TransferMan 4m Micromanipulator

K142207 · Eppendorf AG · MQJ · Jan 23, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K142207
• Device Name: TransferMan 4m Micromanipulator
• Applicant: Eppendorf AG
• Product Code: MQJ · Obstetrics/Gynecology
• Decision Date: Jan 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6150
• Device Class: Class 2

Indications for Use

The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope. The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.

Device Story

TransferMan 4m is a motorized micromanipulator; consists of motor module and control board with joystick; mounts to inverted microscope; provides coarse/fine tool positioning for IVF/ICSI. CellTram Air/Oil/vario are manual piston pumps; generate pressure differences via piston/cylinder system; transmit pressure to microcapillary via tube; used for aspiration/injection of sperm/oocytes. Operated by embryologists/technicians in clinical IVF labs. Output is physical movement of microtools or fluid pressure for cell manipulation. Benefits include precise, controlled cell handling during assisted reproduction.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical bench testing, including electrical safety (UL 61010-1), EMC (EN 61326-1, EN 61000 series), and endurance/packaging validation (ASTM D4169-09).

Technological Characteristics

TransferMan 4m: Motorized X,Y,Z-axis micromanipulator; joystick control; serial interface; 120-240V AC power. CellTram: Manual piston/cylinder pumps; air or oil transmission media; 2,640 µL (Air) or 960 µL (Oil/vario) total volume. Standards: EN 61326-1, EN 55011, EN 61000 series, UL 61010-1, ASTM D4169-09.

Indications for Use

Indicated for assisted reproduction procedures requiring microtool positioning (TransferMan 4m) and ICSI procedures for sperm aspiration and injection into oocytes (CellTram series).

Regulatory Classification

Identification

Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.

Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• IM-11 Pneumatic Microinjector (K113712)
• NAI-5 Micromanipulator Set (K120877)

Submission Summary (Full Text)

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

January 23, 2015

Eppendorf AG % JoAnne Bronikowski Regulatory Services Senior Project Manager Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K142207

Trade/Device Name: TransferMan® 4m Micromanipulator CellTram® Air Microinjector CellTram® Oil Microinjector CellTram® vario Microinjector Regulation Number: 21 CFR 884.6150 Regulation Name: Assisted reproduction micromanipulators and microinjectors Regulatory Class: Class II Product Code: MQJ Dated: December 17, 2014 Received: January 23, 2015

Dear JoAnne Bronikowski,

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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR 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.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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 | |

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

### Indications for Use

510(k) Number (if known) K142207

#### Device Name

TransferMan® 4m Micromanipulator, CellTram® Air Microinjector, CellTram® Vario Microinjector

Indications for Use (Describe)

TransferMan® 4m Micromanipulator Indications for Use:

The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.

CellTram® Air Microinjector / CellTram® Oil Microinjector / CellTrans® vario Microinjector Indications for Use: The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | lebrand |
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FORM FDA 3881 (1/14)

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# 510(k) Summary for the Eppendorf AG

TransferMan® 4m Micromanipulator and CellTram® Microinjectors (per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

### 1. SUBMITTER/510(K) HOLDER

Eppendorf AG Barkhausenweg 1 22339 Hamburg Germany Phone: [phone] - 188 Establishment Registration No: 801047

Contact: Dr. Cornelia Hildebrandt, Global Product Line Manager Cell Handling Contact's Phone: [phone] - 188 Contact's Email: [e-mail] Date Prepared: July 28, 2014

### 2. DEVICE NAME

| Trade Name: | TransferMan ^® 4m Micromanipulator<br>CellTram ^® Air Microinjector<br>CellTram ^® Oil Microinjector<br>CellTram ^® vario Microinjector |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Micromanipulator and microinjectors |
| Device Name: | Assisted reproduction micromanipulators and microinjectors |
| Classification Panel: | Obstetrics/Gynecology Devices |
| Classification Number: | 884.6150 |
| Product Code: | MQJ |

#### 3. PREDICATE DEVICES

The proposed TransferMan® 4m Micromanipulator and CellTram Microinjectors are substantially equivalent to other legally marketed assisted reproduction micromanipulators and microinjectors including the following:

- IM-11 Pneumatic Microinjector (Narishige Co., Ltd., K113712) ●
- NAI-5 Micromanipulator Set (Narishige Co., Ltd., K120877)* ●

* Eppendorf is claiming substantial equivalence of the proposed TransferMan® 4m Micromanipulator only to the Micromanipulator, not to the NAI-5 Micromanipulator Set as a whole.

