(250 days)
Not Found
No
The device description focuses on the material composition and physical function of the gel as a surgical dressing and stent, with no mention of AI or ML capabilities.
Yes.
The device is used to prevent adhesions, control bleeding, and aid in the natural healing process after surgery, which are all therapeutic interventions.
No
This device is described as a space-occupying dressing and/or stent/gel intended to prevent adhesions, separate mucosal surfaces, help control bleeding, and aid in healing after surgery, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly states it is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel, which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The description of Sepragel ENT clearly states its function is as a physical dressing and stent used during and after surgery in the nasal/sinus, middle ear, and external ear canal. It acts as a space-occupying material, prevents adhesions, helps control bleeding, and aids in healing.
- No Specimen Examination: The device does not examine any specimens derived from the human body. It is placed directly within the body cavity.
- No Diagnostic Information: The device does not provide information about a physiological state, state of health, disease, or abnormality. Its purpose is therapeutic and supportive during the healing process.
Therefore, Sepragel ENT falls under the category of a surgical dressing or implantable device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.
Product codes
77KHJ
Device Description
Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.
SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications 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/sinus, middle ear, external ear canal
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
043035
JUL 1 1 2005
genzyme
7
Sepragel™ ENT Bioresorbable Packing/Stent Premarket |510(k)| Notification
510(K) SUMMARY (AS REQUIRED BY 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for SeprageI™ ENT Bioresorbable packing/stent (SeprageI™ ENT).
Sponsor/Applicant Name and Address: 7.1
Genzyme Corporation 500 Kendall Street Cambridge, MA 02142
Sponsor Contact Information: 7.2
Barbara Pizza Manager, Regulatory Affairs Phone: 617.252.7953 FAX: 617.761.8414 email: barbara.pizza@genzyme.com
Date of Preparation of 510(k) Summary: 7.3
Date
Device Trade or Proprietary Name: 7.4
SeprageI™ ENT Bioresorbable Packing/Stent
Device Common/Usual or Classification Name: 7.5
Ear, nose and throat synthetic polymer material
Identification of the Legally Marketed Devices to which Equivalence 7.6 is Being Claimed:
| 510(k) Number | Name of Predicate Device | Name of Manufacturer
(Town, State) |
|----------------------|-----------------------------------------------------------------------------------|---------------------------------------|
| K012532
(K993362) | SepragelTM Sinus | Genzyme Corporation
Cambridge, MA |
| K001148
(K002972) | MeroGelTM Nasal Otologic Pack
(MeroGelTM Control Gel ENT
Surgical Dressing) | Medtronic Xomed
Jacksonville, FL |
Device Description: 7.7
Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal
1
genzyme
surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.
SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications it may be aspirated from the cavity earlier at the discretion of the physician.
Intended Use: 7.8
Seprage! ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.
Comparison of Technological Characteristics of SeprageI™ ENT with 7.9 Legally Marketed Devices:
Table 4 is the Table of Similarities and Differences between Genzyme's Seprage1™ ENT Bioresorbable Packaing/Stent and the legally marketed devices identified in Section 7.6.
2
genzyme
able 4: Comparison to Marketed Device
| Device Name | Sepragel™ ENT | Hylasine™ (Sepragel Sinus) | MeroGel™Nasal Dressing/Sinus Stent
and Otologic Packing |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Genzyme Corporation | Genzyme Corporation | Medtronic Xomed |
| | PROPOSED | (K993362, K012532) | (K001148) |
| | ENT synthetic polymer material | Epistaxis balloon/Intranasal Splint | Epistaxis balloon/ ENT synthetic polymer
material |
| Product Code | 77KHJ | 77EMX/LYA | 77KHJ |
| Intended
Use/Indication | 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,
and stapes and mastoid surgery. | 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. | 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. The
device is indicated for use in the middle
ear and external ear canal following
canalplasty, myringoplasty, tympanoplasty
and, and stapes and mastoid surgery. |
| Material
Composition | Derivative hyaluronic acid | Derivative hyaluronic acid | Derivative hyaluronic acid |
| Bioresorbable | YES | YES | YES |
| Product matrix | Gel in a syringe | Gel in a syringe | Non-woven pad in a protective folded
sheet |
roprietary and Confidentis
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
JUL 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Genzyme Corporation c/o Barbara Pizza Manager Regulatory Affairs 55 Cambridge Parkway Cambridge, MA 02142
Re: K043035
Trade/Device Name: Seprage1™ ENT Nasal/Sinus and Otologic Dressing Regulation Number: 21 CFR 874.3620 Regulation Name: ENT synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: June 17, 2005 Received: June 20, 2005
Dear Ms. Pizza:
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 - Barbara Pizza
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
genzyme
510(k) Number (if known): New Application
Sepragel™ ENT Bioresorbable Packing/Stent Device Name:
Indications for Use:
Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CRF 801.109)
sion Sign-Off ivision of Ophthalmic Ear Nose and Throat I
510(k) Number Proprietary and Confidential OR
Over-The-Counter Use (Optional Format 1-2-96)