(88 days)
KCT
Not Found
No
The device description and intended use are for sterilization trays, and there is no mention of AI or ML in the provided text.
No.
This device is designed for sterile storage, transport, and sterilization of other medical devices, not for diagnosing, treating, or preventing disease in patients.
No
Explanation: The device is described as trays designed for holding devices during sterile storage, transport, and sterilization, and there is no mention of it being used to diagnose diseases or conditions.
No
The device description clearly states it is a physical tray made of a base, latched cover, and silicone peg mat construction, designed to hold devices for sterilization, storage, and transport. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the trays are designed to hold devices during sterile storage, transport, and sterilization. This is a function related to the handling and preparation of medical devices, not the diagnosis of diseases or conditions using in vitro methods.
- Device Description: The description details the physical characteristics of the trays (material, size, components) and their purpose in holding other devices for sterilization. There is no mention of reagents, samples, or any process related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or test kits
The device is a sterilization and storage accessory for other medical devices.
N/A
Intended Use / Indications for 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.
Product codes
78 FEB, KCT
Device Description
The devices are assorted open or closed trays for sterilization, storage and transport.
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.
The instrument container ranges in height from 60mm to 100mm. The tray system consists of: perforated instrument container with peg mat inlay spring catches perforated lid w/ fixed peg mat coding plate for container & lid marker pen. The inner dimension of the trays range from a length of 300mm to 705 mm and widths of 120mm to 200mm. 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. 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
1 Richard Wolf 1 Instrument Container 8582.06, 8584.06, 2 Riley Micropac, Endopak, Scopepak, Multipak, 3 Transmedica Scope trays, Silicone Nipple Mat System, Standard Sterilization Containers, 4 Genesis C.A.S.E. System: Containers and Baskets, 5 Micromedics Instrument Protection and Sterilizing System
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.
0
OCT 1 9 2001
Pg 1 of v
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 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): | (847) 913-1113 |
| Street address: | 353 Corporate Woods Parkway | FAX number (include area code): | (847) 913-0924 |
| 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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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: | |
| 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. |
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_