(132 days)
The VersiTomic™ ACL Flexible Reamer System Sterilization Trav is indicated to enclose the VersiTomic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider.
The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside.
The VersiTomic™ ACL Flexible Reamer System Sterilization tray has been validated with a load that consists of various metallic instruments and implants up to a length of 340 mm and minimum internal diameter of 1.4 mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within the tray.
The VersiTomic™ ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters:
Gravity-Displacement Steam Sterilization
- Sterilizer Type: Gravity .
- Minimum Temperature: 132°C (270°F) .
- Minimum Exposure Time: 10 minutes .
- Minimum Dry Time: 40 minutes .
Pre-Vacuum Steam Sterilization
- Sterilizer Type: Pre-Vacuum .
- Minimum Temperature: 132°C (270°F) ●
- Minimum Exposure Time: 4 minutes .
- Minimum Dry Time: 15 minutes .
The VersiTomic ™ACL Flexible Reamer System Sterilization Tray is a reusable sterilization container system intended to be used to enclose other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and also (when properly wrapped) maintain their sterility device until used. This device is made of durable materials and designed with perforations or slots to allow for steam penetration. It is constructed of machined and formed metal.
The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside.
The device in question is the "VersiTomic™ ACL Flexible Reamer System Sterilization Tray," a reusable sterilization container system.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Validated Parameters) | Reported Device Performance |
|---|---|---|
| Gravity Steam Sterilization | ||
| Sterilizer Type | Gravity | Validated for Gravity |
| Minimum Temperature | 132°C (270°F) | Achieved 132°C (270°F) |
| Minimum Exposure Time | 10 minutes | Achieved 10 minutes |
| Minimum Dry Time | 40 minutes | Achieved 40 minutes |
| Pre-Vacuum Steam Sterilization | ||
| Sterilizer Type | Pre-Vacuum | Validated for Pre-Vacuum |
| Minimum Temperature | 132°C (270°F) | Achieved 132°C (270°F) |
| Minimum Exposure Time | 4 minutes | Achieved 4 minutes |
| Minimum Dry Time | 15 minutes | Achieved 15 minutes |
| Enclosed Devices (Type) | Various metallic instruments and implants | Successfully enclosed and validated with various metallic instruments and implants. |
| Enclosed Devices (Length) | Up to 340 mm | Validated with instruments up to 340 mm. |
| Enclosed Devices (Internal Diameter) | Minimum 1.4 mm | Validated with instruments having a minimum internal diameter of 1.4 mm. |
| Maximum Load | 9.6 kg (21.1 lb) | Validated with a maximum load of 9.6 kg (21.1 lb) distributed equally within the tray. |
| Post-Sterilization Functionality | Maintain sterility of enclosed devices (when properly wrapped) until used. Allow sterilization of enclosed devices. | The device is described as "intended to allow sterilization of the enclosed devices and also (when properly wrapped) maintain their sterility device until used." The validation confirms its performance regarding sterilization parameters, implying it meets this functionality when these parameters are successfully applied. The specific outcome of the "sterility maintenance" test (e.g., microbial ingress testing) is not detailed but is inherent to the type of device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states the device "has been validated with a load that consists of various metallic instruments and implants." It describes the characteristics of this load (length, minimum internal diameter, and maximum weight). However, the exact sample size (number of sterilization cycles, number of trays tested, number of instruments per tray) is not explicitly provided.
The data provenance is from T.A.G. Medical Products Corporation, Ltd. in Israel, submitted to the FDA by MedicSense, USA. This appears to be prospective testing conducted specifically for the purpose of validating the sterilization tray's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For a sterilization container, the "ground truth" would typically involve microbiological culture tests (e.g., spore-bearing coupons) to confirm sterility after the sterilization cycle. Such tests are usually performed by trained laboratory personnel or microbiologists, but the specific number or qualifications are not mentioned.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of medical images or data where there might be inter-reader variability. For a device validation study like this, the results of physical and microbiological tests are objective measures that do not require expert adjudication in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The VersiTomic™ ACL Flexible Reamer System Sterilization Tray is a passive medical device for sterilization, not an AI or diagnostic imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the study was effectively a standalone performance test of the device. While there's no "algorithm" in the conventional AI sense, the validation tests demonstrate the performance of the sterilization tray itself, under specified sterilization parameters, without human intervention in the sterilization process needing to compensate for device shortcomings. The goal was to show the device's inherent capability to facilitate sterilization.
7. The Type of Ground Truth Used:
The ground truth used for this type of validation typically involves:
- Physical and chemical indicators: To confirm that the specified sterilization parameters (temperature, exposure time, steam penetration) were met inside the tray.
- Biological indicators: Contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are placed within the tray. Their absence of growth after the sterilization cycle confirms that a sufficient sterilizing agent has reached them, thus establishing a high level of sterility assurance (sterility ground truth).
