The Medline Microdissection Needle is a monopolar electrosurgical instrument used for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting, and cauterizing soft tissue. The Medline Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system.

Device Description

The Medline Microdissection Needle is a sterile, active electrode that is also referred to as a needle. It is designed for precision cutting, dissecting, and cauterization. The device is comprised of stainless steel, tungsten, and polyolefin heat shrink and will be offered in two different lengths, 4 cm (140936/ESE104A) and 3 cm (140937/ESE103A). The Medline Microdissection Needle is intended for connection with multiple brands of standard cautery pencils, including 510(k)-cleared Medline Cautery Pencil (K190643).

AI/ML Overview

The Medline Microdissection Needle is a medical device and is not an AI/ML powered device, therefore no information about AI/ML acceptance criteria or studies is available in the provided text.

The provided document describes the 510(k) premarket notification for the Medline Microdissection Needle, comparing it to a predicate device. This submission process focuses on demonstrating substantial equivalence to a legally marketed device rather than establishing new acceptance criteria or conducting studies in the way one might for a novel AI/ML product.

Here's a breakdown of the non-clinical testing performed to demonstrate substantial equivalence, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with numerical performance targets in the way an AI/ML product might. Instead, it demonstrates equivalence through a comparison of technological characteristics and various non-clinical tests. The "Comparison Analysis" column in Table 1 serves as the "reported device performance" against the predicate device's characteristics.

Device Characteristic	Proposed Device Performance	Predicate Device Characteristic	Comparison Analysis
Product Name	Medline Microdissection Needle	Stryker Colorado Microdissection Needle®	N/A
510(k) Reference	K242370	K033232	N/A
Manufacturer	Applied Medical Coatings (for proposed device)	Stryker	N/A
Product Code	GEI	GEI	Same
Classification Panel	General & Plastic Surgery	General & Plastic Surgery	Same
Classification Name	Electrosurgical Cutting & Coagulation & Accessories	Electrosurgical Cutting & Coagulation & Accessories	Same
Regulation Number	878.4400	878.4400	Same
Indication for Use	Monopolar electrosurgical instrument for precision soft tissue dissection; single-use for cutting, dissecting, and cauterizing soft tissue; not for CNS or central circulatory system.	Monopolar electrosurgical instrument for precision soft tissue dissection (e.g., tonsillectomy, blepharoplasty); single-use for cutting, dissecting, and cauterizing soft tissue; not for CNS or central circulatory system.	Same – Both devices for precision soft tissue dissection and for cutting, dissecting, and cauterizing soft tissues.
Materials	Tube: Stainless Steel; Tip/Needle: Tungsten; Insulation: Polyolefin heat shrink; Tip Protector: PVC Compound; Tip Protector Colorant: Ethylene Vinyl Acetate	Tube: Stainless Steel; Tip/Needle: Tungsten; Insulation: Polyolefin (latex free); Non-stick coating: Isolation PTFE	Similar: Minor differences in materials of construction are addressed via biological safety testing per ISO 10993-1 and functional testing. The differences do not alter the safety and effectiveness of the product.
Design Features	Ultra-sharp (5 µm) tungsten needle that transfers current from electrosurgical generator to very small tissue surface area.	Ultra-sharp (5 µm) needle that transfers current from electrosurgical generator to very small tissue surface area. PTFE coating on tip to reduce eschar build up.	Similar: Functional testing, including thermal zone damage testing and tip/pencil compatibility testing on the subject device demonstrate the differences do not alter the safety and effectiveness of the product.
Active Accessory	Compatible with a variety of standard monopolar electrosurgical hand pieces.	Compatible with a variety of standard monopolar electrosurgical hand pieces.	Same
Single Use vs. Reusable	Single-Use	Single-Use	Same
Sterile vs. Non-Sterile	Sterile (EO)	Sterile (EO)	Same
OTC vs Rx	Rx only	Rx only	Same
Shelf Life	3 years	5 years	Different: Shelf-life testing supports the proposed expiration date through evaluation of the packaging integrity for maintaining device sterility and/or evaluation of any changes to device performance or functionality.
Dimensions	ESE103A: 51.75 ± 1.78 mm; ESE104A: 61.75 ± 1.78 mm; Outer Shaft Diameter: 2.36 ± 0.1 mm	Not explicitly stated for predicate in table, but discussed in comparison.	Functional testing, including thermal zone damage testing and tip/pencil compatibility, was performed on the subject device to ensure the differences do not alter the safety and effectiveness of the product.
Connector Type	Stainless Steel Tube	Stainless Steel Tube	Same
Performance Specifications	Rated Supply Voltage: 4000Vpeak; Max Power Output: 30 watts	Rated Supply Voltage: 5400 V; Max Power Output: 50 watts	Functional testing, including thermal zone damage testing and IEC 60601-2-2 was performed on the subject device to ensure the differences do not alter the safety and effectiveness of the product.
Compatibility	IFU advises verifying compatibility of all instruments and accessories, always with monopolar electrosurgical generators and accessories tested to IEC 60601 and EN 60601 standards. Compatible with any active handle with same or lower rated accessory voltage and complies with IEC 60601-2-2 given proper and secure fit.	IFU advises using with regulatory cleared and approved generators compatible with monopolar electrosurgical devices. Fits most cautery handpieces with a standard 2.4 mm or 1.6 mm shaft.	Similar