A comparison of the intended use and features of the proposed TransferMan® 4m Micromanipulator and CellTram Microinjectors and the predicate devices described in K113712 and K120877 is provided in Table 5-1.

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### 4. DEVICE DESCRIPTION

The TransferMan® 4m Micromanipulator is a motorized micromanipulator consisting of a Motor module unit and a Control board that allows the user to precisely control the movement of tools (i.e., microcapillaries) used for Intra-Cytoplasmic Spermatozoa Injection (ICSI) and other In Vitro Fertilization (IVF) procedures. The tool is mounted in a Universal Capillary Holder on the TransferMan® 4m Micromanipulator's Motor module unit that is, itself, mounted to an inverted microscope. The user controls the movements of the tool using a joystick on the Control board. The Motor module unit shifts the position of the tool in response to the joystick motions.

The CellTram Microinjectors are manual piston pumps for holding and transfer of suspension cells (e.g., oocytes and sperms for use in ICSI procedures), used in manual microinjection procedures. Using a movable piston in a cylinder system, the CellTram® Microinjectors generate differences in pressure that are transferred directly to a microcapillary via a connected pressure tube. Depending on the piston movement, material can be aspirated or dispensed. Three versions of the CellTram® Microinjectors will be marketed for use in ICSI procedures, the CellTram® Air, the CellTram® Oil, and the CellTram vario. The three versions differ in the medium used for pressure transmission (air versus oil).

## 5. INDICATIONS FOR USE

The TransferMan 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.

The CellTram Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.

## 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

Both the proposed TransferMan® 4m Micromanipulator and the predicate NAI-5 Micromanipulator are motor-driven micromanipulators that allow the user to control the movement of a tool using the joystick on the Control unit. Motors in the Motor module unit shift the position of the tool in response to the joystick motions in X, Y, and Z directions. The manufacturers of both the proposed and predicate devices provide adapters for attaching the Motor module unit to inverted microscopes commonly used for assisted reproduction procedures. The proposed TransferMan® 4m Micromanipulator and predicate NAI-5 Micromanipulator are indicated for coarse and fine tool positioning.

The CellTram Microinjectors and the predicate IM-11 Pneumatic Microinjector are used

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to control aspiration of the sperm into the microcapillary, and after perforation of the oocyte to release of the sperm into the ooplasm. Both the proposed and predicate devices consist of manually controlled pistons that slide within a cylinder system in and out to aspirate or dispense. The CellTram Air, the CellTram® Oil, and the CellTram® vario have different mediums used for pressure transmission (air versus oil). The predicate IM-11 Pneumatic Microinjector operates using air only.

The manufacturer believes that the technological characteristics of the TransferMan 4m Micromanipulator and the CellTram Microinjectors are substantially equivalent to those of the predicate devices.

The tables below provide the comparison of the characteristics between the proposed and predicated devices.

| | Feature | TransferMan® 4m<br>Micromanipulator Eppendorf AG<br>(Proposed) | NAI-5 Micromanipulator Set<br>Narishige Col. Ltd System<br>(K120877) |
|--------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| General | Intended Use | Intended for use in assisted<br>reproduction procedures requiring<br>coarse and fine positioning of a<br>microtool under the microscope. | : "… enables course and fine<br>positioning of a microtool under the<br>microscope and is used in assisted<br>reproduction procedures." |
| | Components | Motor Module<br>Control Board | Drive Unit<br>2 Control Units for coarse and fine<br>Power Supply |
| | Power Supply | Input: 120-240 V AC; 50-60 Hz | Input: 100-240 V; 50 Hz |
| | Range of movement | Coarse: $5 \mu m$ to $12,500 \mu m$ in $5 \mu m$<br>increments<br>Fine: $5 \mu m$ to $2,000 \mu m$ in $5 \mu m$<br>increments<br>X-Fine: $1 \mu m$ to $600 \mu m$ in $1 \mu m$<br>increments | Coarse: 22mm<br>Fine: 10mm<br>Increments not known |
| | Speed | 0 - 10,000 µm/s | Max. 1.4 mm/s |
| | Step Motors | X-,Y-,Z- Module | X-,Y-,Z- Module |
| | Step Size | < 20 nm (calculated resolution) | |
| Motor Module | Mechanical<br>Adjustability | >80 mm | Not known |
| | Dimensions | Module (X,Y,Z): 129 mm x 51 mm x<br>36 mm (W x D x H) | Drive Unit: 57 mm x 138 mm x<br>94 mm (W x D x H) |
| | Weight | Motor module (complete): 2.15 kg<br>Module (X,Y,Z): 570g | Not known |
| | Maximum Traveling<br>Distance | 20 mm | Coarse: 22mm<br>Fine: 10mm |
| | Swivel Joint<br>Direction of<br>Rotation | -45° - +90° | Not known |
| | | | |

