(256 days)
Not Found
No
The summary describes a microprocessor-controlled pump for irrigation and cleaning, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a lens irrigation system for cleaning a surgical telescope, not for treating a disease or condition in a patient. Its function is to maintain clear visualization for the surgeon.
No
Explanation: The device is described as a lens irrigation system for cleaning a telescope lens during surgery, not for diagnosing medical conditions.
No
The device description explicitly states it is a "microprocessor-controlled pump device," indicating it includes hardware components beyond just software.
Based on the provided information, the KSEA Clearvision II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- KSEA Clearvision II Function: The KSEA Clearvision II is a system for cleaning the lens of a surgical telescope during endoscopic procedures. It directly interacts with the surgical equipment and the surgical field, not with patient specimens for diagnostic purposes.
- Intended Use: The intended use clearly states its purpose is for "cleaning the distal lens of the telescope and maintaining clear visualization." This is a functional aid during surgery, not a diagnostic test.
Therefore, the KSEA Clearvision II falls under the category of a surgical accessory or instrument, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GWG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
|--|--|
AY - 9 2008
| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc |
|---|---|
| 600 Corporate Pointe | |
| Culver City, CA 90230-7600 | |
| Phone: (310) 338-8100 | |
| Fax: (310) 410-5519 |
Contact Person: Crystal Dizol Regulatory Affairs Specialist Email: cdizol@ksea.com
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.
1
STORZ ENDOSCOP ARL
Substantial Equivalence Table for KSEA Clearvision® II Lens Irrigation Syster
| Device | KSEA Clearvision® II Lens
Irrigation System | KSEA Clearvision® Lens
Irrigation System (K013838) | Xomed Endo-Scrub/
Endo-Scrub 2 (K982594) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Type of Pump | Microprocessor controlled | Same | Same |
| Function | Irrigation and reverse flow
with adjustable flow intervals | Same | Irrigation and reverse flow with
adjustable cycles |
| Controls | Foot pedal | Same | Same |
| Pump Console Dimensions
(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;
use with 2.7- or 4.0-mm rigid
telescope and disposable
tubing set | Reusable irrigation sheath; use
with 2.7- or 4.0-mm rigid
telescope and reusable or
disposable tubing set | Disposable irrigation sheath; use
with 2.7- or 4.0-mm rigid
telescope and disposable tubing
set |
| Safety Features | IEC 60601-1; IEC 60601-1-2;
CE; power-up test; operating
test; UL 2601.1; CAN/CSA
C22.2 No. 601.1-M90 | IEC 601-1; IEC 60601-1-2;
CE; power-up test; operating
test | IEC 60601-1-1; IEC 60601-1-2;
CE |
| Intended Use | Lens cleaning during
endoscopic neurosurgery
with endonasal approach. | Lens cleaning during
endoscopic sinus surgery. | Lens cleaning during
endoscopic sinus surgery. |
:159
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
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.
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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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