(256 days)
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.
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.
This document describes the 510(k) summary for the KSEA Clearvision® II Lens Irrigation System. Below is an analysis of its acceptance criteria and the study used for its approval, based on the provided text.
Based on the provided 510(k) summary, the KSEA Clearvision® II Lens Irrigation System is not a device typically evaluated with the types of performance studies listed in your request. This is a Class II device (neurological endoscope accessory) and its approval is based on demonstrating "substantial equivalence" to predicate devices, rather than meeting specific quantitative performance metrics like sensitivity, specificity, or accuracy derived from clinical studies with ground truth.
Therefore, many of the requested categories (sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, type of ground truth, training set size, and ground truth establishment for training set) are not applicable to this type of regulatory submission and device.
The "acceptance criteria" for this device are primarily related to its functional and safety characteristics being equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (Characteristics of KSEA Clearvision® II) |
|---|---|
| Type of Pump: Microprocessor controlled | Microprocessor controlled (Same as predicates) |
| Function: Irrigation and reverse flow with adjustable flow intervals | Irrigation and reverse flow with adjustable flow intervals (Essentially same as predicates) |
| Controls: Foot pedal | Foot pedal (Same as predicates) |
| Pump Console Dimensions: Equivalent or comparable | 203 mm x 101 mm x 142 mm (Similar to KSEA Clearvision: 203 mm x 101 mm x 130 mm; No dimensions available for Xomed) |
| Pump Console Weight: Equivalent or comparable | 1.5 kg (Same as KSEA Clearvision; No weight available for Xomed) |
| Details (Irrigation Sheath/Telescope/Tubing): Equivalent functionality and compatibility | Reusable irrigation sheath; use with 2.7- or 4.0-mm rigid telescope and disposable tubing set (Similar to KSEA Clearvision; Xomed uses disposable sheath) |
| Safety Features: Compliance with recognized electrical and medical device safety standards | IEC 60601-1; IEC 60601-1-2; CE; power-up test; operating test; UL 2601.1; CAN/CSA C22.2 No. 601.1-M90 (Includes similar/expanded safety standards compared to predicates) |
| Intended Use: Lens cleaning during endoscopic neurosurgery with endonasal approach | Lens cleaning during endoscopic neurosurgery with endonasal approach (Expanded from predicate's "endoscopic sinus surgery," but considered subtle enough not to raise new safety/effectiveness questions given previous predicate's use in similar areas) |
2. Sample Size Used for the Test Set and Data Provenance:
- N/A. This device's approval is based on a demonstration of substantial equivalence to existing predicate devices, not on a clinical trial with a "test set" in the context of diagnostic or AI device performance. The submission relies on comparative analysis of specifications, intended use, and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- N/A. As above, no "ground truth" test set was used for this type of device submission.
4. Adjudication Method for the Test Set:
- N/A. No test set or adjudication was described.
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:
- N/A. This device is an irrigation system, not an AI or diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical/electronic pump device; the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used:
- N/A. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior approval and marketing. The KSEA Clearvision® II is argued to be safe and effective because it shares fundamental technological and functional characteristics with these already-approved devices, and any minor differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set:
- N/A. No "training set" is relevant for this type of device and submission.
9. How the Ground Truth for the Training Set was Established:
- N/A. No training set or ground truth for a training set was used.
Overall Study Described:
The "study" or evidence presented for the KSEA Clearvision® II Lens Irrigation System's approval is a substantive equivalence comparison with two predicate devices:
The document highlights:
- Device Description: It's a microprocessor-controlled pump providing irrigation to clean the scope lens and remove residual solution.
- Technological Characteristics: Microprocessor control, fixed flow rate, adjustable reverse flow intervals, footswitch activation, self-diagnostic check, and monitoring of current/temperature.
- Summary of Substantial Equivalence: The submission asserts that the KSEA Clearvision® II is substantially equivalent because its basic features, design, and intended uses are similar to the predicate devices. Minor differences are argued not to raise new issues of safety and effectiveness, nor affect performance, function, or intended use.
The provided "Substantial Equivalence Table" is the core of the comparative analysis study. It meticulously lists characteristics of the proposed device alongside the predicate devices across various aspects (type of pump, function, controls, physical dimensions, safety features, and intended use), demonstrating where they are "Same," similar, or have minor differences that are deemed insignificant for safety and effectiveness. The FDA's 510(k) clearance letter (K072410) confirms that the agency agreed with this assessment of substantial equivalence.
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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: (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.
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STORZ ENDOSCOP ARL
Substantial Equivalence Table for KSEA Clearvision® II Lens Irrigation Syster
| Device | KSEA Clearvision® II LensIrrigation System | KSEA Clearvision® LensIrrigation System (K013838) | Xomed Endo-Scrub/Endo-Scrub 2 (K982594) |
|---|---|---|---|
| Type of Pump | Microprocessor controlled | Same | Same |
| Function | Irrigation and reverse flowwith adjustable flow intervals | Same | Irrigation and reverse flow withadjustable 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 rigidtelescope and disposabletubing set | Reusable irrigation sheath; usewith 2.7- or 4.0-mm rigidtelescope and reusable ordisposable tubing set | Disposable irrigation sheath; usewith 2.7- or 4.0-mm rigidtelescope and disposable tubingset |
| Safety Features | IEC 60601-1; IEC 60601-1-2;CE; power-up test; operatingtest; UL 2601.1; CAN/CSAC22.2 No. 601.1-M90 | IEC 601-1; IEC 60601-1-2;CE; power-up test; operatingtest | IEC 60601-1-1; IEC 60601-1-2;CE |
| Intended Use | Lens cleaning duringendoscopic neurosurgerywith endonasal approach. | Lens cleaning duringendoscopic sinus surgery. | Lens cleaning duringendoscopic sinus surgery. |
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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 (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
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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
្រី និង ស្រុក
§ 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).