(58 days)
The KSEA Clearvision® is a lens irrigation system for cleaning the lens and maintaining clear visualization without removing the scope from the surgical site during sinus surgery.
The KSEA Clearvision® is a microprocessor-controlled pump device. The device provides irrigation to clean the objective lens of scope, and removes residual solution on the lens. It is used in conjunction with an irrigation sheath.
This 510(k) summary does not contain the information required to answer your request.
Here's why:
- Acceptance Criteria and Device Performance: The document does not describe specific performance-based acceptance criteria (e.g., a certain flow rate, cleaning effectiveness percentage) or present data from a study demonstrating the device meets such criteria. Instead, it focuses on substantial equivalence to a predicate device based on features and intended use.
- Study Details (Sample Size, Provenance, Ground Truth, Training Set): There is no mention of a study involving a test set, training set, or the establishment of ground truth. The submission is a regulatory comparison against a predicate device, not a performance study.
- Expert Review/Adjudication: Since no performance study (like a clinical trial or algorithm evaluation) is presented, there's no information about experts used for ground truth, their qualifications, or adjudication methods.
- MRMC or Standalone Studies: The document does not discuss multi-reader multi-case comparative effectiveness studies or standalone performance studies. The KSEA Clearvision is a physical pump device, not an AI or imaging-based diagnostic tool that would typically undergo such studies.
In summary, this 510(k) pertains to a medical device's regulatory clearance based on substantial equivalence, rather than a detailed performance study with acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in large, bold letters on the top line, and the words "Karl Storz Endoscopy" are in smaller letters on the bottom line. The "O" in STORZ is a circle.
KO1383
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JAN 1 6 2002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Application: | Karl Storz Endoscopy -- America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100 |
|---|---|
| Contact: | James A. Lee, Ph.D.Regulatory Affairs Specialist |
| Device Identification: | Common Name:Suction/Irrigation Pump |
| Trade Name: (optional)KSEA Clearvision® |
Indication: The KSEA Clearvision® is a lens irrigation system for cleaning the lens and maintaining clear visualization without removing the scope from the surgical site during sinus surgery.
Device Description: The KSEA Clearvision® is a microprocessor-controlled pump device. The device provides irrigation to clean the objective lens of scope, and removes residual solution on the lens. It is used in conjunction with an irrigation sheath.
The KSEA Clearvision® is substantially equivalent to the Substantial Equivalence: predicate device since the basic features and intended uses are the same. The minor differences between the KSEA Clearvision® and the predicate device raise no new questions of safety or effectiveness, as these differences have no effect on the performance, function, or intended use of the devices.
Signed:
:
James A. Lee, Ph.D. Regulatory Affairs Specialist
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COMPARISON CHART FOR THE KSEA CLEARVISION
| FEATURES | KSEA Clearvision® | Xomed Endo-Scrub/ Endo-Scrub 2(K98254) |
|---|---|---|
| Type of Pump | ||
| Function | Microprocessor controlled | Same |
| Controls | Irrigation and reverse flow with adjustableflow intervals | Irrigation and reverse flow with adjustablecycles |
| Pump Console | Foot pedal | Same |
| Dimensions (w x h x d) | 203 mm x 101 mm x 130 mm | Not available from marketing info |
| Pump Console Weight | 1.5 Kg | Not available from marketing info |
| Accessories | Reusable 2.7 or 4.0 mm irrigation Sheath andDisposable Tubing Set | Disposable 2.7 or 4.0 mm irrigation Sheath andDisposable Tubing Set |
| Safety Features | IEC 601-1; IEC 60601-1-2; self diagnosticsduring power up; temperature and currentmonitoring during operation | IEC 60601-1-1; IEC 60601-1-2 |
| Intended Use | Lens cleaning during sinus surgery | Same |
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and human. The text "U.S. Department of Health & Human Services - USA" is arranged in a circular pattern around the eagle. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2002
Re: K013838
c/o James A. Lee, Ph.D.
600 Corporate Pointe 5th Floor Culver City, California 90230
Karl Storz Endoscopy - America, Inc
Trade/Device Name: KSEA Clearvision® Lens Irrigation System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope and accessory Regulatory Class: Class II Product Code: EOB Dated: November 16, 2001 Received: November 19, 2001
Dear Mr. Lee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - James A. Lee, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo features the word "STORZ" in large, bold letters with a circular design in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The logo is in black and white.
510(k) Number (if known):
Device Name: KSEA Clearvision® Lens Irrigation System
Indication for Use: The KSEA Clearvision® is a lens irrigation system for cleaning the lens and maintaining clear visualization without removing the scope from the surgical site during sinus surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-the-Counter Use: __ Prescription Use: (Per 21 CFR 801.109)
4/02
Karen A. Bober
Division Sign Off
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number K013838
(Optional Format 1-2-96)
0003
§ 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.