(780 days)
Not Found
No
The device is a passive instrument tray for organizing and sterilizing surgical instruments, with no mention of any computational or analytical capabilities.
No
The device is described as an instrument tray for organizing, sterilizing, transporting, and storing surgical instruments, which are organizational and logistical functions, not therapeutic.
No
The device is an instrument tray used for organizing, sterilizing, transporting, and storing surgical instruments. It does not perform any diagnostic function.
No
The device description clearly outlines a physical instrument tray made of materials like aluminum, stainless steel, and plastic, used for organizing, sterilizing, transporting, and storing surgical instruments. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses." This is a function related to the handling and sterilization of surgical tools, not for performing tests on samples taken from the human body.
- Device Description: The description details a container for surgical instruments, including bases, lids, insert trays, mats, and holders. These are all components for organizing and protecting physical instruments.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for the purpose of providing information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on the effectiveness of sterilization within the tray, which is relevant to surgical instrument handling, not diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MetaPak Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.
The MetaPak Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The Riley Medical MetaPak Multi-Purpose Instrument Tray (MetaPak Instrument Tray) is an instrument container consisting of a rectangular box base with a cover that fastens to the base using latches on the short ends. The following sizes of bases and lids are available:
- Tall hase and lid: 22" x 10" x 6" .
- Short base and lid: 22" x 10" x 4" .
- Extra long base and lid: 26" x 10" x 6" .
Insert trays can be stacked in the container base to increase the instrument-carrying capacity of the container. The following insert sizes are available:
- . Full insert: 21" x 9.5" x 2.5"
- Small insert: 10" x 9.5" x 2.5" t
Protective mats are available that can be placed on the insert trays and in the bottom of the container base to stabilize and protect the instruments. Slotted instrument bars and holders are also available to organize, stabilize, and protect the instruments in the container.
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)
Validation testing was conducted which confirmed that sterilization conditions were achieved in fully loaded MetaPak Instrument Trays of all three container base material compositions containing one full insert and two half inserts, protective mats, and accessories in prc-vacuum steam and ethylene oxide sterilization processes.
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
DEC 0 7 2001
510(k) Summary
Kg93535
for
Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray
- SPONSOR 1.
Riley Medical, Inc. 27 Wrights Landing Auburn, ME 04210
Contact Person: Mr. Martin M. Moore 207-786-2775 Telephone:
November 28, 2001 Date Prepared:
DEVICE NAME 2.
Riley Modical, Inc. MetaPak Multi-Purpose Instrument Proprietary Name:
Tray
Tray Instrument sterilization tray Common/Usual Name: Accessory to sterilization wrap Classification Name:
PREDICATE DEVICES 3.
- Riley MultiPak Surgical Instrument Tray .
- Sklar Instruments Instrument Tray u
DEVICE DESCRIPTION 4.
The Riley Medical MetaPak Multi-Purpose Instrument Tray (MetaPak Instrument Tray) is an instrument container consisting of a rectangular box base with a cover that fastens to the base using latches on the short ends. The following sizes of bases and lids are available:
- Tall hase and lid: 22" x 10" x 6" .
- Short base and lid: 22" x 10" x 4" .
- Extra long base and lid: 26" x 10" x 6" .
Riley Medical, Inc. Additional Information for K993535
ा -
November 28, 2001
Page C-1
1
Insert trays can be stacked in the container base to increase the instrument-carrying capacity of the container. The following insert sizes are available:
- . Full insert: 21" x 9.5" x 2.5"
- Small insert: 10" x 9.5" x 2.5" t
Protective mats are available that can be placed on the insert trays and in the bottom of the container base to stabilize and protect the instruments. Slotted instrument bars and holders are also available to organize, stabilize, and protect the instruments in the container.
INTENDED USE ર્ણ
The MetaPak Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.
The MetaPak Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed MetaPak Instrument Tray and the predicate MultiPak and Sklar Instrument Trays are all used for storage, transport, and sterilization of surgical instruments between uses. Both the proposed and predicate devices are suitable for use in pre-vacuum steam and ethylene oxide sterilization processes.
The MetaPak Instrument Tray is identical to the predicate MultiPak Instrument Tray, cleared for marketing as K944025, with the exception of a modification to the materials for the container base. The original MultiPak Instrument Tray container base was constructed entirely of Radel plastic. The MetaPak Instrument Tray container base will be offered in aluminum, stainless steel, and an aluminum/Radel combination with the long sides made of aluminum and short sides made of Radel plastic.
PERFORMANCE TESTING 7.
Validation testing was conducted which confirmed that sterilization conditions were achieved in fully loaded MetaPak Instrument Trays of all three container base material compositions containing one full insert and two half inserts, protective mats, and accessories in prc-vacuum steam and ethylene oxide sterilization processes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Riley Medical, Incorporated C/O Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K993535
Trade/Device Name: Metapak Multi-Purpose Instrument Tray Regulation Number: 880.6850 Regulation Name: Instrument Sterilization Tray Regulatory Class: II Product Code: FRG Dated: October 9, 2001 Received: October 10, 2001
Dear Ms. Cullinane:
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.
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.
3
Page 2 - Ms. Cullinane
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an all the Process of CFR Part 801); good manufacturing practice and fishing (21 CFR Part 001), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quady ion 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 This letter will and w you to oegal marketing of substantial equivalence of your device to 910(K) promative nowledge 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 If you desire specific as now as a more diagnostic devices), please contact the and additionally 27 OF FF & 1 301) 594-4618 . Additionally, for questions on the promotion and Office of Coffigur device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nother (11 Cr Cr Cr or a from the Division of Small Manufacturers, International and the Not may be obtained its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K993535
Device Name: Riley Medical MetaPak Multi-Purpose Instrument Tray
Indications For Use:
The Riley Medical MetaPak Multi-Putpose Instrument Tray is used for loading surgical I he Teney Medical Weaks weaks organize, sterilize, transport, and store the instruments between uses.
The Riley Medical MetaPak Multi-Purpose Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.
PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
Prescription Use (Pcr 21 CFR 801.109) ાર
Over - The - Counter Use _____________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Riley Medical, Inc. Additional Information for K993535 November 28, 2001