RIWO SYSTEM TRAYS

K012309 · Richard Wolf Medical Instruments Corp. · FEB · Oct 19, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012309
• Device Name: RIWO SYSTEM TRAYS
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FEB · Gastroenterology, Urology
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The RIWO System Trays 38201.xxx, 38202.xxx, 38301.xxx have been designed to hold devices during sterile storage, transport, and while undergoing steam and ethylene oxide sterilization.

Device Story

RIWO System Trays are sterilization, storage, and transport containers for medical instruments and endoscopes. Trays feature perforated bases and lids, latched covers, and silicone peg mat inlays to secure instruments and prevent damage. Used in clinical settings; operated by healthcare staff. Trays must be wrapped in sterile packaging material (per DIN 58953) prior to sterilization. Compatible with steam and ethylene oxide (EtO) sterilization processes. Benefits include organized instrument handling, protection during transport, and maintenance of device integrity during sterilization cycles.

Clinical Evidence

No clinical data. Bench testing only. Steam and ethylene oxide sterilization tests performed by the manufacturer demonstrated that sterilization processes have no influence on the functional performance of the devices.

Technological Characteristics

Materials: PSU granulate Udel P-1700, PPSU granulate Radel R 5000, silicone, medical grade stainless steel, polyester foil. Design: Perforated container with latched cover and silicone peg mat inlay. Dimensions: Inner length 300-705mm, width 120-200mm; outer length 366-766mm, width 150-266mm, height 47-103mm. Sterilization: Steam and EtO compatible. Requires external sterile wrapping (DIN 58953).

Indications for Use

Indicated for use as a container to hold medical instruments and endoscopes during steam or ethylene oxide sterilization, sterile storage, and transport.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Instrument Container 8582.06, 8584.06 (Richard Wolf)
• Micropac, Endopak, Scopepak, Multipak (Riley)
• Scope trays, Silicone Nipple Mat System, Standard Sterilization Containers (Transmedica)
• C.A.S.E. System: Containers and Baskets (Genesis)
• Instrument Protection and Sterilizing System (Micromedics)

Submission Summary (Full Text)

{0}------------------------------------------------

# OCT 1 9 2001

K612309

Pg 1 of v

353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: [phone] Customer Service: 800-323-WOLF www.richard-wolf.com

Medical Instruments Corporation

## 510(k) Summary of Safety and Effectiveness

| Submitter: | | Date of Preparation: | July 18, 2001 |
|---------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------|----------------|
| Company / Institution name: | Richard Wolf Medical Instruments Corp. | FDA establishment regulation number: | 14 184 79 |
| Division name (if applicable): | N.A. | Phone number (include area code): | [phone] |
| Street address: | 353 Corporate Woods Parkway | FAX number (include area code): | [phone] |
| City: | Vernon Hills | State/Province: | Illinois |
| Country: | USA | ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa | | |
| Contact title: | Quality Assurance Manager | | |
| Product Information: | | | |
| Trade name: | RIWO System Trays | | |
| Model number: | See section 3, "Submitted Devices" | | |
| Common name: | Trays for Sterilization, Storage and Transport | | |
| Classification Name: | Accessories, cleaning, for endoscope | | |
| Information on devices to which substantial equivalence is claimed: | | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
| 1 pre-enact. | 1 Instrument Container 8582.06, 8584.06 | 1 Richard Wolf | |
| 2 | 2 Micropac, Endopak, Scopepak, Multipak | 2 Riley | |
| 3 | 3 Scope trays, Silicone Nipple Mat System, Standard Sterilization Containers | 3 Transmedica | |
| 4 | 4 C.A.S.E. System: Containers and Baskets | 4 Genesis | |
| 5 | 5 Instrument Protection and Sterilizing System | 5 Micromedics | |

#### 1.0 Description

The devices are assorted open or closed trays for sterilization, storage and transport.

### 2.0 Intended Use

The RIWO SYSTEM TRA Ys 3820x.xxx have been designed

- to be equipped as required
- · for steam and EtO sterilization
- · for sterile storage
- · for transport

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Image /page/1/Picture/0 description: The image shows the text "Pg 2 of 2" in a handwritten style. The text is written in black ink on a white background. The letters are connected and have a cursive appearance.

#### 3.0 Technological Characteristics

The RIWO System Trays are blue in color. The assorted trays vary in size and begin with product number 3820x.xxx. Other characteristics are a base, latched cover and silicone peg mat construction. These trays hold the device to be sterilized and the tray must be wrapped for sterilization and sterile storage. They can be used in steam or ethylene oxide sterilization.

#### 4.0 Substantial Equivalence

These devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf and 510(k) devices sold by Riley, Transmedica, Genesis, and Micromedics.

#### 5.0 Performance Data

The steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the pre-vac method.

The EO sterilization tests performed, shows that the ethylene oxide sterilization has no influence on the functional performance of the submitted devices.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.

By: Robert L. Casasa

Robert L. Casarsa Quality Assurance Manager

Date: July 18, 2001

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 19 2001

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway VERNON HILLS IL 60061

Re: K012309

Trade/Device Name: RIWO System Trays for Sterilization and Transport Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR §880.6850 Regulation Name: Sterilization wrap Regulatory Class: II Product Code: 78 FEB and KCT Dated: July 18, 2001 Received: July 23, 2001

Dear Mr. Casarsa:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to the enactment date of the Medical Device Amendments, or to commerce price to that 2011-17-15, in accordance with the provisions of the Federal Food, Drug, devices that have occh rocussion in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicrorely mains of the Act include requirements for annual registration, listing of general controll profitions 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 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I oderal buttatoo the ect's requirements, including, but not limited to: registration and listing Compry with an the Prequently Part 801); good manufacturing practice requirements as set (21 OF IC Part 807), accems (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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This letter will allow you to begin marketing your device as described in your 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 If you desire specific ac-ripliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of reference to pictures under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): // 0 / 2 3 0 9

Trays for Sterilization Device Name:__________________________________________________________________________________________________________________________________________________________________

Intended Use:

The RIWO System Trays 38201.xxx, 38202.xxx, 38301.xxx have been designed to hold devices during sterile storage, transport, and while undergoing steam and ethylene oxide sterilization.

| Material Composition: | PSU granulate UdelP-1700, PPSU granulate Radel R 5000, silicone, medical grade stainless steel, polyester foil | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Physical Properties: | The instrument container ranges in height from 60mm to 100mm. The tray system consists of:<br>perforated instrument container with peg mat inlay spring catches perforated lid w/ fixed peg mat coding plate for container & lid marker pen | |
| Specifications: | The inner dimension of the trays range from a length of 300mm to 705 mm and widths of 120mm to 200mm.<br><br>The outer dimensions of the trays range from a length of 366mm to 766mm; widths of 150mm to 266mm; and heights range from 47mm to 103mm. | |
| Design: | The RIWO System Trays are designed as an accessory for housing and holding endoscopes and instruments. The design provides spaces to position the devices without placing them on top of each other; thus, reducing the potential for damage during sterile storage, transport, and sterilization. They are designed as an aid to sterilization. The trays with the included endoscope/instruments must be wrapped in sterile packaging material (in accordance with DIN | |

58953). The wrapping, not part of this submission, maintains sterility and barrier integrity.

(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 Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K012309 |

Prescription Use

Over-The Counter_