(135 days)
No
The device is a sterilization tray and the description focuses on its materials, design for sterilization, and compatibility with instruments and sterilization wrap. There is no mention of any computational or analytical functions that would involve AI or ML.
No
The device is a sterilization tray used for organizing, transporting, and storing medical devices. It does not provide any therapeutic effect or treatment.
No
The device is a reusable sterilization tray used for organization, transportation, and storage of medical devices, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical instrument tray made of materials like polypheny sulfone and silicone, designed for holding and sterilizing reusable medical instruments. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices." This describes a process for preparing medical instruments for use, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the tray and its function in holding instruments during sterilization. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
The device is a sterilization tray, which is a type of medical device used in the preparation and handling of other medical instruments. It does not perform any diagnostic function itself.
N/A
Intended Use / Indications for Use
DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® III Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
DetachaTip® III Plus Multi-Use Instrument Tray is intended for use with DetachaTip® III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg].
Product codes
KCT
Device Description
The ConMed DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is used to retain reusable instruments during steam sterilization. The tray consists of a perforated tray base and lid made from polypheny sulfone (Radel®). Latches securely hold the tray base, and handles are provided for transportation. A perforated silicone mat protects instruments placed in the bottom of the tray. A Radel® instrument rack separates and secures the DetachaTip® III instruments throughout sterilization processing and/or storage. The tray is not intended to maintain sterility. The instrument tray is to be used with an FDA cleared sterilization wrap.
DetachaTip® III Plus Multi-Use Instrument Tray is designed to fit a standard autoclave, comprised of materials resistant to corrosion, and able to withstand repeat steam sterilization cycles. The tray is designed to withstand repeated use. It is not designed to be serviced or repaired. The materials comprising the tray are biocompatible and will not contaminate reusable medical devices.
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
healthcare providers
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)
DetachaTip® III Plus Multi-Use Instrument Tray meets requirements of ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. Based on the nonclinical performance testing, the subject device is as safe and effective as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is a horizontal line, and below that is the word "CORPORATION" in a smaller, sans-serif font.
FEB 2 1 2013
DetachaTip® III Plus Multi-Use Instrument Tray
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 for 510(k) number K123175 as of January 8, 2013.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration Number: 1320894
B. Company Contact
Anna D'Lima, RAC Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502 Phone: 315-624-3439 Fax: 315-624-3225 e-mail: annadlima@conmed.com
C. Device Name
Trade Name: DetachaTip® III Plus Multi-Use Instrument Tray Common Name: Instrument Tray/Sterilization Tray, Classification Name: Sterilization Wrap Containers, Trays, Cassettes, and other Accessories Regulation Number: 21 CFR 880.6850 Class II КСТ Panel: General Hospital and Personal Use Devices
D. Predicate Device Name
ConMed DetachaTip® Instrument Tray ConMed Corporation 510(k) K092414
1
E. Device Description
The ConMed DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is used to retain reusable instruments during steam sterilization. The tray consists of a perforated tray base and lid made from polypheny sulfone (Radel®). Latches securely hold the tray base, and handles are provided for transportation. A perforated silicone mat protects instruments placed in the bottom of the tray. A Radel® instrument rack separates and secures the DetachaTip® III instruments throughout sterilization processing and/or storage. The tray is not intended to maintain sterility. The instrument tray is to be used with an FDA cleared sterilization wrap.
DetachaTip® III Plus Multi-Use Instrument Tray is designed to fit a standard autoclave, comprised of materials resistant to corrosion, and able to withstand repeat steam sterilization cycles. The tray is designed to withstand repeated use. It is not designed to be serviced or repaired. The materials comprising the tray are biocompatible and will not contaminate reusable medical devices.
