(90 days)
The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.
The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).
The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are a modular, reusable tray and lid system intended for use in health care facilities for the purpose of containing medical devices for sterilization. The system is composed of two pieces, designed to be integrated into a single unit that contains and protects PUREVUE™ Quick Connect Cannula System instruments during sterilization and transport. All components are perforated for steam penetration.
N/A
FDA 510(k) Clearance Letter - PUREVUE™ Quick Connect Cannula System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.03
February 26, 2026
DePuy Mitek, Inc.
Jeffrey Dzialo
Senior Regulatory Affairs Specialist
325 Paramount Dr.
Raynham, Massachusetts 02767
Re: K253791
Trade/Device Name: PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization wrap
Regulatory Class: Class II
Product Code: KCT
Dated: November 26, 2025
Received: November 28, 2025
Dear Jeffrey Dzialo:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K253791 - Jeffrey Dzialo Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253791 - Jeffrey Dzialo Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
STEPHEN A. ANISKO -S
Digitally signed by STEPHEN A. ANISKO -S
Date: 2026.02.26 11:43:35 -05'00'
Stephen Anisko
Acting Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K253791
Device Name: PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid
Indications for Use (Describe):
The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.
The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).
Type of Use (Select one or both, as applicable):
- ☒ Prescription Use (Part 21 CFR 801 Subpart D)
- ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/23) Page 2 of 2
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Table 1 includes validated stem sterilization (moist heat sterilization) cycle parameters.
| Method | Exposure Time (minutes) | Exposure Temperature | Minimum Drying Time (minutes) |
|---|---|---|---|
| Pre-vacuum Steam Sterilization Cycle | 4 | 132 °C (270°F) | 30 to 60 |
| Pre-vacuum Steam Sterilization Cycle | 3 | 134 °C (274°F) | 30 to 60 |
Table 2 includes information regarding the descriptions and dimensions of the tray and lid.
Table 2: Descriptions and Dimensions of PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid.
| Part Number | Part Description | Volume to Vent Ratio (in³/in²) (with Lid) | Weight (lb) | Dimensions (in) (L x W x H) Tray (L x W) Lid |
|---|---|---|---|---|
| 242333 | PUREVUE™ Quick Connect Cannula System Tray | 10.08 | 4.73 | 21.23 x 9.71 x 2.86 |
| 242334 | PUREVUE™ Quick Connect Cannula System Lid | Not applicable | 1.81 | 21.50 x 10.01 x 0.63 |
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510(k) Premarket Notification (Traditional)
PUREVUE™ Quick Connect Cannula System Tray and Lid
K253791 Page 1 of 12
510(k) Summary K253791
| Submitter's Name and Address | DePuy Mitek, Inc.325 Paramount DriveRaynham, MA 02767, USAOn behalf of:Medos International SARLChemin-Blanc 38CH-2400 Le LocleSwitzerland |
|---|---|
| Contact Person | Jeffrey DzialoSenior Regulatory Affairs SpecialistPhone: +1 800-382-4682Email: jdzialo@its.jnj.com |
| Alternate Contact | Pol Fort GrèbolProject Manager Regulatory AffairsPhone: +34 672-672-579Email: pfortgre@its.jnj.com |
| Date Prepared | February 25, 2026 |
| Proprietary Name | PUREVUE™ Quick Connect Cannula System TrayPUREVUE™ Quick Connect Cannula System Lid |
| Common Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulation Number | 21 CFR § 880.6850 (Sterilization wrap) |
| Regulatory Class | Class II |
| Product Code | KCT |
| Predicate Device | Synthes Graphic Case & Tray System (K241927)No reference devices were used in this submission. |
| Device Description Summary | The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are a modular, reusable tray and lid system intended for use in health care facilities for the purpose of containing medical devices for sterilization. The system is composed of two pieces, designed to be integrated into a single unit that contains and protects PUREVUE™ Quick Connect Cannula System instruments during sterilization and transport. All components are perforated for steam penetration. |
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PUREVUE™ Quick Connect Cannula System Tray and Lid
K253791 Page 2 of 12
| Intended Use | The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are intended to hold PUREVUE™ Quick Connect Cannula System instruments during the sterilization process, storage, and transportation between uses. |
|---|
| Indications for Use | The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap). |
|---|
Table 1 includes validated steam sterilization (moist heat sterilization) cycle parameters.
