K Number
K092387
Device Name
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
Manufacturer
Date Cleared
2010-04-05

(243 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system. Rapicide PA contact conditions in the DSD Edge - 5 Minutes 30℃ 850 ppm peracetic acid .
Device Description
The DSD Edge system is an electro-mechanical system intended to test, wash and high level disinfect flexible fiberoptic and video endoscopes between uses. The DSD Edge is capable of asynchronously reprocessing two scopes at a time. The DSD Edge system uses the peracetic acid based Rapicide PA High Level Disinfectant (K082988). The DSD Edge is a single use system in that it mixes Part A and Part B of Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused. Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to being placed in the system for reprocessing. After the endoscopes are connected to the DSD Edge the system tests the scopes for leaks in the outer skin. If the endoscopes pass the leak test the system will proceeds to a scope flush or an optional wash cycle followed by a flush. For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that the water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. A sample of the germicide is retained to test for MRC. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use. The machine has built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product. The DSD Edge also prints records indicating the results of testing, disinfection, etc. which are required for permanent records.
More Information

Not Found

No
The description focuses on the electro-mechanical and chemical processes of endoscope reprocessing, with no mention of AI, ML, or related concepts.

No.
This device is an endoscope reprocessing system intended to clean and disinfect medical devices (flexible endoscopes), not to treat patients or address a medical condition.

No
The device is an endoscope reprocessing system designed to test, wash, disinfect, and rinse flexible endoscopes. It is intended for high-level disinfection of medical devices, not for diagnosing medical conditions. While it performs tests like leak checks and monitors disinfection parameters, these are functional checks of the reprocessing process, not diagnostic tests on a patient.

No

The device is described as an "electro-mechanical system" and details hardware components and processes like testing, washing, disinfecting, and rinsing using physical mechanisms and chemicals. It is not solely software.

Based on the provided text, the Medivators DSD Edge Endoscope Reprocessing System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The primary intended use is to "test, wash, disinfect and rinse flexible endoscopes... between patient uses." This is a process for cleaning and preparing medical devices for reuse, not for performing tests on biological samples to diagnose or monitor a patient's condition.
  • Device Description: The description focuses on the electro-mechanical process of reprocessing endoscopes, including leak testing, washing, disinfection, rinsing, and drying. It also mentions the use of a high-level disinfectant (Rapicide PA). None of these functions involve analyzing biological samples.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Providing diagnostic information about a patient's health
    • Using reagents or assays to detect specific substances
    • Outputting results related to a patient's medical condition

The device is clearly intended for the reprocessing of medical instruments, which falls under a different regulatory category than IVD devices.

N/A

Intended Use / Indications for Use

Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system.

Rapicide PA contact conditions in the DSD Edge

  • 5 Minutes 30℃ 850 ppm peracetic acid .

Product codes

FEB

Device Description

The DSD Edge system is an electro-mechanical system intended to test, wash and high level disinfect flexible fiberoptic and video endoscopes between uses. The DSD Edge is capable of asynchronously reprocessing two scopes at a time.

The DSD Edge system uses the peracetic acid based Rapicide PA High Level Disinfectant (K082988). The DSD Edge is a single use system in that it mixes Part A and Part B of Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.

Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to being placed in the system for reprocessing.

After the endoscopes are connected to the DSD Edge the system tests the scopes for leaks in the outer skin. If the endoscopes pass the leak test the system will proceeds to a scope flush or an optional wash cycle followed by a flush.

For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that the water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. A sample of the germicide is retained to test for MRC. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.

The machine has built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.

The DSD Edge also prints records indicating the results of testing, disinfection, etc. which are required for permanent records.

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

Medivators has provided testing to show that the DSD Edge Endoscope Reprocessing System is safe and effective for its intended use following the requirements listed in the FDA's Guidance on Premarket [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (dated August 1993).

Material Compatibility

The effect of the disinfectant on materials used in the DSD Edge system was evaluated and showed that the system materials showed no significant deterioration over time. Studies were also presented to show that the filters used in the water filtration system were compatible with the disinfectant.

Biocompatibility

The amount if disinfectant residue left on endoscopes after the disinfection and rinsing cycles was evaluated and compared to determine safe levels. The results of the testing showed that any remaining residues would not have an effect on patients or users.

Performance Data

Data was provided to the FDA to show that the machine performs as required. This evaluation included testing to show that the leak check, washing cycle, disinfection cycle, rinse cycles and drying cycles performed correctly. Any error messages were tested to ensure they function properly to notify users of any possible failure modes.

Testing was provided that showed the disinfectant remained at its required temperature for the length of time required for high level disinfection.

Testing was completed that showed the DSD Edge self disinfection cycle works properly by disinfecting all areas of the machine, including the water filtration system.

