(92 days)
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Not Found
No
The summary describes a surgical device for tissue protection and fluid absorption, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML functionality.
No
The device aids during surgery to protect tissue, absorb fluids, and act as an adhesion barrier, which are supportive functions rather than directly treating a disease or condition.
No
The 'Intended Use / Indications for Use' states the device is used to protect tissue, absorb fluids, and act as a barrier, which are therapeutic or protective functions, not diagnostic ones.
No
The intended use describes a physical device (protecting tissue, absorbing fluids, acting as a barrier) used during surgery, which is characteristic of a hardware medical device like a surgical sponge or barrier. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used during surgery to protect tissue, absorb fluids, and act as a barrier. This is a direct interaction with the patient's body during a medical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
The description clearly indicates the device is used within the body during surgery, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
Product codes
EMX 77
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
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Indicated Patient Age Range
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Intended User / Care Setting
during surgery
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(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 § 874.9.
0
Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN". The text is arranged in a circular fashion around the left side of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
George P Korteweg Vice President Ultracell Medical Technologies, Inc. 183 Providence New London Turnpike P.O. Box 326 North Stonington, CT 06359
Re: K973085
Ultracell Packing with Sleeve (Nasal Pack) Dated: September 30, 1997 Received: October 2, 1997 Regulatory Class: I 21 CFR 874.4100/Procode: EMX 77
Dear Mr. Korteweg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketd 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.J.Liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): 297 3085
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973085
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)