These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
These devices are used for I.C.S.I. (Intra cytoplasmic sperm injection)

Device Description

The holding and injection pipettes were made from 30µl borosilicate glass capillary tubes, 78mm in length and with inner and outer diameters of 0.69 and 0.97mm respectively. The glass pipettes were obtained by drawing thin-walled glass capillary tubes using a horizontal microelectrode puller. The holding pipette was cut and firepolished on a microforge to obtain an outer diamter of 50um and an inner diameter of 20um. To prepare the injection pipette, the pulled capillary was opened on a microgriner to an outer diameter of 7um and an inner diameter of 5um; the bevel angle was 45°. This grinding step required ~3 minutes. The whetstone of the grinder was humidified by a slow water drip during the procedure. The microforge was then used to make a sharp spike on the injection piepette and to bend the edge of the holding and injection pipettes to an angle of ~35° to facilitate the injection procedure in the Petri dish.

AI/ML Overview

This is a 510(k) summary for Prodimed Microinjection Pipettes, which are manual tools used in assisted reproduction. This type of device is not an AI/ML device, so many of the requested categories are not applicable.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for this type of medical device submission.

Acceptance Criteria and Device Performance Study

The primary acceptance criteria for this type of device, as implied by the 510(k) submission, revolve around its substantial equivalence to existing, legally marketed predicate devices. This means demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.

The document describes the device's functional and physical characteristics rather than performance metrics from a clinical study. The "study" proving acceptance criteria is effectively the demonstration of these characteristics and their similarity to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit in 510(k))	Reported Device Performance/Characteristics
Intended Use Equivalence: Same indications for use as predicate devices.	Used to "introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body" and specifically for "I.C.S.I. (Intra cytoplasmic sperm injection)." This matches the general intended use of assisted reproduction microtools.
Technological Characteristics Equivalence: - Material composition and physical properties are safe and effective for the intended use and similar to predicates. - Performance (Function) specifications met. - Sterility and biocompatibility.- Manufacturing Quality.	Micro-Injection Pipettes: Made from borosilicate glass capillary tubes. Holding pipette: outer diameter 50um, inner diameter 20um. Injection pipette: outer diameter 7um, inner diameter 5um; bevel angle 45°. Spike present. Holding Pipettes: Made from borosilicate glass capillary tubes. Material: Borosilicate Glass (Boron Oxide, Sodium Oxide). Performance (Function): "Clear view and full control of the sperm for precision manipulation." "Bevel equipped with a short, sharp spike for easy, non-traumatising penetration of the oocyte." "Effective prehension by the holding pipettes to avoid rotation of the oocyte during the micro-injection." Quality and Security: "Manufactured according to ISO 9001 and EN 46001 standards." "Routine performance of tests with revelation of biological indicators, search for endotoxins and embryotoxicity tests." "Guaranteed sterility of pipettes."
Safety and Effectiveness: No new questions of safety or effectiveness raised by differences from predicates.	The FDA letter explicitly states, "we have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This is the ultimate "acceptance" for a 510(k) submission, confirming that no new safety or effectiveness concerns were identified.

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

Not applicable. This is a 510(k) for a physical medical device (pipettes), not an AI/ML device that would involve a "test set" in the computational sense. The submission relies on characterizing the device's physical properties, materials, and manufacturing processes, and demonstrating substantial equivalence to predicate devices, rather than statistical performance on a test dataset.

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

Not applicable. There is no "ground truth" establishment in the context of an AI/ML model for this type of device. The ground truth for device safety and effectiveness is established through adherence to manufacturing standards, material specifications, and comparison to legally marketed predicate devices used in clinical practice. The FDA review team acts as the expert body determining substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" or image/data adjudication process for this type of medical device submission.

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. This is not an AI-assisted device. It is a manual microtool.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the AI/ML sense. The "ground truth" for the acceptance of this device is its demonstrated substantial equivalence to legally marketed predicate devices, established through:

Verification of its physical and functional characteristics.
Confirmation that its materials (borosilicate glass) are safe and commonly used in similar applications.
Adherence to quality manufacturing standards (ISO 9001 and EN 46001).
Performance of biological indicator tests, endotoxin testing, and embryotoxicity tests.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no "training set."

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

Not applicable.

Summary

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8 1999 JUN

K983713

510(K) Summary

February 23, 1999

PRODIMED Laboratories c/o Washington Regulatory Services Randolph L. Cooke 23 Welisewitz Road Ringoes, NJ 08551 609-466-0510 Fax 609-466-4443

1. DEVICE NAME:
  Proprietary Names: Prodimed Microinjection Pipettes

Common Name: Assisted Reproduction Microtools

Classification Name: Assisted Reproduction catheters are classified as Class II at 21 CFR 884.6130. The product code is 85 MQH.

IDENTIFICATION: The Assisted Reproduction microtool devices have been down classified FR Vol. 63, No. 175 September 10, 1998. Effective date: October 13, 1998.

