M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

K161409 · Mermaid Medical A/S · KNW · Aug 2, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161409
• Device Name: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
• Applicant: Mermaid Medical A/S
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Aug 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

(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 Story

M-Biopsy is a disposable, spring-loaded, semi-automatic biopsy instrument; includes coaxial introducer needle. Used for obtaining soft tissue core biopsy samples. Features distal echogenic markers and centimeter depth markings for visualization via X-ray, CT, or ultrasound. Available in 14G to 20G sizes; lengths 6-30 cm. Operated by clinicians in clinical settings for transient use (<60 minutes). Device components include mandrill, needle, trigger, and spring mechanism. Operator selects stroke length (10mm or 20mm) prior to use. Provides histological samples for microscopic examination, aiding in diagnosis of tissue pathology.

Clinical Evidence

Bench testing only. Performance evaluated via simulated biopsy tests in two media types (10 firings each). Metrics included sample form and length, loading/shooting force, trigger firing force, and weight. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, haemocompatibility). Packaging and sterilization (EO) validated.

Technological Characteristics

Disposable spring-loaded instrument. Materials: mandrill, needle, plastic housing, spring, silicone coating. Features: distal echogenic marker, centimeter depth markings. Gauge: 14G-20G; Length: 6-30 cm. Stroke length: 10mm/20mm. Sterilization: Ethylene Oxide (EO). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients requiring percutaneous or surgical histological biopsy of soft tissue (lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas) for microscopic examination.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• SuperCore™ Biopsy Instrument (K974814)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

(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)

| 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.

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### *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:

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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: | [phone] |
| | Fax: | [phone] |
| | E-mail: | [e-mail] |
| | Contact: | Pia Wissing Jensen (Vice President QA & Regulatory Affairs) |
| | Consultant Contact: | Rhonda Alexander, Senior Regulatory Specialist, Medical Device Division<br>Registrar Corp |
| | | 144 Research Drive, Hampton, VA 23666 US |
| | | 1 [phone] [voice] |
| | | 1 [phone] [fax] |
| | | [e-mail] |
| II. | Device | |
| | Trade name: | M-Biopsy™ Semi-Automatic Biopsy Instrument (N301) |
| | | M-Biopsy™ Coaxial Introducer Needle for Semi-Automatic Biopsy<br>Instrument (N302) |
| | | M-Biopsy™ Semi Automatic Instrument and Coaxial Introducer Needle<br>Set (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.

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.

#### IV. Indication for Use

(N301) Disposable Semi Automatic Biopsy Instrument is 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).

#### V. Technological and Substantial Equivalence Summary

The M-Biopsy™ Semi-Automatic Biopsy Instrument is similar in fundamental design, function, device materials, sterilization, operating principle, intended use and technology as the predicate device "SuperCore™ Biopsy Instrument".

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Image /page/5/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" is the text "MERMAID MEDICAL" in a smaller, sans-serif font. Underneath the text is a thin, red line, and below that is the text "CROSSING EXPERTISE" in a smaller font.

The modification from the predicate device includes:

- Shorter mandrill length than the predicate device
- Gauge size/length size print on the device. The predicate device does not have this.
- Loading and shooting force test 10 mm and 20 mm better or equal than the predicate device
- Lighter than the predicate device

The above mentioned differences do not raise new questions of safety and effectiveness.

#### VI. Performance Data

The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The device conformed to and/or passed the testing standard.

The M-Biopsy™ device family including packaging and sterilization met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or effective or performance issues were raised during the testing.

| Design: | Geometric: |
|--------------------------------------------------------|----------------------------------------|
| Handle design | Needle gauge |
| Loading handle and trigger | Needle size |
| Echogenic band on the distal end of the cannula | Stilet size |
| Cannula and Mandrill grind | Needle advancement / penetration depth |
| Mandrill protrudes from the cannula | Sample notch size |
| ID of the product Color code | Number of samples |
| Gauge size/length size print on the device | Spring operated |
| Visibility during incursion (Fluoroscopic, Ultrasound) | Single puncture and sample |
| Visualization of the insertion debt of the cannula. cm | Safety features |
| markers on the cannula shaft. | |
| Biopsy harvest method | Materials in contact with patient |
| Biopsy sample size | Target organs (anatomical) |
| Optional stroke length which the operator chooses | Target population justification |
| prior to use (10mm and 20mm) | |
| Spring operated | Visualization techniques |
| | Method placement |

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Image /page/6/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 MEDICAL" in a smaller, black font. Underneath the words "MERMAID MEDICAL" is a thin, red line, and below that are the words "CROSSING EXPERTISE" in a smaller, black font.

| Mechanical test and Product comparisons test: | Performance tests: |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile pull testing | The performance test is a simulated biopsy test performed according to the IFU. The Biopsy needle is fired into two different medias as listed below. Each product has been fired 10 times each. Form and length of the biopsy sample was recorded. |
| Loading and shooting force test 10mm | |
| Loading and shooting force test 20mm | |
| Trigger firing force test | |
| Weight comparison test | |
| Packaging test: | Sterilization: |
| Sterile barrier Integrity | EO sterilization |
| Transportation test | Biocompatibility |
| World Wide Condition test | According to ISO 10993. See below. |
| Shelf life | |

#### Biocompatibility VII.

The biocompatibility evaluation for the Semi-Automatic Biopsy Instrument and Coaxial Needle was conducted with the FDA and European standard ISO 10993-1"Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk Management Process" as recognized by the FDA. The subject device conformed to or passed the following standards:

- MEM elution cytotoxicity test according to ISO 10993-5
- Sensitization test for delayed hypersensitivity or sensitization according to ISO 10993-10
- Irritation or Intracutaneous reactivity according to ISO 10993-10
- Acute Systemic Toxicity according to ISO 10993-11
- Haemocompatibility test according to ISO 10993-4

### Conclusion

The subject devices, M-Biopsy™ Semi-Automatic Biopsy Instrument (N301), M-Biopsy™ Coaxial Introducer Needle for Semi-Automatic Biopsy Instrument (N302), and M-Biopsy™ Semi Automatic Instrument and Coaxial Introducer Needle Set (NS301), are similar to the predicate device in terms of materials, design, intended use, and performance. There are no differences, which negatively affect a finding of substantial equivalence. Thus, the subject device is considered to be substantially equivalent to the predicate.