(435 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features.
No.
The device is described as organizing, protecting, and transporting medical instruments for sterilization and storage, not for treating or diagnosing any medical condition.
No
The device is an instrument tray used to organize, protect, and transport medical instruments during sterilization and storage. It does not perform any diagnostic function.
No
The device description explicitly details physical components made of anodized aluminum and silicone rubber, indicating it is a hardware device, not software-only.
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 device is for organizing, protecting, and transporting medical instruments during sterilization and storage. It is a container for instruments.
- Device Description: The description details the physical components of the trays and their function in facilitating steam sterilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used to handle and sterilize instruments that will be used on or in the body.
N/A
Intended Use / Indications for 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
Product codes
KCT
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K012105-Poly Vac Surgical Instrument Delivery System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY (PURSUANT TO 21 CFR 807.92)
Submitted by: ContainMed, Inc. 1404 Main St. Speedway. IN 46224 Tel: (317) 487-8800 Fax: (317) 246-3528
Submission Date: 6/29/2007
Contact Person: Todd E. Bettenhausen, Vice-President tbettenhausen@containmed.com
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
1
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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.
Page 1 of 2
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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