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). It can be connected to OLYMPUS light source and OLYMPUS light cable. It is a reusable device subject to cleaning and steam sterilization.

AI/ML Overview

The ShenDa® Sinuscope K161298 is a rigid endoscope intended to provide an endoscopic means to view the nasal cavity and nasopharynx. The device's performance was evaluated through non-clinical tests to verify its design specifications and substantial equivalence to a predicate device (SHARPSITE Ac K965233).

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Test Item	Acceptance Criteria (Standard Reference)	Reported Device Performance
Electrical Safety	IEC 60601-1-2005 (Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance)	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC)	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)	Complies with IEC 60601-1-2
Basic Safety & Essential Performance of Endoscopic Equipment	IEC 60601-2-18:2009 (Medical Electrical Equipment- Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment)	Complies with IEC 60601-2-18
Biocompatibility (Cytotoxicity)	ISO 10993-5:2009 (Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity)	Complies with ISO 10993-5; No adverse reaction demonstrated in cytotoxicity tests.
Biocompatibility (Irritation & Skin Sensitization)	ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)	Complies with ISO 10993-10; No adverse reaction demonstrated in intracutaneous and skin sensitization tests.
General Requirements for Endoscopes	ISO 8600-1:2015 (Endoscopes--Medical endoscopes and Endotherapy Devices--part 1: General Requirements)	Complies with ISO 8600-1
Optical Resolution	ISO 8600-5:2005 (Optics and photonics-Medical endoscopes and endotherapy devices part 5: Determination of optical resolution of rigid endoscopes with optics)	Complies with ISO 8600-5; Specific resolution values are not explicitly stated in the summary but were deemed compliant.
Insertion Width	Design Specifications (Expected to match the stated shaft body diameters)	Available in 2.7mm, 3.0mm, 4.0mm diameters. The test results demonstrated the proposed device met design specifications.
Field of View	Design Specifications (Expected to match the stated field of view angles)	Available in 60, 90, and 110 degrees. The test results demonstrated the proposed device met design specifications, offering a wider range than the predicate device.
Direction of View	Design Specifications (Expected to match the stated direction of view angles)	Available in 0, 12, 30, 45, 70, and 90 degrees. The test results demonstrated the proposed device met design specifications, offering a wider range than the predicate device.
Depth of Field	Design Specifications (Appropriate for clinical use)	1-50mm. The design of the depth of field was considered appropriate for clinical use, even though the predicate device's depth of field was unknown.
Reprocessing	Effective cleaning and steam sterilization	The device is reusable and subject to cleaning and steam sterilization, indicating that the reprocessing methods were validated and found effective.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical tests conducted to verify design specifications and substantial equivalence. These tests likely involved a sample of the manufactured devices for physical and performance measurements. Specific sample sizes for each test are not provided in the summary.
The data provenance is from Shenyang, Liaoning, China, where the manufacturer (Shenyang Shenda Endoscope CO., LTD.) is located. The tests are non-clinical, so "retrospective or prospective" doesn't directly apply in the same way it would to human subject studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the evaluation involved non-clinical performance and safety testing against established engineering and biocompatibility standards, not expert-derived ground truth for diagnostic imaging or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable as the evaluation involved non-clinical performance and safety testing, not adjudication by clinical experts.

5. 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:

No, an MRMC comparative effectiveness study was not done. This device is an endoscope, a viewing tool, not an AI-assisted diagnostic device.
The submission explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This device is a manual medical instrument (endoscope), not a software algorithm or an AI-enabled device.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests was established by international consensus standards (e.g., IEC 60601 series, ISO 10993 series, ISO 8600 series) and the design specifications of the device for parameters like physical dimensions, field of view, and direction of view.

8. The sample size for the training set:

This information is not applicable. The device is an endoscope and does not involve AI or machine learning algorithms that require a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the reasons stated in point 8.

Summary

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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.

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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

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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)

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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

1. Date of Preparation: 08/24/2017
1. 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

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

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

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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-guidecable	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.

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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

1. Identification of Predicate Device
  510(k) Number: K965233 Device Name: SHARPSITE Ac Manufacturer: Medtronic Xomed Inc.
1. 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:
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.

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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.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
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 10993-10No adverse reaction demonstrated in cytotoxicity, intracutaneous and skin sensitization	Not Known
Reprocessing	Cleaning and Steam Sterilization,	Cleaning and Steam Sterilization,

Table 1 SE Comparison

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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.

Regulation Number and Section

§ 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.