OLYMPUS STERILIZATION TRAYS

K033222 · Olympus Winter & Ibe GmbH · KCT · Aug 2, 2004 · General Hospital

Device Facts

• Record ID: K033222
• Device Name: OLYMPUS STERILIZATION TRAYS
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: KCT · General Hospital
• Decision Date: Aug 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device. The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm. The Olympus sterilization trays are to be sterilized in the following cycle: Prevacuum Steam: 132°C - 134°C - 5 minutes minimum. Drying Time: 10 – 20 minutes as needed.

Device Story

Sterilization trays designed to house Olympus medical instruments during steam sterilization; perforated thermoplastic base and lid with stainless steel locking tabs; includes silicone mats for instrument fixation. Used in clinical settings by healthcare providers. Trays allow steam penetration to enclosed instruments; must be used with approved sterilization wrap to maintain microbial barrier. Validated for prevacuum steam sterilization cycles (132°C–134°C). Benefits include organized instrument handling and protection during the sterilization process.

Clinical Evidence

Bench testing only. Validation performed using a process challenge device (PCD) with 2 mm diameter and 1500 mm length in a GLP-approved laboratory to confirm steam sterilization efficacy. Material biocompatibility and compatibility with prevacuum steam sterilization cycles (132°C-134°C) were verified.

Technological Characteristics

Materials: Thermoplastic RADEL, medical grade stainless steel (handles/locking tabs), silicone (mats). Design: Perforated base and lid for aeration. Sterilization: Prevacuum steam (132°C-134°C). Connectivity: None. Form factor: Various tray dimensions for specific instrument sets.

Indications for Use

Indicated for use by healthcare providers to enclose Olympus medical devices (hand instruments, trocars, camera heads, adapters, and endoscopes) during steam sterilization.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• PolyVac Delivery Systems (K012105)

Submission Summary (Full Text)

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## 033222

## AUG - 2 2004

## 510(k) Summary Olympus Sterilization Trays

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92

A. Submitter's Name, Address, Phone, Contact Person and Summary Date

| Manufacturer of subject device: | Olympus Winter & Ibe<br>Kuehnstr. 61<br>D-22045 Hamburg<br>Germany |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration number: | 8010313 |
| Contact Person: | Tina Steffanie-Oak<br>Olympus America Inc.<br>Two Corporate Center Drive<br>Melville NY 11747-3157<br>Registration Number: 2429304<br>Telephone: [phone] |
| B. Device Name | |
| Device Name: | Olympus sterilization trays |
| Common/Usual Name: | Sterilization container |
| Classification Name: | Sterilization container |
| Classification: | 21 CFR 882.1480<br>Class II |

## C. Predicate Devices:

PolyVac Delivery Systems (K012105)

D. Device Description

The Sterilization trays, which are the subject of this premarket notification, are as follows:

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| Item no. | Outer dimensions<br>WxHxD[mm] | Detailed product description |
|-----------|-------------------------------|----------------------------------------------------------------------------|
| A5938* | 595 x 61 x 295 | Instrument tray, with lid, for video telescope |
| A5951* | 478 x 41 x 224 | Insert tray, for 2.7 and 4.0 mm TruView arthroscopes |
| A5952* | 478 x 41 x 224 | Insert tray, for Diver-Line hand instruments |
| A5961* | 665 x 52 x 204 | Insert tray, for ureteroscopes, with lid |
| A5975* | 532 x 63 x 128 | Instrument tray, small, with lid |
| A5976* | 478 x 68 x 224 | Insert tray, for urology |
| A5977* | 478 x 68 x 224 | Insert tray, for 4 TroQ trocars |
| A5984* | Set: A5994 and WA05974 | Instrument tray, for camera head and adapter |
| A5992* | 478 x 54 x 224 | Instrument tray, for A3336A, A2027A and A5226A |
| A5994* | 478 x 68 x 224 | Insert tray, for camera head and adapter |
| A05951A* | 478 x 41 x 224 | Insert tray, for TrueView II and mini TrueView telescopes |
| A05952A* | 665 x 65 x 204 | Instrument tray, for SonoSurg instruments, with lid |
| A05961A* | 405 x 95 x 200 | Instrument tray, for compact cystoscope and compact hysteroscope, with lid |
| WA05970A | 537 x 139 x 268 | Instrument tray, with lid and silicone mat |
| WA05971A | 482 x 60 x 224 | Insert tray, for the upper part of WA05970A, with silicone mat |
| WA05972A | 480 x 47 x 224 | Insert tray, for 5 HiQ shafts and jaw inserts |
| WA05973A | 460 x 39 x 207 | Insert tray, for the bottom of WA05970A, with silicone mat |
| WA05974A | 488 x 31 x 235 | Lid, for insert trays |
| WA05980A | 438 x 176 | Spare mat, nubbly, silicone, for WA05970A and WA05971A |
| WA05981A | 400 x 175 | Spare mat, nubbly, silicone, for WA05973A |
| WA05990A | 446 x 88 x 49 | Instrument tray, for two telescopes, with lid |
| WA05994A* | 478 x 68 x 224 | Insert tray, for camera head and adapter |
| WA05995A* | 478 x 68 x 224 | Insert tray, pediatric urology |
| WA05980A* | 595 x 61 x 295 | Instrument tray, for video telescope |

