(232 days)
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to protect the ReNew Reusable Tips (Scissors, Graspers and Dissectors) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization trays (Catalog #3708 and #3709) is maintained until used.
The Microline Surgical ReNew Sterilization Trays (Catalog #3709) are used to secure the ReNew Reusable Tips (Scissors, Graspers and Dissectors). Catalog #3708 measures at 7.8" length , 4.31" width, and 1.22" height , in dimensional measurements, as intended load during the transport, sterilization and storage between their intended use. Similarly, Catalog #3709 measures at 6.32" length, 3.32" width, and 1.21" height, in dimensional measurements as intended load during the transport, sterilization and storage between their intended use.
The ReNew Sterilization Tray (Catalog #3708 & 3709) have been validated with the ReNew Reusable Tips (Scissors,Graspers and Dissectors) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 280.52 grams, for Catalog number 3708, and 148.195 grams for Catalog #3709. The validation included Cleaning Validation (Automated and Manual) Testing and Steam Sterilization Cycles. The validated prevacuum cycle parameters are as follows: time: 4 minutes at temperature 132 °C, with a dry time of 30 minutes. The validated gravity cycle parameters are as follows: Time: 30 minutes at 121 °C with a dry time of 20 minutes, as well as time: 15 minutes at temperature 132 °C with a dry time of 20 minutes.
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) intended purpose is to secure the ReNew Tips (Graspers, Dissectors, and Scissors) devices during its transportation, and storage purposes.
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) consist of a base, a lid and device holding brackets. The lid can be fastened to the base by means of a locking tab, which is designed as a part of the lid. The brackets are constructed from biomedical grade silicone material. These brackets are used to secure the intended devices during their transport, sterilization and storage purpose. The ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to be used for ReNew Tips sterilization purpose which are non-porous devices including graspers, dissectors, and scissors.
The Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are medical devices intended to protect reusable tips and facilitate the sterilization process.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ (Met using biological indicator (BI) overkill method) |
| Cleaning Validation | Successful (Automated and Manual Testing) |
| Steam Sterilization Cycles | Validated: - Prevacuum cycle: 4 minutes at 132°C, 30 minutes dry time - Gravity cycle: 30 minutes at 121°C, 20 minutes dry time - Gravity cycle: 15 minutes at 132°C, 20 minutes dry time |
| Limits of Reuse | Validation completed (Specific limit not detailed in abstract) |
| Design Tolerance Analysis | Completed (Specific findings not detailed) |
| Shelf-Life Validation | Completed (Specific findings not detailed) |
| Biocompatibility | Not deemed necessary (Implies materials are known to be biocompatible for this use or testing was not required for substantial equivalence) |
| Bench Testing | Not deemed necessary (Implies similar performance to predicate or testing was not required for substantial equivalence) |
| New Validation (Design for Manufacturing/Assembly/Packaging) | Not deemed necessary (Implies processes are sufficiently similar to predicate) |
| Protection of ReNew Reusable Tips | Designed to secure and protect tips during transport, sterilization, and storage |
| Facilitation of Sterilization (Steam Penetration & Air Removal) | Lids and bases designed with evenly distributed hole patterns |
| Maintenance of Sterility (with wrap) | Maintained until used, when used with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "sample size" for a test set in the traditional sense of a clinical trial or a large-scale data analysis. Instead, it refers to validation studies for sterilization and cleaning.
- Test Sample Description:
- ReNew Sterilization Tray (Catalog #3708) with a calculated total weight of 280.52 grams (when loaded with ReNew Reusable Tips, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap).
- ReNew Sterilization Tray (Catalog #3709) with a calculated total weight of 148.195 grams (when loaded with ReNew Reusable Tips, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap).
- Data Provenance: The studies were conducted by Microline Surgical, Inc., or their contract manufacturer (Symmetry Medical, Inc.) in the USA. The data appears to be prospective as it involves validation testing specifically for these devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "sterilization validation testing" and "cleaning validation testing" but does not specify the number of experts or their qualifications involved in establishing a "ground truth" for these tests. For sterility validation, common practice involves microbiologists and sterilization experts, but this information is not detailed in the provided text. The Acceptance Criteria are based on established standards (AAMI TIR12:2010 and EN ISO 17664:2004), implying that the "ground truth" is adherence to these recognized industry and regulatory benchmarks.
