(356 days)
Not Found
No
The device is a physical sterilization tray and the description focuses on its materials, construction, and intended use for organizing and sterilizing surgical instruments. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is a sterilization tray used to organize, sterilize, transport, and store surgical instruments, not to directly treat or diagnose a medical condition.
No
The device is an instrument sterilization tray, designed to organize, sterilize, transport, and store surgical instruments. Its function is to facilitate the sterilization process, not to diagnose any medical condition or disease.
No
The device description clearly states the device is a physical tray made of polymer resin and stainless steel, designed to hold instruments for sterilization. It is a hardware device.
Based on the provided text, the ConMed Linvatec Instrument Sterilization Tray is not an IVD (In Vitro Diagnostic) device.
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 preparation of surgical instruments, not for performing diagnostic tests on samples taken from the human body.
- Device Description: The description focuses on the physical construction of the tray, its materials, and its purpose in holding and protecting instruments during sterilization. There is no mention of reagents, samples, or any components related to diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a sterilization accessory for surgical instruments, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses.
The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization.
The validated sterilization cycles are provided in Table II.
The cycles were validated using Kimguard (Kimberly Clark).
The sterilization exposure times are extended. Please refer to Table 2 for cycle tines. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays.
The sterilized contents are for immediate use and should not be stored for any duration.
The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The ConMed Linvatec sterilization trays consist of base trays, lids and internal individualized insert travs. Each trav is composed of multiple pieces and is designed to be integrated into a single unit, which will contain and protect the interior components during sterilization. The interior structures of the tray have the ability to separately hold each individual piece during the entire duration they are in contact with the tray.
The rigid, multi piece tray holds medical device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain products, which is held to the base by latches designed to fasten the lid to the base not allowing the two to separate. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in a normal operating room.
The tray is designed to allow repeated sterilization cycles. Though these travs are reusable they will not be serviced or repaired. Like the outer containing trays, the interior trays with individual containment custom brackets have been developed to withstand repeated use and will not be serviced or repaired. These custom brackets are made of materials that do not contaminate the tray or any of the parts or pieces contained within the tray.
The lid, base and insert for the proposed trays are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC. This material is identical to the Radel used in the predicate device cleared under K993535. Attachment I includes the material composition for the Radel R-5000.
The latches, which secure the lid to the base, are constructed of 300 Series Stainless Steel, identical to the stainless steel in the predicate devices cleared under K993535 and K944025.
The instruments to be sterilized in the proposed trays are all non-porous devices and including instruments such as suture snares, various hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obturators, etc.
Each tray includes brackets and containment mats which are made of a biomedical grade silicone. These are used to secure the instruments during transport, sterilization and storage. The drawings in Attachment III include the brackets and mats.
Additional device characteristics can be found in the chart included as Attachment A of this 510(k) Summary.
The brackets and containment mats are both constructed from biomedical grade silicone which has been manufactured to meet FDA CFR 177.2600. This material is identical to the predicate devices cleared under K993535 and K944025.
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)
Not Found
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
0C7 1 6 2006
510(k) Submission
Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting a 510(k) Summary of Safety and Effectiveness for the ConMed Linvatec Instrument Sterilization Tray.
510(k) # K052992
Submitter A.
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone FAX (727) 399-5264
C. Device Name
Trade Name: Instrument Sterilization Tray
Common Name: Instrument Sterilization Tray
Classification Name: Accessory to Sterilization Wrap, CFR 880.6850
Proposed Class/Device: Class II
Product Code: FRG
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Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 2 of 4
D. Predicate/Legally Marketed Devices
K993535 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. K023658 - Sterilization cases, trays and cassettes - Carr Medical Products K944025 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc.
E. Device Description
The ConMed Linvatec sterilization trays consist of base trays, lids and internal individualized insert travs. Each trav is composed of multiple pieces and is designed to be integrated into a single unit, which will contain and protect the interior components during sterilization. The interior structures of the tray have the ability to separately hold each individual piece during the entire duration they are in contact with the tray.
The rigid, multi piece tray holds medical device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain products, which is held to the base by latches designed to fasten the lid to the base not allowing the two to separate. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in a normal operating room.
The tray is designed to allow repeated sterilization cycles. Though these travs are reusable they will not be serviced or repaired. Like the outer containing trays, the interior trays with individual containment custom brackets have been developed to withstand repeated use and will not be serviced or repaired. These custom brackets are made of materials that do not contaminate the tray or any of the parts or pieces contained within the tray.
The lid, base and insert for the proposed trays are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC. This material is identical to the Radel used in the predicate device cleared under K993535. Attachment I includes the material composition for the Radel R-5000.
The latches, which secure the lid to the base, are constructed of 300 Series Stainless Steel, identical to the stainless steel in the predicate devices cleared under K993535 and K944025.
2
Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 3 of 4
The instruments to be sterilized in the proposed trays are all non-porous devices and including instruments such as suture snares, various hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obturators, etc.
Each tray includes brackets and containment mats which are made of a biomedical grade silicone. These are used to secure the instruments during transport, sterilization and storage. The drawings in Attachment III include the brackets and mats.
Additional device characteristics can be found in the chart included as Attachment A of this 510(k) Summary.