Table 1: Validated Steam Sterilization Cycle Parameters.
| Method | Exposure Time (minutes) | Exposure Temperature | Minimum Drying Time (minutes) |
|---|---|---|---|
| Pre-vacuum Steam Sterilization Cycle | 4 | 132 °C (270°F) | 30 to 60 |
| Pre-vacuum Steam Sterilization Cycle | 3 | 134 °C (274°F) | 30 to 60 |
Table 2 includes information regarding the descriptions and dimensions of the tray and lid.
Table 2: Descriptions and Dimensions of PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid.
| Part Number | Part Description | Volume to Vent Ratio (in³/in²) (with Lid) | Weight (lb) | Dimensions (in) (L x W x H) Tray (L x W) Lid |
|---|---|---|---|---|
| 242333 | PUREVUE™ Quick Connect Cannula System Tray | 10.08 | 4.73 | 21.23 x 9.71 x 2.86 |
| 242334 | PUREVUE™ Quick Connect Cannula System Lid | Not applicable | 1.81 | 21.50 x 10.01 x 0.63 |
| Indications for Use Comparison | The subject and predicate devices share comparable intended use, indications for use, intended user, and user training requirements. The minor differences in the intended use statements primarily reflect the distinct formatting approaches adopted by DePuy Mitek, Inc. and |
|---|
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510(k) Premarket Notification (Traditional)
PUREVUE™ Quick Connect Cannula System Tray and Lid
K253791 Page 3 of 12
Synthes. These variations are negligible and do not raise new questions of safety or effectiveness.
The subject devices, PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid, are compared to the previously cleared Synthes Graphic Case & Tray System (K241927) regarding intended use, indications for use, technological characteristics (design features), and operating principle.
Comparison of Technological Characteristics with the Predicate Device
| Characteristic | Subject Devices (K253791) | Predicate Device (K241927) | Comparison |
|---|---|---|---|
| General Information | |||
| Proprietary Name | (1) PUREVUE™ Quick Connect System Tray(2) PUREVUE™ Quick Connect System Lid | (1) Synthes Graphic Case & Tray System | Not applicable |
| Representative Image (Tray) | [Image shown] | [Image shown] | Similar |
| Representative Image (Lid) | [Image shown] | [Image shown] | Similar |
| Product Code | Same as the predicate device.KCT | KCT | Same |
| Intended Use | |||
| Intended Use | The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are intended to hold PUREVUE™ Quick Connect Cannula System instruments during the sterilization process, storage, and transportation between uses. | The Synthes Graphic Case and Tray System is designed to hold surgical implants and instruments in order to organize, steam sterilize and transport the devices between uses. The cases and trays are intended to be wrapped with an FDA-cleared sterilization wrap or placed within a reusable sterilization container during the pre-vacuum autoclave sterilization process. | Similar. The predicate device can be used with both instruments and surgical implants, and is qualified for use with a rigid sterilization container. |
| Indications for Use | The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).Table 1 includes validated steam sterilization (moist heat sterilization) cycle parameters.Table 2: Descriptions and Dimensions of PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid. | The Synthes Graphic Case & Tray System is used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures.The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lb (case + contents+ lid+ weight of sterile barrier wrap). | Similar. The predicate device is validated for a greater maximum load and the subject devices include additional pre-vacuum sterilization cycle parameters. |
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PUREVUE™ Quick Connect Cannula System Tray and Lid
K253791 Page 4 of 12
| Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap.The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).Table 1 includes validated steam sterilization (moist heat sterilization) cycle parameters.Table 2: Descriptions and Dimensions of PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid. | transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures.The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lb (case + contents+ lid+ weight of sterile barrier wrap). | devices include additional pre-vacuum sterilization cycle parameters. |
