VERSAPOD (TM) INSTRUMENT TRAYS

K071783 · Containmed, Inc. · KCT · Sep 9, 2008 · General Hospital

Device Facts

• Record ID: K071783
• Device Name: VERSAPOD (TM) INSTRUMENT TRAYS
• Applicant: Containmed, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Sep 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

ContainMed, Inc. VersaPod™ Instrument Trays organize, protect, and transport medical instruments during prevacuum steam sterilization and subsequent storage. They do not maintain sterility unless used in conjunction with an FDA-cleared and legally marketed sterilization wrap. This device has not been validated for sterilization of instruments that are porous or have lumens.

Device Story

VersaPod™ Instrument Trays are anodized aluminum containers designed to organize, protect, and transport medical instruments during prevacuum steam sterilization and storage. The system comprises a perforated base, cover, and optional insert tray, facilitating steam penetration. Accessories include silicone rubber mats, instrument holders, and placards for identification. The device is used in clinical settings where instruments require sterilization. It does not maintain sterility independently; it must be used with an FDA-cleared sterilization wrap. The device is not validated for porous instruments or those with lumens. It is intended for use with a prevacuum steam cycle (132°C for 4 minutes, 45-minute drying time). By providing a structured, protective environment, the trays assist healthcare providers in maintaining instrument integrity and organization throughout the sterilization and storage workflow.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Anodized aluminum, silicone rubber, stainless steel hardware. Design: Perforated base and cover for steam penetration. Dimensions: 510mm length, 250mm width, depths of 40mm, 60mm, or 82mm. Sterilization: Prevacuum steam (132°C, 4 min). Connectivity: None. Software: None.

Indications for Use

Indicated for the organization, protection, and transport of medical instruments during prevacuum steam sterilization and storage. Not indicated for instruments that are porous or have lumens. Requires use with an FDA-cleared sterilization wrap to maintain sterility.

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

• Poly Vac Surgical Instrument Delivery System (K012105)

Submission Summary (Full Text)

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## 510(k) SUMMARY (PURSUANT TO 21 CFR 807.92)

Submitted by: ContainMed, Inc. 1404 Main St. Speedway. IN 46224 Tel: [phone] Fax: [phone]

Submission Date: 6/29/2007

Contact Person: Todd E. Bettenhausen, Vice-President [e-mail]

Trade Name: VersaPod™ Instrument Trays Common Name: Sterilization Trays Device Class: II Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (CFR 880.6850, Product Code KCT)

Predicate Device: K012105-Poly Vac Surgical Instrument Delivery System

Device Description:

ContainMed VersaPod™ Instrument Trays consist of an anodized aluminum base with handles and latches and an anodized aluminum cover. Bases have the following external dimensions: 510mm (length) x 250mm (width) x 40mm. 60mm, or 82mm (depth). An optional anodized aluminum insert trav is available for use with the 82mm deep base only. Bases, covers, and insert trays are highly perforated to facilitate steam sterilant penetration. Anodized aluminum placard, and silicone rubber mat and instrument holding accessories (with stainless steel mounting hardware), are available to identify, organize, and protect the contents during use.

Intended Use:

ContainMed, Inc. VersaPod™ Instrument Trays organize, protect, and transport medical instruments during prevacuum steam sterilization and subsequent storage. They do not maintain sterility unless used in conjunction with an FDA-cleared and legally marketed sterilization wrap. This device has not been validated for sterilization of instruments that are porous or have lumens.

Prevacuum Steam Cycle Parameters: 132°C, 4 minutes Drying: 45 minutes

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 0 9 2008

Mr. Todd E. Bettenhauscn Vice-President ContainMed, Incorporated 1404 Main Street Speedway, Indiana 46224

Re: K071783

Trade/Device Name: ContainMed, Inc. VersaPod™ Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: August 15, 2008 Received: August 18, 2008

Dear Mr. Bettenhausen:

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.

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 - Mr. Bettenhausen

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); 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. This letter will allow you to begin marketing your device as described in your Section 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Th. Kommel-Kerdin-s foell

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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### INDICATIONS FOR USE

510(k) Number (if known): K071783

Device Name: ContainMed, Inc. VersaPod™ Instrument Trays

Indications for Use:

ContainMed, Inc. VersaPod™ Instrument Trays organize, protect, and SontainMod, mor Foreating prevacuum steam sterilization and transport modious instruments as mo | maintain sterility unless used in conjunction with an FDA-cleared and legally marketed sterilization wrap. This device has with an I BA cloured on and rilization of instruments that are porous or have lumens.

Prevacuum Steam Cycle Parameters: 132° C, 4 minutes Drying: 45 minutes

VersaPod™ System Components and Accessories

| CAT. NO. | DESCRIPTION |
|----------|-------------|
|----------|-------------|

| VP-BC40 | Base w/Cover, 40mm |
|----------|--------------------------------|
| VP-BC60 | Base w/Cover, 60mm |
| VP-BC82 | Base w/Cover, 82mm |
| VP-BCT82 | Base w/Insert Tray/Cover, 82mm |
| VP-H20 | Instrument Holder, 20mm |
| VP-H20S | Instrument Holder, 20mm w/Stop |
| VP-H30 | Instrument Holder, 30mm |
| VP-H30S | Instrument Holder, 30mm w/Stop |
| VP-H40 | Instrument Holder, 40mm |
| VP-H40S | Instrument Holder, 40mm w/Stop |
| VP-S40 | Instrument Holding Strip, 40mm |
| VP-M15 | Mat, 15mm |
| VP-PXX | Placard |

Note: All accessories include mounting hardware.

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

# PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shele A. Murphy, HC

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

510(k) Number: K071283