(99 days)
Not Found
No
The device description focuses on the material composition and physical function of the nasal dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
A therapeutic device is one that treats a disease or condition. This device is used as a physical barrier to separate mucosal surfaces after surgery, which is a supportive function rather than an active therapeutic treatment of a disease.
No
The device is described as a "fragmentable nasal dressing" and a "space occupying stent" intended to separate and prevent adhesions, and to fill cavities and keep surfaces separate during healing. Its function is physical support and separation, not to identify or diagnose a condition.
No
The device is a physical, bioresorbable polymeric film intended for use as a nasal dressing, not a software application.
Based on the provided information, the SyntheMed Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "fragmentable nasal dressing... indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces." This describes a device used within the body during and after surgery to provide physical support and prevent complications.
- Device Description: The description details a synthetic, bioresorbable polymeric film that functions to "fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process." This further reinforces its role as a physical implant/dressing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide any diagnostic information about a patient's condition. IVDs are used to perform tests on samples taken from the body to diagnose diseases or conditions.
In summary, the SyntheMed Device is a therapeutic device used to aid in the healing process after nasal/sinus surgery, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications for Use
The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to scparate and prevent adhesions between mucosal surfaces.
Product codes (comma separated list FDA assigned to the subject device)
LYA
Device Description
The SyntheMed Device ("the device") is a single use, synthetic, bioresorbable polymeric film composed of polymers used extensively in implantable, absorbable medical devices. The device comprises bis(hydroxyl)-terminated PLA-PEG-PLA triblocks, where PLA = poly(lactic acid) and PEG = poly(ethylenc glycol). These PLA-PEG-PLA triblocks are chain extended to yicld the device's final high molecular weight polymer. This device functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. The device leaves the site of placement by natural elimination within 4 weeks, 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/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)
Animal studies have been performed on the SyntheMed Device. These tests are described in detail in the Safety/Biocompatibility Section. The GLP studies were conducted to demonstrate and support the safety and biocompatibility of the SyntheMed Device. These studies were conducted by NaMSA under USP and ISO 10993 Guidelines.
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
§ 874.4780 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
NOV 1 8 2008
5 510(k) Summary
| Contact: | Eli Pines, Ph D. |
|---|---|
| Device Trade Name: | SyntheMed Device |
| Manufacturer: | SyntheMed, Inc. |
| 200 Middlesex Essex Turnpike | |
| Suite 210 | |
| Iselin, NJ 08830 | |
| Common Name: | Nasal Dressing |
| Classification: | 21 CFR §874.4780 |
| Class: | I |
| Product Code: | LYA |
Indications For Use:
The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to scparate and prevent adhesions between mucosal surfaces.
Device Description:
The SyntheMed Device ("the device") is a single use, synthetic, bioresorbable polymeric film composed of polymers used extensively in implantable, absorbable medical devices. The device comprises bis(hydroxyl)-terminated PLA-PEG-PLA triblocks, where PLA = poly(lactic acid) and PEG = poly(ethylenc glycol). These PLA-PEG-PLA triblocks are chain extended to yicld the device's final high molecular weight polymer. This device functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. The device leaves the site of placement by natural elimination within 4 weeks, or it may be aspirated from the cavity earlier at the discretion of the physician.
Predicate Device(s):
The SyntheMed Device is substantially equivalent to the following previously cleared devices.
-
- Polyganics Nasospore (K052099)
-
- Genzyme Hylasine (K012532)
-
- Medtronic Xomed Meropack Nasal Dressing (K041381)
Performance Standards:
FDA has not established performance standards for this class of device.
1
6. Substantial Equivalence Summary
The SyntheMed Device is substantially equivalent in materials, indications, function and/or performance to the following predicate devices:
-
- Polyganics Nasosporc (K052099)
-
- Genzyme Hylasine (K012532)
-
- Medtronic Xomed Meropack Nasal Dressing (K041381)
SyntheMcd, Inc believes the SyntheMed Dcvice is substantially equivalent to the above predicates based on design, indications and intended use. SyntheMed has provided a discussion comparing the indications, the materials, and the method of action demonstrating the substantial equivalence of the SyntheMed Device.
