(188 days)
Not Found
No
The device description and intended use clearly define the device as a passive instrument rack for organizing and sterilizing surgical tools, with no mention of AI/ML capabilities or data processing.
No.
The device is described as an instrument rack for organizing, holding, and protecting surgical instruments for transport, storage, and sterilization, and it is not intended to treat or diagnose a disease or condition.
No
Explanation: The device is an instrument rack designed to organize, hold, and protect surgical screwdrivers during transport, storage, and sterilization. It is not used to diagnose any medical condition.
No
The device description clearly states it is a physical instrument rack made of anodized aluminum with polytherimide tube holders, designed for organizing and sterilizing surgical instruments. It does not mention any software components.
Based on the provided text, the Robinson MedSurg QuickScrew Rack RCK24-143 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for organizing, holding, and protecting surgical instruments for transport, storage, sterilization, and use during surgery. This is related to the handling and preparation of surgical tools, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description reinforces its function as an instrument rack for reusable surgical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide information about a patient's health. This device's function is entirely focused on the management of surgical instruments.
N/A
Intended Use / Indications for Use
The Robinson MedSurg QuickScrew Rack RCK24-143 is intended to organize, hold, and protect the QuickScrew screwdrivers for transport, storage, sterilization, and use during surgery. The subject instrument racks are suitable for use in prevacuum steam. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Prevacuum Steam | |||
| Autoclave | 270°F (132°C) | 4 minutes | 60 minutes |
Product codes
KCT
Device Description
The Robinson MedSurg QuickScrew Rack RCK24-143 is an instrument rack for organizing, holding, and protecting reusable surgical instruments during transportation, storage, and sterilization. It is designed for adequate exposure of the trays' contents to sterilant during the sterilization process.
The Rack is made of anodized aluminum with polytherimide tube holders for the instruments and to allow for air and sterilant to flow through and around the rack.
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)
Performance testing was conducted according to AAMI ST77:2006 Containment Devices for reusable medical device sterilization. The rack conforms to this standard and performed as intended.
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
TAB 1
Revised 2
510(k) Summary
As required by the Safe Medical Device Act of 1990, and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Robinson MedSurg QuickScrew Racks
Date Prepared: December 1, 2009
JUN 1 3 2010
- A. Submitter's Name
Robinson MedSurg, LLC 7430 E. Park Meadows Drive, Suite 300 Lone Tree, CO 80124
Establishment Registration Number: #3006119027
- B. Company Contact
Peggy Henline Operations Manager T. 303-706-1100 F. 303-662-8484 phenline(@robinsonmedsurg.com
C. Device Name
| Trade Name: | Robinson MedSurg QuickScrew Rack RCK24-143 |
|---|---|
| Common Name: | Sterilization Rack |
| Classification: | Sterilization Wrap Containers, Trays, Cassettes and Other Accessories |
| Regulatory Class: | II |
| Product Code: | KCT |
| Classification Number: | 21 CFR §880.6850 |
D. Predicate Devices
The subject Robinson MedSurg QuickScrew Rack RCK24-143 is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith and Nephew Instrument Tray cleared under K073551, Smith and Nephew Instrument Trays cleared under K090562, and the ContainMed Versipod Instrument Trays cleared under K071783.
1
E. Description of Device
- DEVICE DESCRIPTION: The Robinson MedSurg QuickScrew Rack RCK24-143 is an instrument rack for organizing, holding, and protecting reusable surgical instruments during transportation, storage, and sterilization. It is designed for adequate exposure of the trays' contents to sterilant during the sterilization process.
The Rack is made of anodized aluminum with polytherimide tube holders for the instruments and to allow for air and sterilant to flow through and around the rack.
Intended Use F.
The Robinson MedSurg QuickScrew Rack RCK24-143 is intended to organize, hold, and protect the QuickScrew screwdrivers for transport, storage, sterilization, and use during surgery. The subject instrument racks are suitable for use in prevacuum steam. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Prevacuum Steam | |||
| Autoclave | 270°F (132°C) | 4 minutes | 60 minutes |
G. Comparison of Technological Characteristics
The subject Robinson MedSurg QuickScrew Racks RCK24-143 have the same fundamental technological characteristics as the predicate devices. The subject racks are substantially equivalent in design, materials, and intended use to the predicate devices. There are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy and is, therefore, substantially equivalent to the predicate devices.
H. Summary of Performance Data
Performance testing was conducted according to AAMI ST77:2006 Containment Devices for reusable medical device sterilization. The rack conforms to this standard and performed as intended.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three intertwined strands representing health, services, and people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Randolph C. Robinson President Robinson Medsurg LLC 7430 East Park Meadows Drive, Suite 300 Lone Tree, Colorado 80124
JUN 1 3 2010
Re: K093800
Trade/Device Name: Robinson MedSurg QuickScrew Rack Model RCK 24-143 Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 16, 2010 Received: May 19, 2010
Dear Mr. Robinson:
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. Robinson
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.html 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 Punno
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
TAB 3
Indications for Use Statement
510(k) Number:
Device Name: Robinson MedSurg QuickScrew Rack Model RCK 24-143 V
Indications for Use:
The Robinson MedSurg QuickScrew Rack RCK24-143 is intended to organize, hold, and protect the QuickScrew screwdrivers for transport, storage, sterilization, and use during surgery. The subject instrument racks are suitable for use in prevacuum steam. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Prevacuum Steam | |||
| Autoclave | 270°F (132°C) | 4 minutes | 60 minutes |
Prescription Use (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use XX (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion Sign-Off)
usion of Anesthesiology, General Hospital
ection Control, Dental Devices
Page 1 of 1
(k) Number: K093800