2. Sample Size Used for the Test Set and Data Provenance:

The document primarily describes non-clinical bench testing, biocompatibility testing, electrical safety, and stability testing. It does not involve a "test set" of patient data or clinical images in the context of an AI/ML device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable as typically understood for AI/ML studies.

For bench tests, sample sizes would relate to the number of devices tested to meet statistical significance for particular tests (e.g., thermal damage, compression, dimensional measurements). These specific numbers are not detailed in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is not an AI/ML study involving human expert ground truth. The "ground truth" for this device's performance is established by adherence to recognized standards and validated physical/electrical performance tests.

4. Adjudication Method for the Test Set:

Not applicable. There is no human adjudication process described as this is not an AI/ML study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. The Medline Microdissection Needle is a surgical instrument.

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

Not applicable. The Medline Microdissection Needle is a physical electrosurgical instrument used by a surgeon, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the Medline Microdissection Needle is established through:

Adherence to recognized international standards: e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 11135, ISO 11607, ASTM F1980, ANSI/AAMI ST 72, USP <85>, IEC 60601 series.
Physical and Electrical Performance Specifications: Demonstrated through bench testing (Thermal Damage Zone Testing, Tip/Pencil Compatibility, Appearance, Dimensional Measurements, Compression Test, Electrical Safety, EMC testing).
Biocompatibility Testing: Evaluating potential biological responses through various ISO 10993 tests.
Stability (Shelf Life) Testing: Demonstrating integrity over the proposed shelf life.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not an AI/ML product.

In summary, the provided document focuses on demonstrating that the Medline Microdissection Needle is substantially equivalent to a predicate device through comprehensive non-clinical testing against established engineering and biological standards, rather than through AI/ML specific performance metrics like accuracy, sensitivity, or human reader improvement.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 19, 2024

Medline Industries, LP Jin Ok Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

RE: K242370

Trade/Device Name: Medline Microdissection Needle (4 cm) (140936 (ESE104A)); Medline Microdissection Needle (3 cm) (140937 (ESE103A)) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2024 Received: December 4, 2024

Dear Jin Ok:

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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long H. Chen =S Digitally signed by Long H.Chen-S
Date: 2024.12.19 07:54:35 -05'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242370

Device Name

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))

Indications for Use (Describe)

The Medline Microdissection Needle is a monopolar electrosurgical instrument used for precision. It is a single-use device intended for cutting, dissecting, and cauterizing soft tissue. The Medline Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system.

Type of Use (Select one or both, as applicable)

☑ Research Use (Part 21 CFR 820 Subpart D)
□ In-Vitro Diagnostic Use (21 CFR Part 809)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized star-like symbol to the right of the text. The symbol is also white and appears to be composed of four elongated triangles pointing outwards from a central point.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

K242370

510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92]

Submitter

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

Jin Ok, Regulatory Affairs Specialist Phone: 224-931-7350 Email: jok(@medline.com

Summary Preparation Date December 18, 2024

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Microdissection Needle Classification Name: Electrosurgical cutting and coagulation device and accessories Product Code: GEI Classification Panel: General and Plastic Surgery Regulatory Class: Class II Regulation Number: 21 CFR 878.4400

Predicate Device Stryker Leibinger Colorado MicroDissection Needle® K033232

Device Description

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Image /page/5/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is prominently displayed in white, bold letters. A stylized white starburst or cross-like symbol is positioned behind the text, adding a visual element to the logo.

