M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem by Mermaid Medical A/S

(N301) Disposable Semi-Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination.

(N302) Coaxial Introducer Needle is used as a guiding needle for (N301)

Device Description

The M-Biopsy™ Semi-Automatic Biopsy Instrument is a disposable lightweight spring loaded biopsy instrument with a biopsy needle fitted into a plastic handle.

The needle has a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.

The M-Biopsy™ Coaxial Introducer Needle has a trocar stylet and a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.

The device (M-Biopsy™ Semi-Automatic Biopsy Instrument) is sold as a single device and as a set combination (M-Biopsy™ Semi-Automatic Biopsy Instrument and M-Biopsy™ Coaxial Introducer Needle).

The M-Biopsy™ Semi-Automatic Biopsy Instrument is used to obtain multiple core biopsy samples from soft tissue such as the liver, kidney, prostate, breast, lymph nodes, etc.

The M-Biopsy™ Coaxial Introducer Needle is used as a guiding needle for the M-Biopsy™ Semi-Automatic Biopsy Instrument.

The M-Biopsy™ device family can be used as transient use less than 60 minutes.

The M-Biopsy™ device family is available from Gauge 14 to Gauge 20 in different lengths ranging from 6 cm to 30 cm.

The M-Biopsy™ Semi-Automatic Biopsy Instrument consists of: Mandrill, Needle, House Lit, House base, Spring bushings, Spring, Cannula sledge, Trigger, Protecting sheath and Silicone coating.

The M-Biopsy™ Coaxial Introducer Needle consists of: Mandrill, Needle, Luer, Hub, Stopper, Protecting sheath and Silicone coating.

The M-Biopsy™ Semi Automatic Instrument and Coaxial Needle (set combination) consists of the above mentioned parts and a 3 Cavity clips to keep the part in place in the pouch.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "M-Biopsy Semi-Automatic Biopsy Instrument" and associated needles. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific clinical acceptance criteria for an AI or diagnostic device.

Therefore, the requested information about acceptance criteria and a study proving a device meets them (especially in the context of AI, multi-reader multi-case studies, standalone performance, and ground truth establishment) is not present in this document. This document describes a traditional medical device (a biopsy instrument) and its bench testing for mechanical and material properties, rather than a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

Here's what can be extracted based on the provided text, while acknowledging that it doesn't fit the typical "diagnostic device acceptance criteria" framework:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests and states that the device "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. Instead, it broadly states the device "conformed to and/or passed the testing standard."

Acceptance Criteria Category	Reported Device Performance
Design	Met predetermined criteria and demonstrated substantial equivalence to predicate.
Handle design	(Implied: Equivalent to predicate)
Loading handle and trigger	(Implied: Equivalent to predicate)
Echogenic band	(Implied: Present and functional)
Cannula and Mandrill grind	(Implied: Equivalent to predicate)
Mandrill protrudes	(Implied: Equivalent to predicate)
ID of product Color code	(Implied: Present)
Gauge size/length size print	(Present, claimed improvement over predicate)
Visibility (Fluoroscopic, US)	(Implied: Good visualization)
Cm markers on cannula shaft	(Implied: Present and functional)
Biopsy harvest method	(Implied: Similar to predicate)
Biopsy sample size	(Implied: Similar to predicate)
Optional stroke length	(10mm and 20mm options available)
Spring operated	(Yes)
Geometric	Met predetermined criteria and demonstrated substantial equivalence to predicate.
Needle gauge	(Implied: Conforms to specified gauges)
Needle size	(Implied: Conforms to specified sizes)
Stilet size	(Implied: Conforms to specified sizes)
Needle advancement/penetration depth	(Implied: Equivalent to predicate)
Sample notch size	(Implied: Equivalent to predicate)
Number of samples	(Implied: Multiple samples can be obtained, similar to predicate)
Spring operated	(Yes)
Single puncture and sample	(Implied: Yes, for each sample)
Safety features	(Implied: Present and functional)
Materials in contact	Met biocompatibility standards.
Target organs	(Implied: Specified, similar to predicate)
Target population justification	(Implied: Clear)
Visualization techniques	(X-ray, CT or ultrasound visualization)
Method placement	(Implied: Similar to predicate)
Mechanical Test & Product Comparisons	Met predetermined criteria and demonstrated substantial equivalence to predicate.
Tensile pull testing	(Implied: Conformed to standard)
Loading and shooting force test 10mm	Demonstrated equivalence or improvement compared to predicate.
Loading and shooting force test 20mm	Demonstrated equivalence or improvement compared to predicate.
Trigger firing force test	(Implied: Conformed to standard)
Weight comparison test	(Lighter than predicate)
Performance Tests	Performed simulated biopsy tests in two media; form and length of biopsy sample recorded.
Packaging Test	Met predetermined criteria.
Sterile barrier Integrity	(Implied: Conformed to standard)
Transportation test	(Implied: Conformed to standard)
World Wide Condition test	(Implied: Conformed to standard)
Shelf life	(Implied: Determined)
Sterilization	EO sterilization, passed.
Biocompatibility	Conformed to ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11.

