(36 days)
The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.
The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device.
This document is a 510(k) premarket notification letter from the FDA regarding a Nasopharyngoscope. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format of AI/ML device performance.
The document primarily focuses on:
- Regulatory clearance: The FDA's determination that the Henke Sass Wolf of America Nasopharyngoscope is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Device classification: Class II, product code EOB.
- Intended use: To examine or treat the nasal cavity and nasal pharynx, specifically between the upper respiratory tracts of the nasal passage and the vocal cords.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. This type of information is typically found in accompanying technical documentation or clinical study reports, which are not included here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 1 2003
Henke Sass Wolf of America, Inc. c/o Lynette L. Howard Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, NJ 08822
Re: K030572
Trade/Device Name: Henke Sass Wolf of America Nasopharyngoscope, Flexible Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: February 12, 2003 Received: February 24, 2003
Dear Ms. Howard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Lynette L. Howard
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A helyi korentbol
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATION FOR USE
510(k) Number:
Device Name: Henke Sass Wolf Nasopharyngoscope
Indications for Use:
The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kuent Boler
(Division Sign-Division of Ophthalmic Ear Nose and Throat Devi
510(k) Number K030572
Prescription Use
(Per 21 CFR 801.109)
| 44 Southbridge Rd. |
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| Dudley, MA 01571 |
| Phone: | 508.765.3200 |
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| Fax: | 508.764.8242 |
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.