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| Contraindications | Same as the predicate device. | There are no contraindications specific to these devices. | Same |
|---|---|---|---|
| Technological Characteristics | |||
| Principles of Operation | The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect System Lid consist of general, non-sterile, reusable sterilization cases intended to contain and organize instruments for sterile processing. All components are perforated to allow ingress and egress of steam during sterilization. The tray and lid facilitate storage, handling, and transport of instruments between uses. | The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration. | Same |
| Device Features | • Basic lid/base design• General use trays• Perforated for steam sterilization• Handles• Latches | • Basic lid/base design• General use trays• Perforated for steam sterilization• Handles• Latches | Same |
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K253791 Page 6 of 12
| Dimensions | Range of Dimensions• Length: 21.23 inches to 21.50 inches• Width: 9.71 inches to 10.01 inches• Height: 0.63 inches to 2.86 inchesTotal Validated System• Weight: 22.1 lb (container + contents + lid + wrap) | Range of Dimensions• Length: 6.34 inches to 20 inches• Width: 9.25 inches to 9.7 inches• Height: 1.77 inches to 6.6 inchesTotal Validated System• Weight: 25 lb (container + contents + lid + wrap) | Similar |
|---|---|---|---|
| Compatible Devices | PUREVUE™ Quick Connect Cannula System instruments | DePuy Synthes Implants and Instruments | Similar |
| Materials | • Lid/base – Aluminum• Inserts – Silicone, Aluminum, Stainless Steel• Latch – Stainless Steel | • Lid/base – Aluminum• Inserts – Silicone, Aluminum, Stainless Steel• Latch – Stainless Steel | Same |
| Sterilization Method | Same as the predicate device.Pre-vacuum Steam Sterilization Cycle | Pre-vacuum Steam Sterilization Cycle | Same |
| Cycle Temperature | The subject devices are validated for the same sterilization cycle as the predicate device. In addition, the subject devices are validated for a pre-vacuum cycle with a 3-minute exposure time at 134 °C (274°F). | 270°F (132°C) | Similar. The subject devices include an additional cycle at 134 °C (274°F). |
| Cycle Time | The subject devices are validated for the same sterilization cycle as the predicate device. In addition, the subject devices are validated for a pre-vacuum cycle with a 3-minute exposure time at 134 °C (274°F). | 4 minutes | Similar. The subject devices include an additional cycle with 3-minute exposure time. |
| Dry Time | 30 minutes to 60 minutes | 20 minutes | Similar |
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| Sterile Barrier | The subject devices are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap. | FDA cleared sterilization wrap or rigid container. | Same. The predicate device is also qualified for use with a rigid container. |
|---|---|---|---|
| Patient Contact | Same as the predicate device. | No direct or indirect patient contact. | Same |
| Performance Data | |||
| Non-clinical Performance Testing | • Steam Sterilization Efficacy• Dry Time Validation• Device Processing Cleaning Efficacy – Manual Cleaning• Device Processing Cleaning Efficacy – Automated (Mechanical) Cleaning• Durability Assessment (Limits of Reuse)• Biocompatibility (Cytotoxicity of Ink Test Coupon)• Design Verification for Tray/Lid Functional Testing | • Steam Sterilization Efficacy• Dry Time Validation• Device Processing Cleaning Efficacy – Manual Cleaning• Device Processing Cleaning Efficacy – Automated (Mechanical) Cleaning• Durability Assessment (Limits of Reuse)• Biocompatibility (Cytotoxicity for Ink Test Coupon) | Same. The subject devices include design verification functional testing. |
The subject and predicate devices utilize the same design characteristics and fundamental technology, as presented in the previous table. The subject and predicate devices are perforated trays and lids composed of anodized aluminum bases with aluminum, stainless steel, and silicon inserts, as well as stainless-steel latches. The subject devices are intended for the storage, organization, transport, and sterile processing of medical devices. The subject and predicate devices are not intended to maintain sterility on their own and are reliant on an FDA-cleared
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sterile barrier. The subject and predicate devices share the same principles of operation, device features, materials, and sterilization method.
