(46 days)
Not Found
No
The summary describes a standard fiberoptic endoscope and does not mention any AI/ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device description states it is "for diagnostic purposes" and its intended use is to "visualize and observe" anatomical sites, rather than to treat them.
Yes
The device description explicitly states it is "for diagnostic purposes."
No
The device description explicitly states it is a "flexible and steerable fiberoptic endoscope," which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is used to directly visualize and observe the pharynx and larynx within the patient's body.
- The intended use clearly states visualization and observation of anatomical sites. This is a diagnostic imaging device, not a device for testing biological samples.
The description and intended use align with a flexible endoscope used for direct visualization, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx.
Product codes
EOB
Device Description
The Schoelly Naso-Laryngo-Pharyngoscope is a flexible and steerable fiberoptic endoscope for diagnostic purposes
Manufactured in two resolutions, 12,000 and 16,000 pixels
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharynx and the larynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons and physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Special 510(k) Summary
| | A) Submitted by Schoelly Imaging, Inc
100 Hartwell St
West Boylston, MA 01583
Registration 8043903 | JAN 1 6 2009 |
|---------|-------------------------------------------------------------------------------------------------------------|--------------|
| Contact | MEDIcept
200 Homer Ave
Ashland, MA 01721
F. David Rothkopf | |
Date of Application November 26, 2008
B) Device Name Naso-Laryngo-Pharyngoscope
508-231-8842 x20 508-231-8861 Fax
Common Name Nasopharyngoscope
Device Class 21 CFR 874 4760 CLASS II
- Product Code EOB
C) Predicate Naso-Laryngo-Pharyngoscope (K991560)
D) Device Description
The Schoelly Naso-Laryngo-Pharyngoscope is a flexible and steerable fiberoptic endoscope for diagnostic purposes
-
E) Intended Use
The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx -
F) Comparison to Predicate Device(s)
The Schoelly Naso-Laryngoscope has the same intended use, target population, clinical setting, and technology as its predicate device Schoelly Naso-Laryngo-Pharyngoscone (K991560) There is no change to in compatibility with the environment or other devices, go differences in electrical, mechanical or chemical safety There are slight changes in the optical and mechanical specifications and patient contact materials, all of which have non-significant impact on device performance All changes have been made under design control, and validation was performed and conformance assured
Schoelly Imaging, Inc Special 510(k) Naso-Laryngo-Pharyngoscope
1
| Features | Schoelly Naso-Laryngoscope
(the Special 510K application
herein) | Schoelly-Naso-
Laryngoscope
(K991560) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Visualize and observe the
pharynx and the larynx | Visualize and observe
the pharynx and the
larynx |
| Design | Flexible and steerable fiberoptic
endoscope for diagnostic
purposes | Flexible and steerable
fiberoptic endoscope
for diagnostic
purposes |
| Parts number | 31 1001s | 31 0001s |
| Specifications | 31 0001s/31 1002s | |
| Tip tubing diameter | $3.2 mm$ | $3.8 mm$ |
| Working Length | $300 mm$ | $300 mm$ |
| Angulation Up | $140^0$ | $150^0$ |
| Angulation Down | $140^0$ | $150^0$ |
| Direction of view | $0^0$ | $0^0$ |
| Field of View | $70^0$ | $85^0$ |
| Length of distal tip
deflection | $20 mm$ | $25 mm$ |
| Depth of field | $6 - 1000 mm$ | $3mm - 50mm$ |
| Total Fibers (pixels) | $7,000$ | $10,000$ |
| Fiber size | $8 3 \mu m$ | $8 3 \mu m$ |
| Magnification³ | $7X$ | $2 5 X$ |
| Energy used | IEC601-1 and IEC 60601-2-18 2000 compliant | |
| Labeling
Sterilization*/Cleaning | The Instruction Manual states
Sterilization | Users Manual states |
| *device is supplied as
non-sterile | Section 7 5 Flexible Schoelly
endoscopes with air-exhaust valve can
also be gas sterilized using ethylene
oxide "
Specifications
Gas mixture 6% EtO, 94% CO₂
Temperature 131°F+/-5°F, 55°C +/-2°C
Relative air humidity 40-90%
Pressure (overpressure), 1 7 bar
(170kpa)
Exposure time 120 mins | "The Schoelly Naso-
Laryngo-Pharyngoscope is
provided non-sterile, and
must be sterilized using
EtO sterilization prior to
use
"
Specifications
EO concentration 600 +/-
25 mg/L
Temperature 54+/- 2°C
(58°C) max)
Relative humidity 70% +/-
5%
Pressure 14 +/- 1 PSIG |
| Cleaning | Gas exposure time 4 hours | |
| Section 7 2 states | | |
| "Place the endoscope and the
unscrewed parts in a suitable
disinfection solution (can also double up
as a cleaning solution) The disinfection
solution used should be permitted by the
manufacturer for such use | | |
| Material compatibility releases exist for
the following disinfectants
*Gigasept FF, Schulke & Mayr GmbH
*Lysetol FF
*Helipur HplusN, B Braun Medical AG
*Cidex, Johnson & Johnson " | "To dissolve various
impurities, use mild
cleaning substances" | |
2
Naso-Laryngo-Pharyngoscope Special 510(k) Premarket-Notification Submission
" Manufactured in two resolutions, 12,000 and 16,000 pixels
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Schoelly Imaging, Inc c/o David McNally 100 Hartwell Street West Boylston, MA 01583
Re K083553
Trade/Device Name Naso-Pharyngoscope Regulation Number 21 CFR 874 4760 Regulation Name Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class Class, II Product Code EOB Dated November 20, 2008 Received December 18, 2008
Dear Mr McNally
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, insting 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
ﻧﺴﻴ
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Drysson of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
M.B. Egelston, mD
Malvina B Eydelman, M D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ko83553
Indications for Use
510(k) Number (if known) Ko 8 3 53 3
Device Name Naso-Laryngo-Pharyngoscope
Indications for Use
The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx.
Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use_21CFR 801 109
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
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Concurrence of CDRH, Office of Device InVitro Diagnostic Device Evaluation and Safety (OIVD)
Karen H. Baker
Division Sign Off Office of Device InVitro Diagnostic Device Evaluation and Safety
510 (K) K083553
Schoelly Imaging, Inc Special 510(k) Naso-Laryngo-Pharyngoscope