The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.

Device Description

The Intractoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for various micro-injection pipettes used in assisted reproduction. However, it does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on indications for use, design, construction, and materials. The "study" mentioned is Mouse Embryo Toxicity testing, but this is a material compatibility test and not a performance study in the context of clinical effectiveness or accuracy.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The submission focuses on substantial equivalence to predicate devices rather than specific quantitative performance criteria for the new devices themselves.	Not specified in the document. No specific performance metrics (e.g., success rate of ICSI, efficiency of denuding, or precision of zona drilling) are reported. The only "performance" mentioned is that the material "meets the requirements" of Mouse Embryo Toxicity tests.

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

Sample Size for Test Set: Not applicable/Not provided. There is no mention of a "test set" in the context of a performance study for the pipettes' intended use.
Data Provenance: Not applicable/Not provided. The Mouse Embryo Toxicity testing is implicitly laboratory-based, but no details on the origin or type of data are given for any performance evaluation.

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

Number of Experts: Not applicable/Not provided. No performance study requiring expert ground truth is described.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not provided. No performance study requiring adjudication is described.

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

MRMC Study Done: No. There is no mention of an MRMC study or any study comparing human readers (or users of the device) with or without AI assistance. The devices are tools, not AI algorithms.
Effect Size of Human Readers with vs. without AI: Not applicable/Not provided.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Study Done: No. The devices are physical tools (pipettes), not algorithms. Performance is related to their physical properties and material safety, not an algorithm's standalone capability.

7. Type of Ground Truth Used

Type of Ground Truth: For the material safety (Mouse Embryo Toxicity test), the "ground truth" would be established by the defined pass/fail criteria of the toxicity test itself, likely based on viability or developmental benchmarks of mouse embryos exposed to the material. No clinical or diagnostic "ground truth" is established for the pipettes' functional performance.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not provided. The submission describes medical devices (pipettes), not an AI algorithm requiring a training set.

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

How Ground Truth Was Established: Not applicable/Not provided. As above, these are physical devices, not an AI algorithm with a training set.

Summary of the K983596 Submission's Approach:

The K983596 submission primarily establishes substantial equivalence by demonstrating that the Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are similar in indications for use, design, construction, and materials to previously marketed predicate devices (Humagen Fertility Diagnostics Inc., SWEMED LAB International AB, and Cook Australia products available in Europe).

The only specific testing mentioned is Mouse Embryo Toxicity testing performed on the borosilicate glass material from which the pipettes are made. The submission states, "Results show the material meets the requirements of these tests," which serves as evidence of biocompatibility and material safety, rather than functional performance or clinical efficacy against specific acceptance criteria.

The FDA's successful clearance (K983596) indicates acceptance of this substantial equivalence argument, rather than a direct demonstration of meeting explicit performance criteria through a dedicated clinical or comparative study as might be expected for novel or higher-risk devices or AI algorithms.

Summary

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K983596

10(k) Premarket Notification tracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes Cook OB/GYN

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS L

Submitted By:

FEB

Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 October 13, 1998

Device:

Trade Name:

Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes

Proposed Classification Name:	Class II Assisted Reproduction Microtools
	85MQH
CFR Reference:	884.6130

Predicate Devices:

Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used other devices as well as Cook Australia devices as our predicate to illustrate safety and effectiveness.

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are substantially equivalent to other pipettes in terms of indications for use, design, construction and materials equivalence.

Specifically, these devices are similar to the Intracytoplasmic Micropipet and Holding Micropipet manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way (No. 2), Charlottesville, VA 22901-7928, the Laboratory Micropipette Art. No. 33311 and Laboratory Micropipette Art. No. 22218 manufactured by SWEMED LAB International AB, Box 4014 S-421 04 V. Frolunda, Sweden and the (ICSI) pipettes, holding

pipettes, denuding pipettes and assisted hatching/zona drilling pipettes manufactured and distributed in Europe by Cook Australia, 12 Electronics Street, Brisbane Industrial Park, Eight Miles Plains, Queensland, 4113, Australia.

Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/2 description: The image shows a logo or seal with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN". Inside the circle is a stylized graphic of three overlapping figures or shapes, possibly representing people or abstract forms. The overall design is simple and monochromatic.

5 1999 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debbie Schmitt Regulatory Affairs Manager Cook Ob/Gyn® 1100 West Morgan Spencer, IN 47460

Re: K983596

Intracytoplasmic Sperm Injection Micro-Injection Pipettes, Holding Pipettes and Assisted Hatching/Zona Drilling Pipettes Dated: December 23, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 884.6130/Procode: 85 MQH

Dear Ms. Schmitt:

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, 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.

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 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 requlation 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,

Cont. 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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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT JOE 35 S

K983596

510(k) Number (if known): Not yet assigned

Device Name:

Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes Holding Pipettes Denuding Pipettes Assisted Hatching/Zona Drilling Pipettes

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K983596/S002

Prescription Use	OR	Over-The-Counter Use
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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.