4. Adjudication Method for the Test Set:
Not applicable. The document describes engineering and performance validation tests against pre-defined acceptance criteria based on standards, rather than expert review or adjudication of complex cases.
5. 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. This device is a sterilization tray, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device for sterilization, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device's validation is based on established industry standards and scientific principles for sterilization and cleaning efficacy. Specifically:
- Sterility Validation: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which is a universally accepted method for demonstrating sterility. This is a scientific and technical ground truth.
- Cleaning Validation: Conducted via Automated and Manual Testing against defined criteria (not explicitly detailed but implied by "Cleaning Validation Testing"). This is a technical ground truth.
- Compliance with Standards: Adherence to AAMI TIR12:2010 and EN ISO 17664:2004, which are recognized standards for reprocessing reusable medical devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set." The development would involve design, prototyping, and testing cycles, but not in the context of data-driven machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of device. The design and performance validation are based on engineering principles, material science, and established sterilization protocols.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
Microline Surgical, Inc. Anu Gaur, Ph.D., MBA, MSRA, RAC Regulatory Affairs Manager 50 Dunham Road. Suite 1500 Beverly, MA 01915
Re: K152745
Trade/Device Name: ReNew Sterilization Trays [Catalog #3708 and #3709] Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 01, 2016 Received: April 04, 2016
Dear Dr. Anu Gaur:
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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Page 2 - Dr. Anu Gaur
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) K152745
Device Name
ReNew Sterilization Trays (Catalog #3708 and #3709)
Indications for Use (Describe)
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to protect the ReNew Reusable Tips (Scissors, Graspers and Dissectors) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization trays (Catalog #3708 and #3709) is maintained until used.
The Microline Surgical ReNew Sterilization Trays (Catalog #3709) are used to secure the ReNew Reusable Tips (Scissors, Graspers and Dissectors). Catalog #3708 measures at 7.8" length , 4.31" width, and 1.22" height , in dimensional measurements, as intended load during the transport, sterilization and storage between their intended use. Similarly, Catalog #3709 measures at 6.32" length, 3.32" width, and 1.21" height, in dimensional measurements as intended load during the transport, sterilization and storage between their intended use.
The ReNew Sterilization Tray (Catalog #3708 & 3709) have been validated with the ReNew Reusable Tips (Scissors,Graspers and Dissectors) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 280.52 grams, for Catalog number 3708, and 148.195 grams for Catalog #3709. The validation included Cleaning Validation (Automated and Manual) Testing and Steam Sterilization Cycles. The validated prevacuum cycle parameters are as follows: time: 4 minutes at temperature 132 ℃, with a dry time of 30 minutes. The validated gravity cycle parameters are as follows: Time: 30 minutes at 121 ℃ with a dry time of 20 minutes, as well as time: 15 minutes at temperature 132 ℃ with a dry time of 20 minutes.
| 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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is written in gray, with a teal circle containing a four-leaf clover design in the middle of the word. Below "MICROLINE" is the word "SURGICAL" in a smaller, gray font.
Traditional 510(k) Summary [As Required by 21 CFR § 807.92]
| 510(k) Submitter: | Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USA |
|---|---|
| Establishment Registration Number: | 1223422 |
| Contact Representative: | Anu Gaur, Ph.D., MBA, MSRA, RACRegulatory Affairs ManagerPhone: 978-867-1726Fax: 978-922-9209 |
| Date Prepared: | May 12, 2016 |
| Trade Name: | ReNew Sterilization Trays[Catalog #3708 and #3709] |
| Common Name(s): | Sterilization Tray |
| Classification: | Class II, in accordance to 21 CFR § 880.6850Sterilization Wrap. |
| Classification Product Code(s): | KCT |
| Regulation Medical Specialty: | General Hospital |
| Predicate Device(s): | PolyVac Surgical Instrument Delivery System (K012105) |
Device Description:
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) intended purpose is to secure the ReNew Tips (Graspers, Dissectors, and Scissors) devices during its transportation, and storage purposes.
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) consist of a base, a lid and device holding brackets. The lid can be fastened to the base by means of a locking tab, which is designed as a part of the lid. The brackets are constructed from biomedical grade silicone material. These brackets are used to secure the intended devices during their transport, sterilization and storage purpose. The ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to be used for ReNew Tips sterilization purpose which are non-porous devices including graspers, dissectors, and scissors.