Side-by-Side Comparison of the TransferMan® 4m Micromanipulator with the NAI-5 Micromanipulator

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| | Feature | TransferMan® 4m<br>Micromanipulator Eppendorf AG<br>(Proposed) | NAI-5 Micromanipulator Set<br>Narishige Col. Ltd System<br>(K120877) |
|--------------|-------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------|
| Control Unit | Capillary Exchange | Direction of rotation: forward (swivel out) | |
| | Sample Replacement | Direction of rotation: backward (swivel in) | |
| | Operating Angle of Angle Head | 0° - 90° | |
| | Microscope Compatibility | All major microscope brands: Leica, Nikon, Olympus, and Zeiss | All major microscope brands: Leica, Nikon, Olympus, and Zeiss |
| | Dimensions | 205 mm x 288 mm x 152 mm (W x D x H) | 70 mm x 100 mm x 120 mm (W x D x H) |
| | Weight | Control board: 1.8 kg (includes mains/power supply device) | Not known |
| | Control Mechanism | Dual Speed joystick | Joystick |
| | Working range | Coarse, fine, x-fine | Coarse, fine |
| | Programmable | Yes | No |
| | External device/PC Connection | Serial interface SubD9, male | Not known |
| | Speed Control | Proportional and dynamic kinetics | |

## Side-by-Side Comparison of the CellTram® Microinjectors with the IM-11 Pneumatic Microinjector

| | Feature | CellTram® Microinjectors<br>Eppendorf AG<br>(Proposed) | IM-11 Pneumatic Microinjector<br>Narishige Co., Ltd.<br>(K113712) |
|---------------------------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Intended Use | Intended for use in Intra-Cytoplasmic<br>Spermatozoa Injection (ICSI)<br>procedures to aspirate and inject<br>sperm into oocytes. | Intended for use for Intra-<br>Cytoplasmic Sperm Injection (ICSI)<br>procedures to aspirate and inject<br>sperm into oocytes, and to hold<br>oocytes during the ICSI procedure |
| | Microinjector Type | CellTram® Air (air transfer medium)<br>CellTram® Oil (oil transfer medium)<br>CellTram® vario (oil transfer medium,<br>coarse/fine adjustment) | Air transfer medium |
| | Operation | Manual microinjection | Manual microinjection |
| | Minimum<br>Adjustment Volume | <0.2 µL | Not known |
| | Adjustment total<br>volume | 2,640 μL | Not known |
| | Applications | Gentle holding of larger cells, e.g.<br>oocytes<br>Manual microinjection, aspiration and<br>dispensing of cells (e.g. sperms) | Holding oocytes<br>Manual aspiration of sperm into<br>injection pipette<br>Microinjection of sperm into oocytes |
| | Air | Type | Manual pressure |
| | | Pressure Generation | Piston/cylinder system, filled with air,<br>maintenance-free |
| | | Max Pressure | 2,900 hPa |
| Minimum Setting<br>Volume | | <200 nL | Not known |
| | Feature | CellTram® Microinjectors<br>Eppendorf AG<br>(Proposed) | IM-11 Pneumatic Microinjector<br>Narishige Co., Ltd.<br>(K113712) |
| | Total Setting<br>Volume | 2,640 µL | Not known |
| | Change in Volume<br>(per dial revolution) | 88 µL | coarse: 1.0 mL<br>fine: 250 µL |
| | Max Range | 15 mm (air) | 40 mm (coarse and fine combined)<br>30 mm coarse<br>17 mm fine |
| | Applications | Gentle holding of larger cells, e.g.<br>oocytes<br>Manual microinjection, aspiration and<br>dispensing of cells (e.g. sperms) | |
| | Type | Manual hydraulic | |
| Oil | Pressure Generation | Piston/cylinder system, filled with oil | |
| | Max Pressure | 20,000 hPa | Not Applicable |
| | Minimum Setting<br>Volume | <20 nL | |
| | Total Setting<br>Volume | 960 µL | |
| | Change in Volume<br>(per dial revolution) | 9.6 µL | |
| | Max Range | 50 mm | |
| vario | Applications | Gentle holding of larger cells, e.g.<br>oocytes<br>Manual microinjection, aspiration and<br>dispensing of cells (e.g. sperms)<br>Manual aspiration, dispensing, and<br>removal of cells and organelles (e.g.<br>polar bodies). | |
| | Type | Manual hydraulic | |
| | Pressure Generation | Piston/cylinder system, with gear,<br>filled with oil | Not Applicable |
| | Max Pressure | 20,000 hPa | |
| | Minimum Setting<br>Volume | <20 nL/<2 nL (coarse/fine) | |
| | Total Setting<br>Volume | 960 µL | |
| | Change in Volume<br>(per dial revolution) | course: 9.6 µL<br>fine: 0.96 µL | |
| | Max Range | 50 mm | |