Key Metrics

Not Found

Predicate Device(s)

K082988, K914145

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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Kog2387 10/4

Medivators DSD Edge Endoscope Reprocessing System

APR - 5 2010

510(k) Summary of Safety and Effectiveness

| Manufacturer:

CorporationMedivators Reprocessing Systems, A Division of Minntech
Address:14605 28th Avenue North
Minneapolis, MN 55447 USA
Establishment Registration No: 2150060
Official Contact:Richard M. Ormsbee
Corporate Regulatory Affairs Manager
Minntech Corporation
14605 28th Avenue North
Minneapolis, MN 55447
763-551-2689
Fax: 763-551-2653

Device Identification:

  • Medivators DSD Edge Endoscope Reprocessing System Device Trade Name: .
  • Common Name: Endoscope washer/disinfector .

II

  • Class .
    Regulation Number/Name 876.1500 Endoscope and accessories .

  • Product Code FEB - Accessories, Cleaning, For Endoscope
    Medivators has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalence of the DSD Edge Endoscope Reprocessing System to other endoscope reprocessors and high level disinfectants currently marketed in the U.S.

1. Device Description

The DSD Edge system is an electro-mechanical system intended to test, wash and high level disinfect flexible fiberoptic and video endoscopes between uses. The DSD Edge is capable of asynchronously reprocessing two scopes at a time.

The DSD Edge system uses the peracetic acid based Rapicide PA High Level Disinfectant (K082988). The DSD Edge is a single use system in that it mixes Part A and Part B of Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.

1

192387 02014

Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to being placed in the system for reprocessing.

After the endoscopes are connected to the DSD Edge the system tests the scopes for leaks in the outer skin. If the endoscopes pass the leak test the system will proceeds to a scope flush or an optional wash cycle followed by a flush.

For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that the water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. A sample of the germicide is retained to test for MRC. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.

The machine has built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.

The DSD Edge also prints records indicating the results of testing, disinfection, etc. which are required for permanent records.

2. Indications for Use Statement

Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semicritical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system.

Rapicide PA contact conditions in the DSD Edge

  • 5 Minutes 30℃ 850 ppm peracetic acid .

2

K092387
Page 3 of 4

3. Comparison to Another Device in Commercial Distribution Within the United States

The DSD Edge is equivalent in function and indications to the Medivators Advantage Plus Endoscope Reprocessing System (K082988) and the Medivators DSD 91 Disinfector for Flexible Endoscopes (K914145). All of the machines have the same indications for use and the same methods for providing disinfection.

4. Summary of Testing

Medivators has provided testing to show that the DSD Edge Endoscope Reprocessing System is safe and effective for its intended use following the requirements listed in the FDA's Guidance on Premarket [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (dated August 1993).

Material Compatibility

The effect of the disinfectant on materials used in the DSD Edge system was evaluated and showed that the system materials showed no significant deterioration over time. Studies were also presented to show that the filters used in the water filtration system were compatible with the disinfectant.

Biocompatibility

The amount if disinfectant residue left on endoscopes after the disinfection and rinsing cycles was evaluated and compared to determine safe levels. The results of the testing showed that any remaining residues would not have an effect on patients or users.

Performance Data

Data was provided to the FDA to show that the machine performs as required. This evaluation included testing to show that the leak check, washing cycle, disinfection cycle, rinse cycles and drying cycles performed correctly. Any error messages were tested to ensure they function properly to notify users of any possible failure modes.

Testing was provided that showed the disinfectant remained at its required temperature for the length of time required for high level disinfection.

3

K092387
page 4 of 4

Testing was completed that showed the DSD Edge self disinfection cycle works properly by disinfecting all areas of the machine, including the water filtration system.

5. Summary of Substantial Equivalence

Medivators has provided the above information in the form of a 510(k) to support the claim that the DSD Edge Endoscope Reprocessing System is safe and effective when used in accordance with the device labeling.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black lines. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The text is in all caps and is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Richard M. Ormsbee Corporate Regulatory Affairs Manager Minntech Corporation 14605 28" Avenue North Minneapolis, Minnesota 55447-4822

APR - 5 2010

Re: K092387

Trade/Device Name: Medivators DSD Edge Endoscope Reprocessing System Regulation Number: 21CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: March 30, 2010 Received: March 31, 2010

Dear Mr. Ormsbee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

5

Page 2 Mr. Ormsbee

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Rh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

6

Indications for Use

Ko92387 510(k) Number (if Known):

Device Name: Medivators DSD Edge Endoscope Reprocessing System

Indications for Use:

Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system.

Rapicide PA contact conditions in the DSD Edge

  • 5 Minutes 30℃ 850 ppm peracetic acid .
    Prescription Use AND/OR (Part 21 CFR 801 Part D)

Over-the Counter Use X (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092387