ReNew Sterilization Tray (Catalog #3708)
The subject device ReNew Sterilization Tray (Catalog #3708) consists of a case, a cover and brackets. The Lid is 7.80" (Length) x 4.31" (Width) x 0.46" (Height) in dimensions; and the Base is 7.60" (Length) x 4.12" (Width) x 0.76" (Height).
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Image /page/4/Picture/0 description: The image shows the logo for Microline Surgical. The logo consists of the word "MICROLINE" in gray, with a teal-colored four-pointed star in the middle of the word. Below the word "MICROLINE" is the word "SURGICAL" in a smaller, gray font. The logo is simple and modern, and the colors are calming and professional.
The ReNew Sterliization Tray (Catalog #3708) Id and base are designed using Radel® Polyphenylsulfone material, which can be reused with steam sterilization methods. The brackets are constructed from biomedical grade silicone material. To support steam sterilization Tray and Lid have an evenly distributed hole pattern in relation to its size for penetration of steam during sterilization process.
ReNew Sterilization Tray (Catalog #3709)
The subject device ReNew Sterilization Tray (Catalog #3709) consists of a cover and brackets. The Lid is 6.32" (Length) x 3.32" (Width) x 0.44" (Height) with ±0.02 in dimensions; and the Base is 6.15" (Length) x 3.14" (Width) x 0.77" (Height) with ±0.02 in dimensions. The ReNew Sterilization Tray (Catalog #3709) lid and base are designed using Radel® Polyphenylsulfone material. which steam sterilization methods. The brackets are constructed from biomedical grade silicone material. To support steam sterilization Tray and Lid have an evenly distributed hole pattern in relation to its size for penetration of steam during sterilization process.
Microline Surgical ReNew Sterilization Trays (Catalog #3709) are non-patient and non-blood/fluid contact devices during their intended use. Microline Surgical ReNew Sterilization Trays (Catalog #3709) are primarily packaged in a foam wrap (Polyethylene foam sheet) and a plastic Bag (Poly-bag) and Bubble), and single wall, 32lbs/inch edge, crushed corrugated white cardboard shipping box, which does not need any special handling requirements during shipment.
Statement of Intended Use:
Indications for Use:
Microline Surgical ReNew Sterilization Trays (Catalog #3709) are intended to protect the ReNew Reusable Tips (Scissors, Graspers and Dissectors) and to facilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization trays (Catalog #3708 and #3709) is maintained until used.
The Microline Surgical ReNew Sterilization Trays (Catalog #3709) are used to secure the ReNew Reusable Tips (Scissors, Graspers and Dissectors). Catalog #3708 measures at 7.8" width, and 1.22" height, in dimensional measurements, as intended load during the transport, sterilization and storage use. Similarly, Catalog #3709 measures at 6.32" length, 3.32" width, and 1.21" height, in dimensional measurements as intended load during the transport, sterilization and storage between their intended use.
The ReNew Sterilization Tray (Catalog #3708 & 3709) have been validated with the ReNew Reusable Tips (Scissors, Graspers and Dissectors) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 280.52 grams, for Catalog number 3708, and 148.195 grams for Catalog #3709. The validation included Cleaning Validation (Automated and Manual) Testing and Steam Sterilization Cycles. The validated prevacum cycle parameters are as follows: time: 4 minutes at temperature 132 °C, with a dry time of 30 minutes. The validated gravity cycle parameters are as follows: Time: 30 minutes at 121 °C with a dry time of 20 minutes, as well as time: 15 minutes at temperature 132 °C with a dry time of 20 minutes.
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Image /page/5/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is written in gray, with a teal circle in the middle of the word. The word "SURGICAL" is written in gray below the word "MICROLINE".
Comparison to Predicate Device:
Microline Surgical. Inc., has determined substantial equivalence of the subject devices ReNew Sterlization Trays (Catalog #3708 and #3709) with their legally marketed predicate device, PolyVac Surgical Instrument Delivery System (K012105); based on the principles of safety and effectiveness applicable to the 510(k) review including the applicable standard and the least burdensome approach.