______________________________________________________________________________________________________________________________________________________________________________

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## 7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The safety and effectiveness of the proposed TransferMan® 4m Micromanipulator has been confirmed by hardware and software testing. The proposed micromanipulator complies with applicable requirements of the following standards:

- EN 61326- 1:2006, "Electrical Equipment for Measurement, Control and Laboratory .

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Use - EMC Requirements"

- . EN 55011:2011, "Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Radio Disturbance Characteristics - Limits And Methods Of Measurement"
- EN 61000-4-2:2009-12, Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques - Section 2: Electrostatic discharge immunity test
- EN 61000-4-3:2011-04, "Electromagnetic compatibility (EMC) Part 4-3: Testing . and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test"
- EN 61000-4-4:2013-04, "Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques - Section 4: Electrical fast transient/burst immunity test"
- EN 61000-4-5:2007-06, "Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques – Section 5: Surge immunity test"
- EN 61000-4-6:2009-12, "Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques – Section 6: Immunity to conducted disturbances, induced by radio-frequency fields"
- EN 61000-4-11:2005-02, "Electromagnetic compatibility (EMC) Part 4: Testing and . measuring techniques - Section 11: Voltage dips, short interruptions and voltage variations immunity tests"
- UL 61010-1 Edition 2:2008/10/28, "Electrical Equipment For Measurement, Control, . and Laboratory Use; Part 1: General Requirements''

The safety and effectiveness of the proposed CellTram® Microinjectors has been confirmed by hardware testing. The proposed CellTram® Microinjectors underwent endurance testing. Packaging validation testing has been performed according to ASTM D4169-09, "Standard Practice for Performance Testing of Shipping Containers and Systems".

## 8. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The indications for use, principles of operation, and technological characteristics of the TransferMan® 4m Micromanipulator and CellTram® Microinjectors are substantially equivalent to the predicate devices NAI-5 Micromanipulator (subject of K120877) and IM-11 Pneumatic Microinjector (subject of K113712), respectively. Differences between the proposed devices and the predicate devices are limited to minor differences in technological characteristics. These differences do not impact the safety and effectiveness of the micromanipulator or microinjectors for their intended use.

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The safety and performance of the TransferMan® 4m Micromanipulator and CellTram® Microinjectors for their intended use is demonstrated by non-clinical testing. Based on the evidence provided, Eppendorf believes that the proposed TransferMan® 4m Micromanipulator and CellTram Microinjectors are substantially equivalent to the predicate devices NAI-5 Micromanipulator and IM-11 Pneumatic Microinjector and the differences between the products are minor, and raise no new issues of safety and effectiveness.