(199 days)
No
The device is a sterilization tray and does not perform any analytical or computational functions.
No
The device is a sterilization tray used to contain medical devices for sterilization and maintain their sterility, not to treat a disease or condition.
No
Explanation: The V-PROTM Sterilization Tray is used for containing reusable medical devices for sterilization and maintaining their sterility, not for diagnosing any condition.
No
The device description clearly describes a physical tray and associated components used for sterilization, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to contain reusable medical devices for sterilization and maintain their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of diseases or conditions using in vitro methods.
- Device Description: The description details a tray with features for holding and stabilizing medical instruments during sterilization. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information
- Use in a laboratory setting for diagnostic purposes
The device is clearly intended to be a container and organizer for medical instruments undergoing sterilization, which is a process related to infection control and device reprocessing, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The V-PROTM Sterilization Tray is used to contain devices for sterilization in the Amsco® V-PROTM 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.
The V-PROTM Sterilization Tray can be used with V-PRO™ Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The Instrument Organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The V-PRO™ Sterilization Tray is available in various sizes, 10''x 10" x 21" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with two clamping mechanisms for securing to the tray. There are numerous 0.01" diameter holes in the lid and tray for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer to maintain sterility of the devices.
The tray can contain medical device organizers to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attach to the V-PRO™ Sterilization Tray. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device requiring stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock.
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)
STERIS Corporation performed qualification testing to support the suitability of the V-PRO™ Sterilization Tray in the Amsco® V-PROM 1 Low Temperature Sterilization System (K062297). The qualification testing data is included in this submission.
The V-PROTN Sterilization Tray qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer as a medical device has been shown to be safe and effective.
The V-PRO 110 Sterilization Tray must demonstrate sterilization of devices when wrapped, material compatibility with the various healthcare processing chemistries and Vaprox HC Sterilant, cleaning efficacy, and the inability to emit harmful substances after processing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
2007 0CT
510(k) Summary For V-PRO™ Sterilization Tray and Instrument Organizers
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Patrick J. McCullagh, Ph.D. Vice President Global Quality Systems Engineering & Regulatory Affairs Telephone:(440) 392-7601 Fax No: (440) 392-8963
March 20, 2007 Submission Date:
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Trade Name: | V-PROTM Sterilization Tray and Instrument
Organizers. |
|----------------------|-----------------------------------------------------------------|
| Common/usual Name: | Sterilization Trays, Cassettes and other Accessories. |
| Classification Name: | General Hospital and Personal Use Devices
(21 CFR 880.6850). |
| Product Code: | KCT |
2. Predicate Devices
The V-PRO 114 Sterilization Tray is substantially equivalent to legally marketed existing devices as indicated in Table 5-1
| Device
Name | Conmed Linvatec
Instrument
Sterilization Tray | Olympus
Sterilization Trays | Aptimax
Instrument
Tray |
|----------------|-----------------------------------------------------|--------------------------------|-------------------------------|
| K# | K052992 | K033222 | K013003 |
| SE Date | 10/16/06 | 08/02/04 | 08/28/02 |
Table 5-1. V-PROTM 136 Tray Predicate Devices information
STERIS Corporation performed qualification testing to support the suitability of the V-PRO™ Sterilization Tray in the Amsco® V-PROM 1 Low Temperature Sterilization System (K062297). The qualification testing data is included in this submission.
The V-PRO 100 Sterilization Tray as well as the predicate devices are intended to hold, transport and store sterilized medical devices. They are supplied in a variety of sizes and configurations to accommodate various medical instruments. The design and material composition of the V-PROTT Sterilization Tray and the indicated predicate devices allow diffusion of the sterilant around the contents when used with approved sterilization wrap.
Description of Device 3.
The V-PRO™ Sterilization Tray is available in various sizes, 10''x 10" x 21" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with two clamping mechanisms for securing to the tray. There are numerous 0.01" diameter holes in the lid and tray for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap
2
for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer to maintain sterility of the devices.
The tray can contain medical device organizers to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attach to the V-PRO™ Sterilization Tray. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device requiring stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock.
4. Intended Use
The V-PRO110 Sterilization Tray is used to contain reusable medical devices for sterilization in the Amsco® V-PRO™ 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.