Microline Surgical ReNew Sterilization Trays (Catalog #3709) are substantially equivalent to their predicate device, PolyVac Surgical Instrument Delivery System (K012105) including the following criteria;
- Selection of the applicable predicate device; O
- Similarities in the intended use and indication for use; O
- Similarities in materials for construction of device; O
- Similarities in performance testing criteria; O
- Similarities in the technological characteristics and fundamental technology. O
- Does not raise new questions of safety and effectiveness; and O
- Demonstrates at least as safe and effective as its legally marketed predicate device. O
The differences between the subject devices ReNew Applier Sterilization Trays (Catalog #3708 and #3709) are the following;
- Internal configuration of the ReNew Sterilization Tray (Catalog #3708) to secure and hold eighteen (18); and O ReNew Sterlization Tray (Catalog #3709) to secure and hold nine (9) ReNew Tips (Graspers, Dissectors and Scissors) devices.
In summary, the subject devices ReNew Sterilization Trays (Catalog #3709) are similar in design, materials, manufacturing, performance, safety, effectiveness, labeling, sterilization, and fundamental technological characteristics as applicable to their legally marketed predicate device, PolyVac Surgical Instrument Delivery System (K012105).
Summary of Technological Characteristics:
Microline Surgical ReNew Sterlization Trays (Catalog #3708 and #3709) intended purpose is to secure the ReNew Tips (18 and 9 configuration arrangements) device during its transportation and storage purposes. The subject devices ReNew Sterilization Trays (Catalog #3708) are technologically similar to their legally marketed predicate device, PolyVac Surgical Instrument Delivery System (K012105). The following pertains to the technological characteristics comparison presented in a tabular format.
| Characteristics | Predicate Device | Subject Device(Proposed) |
|---|---|---|
| Trade Name | PolyVac Surgical InstrumentDelivery System | Microline Surgical ReNew SterilizationTray (Catalog #3708) |
| 510(k) Number | (K012105) | This Submission |
| 510(k) Clearance Date | Aug 02, 2002 | Not Applicable |
| Classification | Class II21 CFR § 880.6850 | Class II21 CFR § 880.6850 |
| Classification Name | Sterilization Wrap Containers, Trays,Cassettes & other Accessories. | Sterilization Wrap Containers, Trays,Cassettes & other Accessories. |
ReNew Sterilization Trav (Catalog #3708)
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Image /page/6/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is written in gray, with a teal circle containing a four-pointed star in the middle. Below "MICROLINE" is the word "SURGICAL" in a smaller, gray font.
| Classification ProductCode | KCT | KCT |
|---|---|---|
| Common Name | Sterilization Wrap | Sterilization Tray |
| Regulation MedicalSpecialty | General Hospital | General Hospital |
| Environment of Use | Hospital, Operating Room (OR) Use(not specified). | Hospital, Operating Room (OR) Useonly. |
| Intended Use(indications for Use) | PolyVac Delivery Systems are intendedto protect medical device instrumentationand to facilitate the sterilization processby allowing steam penetration and airremoval. When used in conjunction withan approved sterilization wrap, sterility ofthe enclosed medical device ismaintained until used. | Microline Surgical ReNew SterilizationTrays (Catalog #3708 and #3709) areintended to protect the ReNewReusable Tips (Scissors, Graspers andDissectors) and to facilitate thesterilization process by allowing steampenetration and air removal. Whenused in conjunction with 2 layers ofFDA-cleared 1-ply polypropylenesterilization wrap, sterility of theenclosed sterilization trays (Catalog#3708 and #3709) is maintained untilused.The Microline Surgical ReNewSterilization Trays (Catalog #3708 and#3709) are used to secure the ReNewReusable Tips (Scissors, Graspers andDissectors). Catalog #3708 measuresat 7.8" length, 4.31" width, and 1.22"height, in dimensional measurements,as intended load during the transport,sterilization and storage between theirintended use. Similarly, Catalog #3709measures at 6.32” length, 3.32" width,and 1.21" height, in dimensionalmeasurements as intended load duringthe transport, sterilization and storagebetween their intended use.The ReNew Sterilization Tray (Catalog#3708 & 3709) have been validatedwith the ReNew Reusable Tips(Scissors, Graspers and Dissectors)wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing acalculated total weight of 280.52 grams,for Catalog number 3708, and 148.195grams for Catalog #3709. Thevalidation included Cleaning Validation(Automated and Manual) Testing andSteam Sterilization Cycles. The |
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Image /page/7/Picture/0 description: The image shows the logo for Microline Surgical. The logo has the word "MICROLINE" in large, gray, sans-serif font. In the middle of the word, there is a teal-colored symbol that looks like four leaves coming together to form a diamond shape. Below the word "MICROLINE", there is the word "SURGICAL" in a smaller, gray, sans-serif font.
