"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.

"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.

REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.

REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.

USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.

Device Description

"THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips.

"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.

AI/ML Overview

The provided document describes the "THE STRIPPER®" Micropipetter and Micropipetter Tips, a device used in In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. The document includes information on the device's testing procedures and, by extension, its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mouse Embryo Bioassay (Toxicity Testing)
% Development to Blastocyst at 96 hours (Test Article)	> 70%
% Development to Blastocyst at 96 hours (Control Medium)	> 70% (Indicates a valid assay)
Sterility Testing
Sterility Assurance Level (SAL)	10⁻⁶
Minimum Radiation Dose (for sterilization)	15 kGy (Established by AAMI Method I, SIP)
Maximum Radiation Dose (for sterilization)	25 kGy
Endotoxin Testing (Limulus Amebocyte Lysate Assay)
Endotoxin Level per device	< 0.03 EU/ml

2. Sample Sizes Used for the Test Set and Data Provenance:

Mouse Embryo Bioassay: The text states "microdrops" are used, and embryos are added to "both the test and control medium." It does not specify the exact number of embryos per microdrop or the total number of embryos tested per lot. The data provenance is implied to be prospective as each "lot of micropipettes" is tested. The country of origin of the data is not specified but is implicitly from Mid-Atlantic Diagnostics, Inc. in the USA.
Sterility Testing: The sterilization validation program follows the United States Pharmacopeia 23 (71) procedure. The document mentions "every lot being validated for sterility." The exact sample size (number of devices per lot tested) is not specified. Data provenance is prospective per lot.
Endotoxin Testing: "Each lot of micropipettes is also tested." The specific number of devices tested per lot is not stated. Data provenance is prospective per lot.

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

The document does not mention the use of experts to establish the ground truth for the device's performance tests. The tests (mouse embryo bioassay, sterility, endotoxin) are laboratory assays with objective, measurable outcomes, not requiring expert human interpretation for ground truth establishment in the described context.

4. Adjudication Method for the Test Set:

Not applicable. The described tests are laboratory assays with predefined quantitative thresholds for acceptance, not requiring an adjudication method involving human interpretation.

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

No, an MRMC comparative effectiveness study was not conducted. The provided document focuses on the safety and performance characteristics of "THE STRIPPER®" itself through laboratory testing, not on comparing the effectiveness of human readers with and without AI assistance.

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

Yes, a standalone study was done. The performance evaluation presented is entirely based on the device's intrinsic characteristics through laboratory assays (mouse embryo bioassay, sterility testing, endotoxin testing). There is no "human-in-the-loop" component to these performance measurements.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations is based on:

Biological/Empirical Outcomes: For the mouse embryo bioassay, the ground truth is the observable development of mouse embryos to the blastocyst stage after exposure to the device extract, compared to a control.
Quantitative/Analytical Measurements: For sterility, the ground truth is the absence of microbial growth as determined by validated microbiological methods to a specified Sterility Assurance Level. For endotoxin, the ground truth is the measured concentration of endotoxins in EU/ml as determined by the Limulus Amebocyte Lysate assay.

8. Sample Size for the Training Set:

Not applicable. This device is a manual micropipetter and tips, not an AI/ML algorithm. Therefore, there is no "training set" in the context of an algorithmic model.

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

Not applicable, as there is no training set for this type of device.

Summary

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ATTACHMENT I

510(K) SUMMARY Mid-Atlantic Diagnostics, Inc. - "THE STRIPPER®"

This 510(K) Summary of safety and effectiveness for the Mid-Atlantic Diagnostics, Inc. "THE STRIPPER®" is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant: Mid-Atlantic Diagnostics, Inc.

Address: 338 Stokes Road Medford, NJ 08055
Contact Person: Terrance J. Fortino, President

Telephone #: (609) 953-3380

Fax #: (609) 953-3286

Preparation Date: October 29, 1999

Device Trade Name: "THE STRIPPER®" Micropipetter and Micropipetter Tips

Common Name: Micropipettes used for IVF

Classification Name: Assisted Reproduction Microtools (per 21 CFR 884.6130) 85-MQH

Substantial Equivalence: Substantial equivalence is being supported by the Federal Register Notice Final Rule entitled "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures. This equivalence is supported by the Summary statement:

Upon the effective date, the Federal Register document may be cited in the absence of an existing predicate device which would be used to support substantial equivalence.

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Description of Mid-Atlantic Diagnostics, Inc. "THE STRIPPER®:

"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.

Testing Procedures:

Each lot of micropipettes is mouse embryo tested for toxicity using a onecell mouse embryo bioassay. The assay is performed utilizing freshly collected embryos and culturing them in HTF medium supplemented with 0.4% BSA which was exposed to the test article. The extracted test media and non-extracted HTF medium (control) is placed in a culture dish in triplicate microdrops and overlaid with light mineral oil. The dish is allowed to equilibrate in an atmosphere of 5% CO2 at 30°C for a minimum of 2 hours. Following equilibration, the embryos are added to both the test and control medium and returned to the incubator. Embryo development is noted at 24 and 96 hours. Test articles that score > 70% development to blastocyst at 96 hours are considered non-toxic. A score of > 70% to blastocyst in the control medium indicates a valid assay.

Sterilization is performed by gamma irradiation. The sterilization validation program follows the United States Pharmacopeia 23(71) procedure. It is justified due to a low bioburden and every lot being validated for sterility. The sterility assurance level for the micropipette is 106.

The minimum established radiation dose is 15 kGy established by AAMI Method I, SIP. The maximum radiation dose is 25 kGy.

Each lot of micropipettes is also tested for endotoxin levels using the Limulus Amebocyte Lysate assay. The level of endotoxin units per device must be less than 0.03 EU/ml to be considered acceptable.

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Intended Use Statement:

"THE STRIPPER®" micropipette family's indication for use is to manipulate and transfer zygotes and embryos during IVF and ICSI procedures.

"THE STRIPPER®" micropipettes are used in the tissue culture techniques performed by embryologists when preparing oocytes for IVF, ICSI and assisted hatching techniques prior to re-implantation.

"THE STRIPPER®" micropipettes are tools used in procedures that have been developed to aid infertile couples achieve pregnancy.

Performance Standards: Not Applicable

Conclusion: Mid-Atlantic Diagnostics, Inc. "THE STRIPPER®" Micropipetter and Micropipette Tips are substantially equivalent to other existing micropippette tools used in the IVF procedure.
Additional Information: None requested at this time

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2000

Mr. Terrance J. Fortino President MidAtlantic Diagnostics, Inc. 338 Stokes Road, Suite E Medford, NJ 08055

Re: K993699 The Stripper® Assisted Reproduction Microtool Dated: February 10, 2000 Received: February 16, 2000 Requiatory Class: Il 21 CFR §884.6130/Procode: 85 MQH

Dear Mr. Fortino:

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 26, 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 provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premattet 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 equivalion 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 regulator, 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 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) 594-4591. 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" (21CFR 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/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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INDICATION FOR USE STATEMENT

510(K) NUMBER: K993699

DEVICE NAME: MID-ATLANTIC DISGNOSTICS, INC. "THE STRIPPER®"

INDICATIONS FOR USE:

"THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES.

"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.

"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.

REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.

REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.

USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

PRESCRIPTION USE L (PER 21 CFR 801.109)

OVER THE COUNTER USE

Urint M. Regerson
(Division Sign-Off)

Division of Reproductive, Abdominal, E. and Radiological Deyices

510(k) Number K993699

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.