KSEA CLEARVISION II, MODEL 40334120

K072410 · KARL STORZ Endoscopy-America, Inc. · GWG · May 9, 2008 · Neurology

Device Facts

• Record ID: K072410
• Device Name: KSEA CLEARVISION II, MODEL 40334120
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GWG · Neurology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

The KSEA Clearvision II is a lens irrigation system for cleaning the distal lens of the telescope and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.

Device Story

Microprocessor-controlled pump system; provides irrigation to clean distal lens of telescope; removes residual solution from lens. Used with irrigation sheath and 2.7- or 4.0-mm rigid telescope. Operated by surgeon via footswitch pedal. Performs self-diagnostic power-up check; monitors current and device temperature during operation. Provides fixed flow rate with adjustable reverse flow intervals. Used in surgical setting to maintain clear visualization without scope removal; improves surgical efficiency and patient outcomes by reducing interruptions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Microprocessor-controlled pump; fixed flow rate; adjustable reverse flow intervals. Footswitch control. Dimensions: 203 mm x 101 mm x 142 mm; Weight: 1.5 kg. Safety standards: IEC 60601-1, IEC 60601-1-2, UL 2601.1, CAN/CSA C22.2 No. 601.1-M90. Reusable irrigation sheath; disposable tubing set.

Indications for Use

Indicated for cleaning the distal lens of a telescope and maintaining visualization during endoscopic neurosurgical procedures via an endonasal approach.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Xomed Endo-Scrub/Endo-Scrub 2 (K982594)
• KSEA Clearvision® Lens Irrigation System (K013838)

Submission Summary (Full Text)

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## 510(k) SUMMARY

|--|--|

AY - 9 2008

| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc |
|--------------------|-------------------------------------|
| | 600 Corporate Pointe |
| | Culver City, CA 90230-7600 |
| | Phone: [phone] |
| | Fax: [phone] |

Contact Person: Crystal Dizol Regulatory Affairs Specialist Email: [e-mail]

Date of Submission: April 15, 2008

Device Trade Name: KSEA Clearvision® II Lens Irrigation System

- Common Name: Suction/Irrigation Pump
- Classification Name: Neurological endoscope.
- Regulation Number: 21 CFR 882.1480
- Product Code: GWG

### Predicate Device(s): Xomed Endo-Scrub/Endo-Scrub 2 (K982594) KSEA Clearvision® Lens Irrigation System (K013838)

Device Description: The KSEA Clearvision® II is a microprocessor-controlled pump device. The device provides irrigation to clean the objective lens of the scope and removes residual solution on the lens. It is used in conjunction with an irrigation sheath.

Indications for Use: The KSEA Clearvision® II is a lens irrigation system for cleaning the distal lens of the telescope and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.

Technological The KSEA Clearvision® II is a microprocessor-controlled pump with a Characteristics: fixed flow rate and adjustable reverse flow intervals. The KSEA Clearvision® II is activated by depressing the footswitch pedal and performs a self-diagnostic check during its power up, in addition to monitoring current and device temperature during operation.

- Summary of The KSEA Clearvision® II is substantially equivalent to the predicate Substantial device since the basic features, design, and intended uses are similar. Equivalence: The minor differences between the KSEA Clearvision® II and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function, or intended use of the devices. Refer to the attached substantial equivalence chart.

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STORZ ENDOSCOP ARL

# Substantial Equivalence Table for KSEA Clearvision® II Lens Irrigation Syster

| Device | KSEA Clearvision® II Lens<br>Irrigation System | KSEA Clearvision® Lens<br>Irrigation System (K013838) | Xomed Endo-Scrub/<br>Endo-Scrub 2 (K982594) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Type of Pump | Microprocessor controlled | Same | Same |
| Function | Irrigation and reverse flow<br>with adjustable flow intervals | Same | Irrigation and reverse flow with<br>adjustable cycles |
| Controls | Foot pedal | Same | Same |
| Pump Console Dimensions<br>(w x h x d) | 203 mm x 101 mm x 142 mm | 203 mm x 101 mm x 130 mm | Not available |
| Pump Console Weight | 1.5 kg | Same | Not available |
| Details | Reusable irrigation sheath;<br>use with 2.7- or 4.0-mm rigid<br>telescope and disposable<br>tubing set | Reusable irrigation sheath; use<br>with 2.7- or 4.0-mm rigid<br>telescope and reusable or<br>disposable tubing set | Disposable irrigation sheath; use<br>with 2.7- or 4.0-mm rigid<br>telescope and disposable tubing<br>set |
| Safety Features | IEC 60601-1; IEC 60601-1-2;<br>CE; power-up test; operating<br>test; UL 2601.1; CAN/CSA<br>C22.2 No. 601.1-M90 | IEC 601-1; IEC 60601-1-2;<br>CE; power-up test; operating<br>test | IEC 60601-1-1; IEC 60601-1-2;<br>CE |
| Intended Use | Lens cleaning during<br>endoscopic neurosurgery<br>with endonasal approach. | Lens cleaning during<br>endoscopic sinus surgery. | Lens cleaning during<br>endoscopic sinus surgery. |

:159

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Karl Storz Endoscopy-America, Inc. % Ms. Crystal K. Dizol Regulatory Affairs Specialist 600 Corporate Pointe, 5th Floor Culver City, California 90230-7600

Re: K072410

Trade/Device Name: KSEA Clearvision® II Lens Irrigation System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Codc: GWG Dated: April 15, 2008 Received: April 22, 2008

Dear Ms. Dizol:

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.

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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Page 2 – Ms. Crystal K. Dizol

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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): K072410

Device Name: KSEA Clearvision® II Lens Irrigation System

Indications for Use: The KSEA Clearvision II is a lens irrigation system for cleaning the distal lens of the telescope and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.

Prescription Use: X AND/OR (21 CFR 801 Subpart D)

Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRI e of Device Evaluation (ODE) (Division Sign Division of General, Restorative. and Neurological Devices

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510(k) Number K072410

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