(473 days)
Not Found
No
The device description and performance studies focus on the optical and physical characteristics of a standard endoscope, with no mention of AI/ML capabilities or image processing beyond basic viewing.
No
The device is intended for viewing and diagnostic purposes, not for treating a disease or condition.
Yes
The device is described as an "endoscopic means to view the nasal cavity and nasopharynx," which implies observation for the purpose of diagnosis.
No
The device description explicitly states it is an "unchanneled endoscope" with various physical dimensions and vision angles, and it connects to external hardware like light sources and cables. This indicates it is a physical medical device, not software-only.
Based on the provided information, the ShenDa® Sinuscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc. The purpose is to provide information about a person's health status, diagnose diseases, or monitor treatment.
- The ShenDa® Sinuscope is an endoscope used for direct visualization of the nasal cavity and nasopharynx. It is inserted into the body to allow a physician to see these anatomical structures. It does not analyze samples taken from the body.
The intended use and device description clearly indicate that the ShenDa® Sinuscope is a medical device for direct endoscopic viewing, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
ShenDa® Sinuscope is an unchanneled endoscope intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Viewing Optics
Anatomical Site
nasal cavity and nasopharynx
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1-2005, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- IEC 60601-2-18:2009, Medical Electrical Equipment- Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
- ISO 8600-1:2015 Endoscopes--Medical endoscopes and Endotherapy Devices--part 1: General Requirements.
- ISO 8600-5:2005 Optics and photonics-Medical endoscopes and endotherapy devices part 5: Determination of optical resolution of rigid endoscopes with optics
The performance test items include the insertion width, field of view and direction of view, and optical resolution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, layered on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Shenyang Shenda Endoscope Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K161298
Trade/Device Name: Shenda Sinuscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: July 26, 2017 Received: July 27, 2017
Dear Diana Hong:
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. 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for 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
2
Indications for Use
510(k) Number (if known) K161298
Device Name ShenDa® Sinuscope
Indications for Use (Describe)
ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
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
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K161298
-
- Date of Preparation: 08/24/2017
-
- Sponsor Identification
Shenyang Shenda Endoscope CO., LTD.
No.123 Hezuo Street, Dadong District, Shenyang, Liaoning, 110044, China
Establishment Registration Number: Not yet registered
Contact Person: Gao, Feng Position: Overseas Sales Manager Tel: +86-24-88093290 Fax: +86-24-88903118 Email: clark_925@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: ShenDa® Sinuscope Common Name: Sinuscope Model: BD-1 19 Product Codes: J0200G, J0200CG, J1200, J2200, J0212, J0230CG, J1230, J2230, J0245G, J0245E, J0270G, J0270CG, J1270, J2270, J0290E, J0200E, J0230E, and J0270E
Regulatory Information
Classification Name: Nasopharyngoscope (Flexible or Rigid) Classification: Class II Product Code: EOB Regulation Number: 21 CFR part 874.4760 Review Panel: Ear Nose & Throat
Intended Use Statement:
ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Device Description
ShenDa® Sinuscope is an unchanneled endoscope intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
The endoscope is available in the various combination of outer diameter (2.7mm, 3mm, 4mm) and vision direction angles (0, 12, 30, 45, 70 and 90 degree), which are listed in Table 1 Specifications of the Proposed Device of this document.
It can be connected to OLYMPUS light source and OLYMPUS light cable; the information of associated OLYMPUS compatible equipments is provided as following:
| Light source | OLYMPUS CLV-180 EVIS EXTRA II XENON LIGHT SOURCE
(K100584) |
|----------------------|------------------------------------------------------------------------------|
| Light-guide
cable | Size S, plug type, 3m, CF type, identification number: WA03200A
(K944072) |
| Connector | Not required |
It is a reusable device subject to cleaning and steam sterilization.