Radel® is a registered trademark of Solvay Advanced Polymers
F. Intended Use/ Indications for Use
DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® III Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
DetachaTip® III Plus Multi-Use Instrument Tray is intended for use with DetachaTip® III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg].
| Table 1 – Reusable Medical Device Challenge Conditions | |
|---|---|
| Minimum | |
| Inner Diameter | Maximum |
| Length | |
| 5 mm | 45 cm |
| 3 mm | 32 cm |
Sterilize the DetachaTip® III Plus Multi-Use Instrument Tray using the following parameters:
| Method | Cycle | Temperature | Exposure Time | Dry Cycle Time |
|---|---|---|---|---|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 30 minutes |
| The devices should be sterilized using an FDA cleared wrap indicated for these sterilization | ||||
| cycles. Allow for a 30 minute cool down prior to handling. |
2
H. Performance Data
DetachaTip® III Plus Multi-Use Instrument Tray meets requirements of ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. Based on the nonclinical performance testing, the subject device is as safe and effective as the legally marketed predicate device.
I. Substantial Equivalence
The DetachaTip® III Plus Multi-Use Instrument Tray and predicate device are substantially equivalent in intended use, device design, materials, performance, effectiveness, and safety. The proposed device and the predicate device are containment devices for sterilization of reusable medical devices using steam sterilization by healthcare providers. The proposed device presents no new issues of safety and efficacy. Note: Prior designs of DetachaTip® instruments shall not be used in the DetachaTip® III Plus Multi-Use Instrument Trays.
| | DetachaTip® III Plus
Multi-Use Instrument Tray | ConMed DetachaTip® Instrument Tray |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| | K123175 | K092414 |
| Model #/ REF | 3-4343 | 1-4327 |
| Description | Containment devices for sterilization of
DetachaTip® III Instruments and ConMed
reusable medical devices meeting challenge
conditions defined in Table 1 using steam
sterilization by healthcare providers. The device
should be used only in conjunction with FDA cleared
wrap indicated for the sterilization cycles. | Containment devices for sterilization of
DetachaTip® II Instruments using steam
sterilization by healthcare providers. The device
should be used only in conjunction with FDA cleared
wrap indicated for the sterilization cycles. |
| Sterilization
Method | Pre-vacuum steam sterilization | Same |
| Materials | Polyphenylsulfone (Radel), Silicone, Stainless Steel | Same |
| Device Design | Four part instrument tray
- Tray lid
- Inner tray includes 10 wells for DetachaTip® III
Instruments and 4 wells for DetachaTip® III
Handles - Silicone mat
- Tray base for ConMed reusable medical devices
meeting challenge conditions defined in Table 1 | Four part instrument tray - Tray lid
- Inner tray includes 10 wells for DetachaTip® II
Instruments - Silicone mat
- Tray base for DetachaTip® II Handles |
| Performance
Testing | ANSI/AAMI ST77:2006/(R)2010 Containment
devices for reusable medical device sterilization | Same |
3
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 circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2013
Ms. Anna D' Lima, RAC Regulatory Affairs Specialist ConMed Corporation 525 French Road UTICA NY 13502
Re: K123175
Trade/Device Name: DetachaTip® III Plus Multi-Use Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 8, 2013 Received: January 11, 2013
Dear Ms. D' Lima:
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.
4
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 devicerelated adverse events) (21 CFR 803); 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.
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.
Image /page/4/Picture/7 description: The image shows a stylized graphic with overlaid text. The text appears to read "for" at the top left, followed by a signature or stylized name in the center, and the word "with" above the word "uroutts." The graphic includes geometric shapes, with a maze-like pattern on the left and a triangular shape on the right, both filled with horizontal lines.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K123175
Device Name: DetachaTip® III Plus Multi-Use Instrument Tray
DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® III Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
DetachaTip® III Plus Multi-Use Instrument Tray is intended for use with DetachaTip® III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg].
| Table 1 - Reusable Medical Device Challenge Conditions | ||
|---|---|---|
| Minimum | ||
| Inner Diameter | Maximum | |
| Length | ||
| 5 mm | 45 cm | |
| 3 mm | 32 cm |
Sterilize the DetachaTip® III Plus Multi-Use Instrument Tray using the following parameters:
| Method | Cycle | Temperature | Exposure Time | Dry Cycle Time |
|---|---|---|---|---|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 30 minutes |
| The devices should be sterilized using an FDA cleared wrap indicated for these sterilization |
cycles. Allow for a 30 minute cool down prior to handling.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)[iZabet]
Page _ of
Elizabeth H. Clavelle
2013.02.20 15:19:01 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number;