(23 days)
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 bleeds). Thev are packaged individually as a sterile, dried and compressed sponge that is 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.
This document is a premarket notification (510(k)) and does not contain the detailed information needed to answer your questions about acceptance criteria and a study proving device performance. The summary statement outlines the device, its intended use, and claims substantial equivalence to existing devices.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria & Reported Performance: The document states, "The device is currently in the validation process and will not be marketed until the validation is complete." This indicates that the performance criteria and the results of a study demonstrating compliance with those criteria are not yet available or are not included in this summary statement.
- Study Details (Sample Size, Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone, Training Set): Since the validation study is still in progress or not yet detailed, none of these specifics related to a performance study can be found.
In summary, the provided text describes the device and its intended use but does not present the results of a performance study against acceptance criteria.
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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.
§ 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.