5
| Table 1 Specifications | |||||
|---|---|---|---|---|---|
| No. | Code | Direction of view (°) | Field of view field (°) | Diameter of inserting section(Φ) | Working length(mm) |
| 1 | J0200G | 0 | 90 | 4 | 175 |
| 2 | J0200CG | 0 | 110 | 4 | 175 |
| 3 | J1200 | 0 | 60 | 3 | 175 |
| 4 | J2200 | 0 | 60 | 2.7 | 175 |
| 5 | J0212 | 12 | 60 | 4 | 175 |
| 6 | J0230G | 30 | 90 | 4 | 175 |
| 7 | J0230CG | 30 | 110 | 4 | 175 |
| 8 | J1230 | 30 | 60 | 3 | 175 |
| 9 | J2230 | 30 | 60 | 2.7 | 175 |
| 10 | J0245G | 45 | 90 | 4 | 175 |
| 11 | J0245E | 45 | 60 | 4 | 175 |
| 12 | J0270G | 70 | 90 | 4 | 175 |
| 13 | J0270CG | 70 | 110 | 4 | 175 |
| 14 | J1270 | 70 | 60 | 3 | 175 |
| 15 | J2270 | 70 | 60 | 2.7 | 175 |
| 16 | J0290E | 90 | 60 | 4 | 175 |
| 17 | J0200E | 0 | 60 | 4 | 175 |
| 18 | J0230E | 30 | 60 | 4 | 175 |
| 19 | J0270E | 70 | 60 | 4 | 175 |
Table 1 Specifications
-
- Identification of Predicate Device
510(k) Number: K965233 Device Name: SHARPSITE Ac Manufacturer: Medtronic Xomed Inc.
- Identification of Predicate Device
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
A IEC 60601-1-2005, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance.
-
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
A IEC 60601-2-18:2009, Medical Electrical Equipment- Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment.
6
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
-
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
-
ISO 8600-1:2015 Endoscopes--Medical endoscopes and Endotherapy Devices--part 1: General Requirements.
-
ISO 8600-5:2005 Optics and photonics-Medical endoscopes and endotherapy devices part 5: Determination of optical resolution of rigid endoscopes with optics
The performance test items include the insertion width, field of view and direction of view, and optical resolution.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | EOB | K965233 |
| Regulation Number | 21 CFR part 874.4760 | EOB |
| 21 CFR part 874.4760 | ||
| Intended Use | ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx. | The Xomed SHARPSITE Ac rigid rod lens endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery. |
| Feature | unchanneled rigid endoscope | unchanneled rigid endoscope |
| Mechanism | Viewing Optics | Viewing Optics |
| Working Length | 175mm | 175mm |
| Direction of View | 0, 12, 30, 45, 70, and 90 degree | 0, 30, and 70 degree |
| Field of View | 60, 90 and 110 degress | 100 and 102 degress |
| Shaft Body diameter | 2.7, 3.0, 4.0mm | 4.0mm |
| Depth of Field | 1-50mm | Not Known |
| Safety | Comply with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-18 | Not Known |
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | |
| No adverse reaction demonstrated in cytotoxicity, intracutaneous and skin sensitization | Not Known | |
| Reprocessing | Cleaning and Steam Sterilization, | Cleaning and Steam Sterilization, |
Table 1 SE Comparison
7
Although the indications for use are expressed differently, the proposed device and predicate device have the similar product structure, working principle and optical performance. This item is considered to be substantially equivalent.
The proposed device provides a more range of field of view and direction of view than the predicate device, additionaly it provides more options of diameters of shaft than the predicate device, to the physicians to fit various patients, these difference it will not affect the safety and effectiveness concerning the SE. Although the depth of filed of the prediate device is unknow, we think the design of the depth of field of the proposed device is appropriate for the clinical use. Although the result of Electrical Safety, EMC and biocompatibility of predicate device is unknown, it is concluded from the relevant testng results of the proposed device, that the proposed device is safe and effective.
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.