(88 days)
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.
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance after Steam Sterilization | 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. (This implies that the functional performance after steam sterilization was maintained to an acceptable degree.) |
| Functional Performance after Ethylene Oxide (EO) Sterilization | The EO sterilization tests performed, shows that the ethylene oxide sterilization has no influence on the functional performance of the submitted devices. (This implies that the functional performance after EO sterilization was maintained to an acceptable degree.) |
| Safety and Effectiveness | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement from the conclusion, implying that the device met internal safety and effectiveness standards, likely encompassing functional performance after sterilization, material compatibility, and structural integrity for holding and transporting instruments without damage.) |
Note: The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "no visible deformation," "maintains structural integrity for X cycles"). The reported performance is qualitative, stating "no influence on functional performance."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document refers to "the submitted devices" but does not quantify how many trays of each type/model were tested, or how many sterilization cycles each tray underwent.
- Data Provenance: The tests were "performed by Richard Wolf," meaning they were internal company tests. The country of origin for the testing is not explicitly stated, but since the submitter is based in Illinois, USA, it is likely the tests were conducted there or at a facility managed by Richard Wolf. The tests were prospective, conducted specifically to support the 510(k) submission.
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. This device is a medical accessory (trays for sterilization, storage, and transport), not an AI/diagnostic device that requires expert ground truth for interpretation. The "ground truth" for its performance would be its physical integrity and functionality after sterilization cycles, as determined by engineering/quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As this is not an AI/diagnostic device, there was no need for expert adjudication of results. The performance testing would be objectively measured/observed based on established protocols.
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
- No. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense for AI/diagnostic devices. For this device, the "ground truth" for its performance would be the direct observation and measurement of its physical properties and functional integrity (e.g., lack of deformation, continued ability to hold instruments, proper latching of covers) after undergoing sterilization cycles according to specified parameters. This is engineering/performance ground truth, not clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device that requires a training set.
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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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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 | (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
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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: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_
§ 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.