The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of blastomeres for pre-implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.

"This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.

Device Description

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of blastomeres for Pre-Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.

These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes). This document asserts substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating performance against specific criteria in the way one would expect for a more complex diagnostic or therapeutic device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) does not explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The reported "performance" is primarily related to material safety and manufacturing quality rather than diagnostic accuracy or clinical efficacy.

Feature / Test	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Substantially equivalent to predicate device for aspiration of blastomeres.	"The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of blastomeres for Pre-Implantation genetic diagnosis." This is stated as being similar to predicate devices.
Design, Construction, Material	Substantially equivalent to predicate device.	"The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are substantially equivalent to other pipettes in terms of indications for use, design, construction and material equivalence." Devices are "manufactured entirely from borosilicate glass."
Sterility	Marketed sterile.	"These devices are intended for one-time use and will be marketed sterile." Compliance to unspecified sterilization standards is implied for marketed sterile devices.
Material Biocompatibility (Mouse Embryo Toxicity)	Material meets requirements of the test.	"Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests."
Material Biocompatibility (Endotoxin)	Material meets requirements of the test.	"Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests."
Manufacturing Process & Quality	Manufactured according to specified process controls and a Quality Assurance Program.	"This device will be manufactured according to specified process controls and a Quality Assurance Program." (No specific metrics provided).

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

Not applicable. This 510(k) submission primarily focuses on substantial equivalence based on design, materials, and intended use to existing devices, and biocompatibility testing. There isn't a "test set" of clinical cases or data in the context of diagnostic accuracy for this type of basic microtool. The data provenance for the biocompatibility tests (Mouse Embryo Toxicity and Endotoxin testing) is not specified (e.g., country of origin, retrospective/prospective).

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

Not applicable. As this device is a microtool for cell manipulation rather than a diagnostic algorithm, there is no "ground truth" derived from expert consensus on clinical cases. The "ground truth" would be the verified safety of the materials and the functional design for its intended purpose.

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. This device is not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical microtool, not an algorithm or software.

7. The Type of Ground Truth Used

For the biocompatibility claims:

Mouse Embryo Toxicity and Endotoxin Testing Results: These tests in laboratories define the "ground truth" for material safety as per established biological evaluation standards. The "results show the material meets the requirements of these tests," indicating a pass/fail ground truth based on the specific test's criteria.

For the substantial equivalence claim:

Comparison to Predicate Device: The "ground truth" for substantial equivalence is the existing, legally marketed predicate device (Cook Australia's pipettes) in terms of its indications for use, design, construction, and materials.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI component requiring a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

K014160

FEB 0 8 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.

Submitted By:

Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 December 14, 20001

Device:

Trade Name:

Pre-Implantation Genetic Diagnosis Pipettes (Biopsy 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 Cook Australia devices as our predicate to illustrate safety and effectiveness.

The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are substantially equivalent to other pipettes in terms of indications for use, design, construction and material equivalence.

Specifically, these devices are similar to the 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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of the human form. The image is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 8 2002

Ms. Debbie Schmitt Regulatory Affairs Manager COOK® Urological 1100 W. Morgan Street SPENCER IN 47460

Re: K014160 Trade/Device Name: Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) Regulation Number: 21 CFR §884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: December 14, 2001 Received: December 19, 2001

Dear Ms. Schmitt:

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.

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

{2}------------------------------------------------

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "COOK" in a bold, sans-serif font. A circled R symbol is present to the right of the letter K, indicating a registered trademark. The text is black against a white background.

Cook Ob/Gyn 1100 W. Morgan Street Spencer, IN 47460 USA Phone: 812-829-6500 Fax: 812-829-1801 www.cookgroup.com

PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K014160

Device Name:

Pre-Implantation Genctic Diagnosis Pipettes (Biopsy Pipettes)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc
(Per 21 CFR 801.109)

Over-The-Counter Use __

Nancy bradlen

Division of Reproductive, Abdominal,
and Radiological Devices K014160
510(k) Numb

Regulation Number and Section

§ 884.6120 Assisted reproduction accessories.

(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.