Aedline Industries Three Lakes Drive Northfield, IL 60093

K242370

Indications for Use

The Medline Microdissection Needle is a monopolar electrosurgical instrument used for precision soft tissue dissection. It is a single-use device intended for cutting, and cauterizing soft tissue. The Medline Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system.

Summary of Technological Characteristics

Table 1 summarizes the technological characteristics of the Medline Microdissection Needle as compared to the predicate device.

Table 1 – Comparison of proposed and predicate device

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline MicrodissectionNeedle	Stryker ColoradoMicrodissection Needle®	N/A
510(k) Reference	K242370	K033232	N/A
Manufacturer	Applied Medical Coatings	Stryker	N/A
Product Code	GEI	GEI	Same
Classification Panel	General & Plastic Surgery	General & Plastic Surgery	Same
Classification Name	Electrosurgical Cutting &Coagulation & Accessories	Electrosurgical Cutting &Coagulation & Accessories	Same
Regulation Number	878.4400	878.4400	Same
Indication for Use	The Medline MicrodissectionNeedle is a monopolarelectrosurgical instrumentused for precision soft tissuedissection. It is a single-usedevice intended for cutting,dissecting, and cauterizingsoft tissue. The MedlineMicrodissection Needle is notintended for use in the centralnervous system or in thecentral circulatory system.	The Colorado MicroDissectionNeedle® is a monopolarelectrosurgical instrument usedfor precision soft tissuedissection. Including but notlimited to tonsillectomy andblepharoplasty. It is a single-use device intended for cutting,dissecting, and cauterizing softtissue. The ColoradoMicrodissection Needle is notintended for use in the centralnervous system or in thecentral circulatory system.	Same – Both devicesare for precision softtissue dissection andfor cutting,dissecting, andcauterizing softtissues.

Materials	Tube – Stainless SteelTip/Needle – TungstenInsulation – Polyolefin heatshrinkTip Protector – PVCCompoundTip Protector Colorant –Ethylene Vinyl Acetate	Tube – Stainless SteelTip/Needle – TungstenInsulation – Polyolefin (latexfree)Non-stick coating - IsolationPTFE	Similar: Minordifferences inmaterials ofconstruction areaddressed viabiological safetytesting per ISO10993-1 andfunctional testing.The differences donot alter the safetyand effectiveness ofthe product
Design Features	The Medline MicrodissectionNeedle is designed with anultra-sharp (5 µm) tungstenneedle that transfers currentfrom the electrosurgicalgenerator to a very smallsurface area of tissue	The Stryker ColoradoMicrodissection Needle® isdesigned with an ultra-sharp (5µm) needle that transferscurrent from the electrosurgicalgenerator to a very smallsurface area of tissue. Thedevice has PTFE coating onthe tip to reduce eschar buildup	Similar: Functionaltesting, includingthermal zonedamage testing andtip/pencilcompatibility testingon the subject devicedemonstrate thedifferences do notalter the safety andeffectiveness of theproduct
Active Accessory	Compatible with a variety ofstandard monopolarelectrosurgical hand pieces	Compatible with a variety ofstandard monopolarelectrosurgical hand pieces	Same
Single Use vs. Reusable	Single-Use	Single-Use	Same
Sterile vs. Non-Sterile	Sterile (EO)	Sterile (EO)	Same
OTC vs Rx	Rx only	Rx only	Same
Shelf Life	3 years	5 years	Different: Shelf-lifetesting supports theproposed expirationdate throughevaluation of thepackaging integrityfor maintainingdevice sterilityand/or evaluation ofany changes todevice performanceor functionality
	ESE103A: 51.75 ± 1.78 mm ESE104A: 61.75 ± 1.78 mm Outer Shaft Diameter: 2.36 ± 0.1 mm		damage testing andtip/pencilcompatibility, wasperformed on thesubject device toensure thedifferences do notalter the safety andeffectiveness of theproduct
Connector Type	Stainless Steel Tube	Stainless Steel Tube	SameDifferent:
Performance Specifications	Rated Supply Voltage:4000VpeakMax Power Output: 30 watts	Rated Supply Voltage: 5400 VMax Power Output: 50 watts	Functional testing,including thermalzone damage testingand IEC 60601-2-2was performed onthe subject device toensure thedifferences do notalter the safety andeffectiveness of theproduct
Compatibility	IFU Statement: Beforebeginning the procedure,verify the compatibility of allinstruments and accessoriesALWAYS use the device onlywith monopolarelectrosurgical generators andaccessories that have beentested to and complies withIEC 60601 and EN 60601standards. The activeelectrode is compatible withany active handle that has thesame or lower rated accessoryvoltage and complies with theIEC 60601-2-2 standard givenproper and secure fit.	IFU Statement: Use theColorado MicroDissectionNeedle only with regulatorycleared and approvedgenerators compatible withmonopolar electrosurgicaldevices. The needle fits mostcautery handpieces with astandard 2.4 mm or 1.6 mmshaft	Similar

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Image /page/6/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points, creating a dynamic and eye-catching design.