- Functionality testing: To ensure the instruments remain contained and undamaged, and that the tray itself withstands the sterilization process without degradation.
While the document summarizes the validated parameters, it does not explicitly detail the specific ground truth methodologies (e.g., which biological indicators were used, specific culture results). However, "validated for steam sterilization" implies these standard methods were employed.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. A "training set" refers to data used to train a machine learning algorithm. The VersiTomic™ ACL Flexible Reamer System Sterilization Tray is a physical medical device, not an AI system. Its performance is evaluated through validation testing, not by training algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of medical device.
{0}------------------------------------------------
K1008852
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com | AUG '09 2010 |
|---|---|---|---|
| 1. (b) | ManufacturerAddress: | T.A.G. Medical Products Corporation, Ltd.D. N. AshratKibbutz Gaaton 25130, Israel | |
| Mfg. Phone: | Tel.: 972-3-647-4840 | ||
| Contact Person: | Dan Moor | ||
| Date: | August 5, 2010 | ||
| 2. | Device &ClassificationName: | Sterilization Container, class II device (product code KCT).VersiTomic ™ACL Flexible Reamer System Sterilization Tray | |
| 3. | Predicate Device: | Paragon Medical Surgical Instrumentation Delivery System (K032119) | |
| 4. | Description: | The VersiTomic ™ACL Flexible Reamer System Sterilization Tray is areusable sterilization container system intended to be used to enclose othermedical devices that are to be sterilized by a healthcare provider. It isintended to allow sterilization of the enclosed devices and also (whenproperly wrapped) maintain their sterility device until used. This device ismade of durable materials and designed with perforations or slots to allowfor steam penetration. It is constructed of machined and formed metal. | |
| 5. | Intended Use: | The VersiTomic™ ACL Flexible Reamer System Sterilization Tray is indicatedto enclose the VersiTomic ACL Flexible Reamer System instruments that areto be sterilized by a health care provider. | |
| The Sterilization Tray consists of an interlocking tray and lid, which are bothperforated to allow the passage of the sterilizing agent from outside the trayto the devices placed inside. | |||
| The VersiTomic™ ACL Flexible Reamer System Sterilization tray has beenvalidated with a load that consists of various metallic instruments andimplants up to a length of 340 mm and minimum internal diameter of 1.4mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally withinthe tray. |
{1}------------------------------------------------
The VersiTomic™ ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters:
Gravity
Gravity-Displacement Steam Sterilization
- Sterilizer Type: .
.
.
- Minimum Temperature: 132°C (270°F) .
- Minimum Exposure Time: 10 minutes
- Minimum Dry Time: 40 minutes
Pre-Vacuum Steam Sterilization
- Sterilizer Type: Pre-Vacuum .
- . Minimum Temperature: 132°C (270°F)
- . Minimum Exposure Time: 4 minutes
- Minimum Dry Time: . 15 minutes
-
- Comparison of Technological Characteristics:
With respect to its indication for use, the VersiTomic™ ACL Flexible Reamer System Sterilization Trav is substantially equivalent to its predicate device in that it intended for the same clinical purpose. With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs the same function in the same manner.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 symbol featuring three overlapping, curved shapes that resemble abstract human figures or waves.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
T.A.G. Medical Products C/O Mr. George J. Hattub MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Alls De 2010
Re: K100887
Trade/Device Name: VersiTomic "" ACL Flexible Reamer System Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: July 19, 2010 Received: July 29, 2010
Dear Mr Hattub:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
{3}------------------------------------------------
Page 2- Mr. Hattub
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Susan Runov
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, . Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
AUG 09 2010
510(k) Number (if known): K100887
Device Name: VersiTomic™ ACL Flexible Reamer System Sterilization Tray
Indications For Use: The VersiTomic™ ACL Flexible Reamer System Sterilization Trav is indicated to enclose the VersiTomic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider.
The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside.
The VersiTomic™ ACL Flexible Reamer System Sterilization tray has been validated with a load that consists of various metallic instruments and implants
up to a length of 340 mm and minimum internal diameter of 1.4 mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within the tray.
The VersiTomic™ ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters:
Gravity-Displacement Steam Sterilization
- Sterilizer Type: Gravity .
- 132°C (270°F) Minimum Temperature: .
- 10 minutes Minimum Exposure Time: .
- Minimum Dry Time: 40 minutes .
Pre-Vacuum Steam Sterilization
- Pre-Vacuum Sterilizer Type: .
- Minimum Temperature: 132°C (270°F) ●
- Minimum Exposure Time: 4 minutes .
- 15 minutes Minimum Dry Time: .
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Device 1 of 1 | |
| 510(k) Number: | K100887 |
§ 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).