M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
Device Facts
| Record ID | K152743 |
|---|---|
| Device Name | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) |
| Applicant | Microline Surgical, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | Feb 8, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) 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 tray (Catalog# 3706) is maintained until used. The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses.
Device Story
The M/L-10 Clip Applier Sterilization Tray is a reusable metal container designed to secure the M/L-10 Clip Applier handpiece during transport, steam sterilization, and storage. The tray consists of a stainless steel base and lid with an evenly distributed hole pattern to allow steam penetration and air removal. Internal brackets made of stainless steel, aluminum, and biomedical-grade silicone secure the handpiece. The tray is used in hospital/OR settings by clinical staff. The device is wrapped in two layers of FDA-cleared 1-ply polypropylene sterilization wrap before processing. The tray facilitates the sterilization process by protecting the instrument and ensuring the sterilization cycle (pre-vacuum or gravity steam) reaches the instrument. It does not contact the patient or bodily fluids. The tray ensures the instrument remains sterile until the point of use, supporting clinical workflows in the OR.
Clinical Evidence
Bench testing only. Validation performed per AAMI TIR12:2010 and EN ISO 17664:2004. Sterilization efficacy validated using biological indicator (BI) overkill method to achieve a sterility assurance level (SAL) of 10^-6. Parameters validated: Pre-vacuum (132°C for 4 minutes) and Gravity cycle (132°C for 15 minutes).
Technological Characteristics
Reusable metal sterilization tray. Materials: Stainless steel (case/lid), aluminum/stainless steel/biomedical-grade silicone (brackets). Surface: Nylon powder coating. Dimensions: 19.875" x 5.50" x 1.450". Connectivity: None. Sterilization: Steam (Pre-vacuum and Gravity).
Indications for Use
Indicated for use as a protective sterilization tray for the M/L-10 Clip Applier handpiece (Catalog #1002) to facilitate steam sterilization, transport, and storage. Not for patient contact.
Regulatory Classification
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.
Predicate Devices
- C/T Med-Systems Cassette System (K980065)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2016
Microline Surgical, Inc. Anu Gaur, Ph.D., MBA, MSRA, RAC Regulatory Affairs Manager 50 Dunham Road, Suite 1500 Beverly, Massachusetts 01915
Re: K152743
Trade/Device Name: M/L-10 Clip Applier Sterilization Tray (Catalog #3706) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 17, 2015 Received: December 18, 2015
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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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) K152743
Device Name
M/L- 10 Clip Applier Sterilization Tray (Catalog# 3706)
#### Indications for Use (Describe)
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) 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 tray (Catalog# 3706) is maintained until used.
The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses.
The ML-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.
| Type of Use (Select one or both, as applicable) | | | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| | <table border="0"><tr><td><span style="text-decoration:none">☐</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><span style="text-decoration:none">☑</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="text-decoration:none">☐</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration:none">☑</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="text-decoration:none">☐</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| <span style="text-decoration:none">☑</span> 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 logo has the word "MICROLINE" in gray, with a teal four-leaf clover symbol in the middle of the word. Below the word "MICROLINE" is the word "SURGICAL" in gray.
# Traditional 510(k) Summary [As Required by 21 CFR § 807.92]
| 510(k) Submitter: | Microline Surgical, Inc.<br>50 Dunham Road, Suite 1500<br>Beverly, MA 01915<br>USA |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1223422 |
| Contact Representative: | Anu Gaur, Ph.D., MBA, MSRA, RAC<br>Requlatory Affairs Manager<br>Phone: 978-867-1726<br>Fax: 978-922-9209 |
| Date Prepared: | February 1, 2016 |
| Trade Name: | M/L-10 Clip Applier Sterilization Tray<br>[Catalog # 3706] |
| Common Name: | Sterilization Cassette |
| Classification: | Class II, in accordance to 21 CFR § 880.6850<br>Sterilization Wrap Containers, Trays, Cassettes &<br>Other Accessories. |
| Classification Product Code(s): | КСТ |
| Regulation Medical Specialty: | General Hospital |
| Predicate Device(s): | C/T Med-Systems Cassette System (K980065) |
## Device Description:
Microline Surgical MIL-10 Clip Applier Sterilization Tray (Catalog #3706) intended purpose is to secure the M/L-10 Clip Applier device during its transportation, sterilization, and storage purposes.