The V-PRO "M Sterilization Tray can be used with V-PRO "10 Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The medical device organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.
Tables 5-2 and 5-3 list the trays and instrument organizers included in this submission.
| Tray Type
(inches) | Recommended Max
Load (lbs)* | Recommended Maximum
Instrument Organizers |
|-----------------------|--------------------------------|----------------------------------------------|
| 21 x 10 | 9.13 | 20 |
| 17 x 10 | 6.47 | 20 |
| 14 x 10 | 5.16 | 16 |
| 10 x 10 | 4.48 | 10 |
Table 5-2. V-PRO™ Sterilization Tray available sizes for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer.
- Includes weight of the tray
3
| Diameter (mm) | Stem Height (mm) |
|---|---|
| 5 | 6 |
| 13 | |
| 25 | |
| 9 | 6 |
| 13 | |
| 25 | |
| 11 | 6 |
| 13 | |
| 25 | |
| 14 | 6 |
| 13 | |
| 25 | |
| 17 | 6 |
| 13 | |
| 25 | |
| 19 | 6 |
| 13 | |
| 25 |
| Table 5-3. V-PROTM Instrument Organizers for use with the | ||||
|---|---|---|---|---|
| V-PRO™ Sterilization Tray |
ട. Description of Safety and Substantial Equivalence
The V-PROTN Sterilization Tray qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer as a medical device has been shown to be safe and effective.
This device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has the same intended use and characteristics, including the availability of different sizes as the predicate devices. Refer to Section 12 for detailed information regarding Substantial Equivalence.
Performance Specifications and Design Requirements 6.
The V-PRO 110 Sterilization Tray must demonstrate sterilization of devices when wrapped, material compatibility with the various healthcare processing chemistries and Vaprox HC Sterilant, cleaning efficacy, and the inability to emit harmful substances after processing.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body. The eagle's wings are suggested by curved lines, and the profiles are stacked vertically, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jack Scoville Fellow Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
OCT 5 2007
Re: K070769
Trade/Device Name: V-PRO™ Sterilization Tray and Instrument Organizers Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 7, 2007 Received: September 10, 2007
Dear Mr. Scoville:
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.
5
Page 2 - Mr. Scoville
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 (OS) 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 Office of Compliance at (240) 276-0115. 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 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/industry/support/index.html.
Sincerely yours.
Clare
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
6
Indications for Use
510(k) Number (if known): K070769
Device Name: V-PROTM Sterilization Tray and Instrument Organizers.
Indications For Use:
The V-PROTM Sterilization Tray is used to contain devices for sterilization in the Amsco® V-PROTM 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.
The V-PROTM Sterilization Tray can be used with V-PRO™ Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The Instrument Organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.
Tables 1 and 2 list the trays and instrument organizers included in this submission.
Table 1. V-PRO™ Sterilization Tray available sizes for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer.
| Tray Type
(inches) | Recommended Max
Load (lbs)* | Recommended Maximum
Instrument Organizers |
|-----------------------|--------------------------------|----------------------------------------------|
| 21 x 10 | 9.13 | 20 |
| 17 x 10 | 6.47 | 20 |
| 14 x 10 | 5.16 | 16 |
| 10 x 10 | 4.48 | 10 |
- Includes weight of the tray
| I able 2. V-PRO™ Instrument Organizers for use with the V-PRO™ Sterilization Tray | ||||||
|---|---|---|---|---|---|---|
| ----------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- |
| Diameter (mm) | Stem Height (mm) |
|---|---|
| 5 | 6 |
| 5 | 13 |
| 5 | 25 |
| 9 | 6 |
| 9 | 13 |
| 9 | 25 |
| 11 | 6 |
| 11 | 13 |
| 11 | 25 |
7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION V-PRO™ Sterilization Tray and Instrument Organizers.
| Diameter (mm) | Stem Height (mm) |
|---|---|
| 14 | 6 |
| 13 | |
| 25 | |
| 17 | 6 |
| 13 | |
| 25 | |
| 19 | 6 |
| 13 | |
| 25 |
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)
Clurs gCJ.fr 88 m.
(Tivision Sign-Off) Livision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: 070769