The primary differences in technological characteristics (dimensions and weight) stem from the compatible devices which are intended to be sterilized within the container systems. The predicate case and tray system can be used with a broad set of instruments and implants, whereas the subject devices are utilized with the PUREVUE™ Quick Connect Cannula System instruments specifically. Because of the differences in compatible devices there are some differences in device dimensions and intended maximum weight. These differences are negligible as they did not result in unexpected design verification or validation results and are consistent with the respective intended use. In summary, all differences in technological characteristics have been identified and do not raise new questions of safety or effectiveness.
Non-clinical and Clinical Performance Data
Design verification and validation testing were performed on the subject PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid as a result of the risk analysis and product requirements.
Performance testing results were compared to those of the predicate device and demonstrated that the proposed devices are suitable for their intended use.
Performance Testing
Performance testing was conducted to ensure the device design meets user needs in the environment of use as shown in the table below.
| Test Performed | Objective of the Test | Pre-defined Acceptance Criteria | Results Summary |
|---|---|---|---|
| Steam Sterilization Efficacy | The purpose of the testing was to validate the sterilization efficacy of the PUREVUE™ Quick Connect Cannula System Tray and Lid when wrapped and processed in a steam pre-vacuum sterilization cycle at 132°C (270°F) with four (4) minutes exposure time. | All biological indicator test samples shall be negative for growth following the minimum incubation period.The positive controls shall be positive for growth.The negative and environmental controls shall be negative for growth.The Chemical Integrators shall demonstrate steam | The subject devices passed the acceptance criteria and met the requirements.The study results demonstrate the efficacy of the steam sterilization process in attaining a minimum microbiological lethality (F0) of 12.0 minutes and therefore, achieving a Sterility Assurance Level (SAL) of 10-6 in the worst case set |
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| penetration.The sterilizer cycle tapes shall verify that the parameters per were achieved. were achieved.NOTE: In the event that a positive sample can clearly be identified as a source other than that of a sterilization efficacy failure, the sample shall be rendered invalid. Specifics to the cause of such a positive sample can be identified with a justification in the final report. | configuration container within the PUREVUE™ Quick Connect Cannula System Tray and Lid. | ||
|---|---|---|---|
| Dry Time Validation | The purpose of the testing was to determine the proper drying time of the DePuy Synthes PUREVUE™ Quick Connect System (including the tray and lid) when processed in a hospital steam pre-vacuum sterilization cycle at 132°C (270°F) with four (4) minutes exposure time and 134°C (273°F) for 3 minutes exposure time. | The wrapped instrument case shall produce a pre- and post-sterilization weight difference of less than 0.2% within five (5) minutes of cycle completion.Each instrument tray of the case and sterilization wrap shall exhibit no visible moisture following thirty (20) minutes of cooling.The integrators shall demonstrate steam penetration.The cycle tapes shall confirm that the required cycle parameters were achieved. | The subject devices passed the acceptance criteria and met the requirements. |
| Device Processing Cleaning Efficacy – Manual Cleaning | The purpose of the testing was to validate the manual cleaning procedure of the PUREVUE™ Quick Connect Cannula System (including the tray and lid). | Protein level shall be ≤ 6.4 µg/cm².Hemoglobin level shall be ≤ 2.2 µg/ cm².Each test sample shall have no visible soil after cleaning.The extraction efficiency shall be | The subject devices passed the acceptance criteria and met the requirements. |
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| greater than or equal to 70%.The standard deviation of the sample set added to the concentration of the highest data point shall not exceed the acceptance criterion of 6.4 μg/cm². | |||
|---|---|---|---|
