(46 days)
The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx.
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.
The provided text describes a Special 510(k) submission for a medical device, the Schoelly Naso-Laryngo-Pharyngoscope. This type of submission is for modifications to a legally marketed device that do not significantly alter its safety or effectiveness. The core of the submission, and therefore this response, is a comparison to a predicate device to demonstrate substantial equivalence, rather than a de novo clinical study with strict acceptance criteria and performance metrics typically seen for new devices or algorithms.
Therefore, the "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device, K991560, by showing that any changes do not adversely affect safety or effectiveness. The "study" proving this largely revolves around the provided comparison table and the assertion that validation was performed under design control.
Here's an breakdown of the information requested, based on the provided text:
Acceptance Criteria and Reported Device Performance
Given this is a Special 510(k) for a hardware device, the acceptance criteria are not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are implicitly related to maintaining safety and effectiveness, as demonstrated by the comparison to the predicate device. The "reported device performance" is essentially captured by the specifications of the new device relative to the predicate.
| Acceptance Criteria Category (Implicit from 510(k) process) | Specific Criteria (Derived from comparison to predicate) | Schoelly Naso-Laryngoscope (New Device) Performance (Reported) | Predicate Naso-Laryngoscope (K991560) Performance |
|---|---|---|---|
| Intended Use | Must be the same as the predicate. | Visualize and observe the pharynx and the larynx. | Visualize and observe the pharynx and the larynx. |
| Design | Must be fundamentally the same technology as the predicate. | Flexible and steerable fiberoptic endoscope for diagnostic purposes. | Flexible and steerable fiberoptic endoscope for diagnostic purposes. |
| Tip Tubing Diameter | Changes should not negatively impact safety or effectiveness. (Smaller diameter is generally considered an improvement for patient comfort/access). | 3.2 mm | 3.8 mm |
| Working Length | Maintained for consistent application. | 300 mm | 300 mm |
| Angulation Up/Down | Acceptable range for maneuverability. (Slight reduction is noted, but likely deemed non-significant for its intended use). | Up: 140°, Down: 140° | Up: 150°, Down: 150° |
| Direction of View | Maintained for consistent visualization. | 0° | 0° |
| Field of View | Acceptable range for visualization. (Slight reduction is noted, but likely deemed non-significant). | 70° | 85° |
| Length of Distal Tip Deflection | Acceptable range for maneuverability. (Slight reduction is noted, but likely deemed non-significant). | 20 mm | 25 mm |
| Depth of Field | Acceptable range for clear imaging. (Widened range is an improvement). | 6 - 1000 mm | 3mm - 50mm |
| Total Fibers (pixels) | Acceptable resolution. (Reduction noted, but likely not considered significant enough to impact diagnostic capability for this type of device/intended use). | 7,000 (Later mentions 12,000 and 16,000 pixels manufactured in two resolutions) | 10,000 |
| Fiber Size | Maintained for consistent optical properties. | 83 µm | 83 µm |
| Magnification | Acceptable for visualization. (Significant increase noted, which would typically be an improvement). | 7X | 2.5X |
| Energy Used | Compliance with relevant electrical safety standards. | IEC601-1 and IEC 60601-2-18 2000 compliant. | Not explicitly stated for predicate in comparison table, but compliance expected. |
| Sterilization/Cleaning | Clear instructions and material compatibility for reprocessing. (Changes in specifications for EtO sterilization and cleaning solutions are detailed). | Detailed EtO and cleaning instructions, material compatibility for specific disinfectants. | Detailed EtO sterilization instructions, "mild cleaning substances." |
Study Details:
As this is a Special 510(k) for a physical device rather than an AI/software device, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in the context of the provided documentation. The "study" referred to is the design control and validation process undertaken by the manufacturer to ensure the modified device remains safe and effective and substantially equivalent to its predicate.
Here's why and what is relevant:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes a medical device's physical and functional specifications. It is not a clinical study involving a test dataset for diagnostic performance evaluation. The "test set" would implicitly refer to the physical testing and verification/validation activities performed during design control to ensure the device meets its specifications and remains safe and effective (e.g., mechanical tests, optical performance tests, biocompatibility tests), but the sample sizes for these engineering tests are not detailed here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth in the context of diagnostic interpretation by experts is not relevant here as there's no diagnostic algorithm being evaluated. The "ground truth" for a physical device effectively refers to its design specifications, regulatory standards, and established performance characteristics of the predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not the subject of this 510(k).
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is not an AI-assisted device, nor is it a multi-reader, multi-case clinical study.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a physical, fiberoptic endoscope, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (in the diagnostic sense). For a physical device, the "ground truth" for its performance is its adherence to engineered specifications, validated through design verification and validation activities (e.g., measurements of tip diameter, angulation, field of view, depth of field, material compatibility for sterilization). The document states "All changes have been made under design control, and validation was performed and conformance assured," indicating that such engineering-level verification and validation activities were conducted.
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The sample size for the training set:
- N/A. No training set is applicable for this physical device.
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How the ground truth for the training set was established:
- N/A. No training set is applicable for this physical device.
In summary, the provided document is a regulatory submission for a hardware modification, demonstrating substantial equivalence to a predicate device. It does not involve the type of clinical study data or AI performance metrics typically requested for software or AI-enabled medical devices. The "study" is the manufacturer's internal design control and validation process, which presumably confirmed that the altered specifications do not compromise safety or effectiveness compared to the predicate.
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Special 510(k) Summary
| A) Submitted by Schoelly Imaging, Inc100 Hartwell StWest Boylston, MA 01583Registration 8043903 | JAN 1 6 2009 | |
|---|---|---|
| Contact | MEDIcept200 Homer AveAshland, MA 01721F. 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
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| Features | Schoelly Naso-Laryngoscope(the Special 510K applicationherein) | Schoelly-Naso-Laryngoscope(K991560) |
|---|---|---|
| Intended Use | Visualize and observe thepharynx and the larynx | Visualize and observethe pharynx and thelarynx |
| Design | Flexible and steerable fiberopticendoscope for diagnosticpurposes | Flexible and steerablefiberoptic endoscopefor diagnosticpurposes |
| 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 tipdeflection | $20 mm$ | $25 mm$ |
| 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 | |
| LabelingSterilization*/Cleaning | The Instruction Manual statesSterilization | Users Manual states |
| *device is supplied asnon-sterile | Section 7 5 Flexible Schoellyendoscopes with air-exhaust valve canalso be gas sterilized using ethyleneoxide "SpecificationsGas mixture 6% EtO, 94% CO₂Temperature 131°F+/-5°F, 55°C +/-2°CRelative air humidity 40-90%Pressure (overpressure), 1 7 bar(170kpa)Exposure time 120 mins | "The Schoelly Naso-Laryngo-Pharyngoscope isprovided non-sterile, andmust be sterilized usingEtO sterilization prior touse"SpecificationsEO concentration 600 +/-25 mg/LTemperature 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 theunscrewed parts in a suitabledisinfection solution (can also double upas a cleaning solution) The disinfectionsolution used should be permitted by themanufacturer for such use | ||
| Material compatibility releases exist forthe following disinfectants*Gigasept FF, Schulke & Mayr GmbH*Lysetol FF*Helipur HplusN, B Braun Medical AG*Cidex, Johnson & Johnson " | "To dissolve variousimpurities, use mildcleaning substances" |
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Naso-Laryngo-Pharyngoscope Special 510(k) Premarket-Notification Submission
" Manufactured in two resolutions, 12,000 and 16,000 pixels
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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
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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
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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
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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
§ 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.