The subject device ML - 10 Clip Applier Sterilization #3706) consists of a case, a cover and brackets. The MIL-10 Clip Applier Sterilization Tray (Catalog #3706) Lid is 19.875" (Width) x .450" (Height); and the Base is 19.875" (Length) x 5.50" (Width) x 1.450" (Height) in dimensions. The ML-10 Clip Applier Sterilization Tray (Catalog #3706) cover and lid (case) are constructed of Stainless Steel material, which could be reused with Steam Sterilization method. The brackets are constructed from Aluminum, Stainless Steel, and biomedical grade Silicone. The ML-10 Clip Applier Sterilization Tray surface is coated with Nylon Coating Powder. The sterilization tray cover is secured to the case by means of assembled hardware and a locking tab, designed as part of the case and cover have an evenly distributed hole pattern in relation to the tray size to support the steam sterilization process. The brackets are designed to secure the ML-10 Clip Applier for sterilization purpose. The subject device MIL-10 Clip Applier Sterilization Tray is non-patient and non-blood/fluid contact during its intended use. The ML - 10 Clip Applier Sterlization
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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 four-leaf clover symbol in the center. Below the word "MICROLINE" is the word "SURGICAL" in a smaller, gray font.
Tray (Catalog #3706) is a metal tray and packaged in bubble wrap, single wall, 32 lbsfinch edge, crushed corrugated brown cardboard shipping box, which does not need any special handling requirements during shipment.
#### Statement of Intended Use:
#### Indications for Use:
Microline Surgical MIL-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the ML-10 Clip Applier handpiece (Catalog #1002) 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 sterility of the enclosed sterilization tray (Cataloq# 3706) is maintained until used.
The Microline Surgical MIL-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the MIL-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, and 0.90" width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses.
The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The MIL-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.
#### Contraindications:
The M/L-10 Clip Applier Sterilization Tray (3706) is not intended for use except as indicated.
#### Comparison to Predicate Device:
Microline Surgical, Inc., has determined substantial equivalence of the subject device ML-10 Clip Applier Sterilization Tray (Catalog #3706) with its legally marketed predicate device C/T Med-System (K980065) based on the principles of safety and effectiveness applicable to the 510(k) review including the applicable standard and the least burdensome approach. The subject device M1-10 Clip Applier Sterilization Tray (Catalog #3706) is substantially equivalent to its predicate device C/T Med-Systems Cassette System (K980065) including 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
- O Similarities in the technological characteristics and fundamental technology.
- 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 predicate and the subject device M/L-10 Clip Applier Sterilization Tray (Catalog #3706) is the following:
- Internal configuration of the MIL-10 Clip Applier Sterilization Tray to secure the MIL-10 Clip Applier device. O
In summary, the subject device MIL-10 Clip Applier Sterilization Tray (Catalog #3706) is similar in its design, materials, manufacturing, performance, safety, effectiveness, labeling, sterilization, and fundamental technological characteristics as applicable to its legally marketed predicate device C/T Med-Systems Cassette System (K980065).
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Image /page/5/Picture/0 description: The image shows the logo for Microline Surgical. The logo consists of the word "MICROLINE" in a gray sans-serif font, with a teal four-leaf clover symbol in the center. Below the word "MICROLINE" is the word "SURGICAL" in a smaller, gray sans-serif font. The TM symbol is located to the right of the word "LINE".
#### Summary of Technological Characteristics:
The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706) intended purpose is to secure the M/L-10 Clip Applier device during its transportation, and storage purposes. The subject device ML-10 Clip Applier Sterilization Tray (Catalog #3706) is technologically similar to its legally marketed predicate device C/T Med-Systems Cassette System (K980065). The following pertains to the technological characteristics comparison presented in a tabular format.
