(362 days)
POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
BACTERISTATIC NASAL DRESSING
I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Bacteristatic Nasal Dressing." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any information related to multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
This document is purely a regulatory clearance notice and does not delve into the specific technical or clinical study data that would inform such a description.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1999
Ms. Heather S. Bond Director Polymer Technology Hydrofera, LLC 322 Main St., Suite 1101 Willimantic, CT 06226
Re: K983276
Device: Hydrofera Bacteristatic Nasal Dressing Dated: August 20, 1999 Received: August 23, 1999 Classification Regulation: 77 EMX, CFR 874.4100 Regulatory Class: II
Dear Ms. Bond:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Ms. Heather S. Bond
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 questions on the promotion and advertising of your devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Alez L. Rosenthal
A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ڀو83276-6-14982325
्र के लिए क
:
Device Name: BACTERISTATIC NASAL DRESSING
Indications For Use: POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) C
and the state of the states of the states
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
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| Division of Ophthalmic Devices | |
| 510(k) Number | K983276 |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
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| --------------------------------------- | --------------------------------------------------- |
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.