| Technological Characteristics | ||
|---|---|---|
| validated prevacuum cycle parametersare as follows: time: 4 minutes attemperature 132 °C, with a dry time of30 minutes. The validated gravity cycleparameters are as follows: Time: 30minutes at 121 °C with a dry time of 20minutes, as well as time: 15 minutes attemperature 132 °C with a dry time of20 minutes. | ||
| Primary Configuration | Plastic Tray | Plastic Tray |
| Primary Materials(Construction) | Polyphenylsulphone (Radel® R-5500)and Biomedical Grade Silicone. | Identical |
| Dimensions | Lid:7.80" (Length) x 4.31” (Width) x 0.46"(Height) inches.Base:7.60" (Length) x 4.12" (Width) x 0.76"(Height) inches. | Identical |
| Air Permeability | Yes | Yes |
| Intended for Reuse | Yes | Yes |
| Material Thickness | 0.0625" | Identical |
| Hole Size | Ø 0.188" | Identical |
| Hole Pattern | Lid:Five (5)X in two (2) rows on bottom andtop edges, Four (4)X – one (1) in eachcorner, Two(2)X – two(2) rows centrallyaligned with bottom and top edge rows.Base:Five (5)X in Two (2) rows on bottom andtop edges, Four (4)X – one (1) in eachcorner, Seven (7)X central row evenlyspaced.[Centrally the lid includes the printedCompany Logo and Trade Name]. | Identical |
| Brackets | Two (2) rows - (.74) x (.29) with taper. | Identical |
| Feet | Four (4) on base, to align with the 4holes in lid corners (0.1405" height) | Identical |
| Weight | 270 grams | Identical |
| Sterilization Method(s) | Steam Sterilization& Ethylene Oxide (EtO) | Steam Sterilization only |
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Image /page/8/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is written in gray, with a teal-colored symbol in the middle of the word. Below the word "MICROLINE" is the word "SURGICAL" in a smaller, gray font. The logo is simple and modern, and it is likely used to represent a medical device company.
| Sterilization CycleParameters | Prevacuum Steam:132°C - 4 MinsDry for 20 - 40 mins (as needed) | Prevacuum Steam:132°C - 4 minutesDry for 30 minutes |
|---|---|---|
| Gravity Air Displacement Cycle:132°C - 30 Mins | Gravity Steam:121°C - 30 minutesDry for 20 minutes | |
| Gravity Steam:121°C - 55 MinsDry for 20 - 50 mins (as needed) | Gravity Steam:132°C -15 minutesDry for 20 minutes | |
| Sterility(Disposable or Multiple Use) | Multiple Use | Multiple Use |
| Patient Contact | No | No |
| Blood/Fluid Contact | No | No |
| Special Conditions(Shipping and Handling) | No | No |
| Manufacturer | Contract Manufacturer:Symmetry Medical, Inc.253 Abby Road,Manchester, NH 03103USA(Registration Number: 1221053)(Symmetry Medical OEM Solutionsacquired by Tecomet, Inc.,December 5, 2014) | Identical |
| Proposed Brand Labeling(Relabeling, Repackagingand Market Distribution) | Not Applicable | Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USA |
| Differences in Technological Characteristics | ||
| Tray Internal Configuration | Not Applicable | ReNew Sterilization Tray (Catalog#3708) internal configuration to securethe ReNew Tips (18 Tips configurationarrangement) only |
ReNew Sterilization Tray (Catalog #3709)
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| (Proposed) | ||
| Trade Name | PolyVac Surqical Instrument Delivery | Microline Surqical ReNew Sterilization |
| System | Tray (Catalog #3709) | |
| 510(k) Number | (K012105) | This Submission |
| 510(k) Clearance Date | Aug 02, 2002 | Not Applicable |
| Classification | Class II | Class II |
| 21 CFR § 880.6850 | 21 CFR § 880.6850 | |
| Classification Name | Sterilization Wrap Containers, Trays, | Sterilization Wrap Containers, Trays, |
| Cassettes & other Accessories. | Cassettes & other Accessories. |
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Image /page/9/Picture/0 description: The image shows the logo for Microline Surgical. The logo consists of the word "MICROLINE" in gray, with a teal four-leaf clover symbol in the middle. Below the word "MICROLINE" is the word "SURGICAL" in a smaller, gray font.
