(175 days)
The Enhance Allograft Wedge Instrument on Tray (7903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments:
| REF | Description | REF | Description |
|---|---|---|---|
| 903106 | Evans Trial 6mm | 903206 | Cotton Trial 6mm |
| 903108 | Evans Trial 8mm | 903207 | Cotton Trial 7mm |
| 903110 | Evans Trial 10mm | 903208 | Cotton Trial 8mm |
| 903112 | Evans Trial 12mm | 903006 | Mallet |
| 903010 | Tamp Evans | 903008 | Distractor |
| 903012 | Tamp Cotton | 903002 | Osteotome 16mm |
| 903205 | Cotton Trial 5mm | 903004 | Osteotome 10mm |
The Enhance Allograft Wedge Instrumentation Tray (T903) is not intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to mainal instruments. Sterilize the instrument. Sterilize the instrument tray using the following sterilization parameters:
| Method | Cycle | Temperature | Exposure | Dry Cycle | Cool Down | Duration |
|---|---|---|---|---|---|---|
| Steam(wrapped) | Pre-vacuum | 270°F (132°C) | 4 minutes | 20 minutes | 118°F (48°C) | 25 minutes |
| Steam(wrapped) | Gravity | 250°F (121°C) | 30 minutes | 15 minutes | 118°F (48°C) | 37 minutes |
Double wrap tray using an FDA cleared wrap.
The Enhance® Allograft Wedge Instrumentation Tray (T903) is constructed primarily of aluminum with perforations to facilitate sterilant penetration, evacuation and drying. The tray dimensions are approximately 21 x 10" and it is designed to fit any standard autoclave. The tray is manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the tray is perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although the tray is reusable it will not be serviced or repaired. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray.
The document provided is a 510(k) premarket notification for a medical device called the "Enhance Allograft Wedge Instrument Tray". This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of acceptance criteria and performance for a new AI/software device. The product in question is a sterilization tray, which is a physical containment device, not a software or AI-based medical device.
Therefore, the requested information elements related to AI/software performance, ground truth, expert consensus, sample sizes for training/test sets, and multi-reader multi-case studies are not applicable to this document.
However, I can extract the general acceptance criteria and information regarding non-clinical performance and a comparison to the predicate device.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Performance Testing):
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Intended Use | Containment device for medical device sterilization, to organize, sterilize, transport, and store instruments. | Same as predicate device. Used to load surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. |
| Manufacturing Materials | Durable, biocompatible, corrosion-resistant, compatible with repeated steam sterilization. | Proposed Device Materials (Enhance Allograft Wedge Instrument Tray):- Tray lid, base and internal tray: 5052-H32 grade aluminum, anodized- Rivets, Handle Wire, Handle Clip, Latch Component, Channel: 301SS, 302SS, 304SS, Silicone- Latches, Screws, Nuts, Washers and Brackets: 17-4 PH SS, 304-2B SS, 316SS, 18-8 SS- Brackets, Internal: Silicone- Silk Screen Ink: Sericoil 301 TP Black Predicate Device Materials (ConMed Linvatec Anodized Aluminum Sterilization Trays):- Tray lid, base and internal tray: 5052-H32 grade aluminum, anodized- Handles: 304SS- Latches: 304SS- Brackets and protective mat: Silicone (21 CFR177.2600) The new device uses similar materials, with some additional elements specified. |
| Design | Perforated tray/lid to organize, sterilize, transport, and store instruments. | Same as predicate device. Perforated tray and lid used to organize, sterilize, transport, and store instruments between uses. Interior structures of the trays have the ability to separately hold individual instruments. Approximately 21 x 10" dimensions, fits standard autoclave. |
| Sterilization Method | Steam sterilization using FDA-cleared wrap. Specific validated parameters. | Same as predicate device. Validated for Steam (wrapped) Pre-vacuum cycle: 270°F (132°C) for 4 minutes exposure, 20 minutes dry cycle, 118°F (48°C) cool down for 25 minutes (total duration 25 minutes). Validated for Steam (wrapped) Gravity cycle: 250°F (121°C) for 30 minutes exposure, 15 minutes dry cycle, 118°F (48°C) cool down for 37 minutes (total duration 37 minutes). Requires double wrap with an FDA cleared wrap. Validation conducted using a maximum load of 14 lbs (6.4 kg). Only single unstacked trays during sterilization. |
| Sterility Assurance Level | SAL 10^-6 | SAL 10^-6 reported, same as predicate device. |
| Performance Testing (General) | Meet requirements of ANSI/AAMI ST77:2013, handle strength, cleaning, biocompatibility, packaging, transportation, user validation. | ConMed conducted verification and validation testing including performance testing in accordance with ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization as well as: handle strength verification, cleaning, biocompatibility, packaging and transportation and a non-clinical user validation. Based on this testing, it was determined the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K090560). |
| Equivalence Claims | Substantially equivalent to predicate device (K090560) in design, manufacturing materials, intended use, principles of operation, and technical characteristics, raising no new issues of safety or effectiveness. | The document concludes that the Enhance Allograft Wedge Instrument Tray is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate device, and the performance testing data demonstrates it is as safe, as effective, and performs as well as the predicate device. |
Since this is a submission for a physical medical device (sterilization tray) and not an AI/software product, the following requested items are not applicable and cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device's performance testing in this context. Performance testing would likely involve laboratory or simulated use tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as there's no "ground truth" in the AI/ML sense for a sterilization tray.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the study/testing described:
The study was a non-clinical performance evaluation and comparison to a predicate device to establish substantial equivalence for regulatory approval.
