(215 days)
Not Found
No
The device is a physical instrument tray for sterilization and transport, with no mention of software, data processing, or any AI/ML related terms or functions.
No.
The device is described as a "perforated containment devices for medical device sterilization" used to "organize, sterilize, and transport Detachatip instruments." Its purpose is to facilitate the sterilization and handling of other medical instruments, not to directly treat a medical condition or perform a therapeutic function itself.
No
The ConMed DetachaTip Instrument Trays are "perforated containment devices for medical device sterilization" used to organize, sterilize, and transport surgical instruments. Their function is not to diagnose.
No
The device is a physical instrument tray made of Radel R Polyphenylsulfone and stainless steel, designed for organizing, sterilizing, and transporting surgical instruments. It is clearly a hardware device.
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 a "perforated containment device for medical device sterilization." It is used to "organize, sterilize, and transport Detachatip instruments." This function is related to the processing of surgical instruments, not the analysis of biological samples or the diagnosis of diseases.
- Device Description: The description details the physical components of the tray and its purpose in holding surgical instruments during sterilization. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis
- Reagents or test kits
The device's function is purely related to the physical handling and sterilization of surgical instruments.
N/A
Intended Use / Indications for Use
The ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed™ DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport DetachaTip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.
The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
| Cat. No. | Description |
|---|---|
| 2-1003 | Metzenbaum, 33cm length |
| 2-1004 | Mini- Metzenbaum, 33cm length |
| 2-1005 | 5mm Babcock Grasper, 33cm length |
| 2-1008 | Fenestrated Grasper, 33cm length |
| 2-1009 | Curved Dissector, 33cm length |
| 1-1010 | Standard Handle |
| 2-1013 | Hook, 33cm length |
| 2-1014 | 10mm Babcock, 33cm length |
| 1-1015 | Compact Handle |
| 2-1017 | Right Angle Meeker dissector 33cm |
| 2-1018 | Tapered Dissector, 33cm length |
| 2-1019 | Allis Grasper, 33cm length |
| 1-1024 | In-line Handle |
| 1-1028 | Endoweave Grasper, 33 cm length |
The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with ConMed's 43cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
| Cat. No. | Description |
|---|---|
| 2-4301 | Metzenbaum, 43cm length |
| 2-4304 | Mini- Metzenbaum, 43cm length |
| 2-4305 | 5mm Babcock Grasper, 43cm |
| 2-4308 | Curved Dissector, 43cm length |
| 2-4307 | Fenestrated Grasper, 43cm length |
| 2-4314 | 10mm Babcock, 43cm |
| 2-4317 | Right Angle Meeker dissector 43cm |
| 2-4318 | Tapered Dissector, 43cm |
| 2-4319 | Allis Grasper, 43cm |
| 2-4328 | Endoweave Grasper, 43cm |
Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:
| Method | Cycle | Temperature | Exposure Time | Dry Cycle Time |
|---|---|---|---|---|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 20 minutes |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The ConMed™ DETACHATIP® INSTRUMENT TRAYS consist of a Radel R Polyphenylsulfone base, a Radel R Polyphenylsulfone tray, a silicone rubber mat, a Radel R Polyphenylsulfone lid with tray lid clips with perforations to facilitate steam penetration, and stainless steel carrying handles. The tray holds the ConMed™ DETACHATIP® surgical instruments before, during, and after the sterilization process. The tray set has a locking lid to contain the instruments.
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)
The the ConMed™ DETACHATIP® INSTRUMENT TRAYS have been validated to perform effectively during prevacuum steam sterilization and drying cycles, using biological indicators and thermocouples to support sterilization and drying processes.
Pre-vacuum
Min temperature =132°C Min. exposure = 4 minutes Min. dry time = 20 minutes
CAUTION: Testing demonstrates that a minimum dry time of 20 minutes is required to prevent wet packs when using the prevacuum cycle.
Note: Validation was conducted using wrapped trays. The device should Note: Vanadion was other with FDA cleared wrap indicated for these sterilization cycles.
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.
Not Found
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
K09241.14
Image /page/0/Picture/1 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized "C" shape in a black square on the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller letters. There is a registered trademark symbol next to the "D" in "CONMED".
MAR 1 0 2010
510(k) Summary of Safety and Effectiveness
ConMed™ Detachatip® Instrument Trays
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Registration Number: 1320894 Date: August 6, 2009
B. Company Contact
Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502
Phone: 315-624-3435 Fax: 315-624-3225 e-mail: sandy_coveleski@mail.conmed.com
C. Device Name
| Trade Name: | ConMed™ Detachatip® Instrument Trays |
|---|---|
| Common Name: | Instrument Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes, |
| and other Accessories | |
| Proposed Class/Device: | Class II |
| Product Code: | KCT |
| Regulation Number: | 21 CFR 880.6850 |
| Panel: | 880 General Hospital |
1
D. Predicate Device
Paragon Medical Surgical Instrument Delivery Tray Paragon Medical 510(K) # K032119
E. Intended Use
The ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.
