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.

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 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.

AI/ML Overview

This document describes the Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706) and its substantial equivalence to a predicate device. The information provided focuses on the safety and effectiveness of the sterilization tray itself, rather than detailing a study that measures device performance against a specific clinical condition using AI.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, AI effect size, standalone algorithm performance) are not applicable or cannot be extracted from this document, as they relate to the evaluation of AI/algorithm performance in a clinical context, which is not the subject of this 510(k) submission.

However, I can provide the available information related to the acceptance criteria and the essential performance characteristics of the sterilization tray.

Acceptance Criteria and Reported Device Performance for Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706)

The evaluation of the Microline Surgical M/L-10 Clip Applier Sterilization Tray focuses on its ability to protect a medical device and facilitate sterilization while maintaining sterility. The primary performance characteristic evaluated is its sterility assurance level (SAL).

1. Table of Acceptance Criteria and the Reported Device Performance

Characteristic / Performance Metric	Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (SAL)	A sterility assurance level of 10⁻⁶ using the biological indicator (BI) overkill method (in accordance with AAMI TIR12:2010 and EN ISO 17664:2004).	"The acceptance criteria required that the sterilization methods demonstrate a sterility assurance level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which met as required." The device was validated with the M/L-10 Clip Applier handpiece within the tray, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap, under specific steam sterilization parameters: Pre-vacuum (4 min at 132°C, 20 min dry) and Gravity Cycle (15 min at 132°C, 45 min dry).
Material Compatibility and Durability	Not explicitly stated as acceptance criteria, but implied through substantial equivalence to predicate device and use of standard materials.	Constructed of Stainless Steel, Aluminum, and Biomedical Grade Silicone. Surface coated with Nylon Coating Powder. Intended for multiple use.
Dimensional Consistency	Not explicitly detailed as an acceptance criterion in the provided text, but implied through design specifications.	Lid: 19.875" (Length) x 5.632" (Width) x 0.450" (Height) inches. Base: 19.875" (Length) x 5.50" (Width) x 1.450" (Height) inches. Internal configuration designed to secure the M/L-10 Clip Applier (17.13" length, 0.90" width). Weight: 1663.10 grams (with contents and wrap). Hole size: Ø 0.250". Hole pattern: Six (6) rows with twenty-five (25) holes, with some centrally removed (50 for lid, 21 for base).
Air Permeability	Essential for steam penetration and air removal during sterilization.	The device is stated to have "Yes" for air permeability, similar to the predicate. The hole pattern is designed to "support the steam sterilization process."
Protection of Enclosed Device	Intended to protect the M/L-10 Clip Applier handpiece.	The tray's internal configuration secures the M/L-10 Clip Applier. The device's primary purpose is "to protect the M/L-10 Clip Applier handpiece".
Sterility Maintenance	Maintained until used, when used with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap.	The "sterility of the enclosed sterilization tray ... is maintained until used" when used as indicated.

The Study Proving Device Meets Acceptance Criteria:

The document broadly states that Microline Surgical, Inc. "successfully completed a full sterilization using Steam Sterilization method" and that "The acceptance criteria required that the sterilization methods demonstrate a sterility assurance level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which met as required."

While the document references relevant standards (AAMI TIR12:2010 and EN ISO 17664:2004), it does not provide detailed methodology, specific protocol numbers, or raw data from this sterilization study. It summarizes the outcome of the study.

Additional Information (Based on the document's content):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the sterilization testing (e.g., number of trays or sterilization cycles tested).
The data provenance is not explicitly stated beyond "Microline Surgical, Inc." completing the study. Given Microline Surgical is a US company, and the FDA submission, the testing would typically adhere to US/international regulatory standards. It's a prospective study in the sense that the testing was conducted specifically for this submission to demonstrate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert readers or ground truth establishment in a diagnostic context. The "ground truth" for sterilization is defined by achieving a 10⁻⁶ SAL, typically verified through biological indicators and laboratory analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This relates to the adjudication of diagnostic assessments, which is not relevant to sterilization validation.

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-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the sterilization study, the "ground truth" is typically established by microbiological testing results (absence of viable microorganisms in biological indicators after sterilization), demonstrating a 10⁻⁶ Sterility Assurance Level, as per recognized sterilization standards (AAMI TIR12:2010, EN ISO 17664:2004).

