(92 days)
The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
Not Found
Based on the provided documents, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail.
The documents are a 510(k) clearance letter and an "Indications For Use" statement for the "Ultracell Packing with Sleeve (Nasal Pack)". This type of submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through detailed performance studies with ground truth establishment, expert adjudication, or MRMC studies.
The provided information indicates:
- Device: Ultracell Packing with Sleeve (Nasal Pack)
- Regulatory Class: I (21 CFR 874.4100/Procode: EMX) - Devices in this class generally have lower risk and often do not require extensive clinical or performance studies for 510(k) clearance if their technological characteristics and indications for use are similar to predicate devices.
- Indications For Use: "The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions."
- Nature of Clearance: Substantial Equivalence to a predicate device marketed prior to May 28, 1976. This means the FDA determined the device is as safe and effective as a legally marketed device, not that it met specific quantitative performance metrics from a formal study as would be required for higher-risk devices or novel technologies.
Therefore, I cannot provide the requested information in the format of a table with acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods because these are typically not part of a Class I 510(k) submission for a device like a nasal pack. Such details would be expected for AI/ML-driven devices, diagnostic devices, or higher-risk therapeutic devices.
The documents only address the regulatory clearance through the 510(k) pathway based on substantial equivalence, not the detailed performance evaluation against specific, measurable acceptance criteria that would be relevant for an AI/ML device as implied by your questions.
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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
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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)
§ 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.