(27 days)
Not Found
No
The summary describes a bioresorbable gel stent with a mechanical function (space occupying, preventing adhesions, controlling bleeding). There is no mention of any computational analysis, learning, or adaptive behavior that would indicate the presence of AI/ML.
Yes
The device is intended to treat specific medical conditions or aid in the healing process, which aligns with the definition of a therapeutic device.
No.
The device is a space-occupying gel stent intended to separate and prevent adhesions, control bleeding, and aid in healing after surgery or trauma. It does not diagnose medical conditions.
No
The device description clearly states it is a "sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid," which is a physical substance, not software.
Based on the provided information, the MeroGel Injectable Bioresorbable Stent is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- MeroGel's Function: The MeroGel Injectable Bioresorbable Stent is a physical device intended to be placed within the body (middle ear, external ear canal, nasal/sinus cavities) to provide structural support, prevent adhesions, and control bleeding during the healing process. It does not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use clearly describes a physical function within the body, not a diagnostic test.
- Device Description: The description details the composition and physical action of the gel within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
Therefore, the MeroGel Injectable Bioresorbable Stent falls under the category of a medical device used for therapeutic and supportive purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MeroGel Injectable Bioresorbable Stent is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.
MeroGel Injectable Bioresorbable Stent is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
MeroGel Injectable Bioresorbable Stent is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel Injectable Bioresorbable Stent fills ENT cavities following surgery or trauma to keep to tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel Injectable leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear, external ear canal, 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): 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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
APR 2 6 2007
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR MeroGel Injectable Bioresorbable Dressing
| 510(k) Owner | Medtronic Xomed, Inc
6743 Southpoint Drive North
Jacksonville, Florida 32216-0980 USA
904-296-9600
904-296-2386 (FAX) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Jayme Wilson
Senior Regulatory Affairs Specialist
Medtronic Xomed, Inc |
| Date Summary Prepared | April 24, 2006 |
| Proprietary Name | MeroGel Injectable Bioresorbable Dressing (Final
name TBD) |
| Common Name | Polymer, Ear, Nose and Throat, Synthetic,
Absorbable |
| Classification Name | Ear, nose and throat synthetic polymer material
(21 CFR 874.3620, Product Code NHB, Class II) |
Marketed device claiming equivalence to
MeroGel Injectable Bioresorbable Stent is equivalent to Genzyme Corporation's Sepragel 104 ENT Nasal/Sinus and Otologic Dressing, K043035 and Medtronic Xomed's MeroGei™ Otologic Pack, K001148.
Device Description
MeroGel Injectable Bioresorbable Stent is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel Injectable Bioresorbable Stent fills ENT cavities following surgery or trauma to keep to tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel Injectable leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
1
Intended Use
MeroGel Injectable Bioresorbable Stent is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.
Indications for Use
MeroGel Injectable Bioresorbable Stent is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.
2
| Device Name | Comparison to Marketed Devices
MeroGel™ Injectable Bioresorbable Stent
Medtronic Xomed
PROPOSED | Sepragel™ ENT Nasal/Sinus and
Otologic Dressing
Genzyme Corporation
K043035 | MeroGel™ Otologic Pack
Medtronic Xomed
K001148 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | ENT synthetic polymer material
77NHB | ENT synthetic polymer material
77KHJ | ENT synthetic polymer material
77KHJ |
| Intended
Use/Indication | MeroGel Injectable Bioresorbable Stent is
a space occupying gel stent intended to
separate and prevent adhesions between
mucosal surfaces, help control minimal
bleeding following surgery or nasal trauma,
and act as an adjunct to aid in the natural
healing process. MeroGel Injectable
Bioresorbable Stent is indicated for use in
the middle ear and external ear canal
following canalplasty, myringoplasty,
tympanoplasty, and stapes and mastoid
surgery. The device is indicated following
nasal/sinus surgery or trauma to prevent
lateralization of the middle turbinate and
nasal adhesions during the post operative
period. | For use in patients undergoing
nasal/sinus surgery as a space-
occupying gel stent to separate and
prevent adhesions between
mucosal surfaces in the nasal
cavity, to help control minimal
bleeding following surgery or
nasal trauma, and to prevent
lateralization of the middle
turbinate during the postoperative
period. The device is also
indicated for use in the middle ear
and external ear canal following
canalplasty, myringoplasty,
tympanoplasty and, stapes and
mastoid surgery | MeroGel Otologic Pack is a space
occupying dressing and/or stent
intended to separate mucosal
surfaces, help control minimal
bleeding and act as an adjunct to
aid in the natural healing process.
MeroGel Otologic Pack is
indicated for use in the middle ear
and external ear canal following
canalplasty, myringoplasty,
tympanoplasty, and stapes and
mastoid surgery. |
| Material
Bioresorbable | Derivative hyaluronic acid
YES | Derivative hyaluronic acid
YES | Derivative hyaluronic acid
YES |
| Sterile | YES | YES | YES |
| Product
Matrix | Gel in a syringe | Gel in a syringe | Non-woven pad in a protective
folded sheet |
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Xomed c/o Jayme Wilson 6743 Southpoint Drive North Jacksonville, Florida 32216-0980
APR 2 6 2007
Re: K070886
Trade/Device Name: MeroGel™ Injectable Bioresorbable Stent Regulation Number: 21 CFR 874.3620 Regulation Name: Ear Nose & Throat Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: March 29, 2007 Received: March 30, 2007
Dear Ms. Wilson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Jayme Wilson
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eichelman SimD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
5
INDICATIONS FOR USE
510(k) Number (if known): _ Kon 08862
MeroGel Injectable Bioresorbable Stent (Final name to be Device Name: determined)
Indications for Use:
MeroGel Injectable Bioresorbable Stent is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.
MeroGel Injectable Bioresorbable Stent is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.
Prescription Use X AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) C)
(21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Keun Bahn
Division Sign-Off) ivision of Opnthalmic Ear, Nose and Throat Devises
510(k) Number K070886
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
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