(232 days)
Not Found
No
The device description and intended use are solely focused on a physical sterilization tray and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device (sterilization trays) is intended to protect reusable tips and facilitate their sterilization, transportation, and storage; it does not directly treat or diagnose a disease or condition.
No
The device is a sterilization tray intended to hold and protect reusable surgical tips during transport, sterilization, and storage. It facilitates the sterilization process but does not diagnose any condition or disease.
No
The device description clearly indicates it is a physical sterilization tray made of a base, lid, and device holding brackets, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect and facilitate the sterilization of surgical instruments (Reusable Tips like Scissors, Graspers, and Dissectors). It is used for transport, sterilization, and storage of these instruments.
- Device Description: The device is a physical tray with a base, lid, and brackets designed to hold surgical instruments.
- No mention of in vitro testing: The description focuses on the physical handling and sterilization of surgical instruments, not on testing samples taken from the human body or other sources outside of the body.
- Performance Studies: The performance studies described relate to sterilization validation, cleaning validation, and shelf-life, which are relevant to reusable surgical instruments and their accessories, not IVD performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, Operating Room (OR) Use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PolyVac Surgical Instrument Delivery System (K012105)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
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
1
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
2
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 1500
Beverly, MA 01915
USA |
|------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1223422 |
| Contact Representative: | Anu Gaur, Ph.D., MBA, MSRA, RAC
Regulatory Affairs Manager
Phone: 978-867-1726
Fax: 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 § 880.6850
Sterilization 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).
4
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.
5
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 Instrument
Delivery System | Microline Surgical ReNew Sterilization
Tray (Catalog #3708) |
| 510(k) Number | (K012105) | This Submission |
| 510(k) Clearance Date | Aug 02, 2002 | Not Applicable |
| Classification | Class II
21 CFR § 880.6850 | Class II
21 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 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) Use | |
| only. | ||
| Intended Use | ||
| (indications for Use) | PolyVac Delivery Systems are intended | |
| to protect medical device instrumentation | ||
| and to facilitate the sterilization process | ||
| by allowing steam penetration and air | ||
| removal. When used in conjunction with | ||
| an approved sterilization wrap, sterility of | ||
| the enclosed medical device is | ||
| maintained until used. | 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 #3708 and | ||
| #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 |
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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 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. | ||
| 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 and
top edges, Four (4)X – one (1) in each
corner, Two(2)X – two(2) rows centrally
aligned with bottom and top edge rows.
Base:
Five (5)X in Two (2) rows on bottom and
top edges, Four (4)X – one (1) in each
corner, Seven (7)X central row evenly
spaced.
[Centrally the lid includes the printed
Company Logo and Trade Name]. | Identical |
| Brackets | Two (2) rows - (.74) x (.29) with taper. | Identical |
| Feet | Four (4) on base, to align with the 4
holes 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 Cycle
Parameters | Prevacuum Steam:
132°C - 4 Mins
Dry for 20 - 40 mins (as needed) | Prevacuum Steam:
132°C - 4 minutes
Dry for 30 minutes |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | Gravity Air Displacement Cycle:
132°C - 30 Mins | Gravity Steam:
121°C - 30 minutes
Dry for 20 minutes |
| | Gravity Steam:
121°C - 55 Mins
Dry for 20 - 50 mins (as needed) | Gravity Steam:
132°C -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 03103
USA
(Registration Number: 1221053)
(Symmetry Medical OEM Solutions
acquired by Tecomet, Inc.,
December 5, 2014) | Identical |
| Proposed Brand Labeling
(Relabeling, Repackaging
and Market Distribution) | Not Applicable | Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915
USA |
| Differences in Technological Characteristics | | |
| Tray Internal Configuration | Not Applicable | ReNew Sterilization Tray (Catalog
#3708) internal configuration to secure
the ReNew Tips (18 Tips configuration
arrangement) 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) Use | |
| only. | ||
| Intended Use | ||
| (Indications for Use) | PolyVac Delivery Systems are | |
| intended to protect medical device | ||
| instrumentation and to facilitate the | ||
| sterilization process by allowing steam | ||
| penetration and air removal. When | ||
| used in conjunction with an approved | ||
| sterilization wrap, sterility of the | ||
| enclosed medical device is maintained | ||
| until used. | 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 #3708 and
#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 |
| | | 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 03103
USA
(Registration Number: 1221053)
(Symmetry Medical OEM Solutions
acquired by Tecomet, Inc.,
December 5, 2014) | Identical |
| Proposed Brand Labeling
(Relabeling, Repackaging and
Market Distribution) | Not Applicable | Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915
USA |
| Differences in Technological Characteristics | | |
| Tray Internal Configuration | Not Applicable | ReNew Sterilization Tray (Catalog
#3709) internal configuration to secure
the ReNew Tips (9 Tips configuration
arrangement) 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).