(86 days)
The EVOTECH™ Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high- level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH System when selecting those cycles that contain a wash stage. (Manual cleaning of mystical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
The EVOTECH™ Endoscope Cleaner and Re-processor was cleared under the Premarket Notification process (K040883) found substantially equivalent on March 15, 2005. Subsequent to that the EVOTECH ECR was granted a cleaning claim in Premarket Notification K061899 (found substantially equivalent on October 26, 2006). The system is designed to clean and disinfect endoscopes. The system performs tests to check for connection of endoscopes, for leaks in endoscopes, and for blockage of lumens. The device will clean and high-level disinfect endoscopes and provides for automated alcohol flush of the lumens. The system also has a self-disinfection cycle that can be selected (recommended to be performed every 5 days) to prevent the build up of biofilm in fluid pathways.
The provided text is a 510(k) summary for a Special 510(k) submission for the EVOTECH™ Endoscope Cleaner and Reprocessor. This type of submission is for modifications to a previously cleared device that do not affect the safety or effectiveness. As such, it does not typically include new clinical studies or detailed performance data against acceptance criteria for cleaning and high-level disinfection, but rather verification that the modifications do not negatively impact these established performances.
Therefore, many of the requested items (e.g., acceptance criteria, detailed device performance, sample sizes for test/training sets, expert qualifications, MRMC studies) are not applicable to this specific type of submission and the information provided.
However, I can extract information related to the modifications and the non-clinical tests performed to ensure they did not impact the device's original performance.
Here's a breakdown of what can be extracted and what is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from modifications) | Reported Device Performance (from modifications) |
|---|---|
| Disinfectant dispenser material compatibility with CIDEX OPA Concentrate Solution | Material was compatible. Did not impact performance. Met specification for dispensing volume and reproducibility. |
| Spray arm guard not impacting rotation or spray pattern | Did not impact rotation or affect spray pattern. |
| MEC Monitor performance equivalent to previous device | Data indicate performance is equivalent to the previous device. |
| Lid motor control preventing opening during operation | Changes implemented to prevent lid opening during operation. |
| Software validation for changes made | Software was validated for the changes made. |
| Risk analysis of changes not implicating a change to performance with respect to cleaning and high-level disinfection claims | Non-clinical testing was not done since risk analysis did not implicate a change. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document focuses on demonstrating that modifications did not impact existing performance, rather than re-proving the device's primary function with new detailed studies. The "non-clinical tests" mentioned are specific to verifying the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This submission is not likely to involve expert ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would have been the established specifications and performance parameters for each modified component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically for clinical studies with subjective assessments. The tests described are objective engineering verifications.
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
- Not applicable/Not provided. This is an endoscope cleaning and reprocessing device, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device with associated software, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the verification of modifications, the "ground truth" was based on:
- Engineering specifications and compatibility testing: For material compatibility, dispensing volume, and reproducibility of the disinfectant dispenser.
- Functional performance standards: For spray arm rotation/pattern, MEC monitor equivalence, and lid motor control safety.
- Software validation protocols.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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082392
Special 510(k) Advanced Sterilization Products
NOV 1 3 2008
pla 3 CONFIDENTIAL EVOTECH™ ECR
K. 510(k) Summary
Applicant's Name, Address, Telephone, FAX, Contact Information
Advanced Sterilization Products A Johnson & Johnson Company Division of Ethicon, Inc. 33 Technology Dr. Irvine, CA 92618
Contact Person:
Joseph M. Ascenzi, Ph.D., RAC Sr. Manager, Regulatory Affairs Phone: (949) 453-6352 FAX: (949) 789-3900 Email: jascenzi@aspus.jnj.com
Submission Date
August 18, 2008
Trade Name
EVOTECH™ Endoscope Cleaner and Reprocessor
Common Name Washer Disinfector
Classification
Class II
Legally Marketed Equivalent Device
EVOTECHTM Endoscope Cleaner and Reprocessor (K061899)
Description of Device
The EVOTECH™ Endoscope Cleaner and Re-processor was cleared under the Premarket Notification process (K040883) found substantially equivalent on March 15, 2005. Subsequent to that the EVOTECH ECR was granted a cleaning claim in Premarket Notification K061899 (found substantially equivalent on October 26, 2006).
The system is designed to clean and disinfect endoscopes. The system performs tests to check for connection of endoscopes, for leaks in endoscopes, and for blockage of lumens. The device will clean and high-level disinfect endoscopes and provides for automated alcohol flush of the lumens. The system
88
K-1
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Special 510(k) Advanced Sterilization Products
K082392 p2/f3
CONFIDENTIAL
EVOTECH™ ECR
also has a self-disinfection cycle that can be selected (recommended to be performed every 5 days) to prevent the build up of biofilm in fluid pathways.
Indications for Use
The EVOTECH™ System, a washer/disinfector, is indicated for use with highlevel disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EvoTech System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
Description of Modification
Several subsystems have been modified in order to increase reliability of the device. No changes to the device have been made that will affect the cleaning and high-level disinfection performance of the device.
Summary of Non-clinical Tests
Verification of all physical and electrical changes were done to ensure that they did not affect the performance of the device with respect to cleaning and highlevel disinfection. Non-clinical testing was not done since risk analysis of the changes did not implicate a change to performance with respect to cleaning and high-level disinfection claims.
Changes to critical parts were evaluated.
Disinfectant dispenser-
The change was made after determining that the material was compatible with CIDEX OPA Concentrate Solution and that the change did not impact the performance to this part, i.e. it met the specification for dispensing volume and reproducibility.
Spray arm guard-
The addition of the spray arm guard was evaluated to show that it did not impact the rotation of the arm or affect the spray pattern and hence would not affect the cleaning and disinfection performance of the device.
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Special 510(k) Advanced Sterilization Products
CONFIDENTIAL p³ of 3
EVOTECH™ ECR
MEC Monitor-
A manufacturing change to the MEC monitor detector was made and evaluated for performance. Data indicate that the performance is equivalent to the previous device.
Lid Motor Control-
Changes to the circuitry of the lid motor driver were made so that the lid would not open while the machine was in operation. This was to prevent a potential safety issue.
Software was validated for the changes made.
Substantial Equivalence
Based on the data obtained from the studies described above, the Modified Device, EVOTECH™ Endoscope Cleaner and Reprocessor is substantially equivalent to the Predicate Device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black and white, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2008
Advanced Sterilization Products A Johnson & Johnson Company Division of Ethicon, Incorporated Joseph M. Ascenzi, Ph.D., RAC Senior Manager, Regulatory Affairs 33 Technology Drive Irvine, California 92618
Re: K082392
Trade/Device Name: EVOTECH™ Endoscope Cleaner and Reprocessor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: October 13, 2008 Received: October 14, 2008
Dear Dr. Ascenzi:
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.
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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); 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.
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 the reporting 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,
Clrs
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082392
Device Name: EVOTECH™ Endoscope Cleaner and Reprocessor
Indications for Use:
The EVOTECH™ Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high- level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH System when selecting those cycles that contain a wash stage. (Manual cleaning of mystical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082392
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.