or for epistaxis. Its function is descriptive of a therapeutic device (aiding recovery or managing a condition), not a diagnostic one (identifying or characterizing a medical condition).
No
The device description clearly states it is a physical sponge made from formalized PVA, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb fluids, provide pressure, and fill space within the nasal and sinus cavities after surgery or for controlling nosebleeds. This is a direct interaction with the body for a therapeutic or supportive purpose.
- Device Description: The device is a physical sponge made from formalized PVA. It is inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health status. This device does not perform any such analysis or testing of biological samples.
The device is a medical device, but it falls under a different category than IVDs. It's a surgical/post-surgical aid for wound management and support within the nasal and sinus cavities.
N/A
Intended Use / Indications for Use
Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose Thev are packaged individually as a sterile, dried and compressed sponge that is bleeds). inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.
Product codes
Not Found
Device Description
M-PACT will market the products under the trade names Clinicel and IVALON. The classification name for the device is evistaxis balloon (per 21 CFR section 874.4100).
M-PACT nasal and sinus packings are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde. Once the chemical reaction has taken place and the foam sponge has cured, the material is washed clean of any residual chemicals.
M-PACT's nasal and sinus products will be sold in different configurations with drawstrings and with and without airway tubes. The products will be provided sterile via gamma radiation in industry standard Tyvek/film and metalized polyester peelable pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, Sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K96 4113
NOV. 7, 1996
SUMMARY STATEMENT
M-PACT Corporation, registration number 1928508, wishes to file an intent to market sterile, single use nasal and sinus packings manufactured from formalized PVA sponge material. M-PACT will market the products under the trade names Clinicel and IVALON. The classification name for the device is evistaxis balloon (per 21 CFR section 874.4100).
Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose Thev are packaged individually as a sterile, dried and compressed sponge that is bleeds). inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.
M-PACT nasal and sinus packings are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde. Once the chemical reaction has taken place and the foam sponge has cured, the material is washed clean of any residual chemicals.
M-PACT's nasal and sinus products will be sold in different configurations with drawstrings and with and without airway tubes. The products will be provided sterile via gamma radiation in industry standard Tyvek/film and metalized polyester peelable pouches.
M-PACT Corporation is the manufacturer of the formalized PVA sponge material and will process it into different configurations of nasal and sinus products. M-PACT has contracted with Surgical Technologies Incorporated (facilities in Brea, CA and St. Paul, MN) to complete the packaging and sterilization processes. Surgical Technicologies Inc. contracts with Sterigenics for sterilization services. Sterilization and packaging protocols have been approved. The device is currently in the validation process and will not be marketed until the validation is complete.
Although this is a new product for M-PACT, it is a product which is substantially equivalent to nasal and sinus packs which are currently marketed in interstate commerce and which were on the market prior to the date of the enactment of the Medical Device Amendment of 1976 (May 28, 1976) (Ultracell Nasal Packing - K920358; Merocel Nasal Packing - pre-amendment, and the Expandacell Nasal Tapon - K900171, K912524). The M-PACT nasal and sinus packs are identical in size, shape, material composition and intended use as the Merocel Nasal Pack and Kennedy Sinus Pack currently marketed by Merocel Corporation, Mystic, CT (Xomed Jacksonville, FL), the Ultracell Nasal Pack currently marketed by Ultracell Medical Technologies. Stonington, CT, and the Expandacell™ Nasal Tampon marketed by Shippert Medical Technologies, Englewood, CO. Since the M-PACT nasal and sinus products are identical to product currently marketed by Merocel, Ultracell Medical Technologies, and Shippert Medical, the only changes will be in regard to labeling and packaging.