RHINOCELL NASAL PACKINGS

K972459 · Boston Medical Products, Inc. · EMX · Aug 4, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972459
• Device Name: RHINOCELL NASAL PACKINGS
• Applicant: Boston Medical Products, Inc.
• Product Code: EMX · Ear, Nose, Throat
• Decision Date: Aug 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4100
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For use as a nasal packing to treat epistaxis.

Device Story

RHINOCELL™ Nasal Packings are sterile, polyvinyl alcohol (PVA) sponge devices designed for nasal hemostasis. The sponge expands upon contact with fluid, allowing surgeons to position the device accurately within the nasal cavity. Available in various shapes and sizes, with or without integral airways. Used by clinicians in a surgical or clinical setting to treat epistaxis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed of polyvinyl alcohol (PVA) sponge. The device is a passive, non-powered, sterile, single-use nasal packing. It functions via fluid-induced expansion.

Indications for Use

Indicated for use as a nasal packing to treat epistaxis in patients requiring nasal hemostasis.

Regulatory Classification

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.

Predicate Devices

• Product Nos. Q600314 - Q603113 manufactured by M-Pact

Submission Summary (Full Text)

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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: [phone] Fax: 508-898

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Boston Medical Products, Inc. 117 Flanders Read Westborough, MA 01581 ATT: Stuart K. Montgomery [phone] 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