| Characteristics | Predicate Device | Subject Device (Proposed) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | C/T Med-Systems Cassette System | Microline Surgical M/L-10 Clip Applier<br>Sterilization Tray (Catalog #3706) |
| 510(k) Number | K980065 | This Submission |
| 510(k) Clearance Date | May 11, 1998 | Not Applicable |
| Classification | Class II<br>21 CFR § 880.6850 | Class II<br>21 CFR § 880.6850 |
| Classification Name | Sterilization Wrap Containers, Trays,<br>Cassettes & other Accessories. | Sterilization Wrap Containers, Trays,<br>Cassettes & other Accessories. |
| Classification Product Code | KCT | KCT |
| Common Name | Sterilization Cassette | Sterilization Cassette |
| Regulation Medical Specialty | General Hospital | General Hospital |
| Environment of Use | Hospital, Operating Room (OR),<br>Physician and dental office or place<br>where instruments are sterilized. | Hospital, Operating Room (OR) Use<br>only. |
| Intended Use<br>(Indication for Use) | General dental/medical instrument<br>cassettes intended to hold instruments<br>and accessories in place throughout the<br>entire instrument use, cleaning and<br>sterilization cycle. These cassettes are<br>suitable for Gravity Steam, Pre-vacuum<br>steam and EO sterilization. | Microline Surgical M/L-10 Clip Applier<br>Sterilization Tray (Catalog# 3706) is<br>intended to protect the M/L-10 Clip<br>Applier handpiece (Catalog #1002)<br>and to facilitate the sterilization<br>process by allowing steam penetration<br>and air removal. When used in<br>conjunction with 2 layers of FDA-<br>cleared 1-ply polypropylene<br>sterilization wrap, sterility of the<br>enclosed sterilization tray (Catalog#<br>3706) is maintained until used.<br><br>The Microline Surgical M/L-10 Clip<br>Applier Sterilization Tray (Catalog#<br>3706) is used to secure the M/L-10<br>Clip Applier handpiece (Catalog<br>#1002) which measures at 17.13"<br>length, 4.94" height, and 0.90"width in<br>dimensional measurements, as the<br>intended load during the transport,<br>sterilization and storage between its<br>intended uses.<br><br>The M/L-10 Clip Applier Sterilization<br>Tray (Catalog# 3706) has been |
| | | validated with the M/L-10 Clip Applier<br>handpiece (Catalog #1002) wrapped in |
| | | 2 layers of FDA-cleared 1-ply |
| | | polypropylene wrap weighing a |
| | | calculated total weight of 1663.10 |
| | | grams. The M/L-10 Clip Applier |
| | | Sterilization Tray (Catalog# 3706) has |
| | | been validated with the following |
| | | Steam Sterilization Parameters: Pre-<br>vacuum, Time: 4 minutes at |
| | | Temperature of 132 °C. The Gravity |
| | | Cycle parameters include: Time: 15 |
| | | minutes and Temperature of 132 °C. |
| | Technological Characteristics | |
| Primary Configuration | Metal Tray | Metal Tray |
| Primary Materials | Stainless Steel and Aluminum | Stainless Steel, Aluminum and |
| (Construction) | | Biomedical Grade Silicone. |
| | Tray Coating: Nylon Coating Powder | Tray Coating: Nylon Coating Powder |
| Dimensions | Lid:19.875" (Length) x 5.632" (Width) x<br>.450" (Height) inches | Identical |
| | Base:19.875" (Length) x 5.50" (Width) x | |
| | 1.450" (Height) inches | |
| Air Permeability | Yes | Yes |
| Intended for Reuse | Yes | Yes |
| Material Thickness | .036" | Identical |
| Hole Size | Ø 0.250" | Identical |
| Hole Pattern | Lid: | Identical |
| | Six (6) rows evenly spaced with | |
| | Twenty-five (25) Holes, with Fifty (50) | |
| | centrally removed to account for the<br>Company Logo and Trade Name. | |
| | Base: | |
| | Six (6) rows evenly spaced with | |
| | Twenty-five (25) Holes, with Twenty- | |
| | one (21) removed to account for the | |
| | brackets. | |
| Brackets | Two (2) Silicone, Two (2) Stainless | Identical |
| | Steel and One (1) Aluminum. | |
| Feet | None | None |
| Weight<br>Sterilization Method(s) | 1663.10 grams<br>Steam Sterilization<br>& Ethylene Oxide (EtO) | Identical<br>Steam Sterilization only |
| Sterilization Cycle | Prevacuum Steam: | Prevacuum Steam: |
| Parameters | 132°C - 4 minutes | 132°C – 4 minutes…
