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.

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).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Eppendorf AG TransferMan® 4m Micromanipulator and CellTram® Microinjectors (Air, Oil, and Vario). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new acceptance criteria through a study demonstrating novel device performance.

Therefore, the document does not report on a study designed to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against predefined metrics for efficacy or diagnostic accuracy. Instead, it focuses on demonstrating that the new devices are substantially equivalent to existing predicate devices based on technological characteristics and established safety standards.

Here's a breakdown based on the information provided, highlighting why certain questions cannot be fully answered in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on technological characteristics, the "acceptance criteria" are primarily related to conforming to existing standards and demonstrating similar functionality to predicate devices. There are no performance metrics stated as "acceptance criteria" with quantitative results from a specific clinical or performance study in the way one might expect for a new diagnostic or interventional device.

Aspect	Acceptance Criteria (Implicit from 510(k) process)	Reported Device Performance
Intended Use	Must be the same or highly similar to predicate device.	TransferMan® 4m Micromanipulator: Intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope. CellTram® Microinjectors: Intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes. (Matching predicates)
Technological Characteristics	Must be highly similar or any differences must not raise new questions of safety or effectiveness.	TransferMan® 4m Micromanipulator: Motor-driven micromanipulator, joystick control, 3-axis movement (X, Y, Z), similar speed and range of movement to NAI-5 Micromanipulator. Includes "X-Fine" movement and programmability not specified for the predicate. CellTram® Microinjectors: Manual piston pumps for aspiration/dispensing, operating with air or oil. Similar operation to IM-11 Pneumatic Microinjector, but offers oil-based variants (Oil, Vario) in addition to air.
Safety and EMC	Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.	TransferMan® 4m Micromanipulator: Complies with EN 61326-1:2006, EN 55011:2011, EN 61000-4-x series for EMC, and UL 61010-1 Edition 2:2008/10/28 for electrical safety. CellTram® Microinjectors: Safety confirmed by hardware testing, underwent endurance testing. Packaging validated per ASTM D4169-09.
Biocompatibility (Implicit)	If applicable, materials should be commonly used and compatible or proven safe.	Not explicitly detailed in the provided summary, but generally implied by "safety and effectiveness... confirmed by hardware testing."

2. Sample size used for the test set and the data provenance

This document does not describe a clinical or performance study with a "test set" of patient data in the context of a new diagnostic or prognostic tool. The testing performed is related to engineering verification and validation (e.g., hardware testing, endurance testing, EMC testing) rather than a clinical trial with a patient sample size. Therefore, there is no sample size or data provenance (country of origin, retrospective/prospective) for a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert-established ground truth on patient cases.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The devices described are mechanical micromanipulators and microinjectors, not AI-powered diagnostic or assistive tools for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. These are mechanical devices, not algorithms.

7. The type of ground truth used

The "ground truth" in this context refers to the established standards for safety and performance for similar medical devices and the functional equivalence to predicate devices. This is demonstrated through:

Compliance with recognized national and international electrical safety and EMC standards (e.g., EN 61326-1, EN 55011, UL 61010-1).
Hardware testing and endurance testing to ensure mechanical integrity and function.
Comparison of technological characteristics and intended use with already-marketed predicate devices, which have a history of safe and effective use.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of new medical devices to existing ones. It relies on standard engineering and safety testing, and direct comparison of technological specifications and intended use against predicates, rather than generating new clinical performance data against specific acceptance criteria for a novel clinical claim.

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 is circular and features the department's name around the perimeter. In the center is a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a modern, abstract design.

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 (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" (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 (800) 638-2041 or (301) 796-7100 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.

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
------------------------------------------------------------------------------	---------

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.

