(22 days)
Not Found
Not Found
No
The summary describes a gel for vocal fold medialization and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is indicated for vocal fold medialization to improve glottal closure, phonation, cough, and airway protection, which are all therapeutic benefits.
No
The device is VF Gel, a temporary implant used for vocal fold medialization to improve glottal closure. Its intended use is therapeutic (treating vocal fold insufficiency) rather than diagnosing a condition.
No
The device description clearly describes a physical gel material intended for injection, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for vocal fold medialization through injection of a bulking agent to improve vocal function, cough, and airway protection. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a gel intended for injection as a temporary implant.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are used to test samples like blood, urine, tissue, etc., to diagnose diseases or conditions.
This device is a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
Product codes
MIX
Device Description
Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vocal fold
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
The VF Gel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
APR 2 5 2008 510(k) SUMMARY 10.0
10.1 510(k) Summary
Coapt Systems is providing a summary of the safety and effectiveness information available for the VF Gel. This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990.
SPONSOR/APPLICANT NAME AND ADDRESS
Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7600 Facsimile: (650) 213-9336
CONTACT INFORMATION
Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: Iruedy@coaptsystems.com
DATE OF PREPARATION OF 510(K) SUMMARY
April 2, 2008
DEVICE TRADE OR PROPRIETARY NAME VF Gel
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Vocal Cord Medialization Implant Regulation Number: 874.3620 Class: II Product Code: MIX
1
IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED
| WEREN CONSULERS CONSULERS CONSULERS BENERES EXES SEAR
.
.
.
ALA HERREREES BERREAR
.
.
more considerarian consideration of the discluding | HAMBANDIRANING RESIREURUS BEREAKHERE ELE &
.
.
.
.
.
. But the state of the comments of the commended to the commended to the contraction of the commended | BRIDGER BERGURBERES BE F
BALDMANDEL ESSUE
.
.
.
.
.
.
.
.
.
:
.
Company of the control control control control controlled and charges and controlled to the contribution of the contribution of the contribution of the contribution of the co
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | FOR FORMIC FIFA FORMIC LIBE
.
.
:
A B S S S S S . C . C . C . C . C . C | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--|
| A B E R L & L C L C . C . C . C . C . C . C . C | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | |
DEVICE DESCRIPTION
Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.
INTENDED USE STATEMENT
The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing.
SUBSTANTIAL EQUIVALANCE COMPARISON
1. Indications Summary
The "Indication Statement" for the VF Gel is substantiated by the results of the performance evaluations and comparison testing to the predicate device. The differences between the Subject and the Predicate do not affect the safety and effectiveness of the VF Gel. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
2. Technological Characteristics Summary
The VF Gel is substantially equivalent in design, materials and fundamental scientific technology to the predicate devices. Any differences between the Subject and the Predicate device are minor and do not raise issues regarding safety or effectiveness.
3. Performance Summary
The VF Gel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.
2
| Parameter | VF Gel (Predicate) | VF Gel Plus (Subject) | Comparison | Impact on
Safety and
Effectiveness |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------|
| Indication for Use | The VF Gel is indicated for
vocal fold medialization in
the treatment of vocal fold
insufficiency, where
insufficiency may be
improved by injection of a
soft tissue bulking agent. VF
Gel injection augments the
size of the displaced or
deformed vocal fold so that it
may meet the opposing fold
at the midline for improved
glottal closure. Improved
glottal closure may allow
improved phonation,
improvement of cough, and
an improved ability to protect
the airway during
swallowing. VF Gel is a
temporary implant that
degrades over time. The
product is intended to be
durable for a minimum of
one month. | The VF Gel Plus is indicated
for vocal fold medialization
in the treatment of vocal fold
insufficiency, where
insufficiency may be
improved by injection of a
soft tissue bulking agent. VF
Gel Plus injection augments
the size of the displaced or
deformed vocal fold so that it
may meet the opposing fold
at the midline for improved
glottal closure. Improved
glottal closure may allow
improved phonation,
improvement of cough, and
an improved ability to protect
the airway during
swallowing. VF Gel Plus is a
temporary implant that
degrades over time. The
product is intended to be
durable for a minimum of
one month. | Equivalent | None |
| Target Population | Patients requiring temporary
vocal fold medialization | Same | Equivalent | None |
| Surgical Approach | Percutaneous | Same | Equivalent | None |
| Design | Cohesive gel supplied in a
syringe ready to use | Same | Equivalent | None |
| Materials | A gel of injection grade
water, glycerin, mannitol and
Carbopol 974P NF | Same as VF Gel with the
addition of calcium
hydroxylapatite particles | Equivalent | None |
| Biocompatibility | Meets ISO 10993 | Same | Equivalent | None |
| Materials Standards | NF/USP requirements | Same | Equivalent | None |
| Mechanism of Action | Gel providing temporary
space filling | Same | Equivalent | None |
| Human Factors/How
Supplied | Supplied Sterile in a syringe
premixed and ready for
injection | Same | Equivalent | None |
| Human Factors/
Quantity Supplied | Supplied pre-filled in a
syringe filled to 0.5 and 1.3
cc for use in individual
patients | Same | Equivalent | None |
| Sterility | Supplied sterile ready to use,
Not to be resterilized | Same | Equivalent | None |
| Compatibility with
other Devices | Syringe has Luer lock
syringe that is compatible
with needles with Luer fitting | Same | Equivalent | None |
Table 7: Substantial Equivalence Summary
3
SUBSTANTIAL EQUIVALENCE CONCLUSION
Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the VF Gel is substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the VF Gel Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
Coapt Systems, Inc. C/O Ms. Linda Ruedy Director, Regulatory and Clinical Affairs 1820 Embarcadero Road Palo Alto, CA 94303
Re: K080956 Trade/Device Name: VF Gel Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: April 2, 2008 Received: April 3, 2008
Dear Ms. Ruedy:
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.
5
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 Compliance at (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 Postmarket 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,
Zubir A. Malik
Malvina B. Eydelman, Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K080956
Device Name: VF Gel
Indications For Use: The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
510(k) Number K080956
Page 1 of /