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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)

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)	☐ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)
☐ 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 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.50 Dunham Road, Suite 1500Beverly, MA 01915USA
Establishment Registration Number:	1223422
Contact Representative:	Anu Gaur, Ph.D., MBA, MSRA, RACRequlatory Affairs ManagerPhone: 978-867-1726Fax: 978-922-9209
Date Prepared:	February 1, 2016
Trade Name:	M/L-10 Clip Applier Sterilization Tray[Catalog # 3706]
Common Name:	Sterilization Cassette
Classification:	Class II, in accordance to 21 CFR § 880.6850Sterilization Wrap Containers, Trays, Cassettes &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.

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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 ApplierSterilization Tray (Catalog #3706)
510(k) Number	K980065	This Submission
510(k) Clearance Date	May 11, 1998	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.
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),Physician and dental office or placewhere instruments are sterilized.	Hospital, Operating Room (OR) Useonly.
Intended Use(Indication for Use)	General dental/medical instrumentcassettes intended to hold instrumentsand accessories in place throughout theentire instrument use, cleaning andsterilization cycle. These cassettes aresuitable for Gravity Steam, Pre-vacuumsteam and EO sterilization.	Microline Surgical M/L-10 Clip ApplierSterilization Tray (Catalog# 3706) isintended to protect the M/L-10 ClipApplier handpiece (Catalog #1002)and to facilitate the sterilizationprocess by allowing steam penetrationand air removal. When used inconjunction with 2 layers of FDA-cleared 1-ply polypropylenesterilization wrap, sterility of theenclosed sterilization tray (Catalog#3706) is maintained until used.The Microline Surgical M/L-10 ClipApplier Sterilization Tray (Catalog#3706) is used to secure the M/L-10Clip Applier handpiece (Catalog#1002) which measures at 17.13"length, 4.94" height, and 0.90"width indimensional measurements, as theintended load during the transport,sterilization and storage between itsintended uses.The M/L-10 Clip Applier SterilizationTray (Catalog# 3706) has been
		validated with the M/L-10 Clip Applierhandpiece (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.
	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.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 theCompany 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
WeightSterilization Method(s)	1663.10 gramsSteam Sterilization& Ethylene Oxide (EtO)	IdenticalSteam Sterilization only
Sterilization Cycle	Prevacuum Steam:	Prevacuum Steam:
Parameters	132°C - 4 minutes	132°C – 4 minutes
	Dry for 20 minutes	Dry for 20 minutes

	Gravity Steam:	Gravity Steam:
	132°C -15 minutes	132°C -15 minutes
	Dry for 30 minutes	Dry for 45 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:MEDIN Corporation11 Jackson Road,Totowa, NJ 07512USA(Registration Number: 3011296511)	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	M/L-10 Clip Applier Sterilization Trayinternal configuration to secure theM/L-10 Clip Applier device only.

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Image /page/6/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is in large, gray, sans-serif font. In the center of the word is a teal-colored circle with a four-leaf clover design inside. Below the word "MICROLINE" is the word "SURGICAL" in a smaller, gray, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for Microline Surgical. The logo consists of the word "MICROLINE" in gray, with a teal circle containing four leaf-like shapes in the center of the word. Below "MICROLINE" is the word "SURGICAL" in a smaller, gray 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 method, which met as required. The sterilization testing and limits of reuse of the device, design tolerance andysis and shelf-life validation were completed. The subject device MIL-10 Clip Applier Sterilization Tray (Catalog #3706), is substantially equivalent to its predicate device in terms of fundamental technology, materials and design and meets the identical design inputs and output requirements. As the subject device, ML-10 Clip Applier Sterilization Tray (Catalog #3706) will be fully contract manufactured, assembled and packaged by contract manufacturer MEDIN Corporation (Registration Number: 3011296511), any new validation testing including biocompatibility, bench testing including new validation or documentation pertaining to 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 device ML-10 Clip Applier Sterilization Tray (Catalog #3706) is deemed substantially equivalent (SE) to its legally marketed predicate device C/T Med-System (K98065). Similar to its predicate device, the subject device ML-10 Clip Applier Sterilization Tray is a Class II device per 21 CFR § 880.6850 (Product Code KCT) and under this classification category identified as Sterilization Wrap Containers, Trays, Cassettes & other Accessories. The subject device MIL-10 Clip Applier Sterilization Tray (Catalog #3706) does not raise new questions of safety and effectiveness; and demonstrates at least as safe and effective as its legally marketed predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for Microline Surgical. The word "MICROLINE" is in gray, with a teal circle containing a four-pointed star in the middle. Below that, the word "SURGICAL" is also in gray.

Substantial Equivalence Statement:

The performance testing data for the subject device M/L-10 Clip Applier Sterilization Tray (Catalog #3706) demonstrates the subject device is as safe, as effective, and performs as well as the predicate device (K980065).

Regulation Number and Section

§ 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).