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

Q: Who is the manufacturer of Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

Medline Industries, LP filed the 510(k) submission for Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (K242370).

Q: What is the FDA product code for Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

Stryker Leibinger Colorado MicroDissection Needle (K033232).

Q: Who can help prepare an FDA 510(k) submission like Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K242370 · Medline Industries, LP · GEI · Dec 19, 2024 · General, Plastic Surgery

Device Facts

Record ID	K242370
Device Name	Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
Applicant	Medline Industries, LP
Product Code	GEI · General, Plastic Surgery
Decision Date	Dec 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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, 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 Story

Sterile, single-use monopolar electrosurgical active electrode (needle); used for precision cutting, dissecting, and cauterizing soft tissue. Device consists of stainless steel tube, tungsten needle tip, and polyolefin heat shrink insulation. Operates by transferring electrical current from standard monopolar electrosurgical generators to a small tissue surface area via an ultra-sharp (5 µm) tungsten tip. Used by clinicians in surgical settings; compatible with standard cautery pencils. Output is thermal energy for tissue effect. Benefits include precise tissue management during surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including thermal damage zone analysis, tip/pencil compatibility, dimensional measurements, compression testing, biocompatibility (ISO 10993), and electrical safety/EMC testing (IEC 60601 series).

Technological Characteristics

Monopolar electrosurgical needle; stainless steel tube, tungsten tip, polyolefin heat shrink insulation. Rated 4000Vpeak, 30W max. Sterile (EO) per ISO 11135. Biocompatibility per ISO 10993-1. Electrical safety per AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2. 3-year shelf life per ASTM F1980.

Indications for Use

Indicated for precision soft tissue dissection, cutting, and cauterizing in patients requiring electrosurgical intervention. Contraindicated for use in the central nervous system or central circulatory system.

Regulatory Classification

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.

Predicate Devices

Stryker Leibinger Colorado MicroDissection Needle (K033232)

Reference Devices

Medline Cautery Pencil (K190643)

Related Devices

K033232 — COLORADO MICRODISSECTION NEEDLE · Stryker Corp. · Feb 25, 2004
K192128 — Sutter Arrowtip Monopolar Electrodes · Sutter Medizintechnik GmbH · Oct 4, 2019
K163442 — Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) · Modern Medical Equipment Manufacturing Limited · Sep 28, 2017
K052297 — POREX ELECTROSURGERY NEEDLE · Porex Surgical, Inc. · Mar 28, 2006
K210338 — Edge Insulated Blade Electrode · Covidien, LLC · Apr 15, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 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). {5}------------------------------------------------ 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 | Comparison Analysis | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | Medline Microdissection Needle | Stryker Colorado Microdissection 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 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. | The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectomy and blepharoplasty. It is a single- use device intended for cutting, dissecting, and cauterizing soft tissue. The Colorado Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system. | Same – Both devices are 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 | The Medline Microdissection Needle is designed with an ultra-sharp (5 µm) tungsten needle that transfers current from the electrosurgical generator to a very small surface area of tissue | The Stryker Colorado Microdissection Needle® is designed with an ultra-sharp (5 µm) needle that transfers current from the electrosurgical generator to a very small surface area of tissue. The device has PTFE coating on the 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 | | | ESE103A: 51.75 ± 1.78 mm ESE104A: 61.75 ± 1.78 mm Outer Shaft Diameter: 2.36 ± 0.1 mm | | 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 Different: | | 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 Statement: Before beginning the procedure, verify the compatibility of all instruments and accessories ALWAYS use the device only with monopolar electrosurgical generators and accessories that have been tested to and complies with IEC 60601 and EN 60601 standards. The active electrode is compatible with any active handle that has the same or lower rated accessory voltage and complies with the IEC 60601-2-2 standard given proper and secure fit. | IFU Statement: Use the Colorado MicroDissection Needle only with regulatory cleared and approved generators compatible with monopolar electrosurgical devices. The needle fits most cautery handpieces with a standard 2.4 mm or 1.6 mm shaft | Similar | {6}------------------------------------------------ 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ 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: {9}------------------------------------------------ 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. {10}------------------------------------------------ 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.