| Device Processing Cleaning Efficacy – Automated (Mechanical) Cleaning | The purpose of the testing was to validate the automated cleaning procedure of the PUREVUE™ Quick Connect Cannula System (including the tray and lid). | The study results shall validate that the manufacturer's automated cleaning instructions are efficacious in removing gross amounts of soil from the DePuy Synthes PUREVUE™ Quick Connect Cannula System (including the tray and lid).Protein levels shall be less than 6.4 μg/cm².Hemoglobin levels shall be less than 2.2 μg/cm². | The subject devices passed the acceptance criteria and met the requirements. |
| Durability Assessment (Limits of Reuse) | The purpose of the testing was to demonstrate that the subject devices can withstand repeated clinical reprocessing cycles without unacceptable effects occurring to the material, joints, surfaces, color, labeling, function, etc. which could compromise patient / user safety or product's function during its intended lifetime. | The PUREVUE™ Quick Connect Cannula System Tray shall have direct part markings identifying instrument profiles with instrument descriptionThe PUREVUE™ Quick Connect Cannula System Tray shall allow for insertion and removal of instruments without damage.The PUREVUE™ Quick Connect Cannula System Tray shall group 10 cannulas, 2 bridges, 6 obturators, and 1 switching stick, accommodating either length cannula | The subject devices passed the acceptance criteria and met the requirements. |
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| or obturator.The PUREVUE™ Quick Connect Cannula System Tray and Lid shall lock and unlock via side latch, forming a sterilization container.All products in scope shall meet the criteria of 500 reprocessing cycles.There shall be no observations of unacceptable damage, including but not limited to, corrosion (rust, pitting), discoloration, excessive scratches, flaking, cracks and wear, or illegible part markings post testing.The devices shall demonstrate proper function, including but not limited to, connection and functional fit. | |||
|---|---|---|---|
| Biocompatibility (Cytotoxicity for Ink Test Coupon) | The purpose of this study was to determine the potential of the Aluminum Coupon (Fujifilm Ink) test article to cause cytotoxicity. | The results of the testing shall show Grade ≤ 2 cytotoxicity (mildly reactive). | The subject devices passed the acceptance criteria and met the requirements.The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). |
| Design Verification for Tray/Lid Functional Testing | The objective of this testing was to establish evidence that the PUREVUE™ Quick Connect Cannula System Tray and Lid meet the form, fit, and functional | The PUREVUE™ Quick Connect Cannula System Tray and Lid shall meet the following pre-determined acceptance criteria:• Dimensional | The subject devices passed the acceptance criteria and met the requirements. |
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PUREVUE™ Quick Connect Cannula System Tray and Lid
K253791 Page 12 of 12
| requirements outlined in the Requirements Traceability Matrix and mitigate associated risk. | • Functional fit• Visual• Loaded weight |
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Software Verification and Validation
No software verification or validation testing was required or performed for the subject devices, as they do not incorporate software functions.
Electrical Safety and Electromagnetic Compatibility (EMC)
No electrical safety or EMC testing was required or performed for the subject devices, as they do not contain electrical components.
Animal Study
No animal testing was required or performed for the subject devices, as their design and materials do not necessitate such evaluation to establish safety and effectiveness.
Clinical Studies
No human clinical testing was required or performed for the subject devices, as their design and intended use do not necessitate such evaluation to establish safety and effectiveness.
Comparison of Subject and Predicate Devices
The assessment of the comparison between the subject devices and the predicate device was based on a detailed device description, performance data, and conformance to consensus and voluntary standards.
The testing included in this submission demonstrates that:
• Any differences in technological characteristics of the predicate device do not raise any new questions of safety or effectiveness.
• The proposed devices are at least as safe and effective as the predicate device.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject devices in 510(k) submission K253791, the PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid, are as safe and effective as, and perform as well as or better than, the legally marketed predicate device cleared under K241927.
§ 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).