| | SYNTHEMED
DEVICE | NasoSpore | Hylasine | MeroPack |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | SyntheMed Inc | Polyganics | Genzyme | Medtronic/Xomed |
| 510(k)Reference | This submission | K052099 | K012532 | K041381 |
| Device name | IntraNasal Splint | IntraNasal Splint | IntraNasal Splint | IntraNasal Splint |
| Used In | Nasal/sinus surgery | Nasal/sinus surgery | Nasal/sinus surgery | Nasal/sinus surgery |
| Indications for Use | The SyntheMed Device
is a fragmentable nasal
dressing and is
indicated for use in pa-
tients undergoing
nasal/sinus surgery as a
space occupying stent
to separate and prevent
adhesions between
mucosal surfaces. | Nasopore is a
fragmentable nasal
dressing and is indicated
for use in patients
undergoing nasal/sinus
surgery as a space
occupying stent to separate
and prevent adhesions
between mucosal surfaces;
to help control minimal
bleeding following surgery
or nasal trauma by
tamponade effect and
blood absorption. | HylaSine is indicated 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 post operative period. | MeroPack Tm Bioresorbable
Nasal Dressing and Sinus
Stent is 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. |
| Material Composition | PLA, PEG | Fragmentable poly (DL-
lactide/co caprolactone)
urethane | Chemically modified
hyaluronic acid and
carboxymethylcellulose | Esterified hyaluronic acid and
collagen |
| Method of action | Hygroscopic, fragments
in contact with fluids | Hygroscopic, fragments in
contact with fluids | Hygroscopic, forms
gelatinous mass in
contact with fluids | Hygroscopic, forms
gelatinous mass in contact
with fluids |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 and FDA
Guidance G95-1 |
| Sterile | Yes | Yes | Yes | Yes |
A table comparing the subject and predicate devices is presented below.
2
General Substantial Equivalence
The SyntheMed Device shares indications for the intended use with all predicate devices referenced in the above Table. The SyntheMed Device is a resorbable, synthetic polymeric material similar to Nasospore, Meropack and Hylasine.
The SyntheMed Device is applicd with in a similar manner as the prodicates listed. It is placed at the surgical site at the conclusion of the procedure.
Material Substantial Equivalence
The SyntheMed Device is a synthetic, resorbable polymeric film comprised of polylactic acid (PLA) and polyethylene glycol (PEG) polymers.
Polyethylene glycol (PEG) is an FDA-approved Generally Recognized as Safe (GRAS) polymer that is widely used in foods, cosmetics and pharmaceuticals, including topical, ingestable and injectable drug formulations as well as hydrogels..
PLA is an FDA-approved Generally Recognized as Safe (GRAS) polymer that is used in numerous resorbable surgical devices such as sutures, ligatures and meshes.
The SyntheMed Device biodegrades (resorbs) within a similar timeframe as the prodicate devices.
Animal studies have been performed on the SyntheMed Device. These tests are described in detail in the Safety/Biocompatibility Section. The GLP studies were conducted to demonstrate and support the safety and biocompatibility of the SyntheMed Device. These studies were conducted by NaMSA under USP and ISO 10993 Guidelines.
Conclusion
The SyntheMed Device is substantially equivalent to the predicates in the nasal dressing product category. The indications, design principles and instructions for use are comparable to the referenced predicates and the SyntheMed Device shares similar indications for use language with these predicate devices. In summary, the SynthcMed Device is substantially cquivalent to valid predicate nasal dressings.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2008
SyntheMed, Inc. c/o Eli Pines, Ph.D. Vice President and Chief Scientific Officer 200 Middlesex Essex Turnpike: Suite 210 Iselin, NJ 08830
Re: K082276
Trade/Device Name: SyntheMed Device Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: October 27, 2008 Received: October 28, 2008
Dear Dr. Pines:
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 -Eli Pines, Ph.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pa (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Melvin B. Eggers, und
Malvina B. Eydelman, M.L Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4 Indications for Use
510(k) Number (if known): Ko B22760
Device Name: SYNTHEMED DEVICE
The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces.
Prescription Use ﺮ ﮨﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Cce Be
(Division Sig. or Off.
(Division Sign-Off Division of Ophthalmic and Ear. Nose and Throat Devices
510(k) Number K082276