- Validation Testing: ConMed conducted verification and validation testing.
- Standards Adhered To: ANSI/AAMI ST77:2013 (Containment Devices for Reusable Medical Device Sterilization).
- Specific Tests Mentioned: Handle strength verification, cleaning, biocompatibility, packaging and transportation, and a non-clinical user validation.
- Sterilization Parameters Tested: Pre-vacuum and Gravity steam sterilization cycles with specific temperatures, exposure times, dry cycles, and cool-down periods.
- No Clinical Performance Data: The submission explicitly states, "This submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
ConMed Corporation Ms. Dionne Sanders, MS. COA. RAC Manager, Regulatory Affairs 11311 Concept Blvd. Largo, Florida 33773
Re: K152969
Trade/Device Name: Enhance Allograft Wedge Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 02, 2016 Received: March 03, 2016
Dear Ms. Sanders:
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.
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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152969
Device Name
Enhance Allograft Wedge Instrument Tray
Indications for Use (Describe)
The Enhance Allograft Wedge Instrument on Tray (7903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments:
| REF | Description | REF | Description |
|---|---|---|---|
| 903106 | Evans Trial 6mm | 903206 | Cotton Trial 6mm |
| 903108 | Evans Trial 8mm | 903207 | Cotton Trial 7mm |
| 903110 | Evans Trial 10mm | 903208 | Cotton Trial 8mm |
| 903112 | Evans Trial 12mm | 903006 | Mallet |
| 903010 | Tamp Evans | 903008 | Distractor |
| 903012 | Tamp Cotton | 903002 | Osteotome 16mm |
| 903205 | Cotton Trial 5mm | 903004 | Osteotome 10mm |
The Enhance Allograft Wedge Instrumentation Tray (T903) is not intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to mainal instruments. Sterilize the instrument. Sterilize the instrument tray using the following sterilization parameters:
| Method | Cycle | Temperature | Exposure | Dry Cycle | Cool Down | Duration |
|---|---|---|---|---|---|---|
| Steam(wrapped) | Pre-vacuum | 270°F (132°C) | 4 minutes | 20 minutes | 118°F (48°C) | 25 minutes |
| Steam(wrapped) | Gravity | 250°F (121°C) | 30 minutes | 15 minutes | 118°F (48°C) | 37 minutes |
Double wrap tray using an FDA cleared wrap.
] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square is the word "CONMED" in black, sans-serif font. Below the word "CONMED" is a thin blue line, and below that is the word "CORPORATION" in a smaller, sans-serif font.
510(k) SUMMARY
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd. Largo, Florida 33773
Phone: 727-399-5564 Fax: 727-399-5264
Contact Person: Dionne Sanders, RAC Date Prepared: March 25, 2016 510k#: K152969
II. DEVICE
| Name of Device: | Enhance Allograft Wedge Instrument Tray |
|---|---|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap (21 CFR Part 880.6850) |
| Regulatory Class: | Class II |
| Product Codes: | KCT |
III. PREDICATE DEVICE
| Device Name: | ConMed Linvatec Anodized Aluminum Sterilization Trays |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K090560 |
IV. DEVICE DESCRIPTION
The Enhance® Allograft Wedge Instrumentation Tray (T903) is constructed primarily of aluminum with perforations to facilitate sterilant penetration, evacuation and drying. The tray dimensions are approximately 21 x 10" and it is designed to fit any standard autoclave. The tray is manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the tray is perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although the tray is reusable it will not be serviced or repaired. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray.
V. INTENDED USE / INDICATIONS FOR USE
The Enhance Allograft Wedge Instrumentation Tray (T903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge
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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, curved shape inside on the left. To the right of the square, the word "CONMED" is written in black, sans-serif font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, sans-serif font, with a blue line above it.
Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.
| REF | Description | REF | Description |
|---|---|---|---|
| 903106 | Evans Trial 6mm | 903206 | Cotton Trial 6mm |
| 903108 | Evans Trial 8mm | 903207 | Cotton Trial 7mm |
| 903110 | Evans Trial 10mm | 903208 | Cotton Trial 8mm |
| 903112 | Evans Trial 12mm | 903006 | Mallet |
| 903010 | Tamp Evans | 903008 | Distractor |
| 903012 | Tamp Cotton | 903002 | Osteotome 16mm |
| 903205 | Cotton Trial 5mm | 903004 | Osteotome 10mm |
This tray is intended for use with the following instruments:
The Enhance Allograft Wedge Instrumentation Tray (T903) 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. Sterilize the instrument tray using the following sterilization parameters:
| Method | Cycle | Temperature | Exposure | Dry Cycle | Cool Down | Duration |
|---|---|---|---|---|---|---|
| Steam(wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 20 minutes | 118°F(48°C) | 25 minutes |
| Steam(wrapped) | Gravity | 250°F(121°C) | 30 minutes | 15 minutes | 118°F(48°C) | 37 minutes |
Validation was conducted using an FDA cleared sterilization wrap with a maximum load 14 lbs. (6.4 kg).
Only single unstacked trays may be used during the sterilization process.
Double wrap tray using an FDA cleared wrap.
VI. COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
ConMed's Enhance Allograft Wedge Instrument Tray is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Anodized Aluminum Sterilization Trays, specifically the Hip Arthroscopy Master Tray, and raises no new issues of safety or effectiveness.
The similarities and differences between the predicate and proposed sterilization trays are the following-
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Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller, thinner letters, with a blue line above it.
| Proposed DeviceEnhance Allograft WedgeInstrument Tray | Predicate DeviceConMed Linvatec Anodized AluminumSterilization Tray (K090560) | |
|---|---|---|
| Intended Use | Same | A family of containment devices formedical device sterilization. |
| Indications forUse | Same | The trays are intended for use only withthe instruments sets listed in the IFU. |
| Contraindications | None Known | None known |
| Materials ofConstruction | Tray lid, base and internal tray:5052-H32 grade aluminum,anodizedRivets, Handle Wire, HandleClip, Latch Component, Channel:301SS, 302SS, 304SS, SiliconeLatches, Screws, Nuts, Washersand Brackets: 17-4 PH SS, 304-2B SS, 316SS, 18-8 SSBrackets, Internal: SiliconeSilk Screen Ink: Sericoil 301 TPBlack | Tray lid, base and internal tray: 5052-H32grade aluminum, anodizedHandles: 304SSLatches: 304SSBrackets and protective mat: Silicone(21 CFR177.2600) |
| Design | Same | Perforated tray and lid used to organize,sterilize, transport, and store instrumentsbetween uses |
| OverallDimensions | 21.29" x 10.03" x 3.30" | 20.77" x 10.02" x 6.00" |
| Filled Weight | 11.70lbs | 18.20lbs |
| Gaskets, Filters,Valves, Seals | Same | None |
| Latches | Same | Yes, to secure the tray lid to the base |
| SterilizationMethod | Same | Steam sterilization using aFDA-cleared sterilization wrap |
| External Stacking | Same | Do not stack |
| Same w/added cool down time | Min temperature: 270° F (132° C) | |
| Pre-vacuum cycleSteam (wrapped) | Cool down: 48° C for 25 minutes | Min exposure: 4 minMin dry cycle: 20 min |
| Method: Steam (wrapped) | Method: Steam (wrapped) | |
| Gravity cycleSteam (wrapped) | Temperature: 250° F (121° C)Exposure: 30 minDry Cycle: 15 minCool Down: 48° C for 37 min | Min temperature: 270° F (132° C)Min exposure: 15 minMin dry cycle: 25 min |
| SterilityAssurance Level(SAL) | SAL 10-6 | SAL 10-6 |
| Tamper Evident | Same | Secured with autoclave tape |
| Instrumentation | Same | For use with specific instrumentation |
| Packaging | Shipped empty | Shipped loaded with instrumentation |
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Image /page/6/Picture/0 description: The image is the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside on the left. To the right of the square is the company name, "CONMED," in bold, black letters. Below the name is the word "CORPORATION" in smaller, gray letters.
VII. PERFORMANCE DATA
Non-Clinical Performance
ConMed conducted verification and validation testing including performance testing in accordance with ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization as well as: handle strength verification, cleaning, biocompatibility, packaging and transportation and a non-clinical user validation. Based on this testing, it has been determined that the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device cleared under (K090560).
Clinical Performance
This submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
VIII. CONCLUSION
The Enhance Allograft Wedge Instrument Tray is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate device.
IX. SUBSTANTIAL EQUIVALENCE STATEMENT
The performance testing data for the subject device Enhance Allograft Wedge Instrument Tray (T903) demonstrates the subject device is as safe, as effective, and performs as well as the predicate device (K090560).
§ 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).