(181 days)
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Not Found
No
The summary describes a biomaterial dressing/stent and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a "nasal dressing and sinus stent" intended to "separate mucosal surfaces and to help control minimal bleeding following surgery," which are therapeutic actions.
No
Explanation: The device is a nasal dressing and sinus stent used to separate mucosal surfaces and control bleeding after surgery. It does not perform any diagnostic function.
No
The device description clearly states it is a biomaterial composed of HYAFF®, which is a physical substance intended for insertion into the body. This 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 clearly states it's for use in the nasal/sinus cavities as a dressing and stent. This is a device used in vivo (within the body) for a physical purpose (space-occupying, separating surfaces, controlling bleeding).
- Device Description: The description details its composition and how it functions within the body (absorbing fluids, changing to a gel, dissolving).
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide diagnostic information. IVDs are used to perform tests in vitro (outside the body) on these samples.
Therefore, the Xomed MeroGel™ Nasal Dressing and Sinus Stent is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.
Product codes (comma separated list FDA assigned to the subject device)
77LYA, 79MGQ, 79MGP, 77 EMX
Device Description
Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal/sinus cavities
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): 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).
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
FEB 2
X. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1.0 Date Prepared
August 3, 1998
2.0 Submitter (Contact)
Roy Berens, Manager Regulatory Affairs Xomed Surgical Products Jacksonville, FL 32216 Telephone: 904-296-6454 904-281-1057 Fax: e-mail:rberens@xomed.com
3.0 Device Name
Xomed MeroGel™ Nasal Dressing and Sinus Stent Proprietary Name:
Absorbent Intranasal Splint Common Name(s): Absorbent Intranasal Packing Material Non-Woven Surgical Packing Non-Woven Wound Dressing Non-Woven Compress
Classification Name: Intranasal splint and/or Non-Woven Wound Dressing
4.0 Device Classification
| Intranasal Splint | ProCode 77LYA | Class I ; 21 CFR 874.4780 (proposed) |
|---|---|---|
| or | ||
| Wound Dressing | ProCode 79MGQ | Class I ; 21 CFR 878.4022 |
| or | ||
| Wound Dressing | ProCode 79MGP | Class II ; 21 CRF 878.4012 |
5.0 Device Description
Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.
1
6.0 Intended Use
MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.
7.0 Substantial Equivalence
Xomed markets both Merocel® Sinus-Pak™ and Merocel® Standard Nasal Dressing for use in nasal/sinus cavities to control bleeding and/or ald in the prevention of adhesions after surgery. These predicate devices are indicated for nasal/sinus surgery and/or trauma. Xomed MeroGel™ Nasal Dressing and Sinus Stent is substantially equivalent to these predicate products in that it has a similar intended use and indications. The subject and predicate devices are made from materials which have demonstrated satisfactory biocompatibility, are highly absorbent for collecting postop fluids, and are sterile single use.
The difference are that the Xomed MeroGel™ Nasal Dressing and Sinus Stent changes from its original form of a white fibrous material with a physical appearance similar to spun cotton to a gelatinous mass whereas the predicate devices do not dissolve or form a gelatinous mass. Xomed MeroGel™ Nasal Dressing and Sinus Stent can be removed via gentle irrigation whereas the predicate devices require manual removal by moistening and extracting engorged sponge with forceps.
In conclusion, Xomed MeroGel™ Nasal Dressing and Sinus Stent has the same intended use as the predicate devices and differs only in the material which has been shown as biocompatible, as based on the data in the submission raises no new issue of safety or effectiveness.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1599 FEB
Manager, Quality Systems Regulations
Re:
K982731 MeroGel™ Nasal Dressing and Sinus Stent Dated: January 11, 1999 Received: January 13, 1999 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
Dear Mr. Berens:
6743 Southpoint Dr. N.
Jacksonville, FL 32216-0980
Roy Berens
Xomed® Inc.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration,
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Intended Use Statement
510(k) Number (if known): K982732
Device Name: MeroGel TM Nasal Dressing and Sinus Stent
Indications for Use: Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space occupying dressing and/or stent, to separate mucosal surfaces and help control minimal bleeding following surgery.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Or
Prescription Use __
(Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982731