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (101) 443-6740

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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: +49 40 53801 - 188 Establishment Registration No: 801047

Contact: Dr. Cornelia Hildebrandt, Global Product Line Manager Cell Handling Contact's Phone: +49 40 53801 - 188 Contact's Email: hildebrandt.c@eppendorf.de Date Prepared: July 28, 2014

2. DEVICE NAME

Trade Name:	TransferMan ® 4m MicromanipulatorCellTram ® Air MicroinjectorCellTram ® Oil MicroinjectorCellTram ® 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

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® 4mMicromanipulator Eppendorf AG(Proposed)	NAI-5 Micromanipulator SetNarishige Col. Ltd System(K120877)
General	Intended Use	Intended for use in assistedreproduction procedures requiringcoarse and fine positioning of amicrotool under the microscope.	: "… enables course and finepositioning of a microtool under themicroscope and is used in assistedreproduction procedures."
	Components	Motor ModuleControl Board	Drive Unit2 Control Units for coarse and finePower 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 $5 \mu m$incrementsFine: $5 \mu m$ to $2,000 \mu m$ in $5 \mu m$incrementsX-Fine: $1 \mu m$ to $600 \mu m$ in $1 \mu m$increments	Coarse: 22mmFine: 10mmIncrements 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	MechanicalAdjustability	>80 mm	Not known
	Dimensions	Module (X,Y,Z): 129 mm x 51 mm x36 mm (W x D x H)	Drive Unit: 57 mm x 138 mm x94 mm (W x D x H)
	Weight	Motor module (complete): 2.15 kgModule (X,Y,Z): 570g	Not known
	Maximum TravelingDistance	20 mm	Coarse: 22mmFine: 10mm
	Swivel JointDirection ofRotation	-45° - +90°	Not known

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

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	Feature	TransferMan® 4mMicromanipulator Eppendorf AG(Proposed)	NAI-5 Micromanipulator SetNarishige Col. Ltd System(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® MicroinjectorsEppendorf AG(Proposed)	IM-11 Pneumatic MicroinjectorNarishige Co., Ltd.(K113712)
General	Intended Use	Intended for use in Intra-CytoplasmicSpermatozoa Injection (ICSI)procedures to aspirate and injectsperm into oocytes.	Intended for use for Intra-Cytoplasmic Sperm Injection (ICSI)procedures to aspirate and injectsperm into oocytes, and to holdoocytes during the ICSI procedure
	Microinjector Type	CellTram® Air (air transfer medium)CellTram® Oil (oil transfer medium)CellTram® vario (oil transfer medium,coarse/fine adjustment)	Air transfer medium
	Operation	Manual microinjection	Manual microinjection
	MinimumAdjustment Volume	<0.2 µL	Not known
	Adjustment totalvolume	2,640 μL	Not known
	Applications	Gentle holding of larger cells, e.g.oocytesManual microinjection, aspiration anddispensing of cells (e.g. sperms)	Holding oocytesManual aspiration of sperm intoinjection pipetteMicroinjection of sperm into oocytes
	Air	Type	Manual pressure
		Pressure Generation	Piston/cylinder system, filled with air,maintenance-free
		Max Pressure	2,900 hPa
Minimum SettingVolume		<200 nL	Not known
	Feature	CellTram® MicroinjectorsEppendorf AG(Proposed)	IM-11 Pneumatic MicroinjectorNarishige Co., Ltd.(K113712)
	Total SettingVolume	2,640 µL	Not known
	Change in Volume(per dial revolution)	88 µL	coarse: 1.0 mLfine: 250 µL
	Max Range	15 mm (air)	40 mm (coarse and fine combined)30 mm coarse17 mm fine
	Applications	Gentle holding of larger cells, e.g.oocytesManual microinjection, aspiration anddispensing 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 SettingVolume	<20 nL
	Total SettingVolume	960 µL
	Change in Volume(per dial revolution)	9.6 µL
	Max Range	50 mm
vario	Applications	Gentle holding of larger cells, e.g.oocytesManual microinjection, aspiration anddispensing of cells (e.g. sperms)Manual aspiration, dispensing, andremoval of cells and organelles (e.g.polar bodies).
	Type	Manual hydraulic
	Pressure Generation	Piston/cylinder system, with gear,filled with oil	Not Applicable
	Max Pressure	20,000 hPa
	Minimum SettingVolume	<20 nL/<2 nL (coarse/fine)
	Total SettingVolume	960 µL
	Change in Volume(per dial revolution)	course: 9.6 µLfine: 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.

Regulation Number and Section

§ 884.6150 Assisted reproduction micromanipulators and microinjectors.

(a)
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.(b)
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.