ShenDa Sinuscope

K161298 · Shenyang Shenda Endoscope Co., Ltd. · EOB · Aug 25, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K161298
• Device Name: ShenDa Sinuscope
• Applicant: Shenyang Shenda Endoscope Co., Ltd.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Aug 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

Device Story

ShenDa® Sinuscope is a reusable, unchanneled rigid endoscope used for visualizing the nasal cavity and nasopharynx. It functions as an optical viewing device, requiring connection to an external light source (e.g., Olympus CLV-180) and light-guide cable to illuminate the target anatomy. The device is available in various configurations, including outer diameters of 2.7mm, 3mm, and 4mm, and multiple viewing angles (0, 12, 30, 45, 70, and 90 degrees). It is intended for use by clinicians in a clinical setting. The device provides direct optical visualization to the physician, aiding in diagnostic or surgical assessment of the nasal and nasopharyngeal regions. It is reprocessed via cleaning and steam sterilization.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993-5, ISO 10993-10, ISO 8600-1, and ISO 8600-5. Performance testing included insertion width, field of view, direction of view, and optical resolution.

Technological Characteristics

Rigid, unchanneled endoscope; optical viewing principle; reusable; steam sterilization. Available in 2.7mm, 3mm, 4mm diameters; 0-90 degree viewing angles. Complies with IEC 60601-1, IEC 60601-2-18, ISO 10993-5/10, and ISO 8600-1/5. No internal software or electronic processing.

Indications for Use

Indicated for visualization of the nasal cavity and nasopharynx in patients requiring endoscopic examination.

Regulatory Classification

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.

Predicate Devices

• SHARPSITE Ac (K965233)

Reference Devices

• OLYMPUS CLV-180 EVIS EXTRA II XENON LIGHT SOURCE (K100584)
• Light-guide cable WA03200A (K944072)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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<br>(K100584) |
|----------------------|------------------------------------------------------------------------------|
| Light-guide<br>cable | Size S, plug type, 3m, CF type, identification number: WA03200A<br>(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

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

- 6. 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.

- 7. 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 10993-10<br>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

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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.