(344 days)
No
The summary describes a washer/disinfector with automated cycles and monitoring, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is a washer/disinfector used for reprocessing heat-sensitive medical devices (endoscopes), not for direct therapeutic treatment of a patient.
No
This device is a washer/disinfector used for reprocessing heat-sensitive semi-critical endoscopes, not for diagnosing medical conditions.
No
The device is a washer/disinfector system, which is a piece of hardware designed to reprocess endoscopes. While it likely contains software for control and monitoring, the core function and description are centered around the physical machine and its processes.
Based on the provided information, the EvoTech System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the EvoTech System is a "washer / disinfector" for reprocessing heat-sensitive semi-critical endoscopes. Its purpose is to clean and disinfect medical devices, not to perform tests on biological samples to diagnose or monitor a patient's condition.
- Device Description: The description details the system's function in cleaning, disinfecting, and rinsing endoscopes. It focuses on the process of reprocessing the medical device itself.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The EvoTech System is a medical device used in the reprocessing of other medical devices (endoscopes) to ensure they are safe for subsequent use on patients. It falls under the category of device reprocessing equipment, not IVDs.
N/A
Intended Use / Indications for Use
The EvoTech™ System is intended for use as a washer / disinfector for reprocessing flexible endoscopes that do not contact normally sterile areas of the body.
The EvoTech System, a washer / disinfector, is indicated for use with the high level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum temperature of 50°C for a contact time of 5 minutes) for reprocessing heat sensitive (
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS J.
| 1. 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|
| Contact | Neelu Medhekar R.E.H.S., R.A.C., | |
| Project Manager, Regulatory Affairs | ||
| Phone: 949 789 3838 | ||
| Fax: 949 789 3900 | ||
| Advanced Sterilization Products | ||
| Division of Ethicon Inc. a Johnson & Johnson company | ||
| 33 Technology Drive | ||
| Irvine, CA 92618 | MAR 1 5 2005 | |
| Date | April 2, 2004 | |
| Device name | Classification: | Endoscope and accessories |
| Trade Name: | EvoTech™ System | |
| Proprietary Name: | EvoTech™ Integrated Endoscope Disinfection System | |
| Legally marketed device | The EvoTech System claims equivalence to the Medivators DSD-91 | |
| Disinfector (K914145). The predicate is a system that utilizes a sterilant / | ||
| high level disinfectant solution to reprocess reusable medical devices. It | ||
| regulates the contact conditions (for example temperature, concentration, | ||
| appropriate rinsing) required for effective disinfection / sterilization of the | ||
| devices being reprocessed. | ||
| Device description | The EvoTech™ System is a two-basin washer / disinfector utilizing a | |
| concentrated high-level disinfectant (CIDEX® OPA Concentrate – | ||
| K032959) that is diluted within the system to an In-Use concentration. | ||
| The system performs a leak test, a block test, pre-rinse, wash, disinfect, | ||
| rinse, and alcohol flush on the endoscope being reprocessed. The | ||
| disinfection temperature is 50-55°C. The In-Use disinfectant is discarded | ||
| after each use by the system. | ||
| Intended use | The EvoTech™ System is intended for use as a washer / disinfector for | |
| reprocessing flexible endoscopes that do not contact normally sterile areas | ||
| of the body. |
1. 510(k) Summary of Safety and Effectiveness
1
Image /page/1/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KC40883". The characters are handwritten and appear to be slightly faded or worn. The numbers are clearly distinguishable, and the letters are in uppercase.
The EvoTech System, a washer / disinfector, is indicated for use with the Performance data high level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum temperature of 50℃ for a contact time of 5 minutes) to achieve high-level disinfection of flexible endoscopes. Endoscopes must be manually cleaned prior to placement in the EvoTech System. The System includes an on-board MEC monitor, performs automated leak test, block test and post processing alcohol flush. The EvoTech System was tested using the standard array of tests defined Efficacy Testing in the FDA Guidance on Premarket Notification [510(k)] Submission for Automated Endoscope Washers, Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities, august, 1993 Simulated Use Testing: The high level disinfectant indicated for use with the EvoTech System was tested for efficacy in a simulated use environment. A 6 Logio reduction of Mycobacterium terrae was achieved when flexible endoscopes, contaminated with spores and artificial soil and were exposed to CIDEX OPA Concentrate In Use solution without cleaning. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% OPA concentration at 50°C is effective against Mycobacterium terrae in artificial soil. In Use Testing: Endoscopes used in a clinical environment were reprocessed in the EvoTech System without manual cleaning. Sterility testing demonstrated no growth. An endoscope reprocessed in the EvoTech System was evaluated for Biocompatibility residue levels. The analysis indicates that the level of OPA residual remaining on an endoscope is not likely to cause toxic effects in humans. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Material The EvoTech System using CIDEX OPA Concentrate In-Use solution compatibility was evaluated for its effect on materials commonly used in medical devices. Multiple disinfection cycles over extended periods of time resulted in minimal effect on the test articles. The effects seen were similar to those seen with the predicate device for the high level disinfectant - CIDEX OPA Solution K991487. Stability N / A The data presented and the equivalence demonstrated to the predicate Conclusion device support the claim of substantial equivalency for the EvoTech System.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2005
Advanced Sterilization Products® Ms. Neelu Medhekar Project Manager, Regulatory Affairs Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618
Re: K040883
Trade/Device Name: EvoTech™ Integrated Endoscope Disinfection System Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: December 23, 2004 Received: December 27, 2004
Dear Ms. Medhekar:
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 Eederal Register.
3
Page 2 - Ms. Medhekar
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smith M. cheri C.M.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K040883 EvoTech™ Integrated Endoscope Disinfection System Device Name Indications For Use:
The EvoTech System, a washer / disinfector, is indicated for use with the high level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum temperature of 50°C for a contact time of 5 minutes) for reprocessing heat sensitive ( |
| | (Optional Format 1-2-96) |
33 Technology Drive, Irvine, CA 92618 (949) 453 6400 FAX (949) 789 3900
Shalie A. Murphy Ko
K 240883