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

The document mentions "Each product has been fired 10 times each" for the simulated biopsy performance test. It does not provide further details on the sample size for other mechanical tests or the "test set" in the context of a diagnostic device. Data provenance refers to bench testing, performed by the manufacturer, not clinical data.

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

Not applicable. This is a mechanical device, and "ground truth" in the diagnostic sense (e.g., expert consensus on images or pathology) is not established or reported. The tests conducted are physical and material property assessments.

4. Adjudication Method for the Test Set:

Not applicable. There is no expert review or adjudication process for the bench tests described. The tests are directly measured against predetermined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device involving human readers interpreting images.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This is not an algorithm or AI device. The performance refers to the physical function of the biopsy instrument.

7. Type of Ground Truth Used:

Not applicable in the diagnostic sense. The "ground truth" or reference standards for the tests performed are typically engineering specifications, material standards, and functional requirements for a biopsy device (e.g., consistent sample size, sufficient cutting force, sterility, biocompatibility). For the simulated biopsy test, the "form and length of the biopsy sample" was recorded, implying these were the measured outcomes compared against expected values or predicate performance.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, no training set or associated ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 2, 2016

Mermaid Medical A/S % Ms. Rhonda Alexander Registrar Corp. 144 Research Drive Hampton, Virginia 23666

Re: K161409

Trade/Device Name: M-Biopsy Semi-Automatic Biopsy Instrument (N301) M-Biopsy Coaxial Introducer Needle for Semi-automatic Biopsy Instrument (N302) M-Biopsy Semi-Automatic Instrument and Coaxial Introducer Needle Set (NS301) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: July 18, 2016 Received: July 20, 2016

Dear Ms. Alexander:

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

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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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161409

Device Name

(N301) M-BiopsyTM Semi-Automatic Biopsy Instrument

(N302) M-Biopsy™ Coaxial Introducer Needle for Semi-Automatic Biopsy Instrument (N301)

(NS301) M-BiopsyTM Semi Automatic Instrument and Coaxial Introducer Needle Set

Indications for Use (Describe)

(N302) Coaxial Introducer Needle is used as a guiding needle for (N301)

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)

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."

FORM FDA 3881 (8/14)

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Image /page/3/Picture/1 description: The image shows the logo for Mermaid Medical. The logo features a large, red letter "M" at the top. Below the "M" are the words "MERMAID" and "MEDICAL" stacked on top of each other in a smaller, black font. A thin, red line is underneath the word "MEDICAL", and the words "CROSSING EXPERTISE" are below the line in a smaller, black font.

Date prepared: July 21, 2016

I.	Submitter
	Submitters Name:	Mermaid Medical A/S
	Address:	Frydensbergvej 25, DK-3660 Stenloese, Denmark
	Phone:	+45 47 10 85 70
	Fax:	+45 47 10 85 71
	E-mail:	pwj@mermaidmedical.com
	Contact:	Pia Wissing Jensen (Vice President QA & Regulatory Affairs)
	Consultant Contact:	Rhonda Alexander, Senior Regulatory Specialist, Medical Device DivisionRegistrar Corp
		144 Research Drive, Hampton, VA 23666 US
		1 (757) 224-0177 [voice]
		1 (757) 224-0179 [fax]
		ralexander@registrarcorp.com
II.	Device
	Trade name:	M-Biopsy™ Semi-Automatic Biopsy Instrument (N301)
		M-Biopsy™ Coaxial Introducer Needle for Semi-Automatic BiopsyInstrument (N302)
		M-Biopsy™ Semi Automatic Instrument and Coaxial Introducer NeedleSet (NS301)

	Regulation Number:	876.1075
	Classification Name:	Gastroenterology-Urology Biopsy Instrument
	Product Code:	KNW
	Classification Panel:	Gastroenterology/Urology
	Regulatory Class:	Class II
	Predicate Device:	SuperCore™ Biopsy Instrument (K974814)

Device Description lll.

The M-Biopsy™ Semi-Automatic Biopsy Instrument is a disposable lightweight spring loaded biopsy instrument with a biopsy needle fitted into a plastic handle.

The needle has a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.

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Image /page/4/Picture/1 description: The image shows the logo for Mermaid Medical. The logo features a large, red letter "M" at the top. Below the "M" are the words "MERMAID" in a larger font and "MEDICAL" in a smaller font. Underneath the words "MERMAID MEDICAL" is a thin, horizontal line, and below that are the words "CROSSING EXPERTISE" in a smaller font.