(134 days)
Not Found
No
The description focuses on the optical and mechanical components of the sinuscope and mentions image processing by a separate camera system, but there is no mention of AI or ML within the device itself or its function.
No
The device description states that the sinuscopes are used for examination, diagnosis, and therapy, but the detailed description of how the sinuscopes achieve their intended use focuses solely on imaging internal patient anatomy. There is no information provided about the therapeutic function of the device itself.
Yes
The device description explicitly states that the sinuscopes are used to provide a view of internal patient anatomy for "examination, diagnosis, and therapy". The inclusion of "diagnosis" indicates its function as a diagnostic device.
No
The device is a physical, tubular optical instrument with lenses and requires cleaning and sterilization, indicating it is hardware.
Based on the provided information, the Precision S 4K Sinuscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Sinuscope Function: The description clearly states the sinuscope is a tubular optical instrument used to provide a view of internal patient anatomy during procedures. It directly visualizes structures within the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing or testing any biological specimens taken from the patient. Its function is purely for visualization.
The device is a surgical endoscope used for direct visualization of internal anatomy, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.
Product codes
EOB
Device Description
Stryker's Precision S 4K Sinuscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during otorhinolaryngology procedures. The devices are available in a variety of outer diameters and working lengths.
The sinuscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process (i.e. clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The sinuscope connects to the camera system through a separate coupler. The coupler is provided by the camera system and is not subject of this premarket notification.
The sinuscopes achieve their intended use by guiding light to illuminate and image a patient's internal anatomy, then relaying the image out of the surgical site for processing and display by a separate camera system. The sinuscope's optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, and Throat (ENT), Head and Neck
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
| Test Category | Applicable Standards / Guidance | Result |
|---|---|---|
| Biocompatibility | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-11 FDA Guidance: Use of International Standard ISO 10993-1 | Pass |
| Cleaning | AAMI TIR30 AAMI ST15883-5 | Pass |
| Disinfection | AAMI TIR 12 ISO 15883-2 | Pass |
| Sterilization | ISO 14937 ANSI/AAMI ST79 ANSI/AAMI ST58 ISO 17665-1 | Pass |
| Electrical Safety & Temperature Testing | IEC 60601-1 IEC 60601-2-18 | Pass |
| Packaging Qualification | ASTM D4149 | Pass |
| Optical Performance | ISO 8600-1 | Pass |
| Design Validation | AAMI/ANSI HE75 AAMI/IEC 62366 FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices | Pass |
| Performance - Bench | In accordance with device performance specifications | Pass |
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2019
Stryker Jessie Duong Sr. Staff, Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K191102
Trade/Device Name: Precision S 4K Sinuscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: April 23, 2019 Received: April 25, 2019
Dear Jessie Duong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Precision S 4K Sinuscope
Indications for Use (Describe)
The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and connected, giving the word a modern and sleek appearance. The color of the text is black, contrasting with the white background.
510(k) Summary
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jessie Duong
Senior Staff Regulatory Affairs Specialist
Phone: (408) 754-2077
Facsimile: (408) 754-2598
Email: jessie.duong@stryker.com |
| Date Prepared | April 23, 2019 |
Subject Device:
| Name of Device | Stryker Precision S 4K Sinuscope |
|---|---|
| Common or Usual Name | Sinuscope |
| Classification Name | Nasopharyngoscope, 21 CFR 874.4760 |
| Regulatory Class | Class II |
| Product Code | EOB |
Predicate Device:
Note: The predicate device has not been subject to a design-related recall.
Device Description:
Stryker's Precision S 4K Sinuscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during otorhinolaryngology procedures. The devices are available in a variety of outer diameters and working lengths.
The sinuscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process (i.e. clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The sinuscope connects to the camera system through a separate coupler. The coupler is provided by the camera system and is not subject of this premarket notification.
The sinuscopes achieve their intended use by guiding light to illuminate and image a patient's internal anatomy, then relaying the image out of the surgical site for processing and display by a separate camera system. The sinuscope's optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.
4
Indications for Use:
The Precision S 4K Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
| Feature | Subject Device | Predicate Device |
|---|---|---|
| Precision S 4K Sinuscope | Schoelly Sinuscope | |
| Manufacturer | Stryker Endoscopy | |
| 5900 Optical Court | ||
| San Jose, CA 95138 | ||
| USA | Schoelly Fiberoptic GmbH | |
| Robert-Bosch-Str. 1-3 | ||
| 79211 Denzlingen | ||
| Germany | ||
| Submission Reference | Current Submission | K142249 |
| Indications for Use | ||
| Statement | The Precision S 4K Sinuscope is | |
| intended for use in otolaryngology | ||
| and Head and Neck procedures, | ||
| including rhinology, and endoscopic | ||
| plastic and reconstructive surgery | The Schoelly Sinuscope is intended | |
| for use in otolaryngology and Head | ||
| and Neck procedures, including | ||
| rhinology, and endoscopic plastic | ||
| and reconstructive surgery | ||
| Image Transmission | Rigid rod lenses | Rigid rod lenses |
| Outer diameter | 4.0mm, 3.1mm | 4.0mm, 2.7mm |
| Working Length | 125mm - 180mm | 110mm - 175mm |
| DOV | 0°-70° | 0°-70° |
| FOV | 80°-105° | 80°-100° |
| Key Patient-Contacting | ||
| Materials | Stainless Steel, Optical Glass, | |
| Glass Fibers | Stainless Steel, Optical Glass, | |
| Glass Fibers, Co-Cr-Ni Alloy | ||
| Single Use or Reusable | Reusable | Reusable |
| Cleaning | Manual and Automated | Manual and Automated |
| Disinfection | Manual and Automated | Not available |
| Sterilization | ||
| Methods | Autoclave, Steris VPRO, | |
| APS Sterrad | Autoclave, APS Sterrad | |
| Sterility Assurance Level | 10-6 | 10-6 |
Comparison of Technological Characteristics with the Predicate Device:
5
Performance Testing:
The following performance data were provided in support of the substantial equivalence determination.
| Test Category | Applicable Standards / Guidance | Result |
|---|---|---|
| Biocompatibility | ISO 10993-1 | |
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 10993-11 | ||
| FDA Guidance: Use of International | ||
| Standard ISO 10993-1 | Pass | |
| Cleaning | AAMI TIR30 | |
| AAMI ST15883-5 | Pass | |
| Disinfection | AAMI TIR 12 | |
| ISO 15883-2 | Pass | |
| Sterilization | ISO 14937 | |
| ANSI/AAMI ST79 | ||
| ANSI/AAMI ST58 | ||
| ISO 17665-1 | Pass | |
| Electrical Safety & | ||
| Temperature Testing | IEC 60601-1 | |
| IEC 60601-2-18 | Pass | |
| Packaging Qualification | ASTM D4149 | Pass |
| Optical Performance | ISO 8600-1 | Pass |
| Design Validation | AAMI/ANSI HE75 | |
| AAMI/IEC 62366 | ||
| FDA Guidance: Applying Human | ||
| Factors and Usability Engineering to | ||
| Medical Devices | Pass | |
| Performance - Bench | In accordance with device | |
| performance specifications | Pass |
Conclusions:
The Precision S 4K Sinuscope is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the Precision S 4K Sinuscope when used as instructed.