The brackets and containment mats are both constructed from biomedical grade silicone which has been manufactured to meet FDA CFR 177.2600. This material is identical to the predicate devices cleared under K993535 and K944025.
Intended Use F. Intended Use
The ConMed Linvatec® Instrument Sterilization Trays are for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instrument between uses.
ConMed Linvatec® Instrument Sterilization Trays can be used in a steam sterilization cycles. The validated sterilization cycles are provided in Table II. Important Notes
The cycles were validated using Kimguard (Kimberly Clark) wrap. The sterilization exposure times are extended. Please refer to Table 2 for cycle times. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays. The sterilized contents are for immediate use and should not be stored for any duration.
The trays are intended for sterilization of non-porous loads, e.g. hooks, grassers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.
The travs are not intended to be stacked during the sterilization process Substantial Equivalence ت
The ConMed Linvatec Instrument Sterilization Tray is substantially equivalent in materials and is similar in intended use and design to the below identified predicate devices. The proposed Instrument Sterilization Tray and the predicate devices are used for storage, transport, and sterilization of surgical instruments between uses. Both the proposed and predicate devices are suitable for use in steam sterilization processes.
The ConMed Linvatec Instrument Sterilization Tray will be offered in a combination of various metals and plastics.
3
Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 4 of 4
There are no significant differences between the proposed device and the predicate devices other than various tray sizes and layout of custom containment brackets. Also see Attachment B of this 510(k) summary for further details.
Substantially Equivalent Predicate Marketed Device:
K993535 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. K023658 - Sterilization cases, trays and cassettes - Carr Medical Products K944025 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc.
H. Technological Characteristics
The design and materials used in of the ConMed Linvatec Instrument Sterilization Trays, a perforated plastic tray with a stainless steel latch and silicone containment brackets. that allows free steam passage is the substantially equivalent to the predicate devices. All trays have various dimensions such that the proposed trays and the predicates devices are substantially equivalent in size and volume. The sterilization validation of all trays has met the requirements of the same performance standard, AAMI TIR No.12-1994. The associated procedures for the use of the devices , i.e. the manufacturer's recommended sterilization cycles, are all similar.
I. Summary and Conclusion
The Conmed Linvatec Instrument Sterilization Tray has the same intended use, technological characteristics and performance characteristics as the predicate devices. Thus, the proposed tray does not raise any new issues of safety and efficacy and per the definition under 21 CFR 807.100 is substantially equivalent to the referenced predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background. The overall design is simple and recognizable, representing the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 2006 Manager, Regulatory Affairs
Re: K052992
Ms. Elizabeth M. Paul
11311 Concept Boulevard Largo, Florida 33773-4908
ConMed Linvatec
Trade/Device Name: ConMed Linvatec Instrument Sterilization Tray Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 19, 2006 Received: September 21, 2006
Dear Ms. Paul:
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.
5
Page 2 – Ms. Paul
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K052992
Device Name: ConMed Linvatec Instrument Sterilization Tray
Indications for Use:
The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses.
The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization.
The validated sterilization cycles are provided in Table II.
The cycles were validated using Kimguard (Kimberly Clark).
The sterilization exposure times are extended. Please refer to Table 2 for cycle tines. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays.
The sterilized contents are for immediate use and should not be stored for any duration.
The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.
| Table 1 Tray Characteristics | |||||
|---|---|---|---|---|---|
| Catalog | |||||
| Number | Description | Recommended | |||
| Max load | |||||
| (lbs.)* | Length | ||||
| (Inches) | Width | ||||
| (Inches) | Depth | ||||
| (Inches) | |||||
| 9895 | ROTATOR CUFF STERILATION CASE | ||||
| TRAY | 2.54 | 14.60 | 9.52 | 0.82 | |
| ROTATOR CUFF STERILE CASE (BASE) | 14.45 | 9.4 | 0.4 | ||
| 8217 | OSTEOPREP STERILE TRAY (LID) | 4.08 | 20.88 | 10.13 | 0.82 |
| OSTEOPREP STERILE TRAY (BASE) | 20.63 | 9.81 | 1.19 | ||
| C6355 | SPECTRUM II (LID) | 11.90 | 20.75 | 9.93 | 1.116 |
| SPECTRUM II (UPPER TRAY) | 19.75 | 8.94 | 1.97 | ||
| SPECTRUM II (BASE) | 20.46 | 9.67 | 4.76 |
Table 1 lists the trays included in this submission.
*Includes the weight of the tray.
7
| Table 2 | ||||
|---|---|---|---|---|
| Validated Sterilization Cycles | ||||
| Method | Cycle | Minimum | ||
| Temperature | Minimum | |||
| Exposure | Minimum | |||
| Dry Cycle | ||||
| Steam | Pre-vacuum | 270°F (132°C) | 5 minutes | 10 minutes |
| Steam | Gravity | 270°F (132°C) | 30 minutes | 10 minutes |
Prescription Use______________________________________________________________________________________________________________________________________________________________ OR Over-the-Counter Use __X
(Part 21 CFR 801 subpart D)
(Part 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)
Elaine S. Maglull fus. Murphy
(Sign-Off)
n of Anesthesiology, General Hospital.
nesthesiology, General Hospital, tal Devices