(132 days)
No
The 510(k) summary describes a simple electrosurgical instrument (a needle) and its physical characteristics and performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is an electrosurgical instrument used for cutting, dissecting, and cauterizing soft tissue, which are surgical procedures, not therapies.
No
Explanation: The Medline Microdissection Needle is described as a surgical instrument used for cutting, dissecting, and cauterizing soft tissue. Its function is to perform a medical procedure, not to diagnose a condition.
No
The device description clearly states it is a physical instrument made of stainless steel, tungsten, and polyolefin, and bench testing was performed on the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Medline Microdissection Needle is a surgical instrument used directly on soft tissue within the body for cutting, dissecting, and cauterizing. It is an active electrode used in electrosurgery.
- Intended Use: The intended use clearly states it's for "precision soft tissue dissection" and "cutting, dissecting, and cauterizing soft tissue." This is an in vivo (within the living body) application, not an in vitro (in glass, or outside the body) diagnostic test.
The description and intended use clearly indicate this is a surgical tool, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; not intended for use in the central nervous system or in the central circulatory system.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Testing included: Biocompatibility Testing (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) (Thermal Damage Zone Testing, Tip/Pencil Compatibility, Appearance, Dimensional Measurements, Compression Test), Electrical Safety and Electromagnetic Compatibility (AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2), and Stability (Shelf Life) studies. Animal and Clinical testing were not performed. Shelf-life testing supports the proposed 3-year expiration date through evaluation of packaging integrity and device performance/functionality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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)
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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
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).
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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
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 |
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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
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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
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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
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
- 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
- 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 , 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.