The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
| CAT. NO. | DESCRIPTION |
|---|---|
| 2-1003 | METZENBAUM, 33CM LENGTH |
| 2-1004 | MINI-METZENBAUM, 33CM LENGTH |
| 2-1005 | 5MM BABCOCK GRASPER, 33CM LENGTH |
| 2-1008 | FENESTRATED GRASPER, 33CM LENGTH |
| 2-1009 | CURVED DISSECTOR, 33CM LENGTH |
| 1-1010 | STANDARD HANDLE |
| 2-1013 | HOOK, 33CM LENGTH |
| 2-1014 | 10MM BABCOCK, 33CM LENGTH |
| 1-1015 | COMPACT HANDLE |
| 2-1017 | RIGHT ANGLE MEEKER DISSECTOR 33CM |
| 2-1018 | TAPERED DISSECTOR, 33CM LENGTH |
| 2-1019 | ALLIS GRASPER, 33CM LENGTH |
| 1-1024 | IN-LINE HANDLE |
| 1-1028 | ENDOWEAVE GRASPER, 33 CM LENGTH |
The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with The 15cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, Convice 3 +20m Detacha is is and DetachaTip handles. The trays are intended to be used specifically with the following:
2
| CAT. NO. | DESCRIPTION |
|---|---|
| 2-4301 | METZENBAUM, 43CM LENGTH |
| 2-4304 | MINI-METZENBAUM, 43CM LENGTH |
| 2-4305 | 5MM BABCOCK GRASPER, 43CM |
| 2-4308 | CURVED DISSECTOR, 43CM LENGTH |
| 2-4307 | FENESTRATED GRASPER, 43CM LENGTH |
| 2-4314 | 10MM BABCOCK, 43CM |
| 2-4317 | RIGHT ANGLE MEEKER DISSECTOR 43CM |
| 2-4318 | TAPERED DISSECTOR, 43CM |
| 2-4319 | ALLIS GRASPER, 43CM |
| 2-4328 | ENDOWEAVE GRASPER, 43CM |
Materials The ConMed™ DETACHATIP® INSTRUMENT TRAYS consist of a Radel R Polyphenylsulfone base, a Radel R Polyphenylsulfone tray, a silicone rubber mat, a Radel R Polyphenylsulfone lid with tray lid clips with perforations to facilitate steam penetration, and stainless steel carrying handles. The tray holds the ConMed™ DETACHATIP® surgical instruments before, during, and after the sterilization process. The tray set has a locking lid to contain the instruments.
Sterilant Penetration The the ConMed™ DETACHATIP® INSTRUMENT TRAYS have been validated to perform effectively during prevacuum steam sterilization and drying cycles, using biological indicators and thermocouples to support sterilization and drying processes.
Pre-vacuum
Min temperature =132°C Min. exposure = 4 minutes Min. dry time = 20 minutes
CAUTION: Testing demonstrates that a minimum dry time of 20 minutes is required to prevent wet packs when using the prevacuum cycle.
Note: Validation was conducted using wrapped trays. The device should Note: Vanadion was other with FDA cleared wrap indicated for these sterilization cycles.
SheIf Life The sterilization tray is reusable and will not be serviced or repaired.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 0 2010
Ms. Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, New York 13502
Re: K092414
Trade/Device Name: ConMedTM DetachaTip® Instrument Trays 33cm DetachaTip Instrument Tray (1-1027) 43cm Detachatip Instrument Tray (1-4327) Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 16, 2010 Received: February 17, 2010
Dear Ms. Coveleski:
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
Page 2- Ms. Coveleski
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 (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 /ucm ! 1 5809.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/ResourcesforYou/Industry/default.htm.
Sincerely vours
Susan Runser
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
5
INDICATIONS FOR USE
| 510(k) Number (if known): | 092414 | |||||||
|---|---|---|---|---|---|---|---|---|
| A Property Company Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Co | C 11 1 M . 1 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . |
| Family Name: | ConMed" DetachaTip® Instrument Trays |
|---|---|
| Trade Name: | 33cm DetachaTip Instrument Tray (1-1027) |
| 43cm DetachaTip Instrument Tray (1-4327) |
Indications for Use
The ConMed" DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.
The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
| Cat. No. | Description |
|---|---|
| 2-1003 | Metzenbaum, 33cm length |
| 2-1004 | Mini- Metzenbaum, 33cm length |
| 2-1005 | 5mm Babcock Grasper, 33cm length |
| 2-1008 | Fenestrated Grasper, 33cm length |
| 2-1009 | Curved Dissector, 33cm length |
| 1-1010 | Standard Handle |
| 2-1013 | Hook, 33cm length |
| 2-1014 | 10mm Babcock, 33cm length |
| 1-1015 | Compact Handle |
| 2-1017 | Right Angle Meeker dissector 33cm |
| 2-1018 | Tapered Dissector, 33cm length |
| 2-1019 | Allis Grasper, 33cm length |
| 1-1024 | In-line Handle |
| 1-1028 | Endoweave Grasper, 33 cm length |
The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with ConMed's 43cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
6
INDICATIONS FOR USE
| Cat. No. | Description |
|---|---|
| 2-4301 | Metzenbaum, 43cm length |
| 2-4304 | Mini- Metzenbaum, 43cm length |
| 2-4305 | 5mm Babcock Grasper, 43cm |
| 2-4308 | Curved Dissector, 43cm length |
| 2-4307 | Fenestrated Grasper, 43cm length |
| 2-4314 | 10mm Babcock, 43cm |
| 2-4317 | Right Angle Meeker dissector 43cm |
| 2-4318 | Tapered Dissector, 43cm |
| 2-4319 | Allis Grasper, 43cm |
| 2-4328 | Endoweave Grasper, 43cm |
Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:
| Method | Cycle | Temperature | Exposure Time | Dry Cycle Time |
|---|---|---|---|---|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 20 minutes |
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use__X (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)
Eshlata T. Queda-Wells
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092414