(88 days)
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Not Found
No
The summary describes a gel for surgical use and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
Yes
The device is described as aiding the natural healing process and controlling bleeding following surgery, which directly relates to treating or managing a medical condition or assisting in recovery.
No
This device is a space-occupying gel used for therapeutic purposes (controlling bleeding, preventing adhesions, aiding healing) after ENT surgery, not for diagnosing conditions.
No
The device description explicitly states it is a "space-occupying 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:
- IVDs are used to examine specimens from the human body. The intended use of CLEARADEX GEL is to be applied directly to the nasal cavity during and after surgery. It acts as a physical barrier and aid to healing within the body.
- The description focuses on a physical gel. There is no mention of analyzing biological samples or providing diagnostic information based on those samples.
The intended use and device description clearly indicate that CLEARADEX GEL is a therapeutic device used within the body, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
CLEARADEX GEL is a space-occupying gel is intended for use by a medical professional:
- to control minimal bleeding following ENT surgery
- to separate and prevent adhesions between mucosal surfaces in the nasal cavity
- as an adjunct to aid in the natural healing process during the postoperative period
Product codes
KHJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Nasal cavity
Indicated Patient Age Range
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Intended User / Care Setting
Medical professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 U 2006
CambridgeMed c/o Paul Strati, CEO 800 West Cummings Park Suite 2900 Woburn. MA 01801
Re: K060561
Trade/Device Name: Clearadex Gel Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: KHJ Dated: April 26, 2006 Received: April 28, 2006
Dear Mr. Strati:
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.
1
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) 276-8910. 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,
M.B. Eycholtz, M.D.
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
2
Indications for Use
510(k) Number (if known): اماكن ما 0
- to separate and prevent adhesions between mucosal surfaces in the nasal イ cavity
- as an adjunct to aid in the natural healing process during the postoperative ノ period
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(Division Sign Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K060561 |
|---|---|
| --------------- | --------- |
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