4) DESCRIPTION OF DEVICE:

As found in the labeling/promotional material:

Quality and Security:

Permanence and reproducibility of production .
Manufactured according to ISO 9001 and EN 46001 standards .
. Routine performance of tests with revelation of biological indicators, search for endotoxins and embryotoxicity tests

Performance: (Function)

Clear view and full control of the sperm for precision manipulation .
. Bevel equipped with a short, sharp spike for easy, non-traumatising penetration of the oocyte
. Effective prehension by the holding pipettes to avoid rotation of the oocyte during the micro-injection

Ergonomics:

Totally safe transport of pipettes thanks to a patented protective stand .
. Easy, safe handling by simply pressing the base of the instrument between the thumb and index finger

00:

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Wide Range:

Standard availability of pipettes with spike and 8um opening, straight or curved at . 20° and 30°
Availability on order of spiked or non-spiked pipettes, opening of 6um, or 8um, . straight or curved at 20° and 30°
Wide choice suitable for every type of installation on all microscopes and . instrument stands

UNILAM:

Ready-to-use and easy to handle device ●
Provides rapid location of the oocyte .
. Guaranteed sterility of pipettes and perfect visibility
Adapted to heating plates in order to keep the most convenient ternperature for ● gamete survival

Function of Device/Significant Physical Characteristics of Device:

Device Design/ Material Used/ Physical Properties:

Micro-Injection Pipettes: N51-A Device Part Borasilicate Glass

Material Used Borone Oxide Sodium Oxide

5) STATEMENT OF INTENDED USED

These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

MICRO-INJECTION PIPETTES - Box of 10 units

13810008 Opening 8um with Spike Straight

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13812008	Opening 8μm with Spike Angle 20°
----------	----------------------------------

Opening 8um with Spike Angle 30° 13813008

HOLDING PIPETTES - Box of 10 units

13900015	Opening 15μm Straight
13902015	Opening 15μm Angle 20°
13903015	Opening 15μm Angle 30°
1303200	UNILAM

SPECIAL MANUFACTURING

MICOR-INJECTION PIPETTES - Box of 10 units Delivery delay of 8 weeks after confirmation order

13800008	Opening 8µm without Spike Straight
13802008	Opening 8µm without Spike Angle 20°
13803008	Opening 8µm without Spike Angle 30°
13810006	Opening 6µm with Spike Straight
13812006	Opening 6µm with Spike Angle 20°
13813006	Opening 6µm with Spike Angle 30°
13800006	Opening 6µm without Spike Straight
13802006	Opening 6µm without Spike Angle 20°
13803006	Opening 6µm without Spike Angle 30°

6) TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE:

Design Material:

の --------------------------------------------------------------------------------------------------------------------------------------------------------------------------

ICSI Injection: Intracytoplasmic injection micropipettes are prepared from borosilicate glass tubing (OD: 1mm ID: 0,75m)

ICSI Holding: Intracytoplasmic injection micropipettes are prepared from borosilicate glass tubing (OD: 1mm ID: 0,75m)

Chemical Composition
Borasilicate Glass:	Boron Oxide	ACGIH TLV 10mg/m3
		OSHA PEL 15mg/m3
	Sodium Oxide	ACGIH TLV Not Recommended
		OSHA PEL Not Regulated

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Image /page/3/Picture/2 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 a stylized image of an eagle with three overlapping wing shapes, suggesting movement or flight.

JUN 8 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PRODIMED Laboratories c/o Washington Regulatory Services, Inc. Mr. Randolph L. Cooke 23 Welisewitz Road Ringoes, N.J. 08551

Re: K983713

Prodimed Microinjection Pipettes Dated: March 11, 1999 Received: March 15, 1999 Regulatory Class: II 21 CFR 884.6130/Procode: 85 MQH

Dear Mr. Cooke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls r outs an ook 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requiration entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CART Daniel C. Schultz, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN)____________________________________________________________________________________

DEVICE NAME: Micro-Injection Pipettes

INDICATIONS FOR USE:

These devices are used for I.C.S.I. (Intra cytoplasmic sperm injection)

MICRO-INJECTION PIPETTES - Box of 10 units

13810008	Opening 8µm with Spike Straight
13812008	Opening 8µm with Spike Angle 20°
13813008	Opening 8µm with Spike Angle 30°

HOLDING PIPETTES - Box of 10 units

13900015	Opening 15µm Straight
13902015	Opening 15µm Angle 20°
13903015	Opening 15µm Angle 30°
1303200 UNILAM

SPECIAL MANUFACTURING MICOR JINIT CITION PIPETTES - Box of 10 units Delivery delay of 8 weeks after confirmation order

13800008	Opening 8µm without Spike Straight
13802008	Opening 8µm without Spike Angle 20°
13803008	Opening 8µm without Spike Angle 30°
13810006	Opening 6µm with Spike Straight
13812006	Opening 6µm with Spike Angle 20°
13813006	Opening 6µm with Spike Angle 30°
13800006	Opening 6µm without Spike Straight
13802006	Opening 6µm without Spike Angle 20°
13803006	Opening 6µm without Spike Angle 30°

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFE 801.109 OR

Over-The Counter-Use _________________________________________________________________________________________________________________________________________________________ (Options Format 1-2-96)

Ra-Pales

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Regulation Number and Section

§ 884.6130 Assisted reproduction microtools.

(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.