| Classification Product Code | KCT | KCT |
|---|---|---|
| Common Name | Sterilization Wrap | Sterilization Tray |
| Regulation Medical Specialty | General Hospital | General Hospital |
| Environment of Use | Hospital, Operating Room (OR) Use(not specified). | Hospital, Operating Room (OR) Useonly. |
| Intended Use(Indications for Use) | PolyVac Delivery Systems areintended to protect medical deviceinstrumentation and to facilitate thesterilization process by allowing steampenetration and air removal. Whenused in conjunction with an approvedsterilization wrap, sterility of theenclosed medical device is maintaineduntil used. | Microline Surgical ReNew SterilizationTrays (Catalog #3708 and #3709) areintended to protect the ReNewReusable Tips (Scissors, Graspers andDissectors) and to facilitate thesterilization process by allowing steampenetration and air removal. Whenused in conjunction with 2 layers ofFDA-cleared 1-ply polypropylenesterilization wrap, sterility of theenclosed sterilization trays (Catalog#3708 and #3709) is maintained untilused.The Microline Surgical ReNewSterilization Trays (Catalog #3708 and#3709) are used to secure the ReNewReusable Tips (Scissors, Graspers andDissectors). Catalog #3708 measuresat 7.8" length, 4.31" width, and 1.22"height, in dimensional measurements,as intended load during the transport,sterilization and storage between theirintended use. Similarly, Catalog #3709measures at 6.32" length, 3.32" width,and 1.21" height, in dimensionalmeasurements as intended load duringthe transport, sterilization and storagebetween their intended use.The ReNew Sterilization Tray (Catalog#3708 & 3709) have been validatedwith the ReNew Reusable Tips(Scissors, Graspers and Dissectors)wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing acalculated total weight of 280.52 grams,for Catalog number 3708, and 148.195grams for Catalog #3709. Thevalidation included Cleaning Validation(Automated and Manual) Testing andSteam Sterilization Cycles. Thevalidated prevacuum cycle parameters |
| temperature 132 °C, with a dry time of | ||
| 30 minutes. The validated gravity cycle | ||
| parameters are as follows: Time: 30 | ||
| minutes at 121 °C with a dry time of 20 | ||
| minutes, as well as time: 15 minutes at | ||
| temperature 132 °C with a dry time of | ||
| 20 minutes. | ||
| Technological Characteristics | ||
| Primary Configuration | Plastic Tray | Plastic Tray |
| Primary Materials | Polyphenylsulphone (Radel® R-5500) | Identical |
| (Construction) | and Biomedical Grade Silicone. | |
| Dimensions | Lid: | Identical |
| 6.32" (Length) x 3.32" (Width) x 0.44" | ||
| (Height) ±0.02 inches. | ||
| Base: | ||
| 6.15" (Length) x 3.14" (Width) x 0.77" | ||
| (Height) inches. | ||
| Air Permeability | Yes | Yes |
| Intended for Reuse | Yes | Yes |
| Material Thickness | 0.0625" | Identical |
| Hole Size | Lid: Ø.19, Base: Ø.175 | Identical |
| Hole Pattern | Lid: | Identical |
| Nine (9)X in Three (3) rows on bottom | ||
| and top edges, Four (4)X evenly | ||
| spaced in center of lid. | ||
| Base: | ||
| Nine (9)X in Three (3) rows | ||
| [Centrally the lid includes the printed | ||
| Company Logo and Trade Name]. | ||
| Brackets | Two (2) rows - (.74)X(.29) with taper | ldentical |
| Feet | Four (4) on base in corners (0.1955" | Identical |
| height) | ||
| Weight | 137 grams | ldentical |
| Sterilization Method(s) | Wide Variety of Sterilization Methods | Steam Sterilization only |
| applicable. | ||
| Sterilization Cycle | Prevacuum Steam: | Pre vacuum Steam: |
| Parameters | 132ºC - 4 Mins | 132ºC - 4 minutes |
| Dry for 20 - 40 mins (as needed) | Dry for 30 minutes | |
| Gravity Air Displacement Cycle: | Gravity Steam: | |
| 132ºC - 30 Mins | 121ºC - 30 minutes | |
| Dry for 20 minutes | ||
| Gravity Steam: | ||
| 121ºC - 55 Mins | Gravity Steam: | |
| Dry for 20 - 50 mins (as needed) | 132ºC -15 minutes | |
| Dry for 20 minutes | ||
| Sterility(Disposable or Multiple Use) | Multiple Use | Multiple Use |
| Patient Contact | No | No |
| Blood/Fluid Contact | No | No |
| Special Conditions(Shipping and Handling) | No | No |
