(34 days)
Q600314, Q603113
Not Found
No
The device description and performance studies focus on the material properties and physical function of the nasal packing, with no mention of AI or ML.
Yes
The device is intended for use as a nasal packing to treat epistaxis, which is a medical condition (nosebleed). By directly addressing a medical condition and providing a physical means of treatment, it functions as a therapeutic device.
No
The device is described as a nasal packing used to treat epistaxis (nosebleeds), which is a therapeutic function, not a diagnostic one. It expands to provide accurate positioning for the surgeon and is made of PVA sponge. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a physical nasal packing constructed of polyvinyl alcohol (PVA) sponge, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use as a nasal packing to treat epistaxis." This describes a device used in vivo (within the body) to physically treat a condition (nosebleed).
- Device Description: The description details a physical sponge material used for packing. It doesn't mention any components or processes related to testing samples of bodily fluids or tissues in vitro (outside the body).
- Lack of IVD Characteristics: The provided information does not include any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
This device is a medical device used for a therapeutic purpose within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
For use as a nasal packing to treat epistaxis.
Product codes
77 EMX
Device Description
RHINOCELL™ Nasal Packings are constructed of polyvinyl alcohol (PVA) sponge using a patented formula. The packings will expand as fluid is introduced, giving the surgeon time for accurate positioning. There is a variety of RHINOCELL™ shapes and sizes to choose from, both with and without integral airways. All RHINOCELL™ packings are sold sterile, ready to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Q600314, Q603113
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 the logo for Boston Medical Products. The logo consists of a stylized heart shape on the left and the text "Boston Medical Products" on the right. The heart shape is made up of two curved lines that meet at the bottom and form a point at the top. The text is in a simple, sans-serif font.
AUG - 4 1997
SMDA Summary
16972459
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Description: RHINOCELL™ Nasal Packings are constructed of polyvinyl alcohol (PVA) sponge using a patented formula. The packings will expand as fluid is introduced, giving the surgeon time for accurate positioning. There is a variety of RHINOCELL™ shapes and sizes to choose from, both with and without integral airways. All RHINOCELL™ packings are sold sterile, ready to use.
Indication For Use: For use as a nasal packing to treat epistaxis.
Contraindications: None known.
Predicate Devices: Product Nos. Q600314 - Q603113 manufactured by M-Pact, 1040 OCL Parkway, Eudora, KS.
Testing: Device is constructed using well-established polyvinyl alcohol (PVA) sponge.
Submitted by:
Stuart K. Montgomery, President
Date:
6/27/97
Boston Medical Products, Inc 117 Flanders Road, Westborough, MA 01581 CUSTOMER SERVICE: 1-800-433-BMPI (267 Tel: 508-898-9300 Fax: 508-898
1
Image /page/1/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 1997
Stuart K. Montgomery President Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581
Dear Mr. Montgomery:
Re: K972459 RHINOCELL TH Nasal Packings Dated: June 27, 1997 Received: July 1, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
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 ciassified (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 the Act for devices under the Electronic Product 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of clectromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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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 questions on the promotion 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 to!!-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yi
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
: 【 すぎには88名義は昨日
3
Boston Medical Products, Inc. 117 Flanders Read Westborough, MA 01581 ATT: Stuart K. Montgomery (508) 898-9300 ext. 240
Page 1 of 1
| 510(k) Number (if known): | K972459 |
|---|---|
| Device Name: | RHINOCELL™ Nasal Packings |
| Indications For Use: | For use as a nasal packing to treat epistaxis. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
4
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
. . * (Optional Format 1-2-96)
Ru-R
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 9724 510(k) Number