(108 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device is a passive, bioresorbable material.
Yes
The device is described as a 'nasal dressing and sinus stent' that helps to control bleeding and prevent adhesions, indicating it is used for therapeutic purposes.
No
The device is described as a "bioresorbable nasal dressing and sinus stent" used to prevent adhesions, control bleeding, and prevent turbinate lateralization post-nasal/sinus surgery. Its primary function is therapeutic and supportive, not diagnostic.
No
The device description clearly states it is a physical, bioresorbable nasal dressing and sinus stent made of HYAFF® and Collagen, which are material components, not software.
Based on the provided information, the MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the body during and after nasal/sinus surgery to provide physical support, control bleeding, and prevent adhesions. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical material that absorbs fluid, swells, and degrades within the nasal cavity. This is consistent with a medical device used for physical support and healing, not for analyzing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is used directly within the nasal cavity, which is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The MeroPack™ does not perform this function.
N/A
Intended Use / Indications for Use
MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; to help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to prevent lateralization of the middle turbinate during the postoperative period.
Product codes
LYA
Device Description
MeroPack™ is a sterile bioresorbable nasal dressing and sinus stent composed of lyophilized and compressed HYAFF® and Collagen. When placed appropriately, MeroPack™ absorbs fluid and swells, conforming to the nasal cavity and creating a tamponade effect that helps to control the minimal bleeding normally associated with routine sinus surgery. The stent gradually degrades over time and is slowly absorbed within 14 days, 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
Nasal cavity
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
Studies were conducted both by a contract laboratory and by in-house laboratories; all followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7. The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the requested indication. The risks of the subject device, as well as the benefits to the patient, are the same as those normally attributed to the use of a space occupying nasal dressing/stent.
Key Metrics
Not Found
Predicate Device(s)
Seprapack/Sepragel, MeroGel™ Nasal Dressing and Sinus Stent
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(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 the limitations in § 874.9.
0
:
SEP 1 0 2004
Image /page/0/Picture/2 description: The image shows the Medtronic XOMED logo. The logo consists of a circular graphic on the left, with three figures arranged in a circular pattern. To the right of the graphic is the word "Medtronic" in a bold, sans-serif font, and below that is the word "XOMED" in a smaller font. A horizontal line runs beneath the text.
Summary of 510(k) Submission
| Name and
address of
submitter | Medtronic Xomed Inc.
6743 Southpoint Drive North
Jacksonville, Florida 32216
Contact: David S. Dodd
Phone: (904) 332-8746
Date Prepared: May 24, 2004 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification
of Devices | Trade name: MeroPack™ Nasal Packing and Sinus Stent. Common or usual name: Ear, Nose and Throat Packing, Dressing, and/or Stent Classification Name: Intranasal Splint (per 21 CFR §874.4780) FDA Classification: Class I - Non-Exempt. |
| Predicate
Device | MeroGel™ Nasal Dressing and Sinus Stent, and Seprapack/Sepragel (Genzyme) |
| Description of
Device | MeroPack™ is a sterile bioresorbable nasal dressing and sinus stent
composed of lyophilized and compressed HYAFF® and Collagen.
When placed appropriately, MeroPack™ absorbs fluid and swells,
conforming to the nasal cavity and creating a tamponade effect that
helps to control the minimal bleeding normally associated with routine
sinus surgery. The stent gradually degrades over time and is slowly
absorbed within 14 days, or it may be aspirated from the cavity earlier
at the discretion of the physician. |
| Indications
For Use | MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is
indicated for use in patients undergoing nasal/sinus surgery as a
space occupying stent to separate and prevent adhesions between
mucosal surfaces during mesothelial cell regeneration in the nasal
cavity; to help control minimal bleeding following surgery or nasal
trauma by tamponade effect, blood absorption and platelet
aggregation; and to prevent lateralization of the middle turbinate
during the postoperative period. |
1
Summary of 510(k) Submission, Continued
| | Predicate Device:
Seprapack / Sepragel | Predicate Device:
MeroGel™ Nasal Dressing
and Sinus Stent | Proposed Device:
MeroPack™ Nasal
Packing and Sinus Stent |
|----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Intended Use | Post-op, help control
minimal bleeding and
separate mucosal surfaces /
adhesion prevention | Post-op, help control
minimal bleeding and
separate mucosal surfaces
/ adhesion prevention | Post-op, help control
minimal bleeding and
separate mucosal
surfaces / adhesion
prevention |
| Indications | nasal/sinus surgery | nasal/sinus surgery | nasal/sinus surgery |
| Material /
Construction | Chemically modified
hyaluronic acid and
carboxymethylcellulose | esterified hyaluronic acid | esterified hyaluronic acid
and collagen |
| Absorbent
Qualities | unknown | in excess of 10 times
weight of the device | in excess of 10 times
weight of the device |
| Sterility | gamma irradiation | gamma irradiation | gamma irradiation |
| Resorption time | 7-10 days | approx. 14 days | Within 14 days |
| Biocompatibility | ISO 10993-1 | ISO 10993 1 | ISO 10993 1 and FDA
Guidance G95-1 |
| Method of
Action | hygroscopic, forms
gelatinous mass in contact
with fluids | hygroscopic, forms
gelatinous mass in contact
with fluids | hygroscopic, forms
gelatinous mass in
contact with fluids |
| Method of
Removal | gentle irrigation of residues | gentle irrigation of residues | gentle irrigation of
residues |
Substantial Equivalence table:
| Conclusions
drawn from
studies | Validity of
Scientific Data | Studies were conducted both by a contract
laboratory and by in-house laboratories; all
followed scientific protocols. The data were
determined to be scientifically valid under 21 CFR
860.7. |
|--------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Substantial
Equivalence | The data presented in this Premarket Notification
support that the subject device is safe and effective
and performs in the same manner as the predicate
devices when used in accordance with the labeled
directions for use and for the requested indication. |
| | Risk and
Benefits | The risks of the subject device, as well as the
benefits to the patient, are the same as those
normally attributed to the use of a space occupying
nasal dressing/stent. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Medtronic Xomed c/o David S. Dodd Sr. Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, FL 32216
K041381 Re:
Trade/Device Name: MetroPack™ Bioresorbable Nasal Dressing and Sinus Stent Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: September 2, 2004 Received: September 3, 2004
Dear Mr. Dodd:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave roview 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 (21 CFR Part 807), accems (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.
3
Page 2 - David S. Dodd
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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A helyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Koy 1381 510(k) Number (if known): Device Name: MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent
Indications For Use
MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; to help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to prevent lateralization of the middle turbinate during the postoperative period.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
Or
Over-the-Counter Use
(Optional Format 1-2-96)
KaunBoke
ion of Oohthalmic Ear, Nose and Throat Day
510(k) Number