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

K242370

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol to the right of the text. The starburst is white, and the background is a solid dark blue color.

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

K242370

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Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, with a stylized white starburst symbol to the right of the text. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a memorable symbol.

ledline Industrie Three Lakes Drive Northfield II 6009

K242370

Summary of Non-Clinical Testing

Biocompatibility Testing

The biological evaluation for Medline Microdissection Needle was conducted in accordance with ANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. Medline Microdissection Needle is categorized as an externally communicating device in contact with tissue/bone/dentin for a limited duration (less than 24hrs). Specific biocompatibility tests were selected under the guidance of ISO 10993-1 Annex A:

ISO 10993-5: Cytotoxicity ●
ISO 10993-10: Skin Sensitization
ISO 10993-10: Skin Irritation ●
ISO 10993-11: Acute Systemic Toxicity ●
ISO 10993-11: Material Mediated Pyrogenicity

Performance Testing (Bench)

Non-clinical performance testing was completed on the Medline Microdissection Needle to demonstrate substantial equivalence to the predicate device as well as to support the safety and effectiveness of the subject device in accordance with the relevant test methods described below:

Thermal Damage Zone Testing
Tip/Pencil Compatibility
. Appearance
Dimensional Measurements
. Compression Test

Electrical Safety and Electromagnetic Compatibility

Electrical safety and EMC testing were completed on the Medline Microdissection Needle in accordance with 60601 series of standards listed below:

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Image /page/9/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white symbol resembling a compass or a star above it. The symbol has a sharp, angular design. A small gray rectangle is visible in the upper right corner of the image.

Medline Industries. Three Lakes Drive Northfield. IL 60093

K242370

AAMI/ANSI ES 60601-1 Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety ● and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2 Medical electrical equipment Part 2-2: Particular requirements for the basic ● safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Performance Testing (Animal)

This section does not apply. No animal testing was performed.

Performance Testing (Clinical)

This section does not apply. No clinical testing was performed.

Stability (Shelf Life)

The Medline Microdissection Needle has a 3-year expiration date. In accordance with ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify the physical and mechanical properties of the device to ensure it will perform adequately and consistently during the proposed shelf life and does not degrade over time.

Medline Microdissection Needles are packaged in a Peelmaster Poly/Tyvek pouch. The pouch has a 5year shelf life and is validated for performance in accordance with ISO 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes. A packaging description, including how the pouch has maintained the device's sterility, a description of the package integrity test methods, and a summary of the package integrity test results have been completed in accordance with ISO 11607-1.

Sterilization

Medline Microdissection Needle will be supplied as a sterilized by ethylene oxide gas to a sterility assurance level (SAL) of 1x10). The sterilization for the Microdissection Needle complies with the requirements of ISO 11135 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.

. Ethylene oxide residual was evaluated in accordance with ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals.

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Image /page/10/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized star-like symbol. The star is formed by four white lines intersecting at a central point, creating a visual effect reminiscent of a compass or a medical cross. The overall design is clean and professional, reflecting Medline's presence in the healthcare industry.

ledline Industries Three Lakes Drive Northfield, IL 60093

K242370

Bioburden testing was conducted in accordance with ISO 11737-1 Sterilization of health care ● products – Microbiological methods – Part 1: Determination of a population of microorganisms on products.
Bacterial Endotoxin LAL Validation was conducted in accordance with ANSUAAMI ST 72 Bacterial endotoxins- Test methods, routine monitoring, and alternatives to batch testing and USP <85>, Bacterial Endotoxins

Summary of Clinical Testing

Not applicable.

Conclusion

In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Medline Industries, LP concludes that the Medline Microdissection Needle is as safe and effective as the predicate device Stryker Leibinger Colorado MicroDissection Needle® based on the similarities in the intended use, indications for use, mechanism of action, as well as the functions and specifications.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.