The Olympus sterilization trays consist of perforated bottoms with or without perforated lids. The material of the bottom is thermoplastic, the material of the lid is thermoplastic with handles and locking tabs made from medical grade stainless steel. The silicone mats for fixture of the instruments are perforated for aeration.

The stripes are designed for minimal contact area with instruments and secure fixing.

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Olympus sterilization trays will be sold non-sterile and can be reused after proper cleaning and sterilization.

E. Intended Use of Device

The Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device.

The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm.

The Olympus sterilization trays are to be sterilized in the following cycle:

Prevacuum Steam:

Drying Time:

Comparison to Predicate Devices

| | Subject | Predicate |
|-------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------|
| | Olympus Sterilization<br>Trays | Poly Vac's Delivery<br>Systems |
| ELEMENT | | |
| Intended Use: to enclose<br>medical devices during steam sterilization. | Yes | Yes |
| Intended to be reused | Yes | Yes |
| Material Composition | Thermoplastic RADEL® | Thermoplastic RADEL® |
| Consist of base with lid, lid can be fastened<br>to the base by a locking tab | Yes | Yes |
| Usable with silicone mats or special silicone<br>holders | Yes | Yes |
| PERFORMANCE | | |
| Sterilant Pentration for Steam with<br>Prevacuum validated | Yes | Yes |
| Microbial Barrier Properties | To be used with approved<br>sterilization wrap | To be used with approved<br>sterilization wrap |
| Material Compatibility | Compatible to Steam<br>Sterilization at 134°C | Compatible to Steam<br>Sterilization at 132°C |
| Toxicological Properties | Material biocompatible | Material biocompatible |
| Shelf Life | depends on wrapping<br>material and storage<br>conditions. | n.a. |
| Drying time | 10 - 20 minutes | 20 - 40 minutes |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 2004

Olympus Winter & Ibe GmbH C/O Ms. Tina Steffanie-Oak Olympus America, Incorporated Two Corporate Center Drive Melville, New York 11747-3157

Re: K033222

Trade/Device Name: Olympus Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 20, 2004 Received: May 21, 2004

Dear Ms. Steffanie-Oak:

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 mendments, 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 Federal Register.

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Page 2 - Steffanie-Oak

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 incan that I DAT has mace a development regulations administered by other Federal agencies. 01 the Act of any 1 ederal states and equirements, including, but not limited to: registration 1 ou inust comply was 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF Part 801), and 1001), and many (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality significal (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) This letter will anon you to objan middle substantial equivalence of your device to a premarket notification. - The PDF 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), if you desire specific acroof Compliance at [phone]. 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 may overn 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,

Clus

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

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510(k) Number (if known): K033222 Olympus Sterilization Trays Device Name: Indications for Use:

The Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device.

The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm.

The Olympus sterilization trays are to be sterilized in the following cycle:

| Prevacuum Steam: | 132°C - 134°C - 5 minutes minimum. |
|------------------|------------------------------------|
| Drying Time: | 10 – 20 minutes as needed. |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Re Melby

esthesiology, General Hospital,

510(k) Number: K033222