| Manufacturer | Contract Manufacturer:Symmetry Medical, Inc.253 Abby Road,Manchester, NH 03103USA(Registration Number: 1221053)(Symmetry Medical OEM Solutionsacquired by Tecomet, Inc.,December 5, 2014) | Identical |
| Proposed Brand Labeling(Relabeling, Repackaging andMarket Distribution) | Not Applicable | Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USA |
| Differences in Technological Characteristics | ||
| Tray Internal Configuration | Not Applicable | ReNew Sterilization Tray (Catalog#3709) internal configuration to securethe ReNew Tips (9 Tips configurationarrangement) only. |
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Image /page/10/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is written in large, gray, sans-serif letters. In the middle of the word, there is a teal-colored symbol that looks like a four-leaf clover or a plus sign inside a circle. Below the word "MICROLINE", the word "SURGICAL" is written in smaller, gray, sans-serif letters.
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Image /page/11/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is written in gray, with a teal circle in the middle of the word. Inside the circle is a four-pointed star. Below the word "MICROLINE" is the word "SURGICAL" in a smaller font.
Performance Characteristics:
Microline Surgical, Inc., has successfully completed a full sterilization using Steam Sterilization method in accordance to AAMI TIR12:2010 - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities; and EN ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. The acceptance criteria required that the sterilization methods demonstrate a sterility assurance level (SAL) of 106 using the biological indicator (BI) overkill met as required. The sterilization validation testing and limits of reuse of the device, design tolerance analysis and shelf-life validation were completed. The subject devices ReNew Sterlization Tray (Catalog #3708 and #3709) are substantially equivalent to their respective predicate device, PolyVac Surgical Instrument Delivery System (K012105); in terms of fundamental technology, materials, design, meets the identical design inputs, and output requirements. The subject devices ReNew Sterilization Trays (Catalog #3709) will be fully contract manufactured, assembled and packaged by contract manufacturer Symmetry Medical, Inc., (Registration Number: 1221053) Iocated at 253 Abby Road, Manchester, NH 03103, USA., which is the same contract manufacturer for the predicate device. Any new validation testing including biocompatibility, bench testing and new validation, pertaining to design for manufacturing or design for assembly and packaging by Microline Surgical, Inc., were not deemed necessary.
Substantially Equivalent Conclusion:
Conclusively, based upon the similarities in fundamental technology, materials of construction and the intended use, Microline Surgical, Inc., has determined that the subject devices ReNew Sterilization Trays (Catalog #3708) are deemed substantially equivalent (SE) to their legally marketed predical Instrument Delivery System (K012105). Similar to their predicate devices ReNew Sterilization Trays (Catalog #3708 and
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Image /page/12/Picture/0 description: The image shows the logo for Microline Surgical. The logo has the word "MICROLINE" in gray, with a teal geometric shape in the middle. Below the word "MICROLINE" is the word "SURGICAL" in a smaller gray font.
#3709) are Class II devices per 21 CFR § 880.6850 (Product Code KCT) and under this classification category identified as Sterlization Wrap Containers, Trays, Cassettes & other Accessories. The subject devices ReNew Sterilization Tray (Catalog #3708 and #3709) do not raise new questions of safety and demonstrate at least as safe and effective as their legally marketed predicate device (K012105).
Substantial Equivalence Statement:
The performance testing data for the subject devices ReNew Sterilization Tray (Catalog #3708 and #3709) demonstrates the subject devices are as safe, as effective, and performs as well as the predicate device (K012105).
§ 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).