The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows:

Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI)

Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy

Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s)

Polar Body Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s)

Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos

Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation

Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically

Device Description

The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

a. Injection pipette;
b. Holding pipette;
c. Biopsy pipette;
d. Polar body biopsy pipette;
e. Denuding pipette;
f. Partial zona dissection (PZD) pipette;
g. Assisted hatching (AH) pipette.

AI/ML Overview

The provided document describes Jieying Laboratory Inc.'s micro-manipulation pipettes and their equivalence to predicate devices, focusing on the safety and performance characteristics for regulatory approval.

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
LAL (Limulus Amboycte Lysate) Testing:	Each batch performs LAL testing. Level of endotoxin units must be < 20 EU/device.
Endotoxin levels	All test samples met the < 20 EU/device requirement.
MEA (Mouse Embryo Assay) Testing:	1-cell zygotes cultured with the broken tip of the pipette for 96 hours in 37°C, 5% CO2 incubator. Product is non-toxic if ≥ 80% embryos develop to blastocyst stage.
Embryo development to blastocyst stage	All test samples showed ≥ 80% of embryos developing to blastocyst stage, indicating non-toxicity.
Sterility Testing:	Samples over two years of age undergo sterility testing.
Sterility of aged samples	All test samples passed sterility testing.
Shelf-Life Evaluation:	Defined shelf-life based on testing.
Shelf-life	Shelf-Life has been set at two years.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the specific sample sizes for the LAL, MEA, and sterility tests. It refers to "each batch" for LAL and "samples" for MEA and sterility testing.
- The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be internal testing conducted by Jieying Laboratory Inc.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable. The ground truth for these tests (endotoxin levels, embryo development, sterility) is established by quantitative laboratory assays with predefined thresholds, not by expert consensus.
Adjudication Method for the Test Set: Not applicable. The tests are laboratory assays with clear pass/fail criteria, not subjective assessments requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for the described safety and performance tests of micro-manipulation pipettes. These are not imaging devices or diagnostic tools requiring human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI/algorithm-based device. The "device" refers to physical micro-manipulation pipettes.
The type of ground truth used:
- LAL Testing: Quantitative measurement of endotoxin units (EU/device).
- MEA Testing: Percentage of 1-cell zygotes developing to the blastocyst stage.
- Sterility Testing: Confirmation of absence of microbial growth.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to the development and validation of the manufacturing processes and quality control methods.
How the ground truth for the training set was established: Not applicable, as there is no training set in the context of an AI/ML device. For the manufacturing and quality control processes, the "ground truth" is established through standard laboratory methods and regulatory guidelines (e.g., ISO, FDA guidance) for medical device manufacturing and testing.

Summary

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

APR 1 9 2011

510(k) Summary

Image /page/0/Picture/3 description: The image shows a logo with a circle containing a stylized, curved line that resembles a bird in flight or a wave. Below the circle, the text "JY LABS" is printed in a simple, sans-serif font. The logo is black and white and appears to be a company or brand identifier.

J. Y. Laboratory Inc. 982 Trans-Canada, Longueuil, Quebec, Canada J4G 2M1 Tel: 450-674-6886; Fax: 450-674-8282; Website: www.jieyinglabs.com

SUMMARY

Jieying Laboratory Inc. Submitter's name: 982 Trans-Canada Address: Longueuil, Quebec Canada J4G 2M1 Phone: +1 450 674 6886 +1 450 674 8282 Fax number: Grace Holland Name of contact person: Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821 April 15, 2011 Date Summary was revised: · Name of the devices: a. Injection pipette; b. Holding pipette; Biopsy pipette; ﻥ d. Polar body biopsy pipette; e. Denuding pipette; f. Partial zona dissection (PZD) pipette; g. Assisted hatching (AH) pipette. Jieying Laboratory Inc. Micro-Manipulation Trade or proprietary name: Pipettes Assisted reproduction microtools or pipettes Common or usual name: Classification name: Microtools, Assisted Reproduction (Pipettes)

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

JieyingLaboratory Device	Predicate DeviceName	Predicate KReference	Applicant
Injection pipette	IntracytoplasmicSperm InjectionMicropipets (ICSI)	K990847	Humagen FertilityDiagnostics, Inc.
Holding pipette	Holding Micropipets	K990847	Humagen FertilityDiagnostics, Inc.
Biopsy pipette	Blastomere BiopsyMicropipet	K012811	Humagen FertilityDiagnostics, Inc.
Polar body biopsypipette	Polar Body BiopsyMicropipet	K012811	Humagen FertilityDiagnostics, Inc.
Denuding pipette	DenudingMicropipettes	K990847	Humagen FertilityDiagnostics, Inc.
Partial zonadissection (PZD)pipette	Partial ZonaDissection (PZD)pipette	K990847	Humagen FertilityDiagnostics, Inc.
Assisted hatching(AH) pipette	Assisted Hatching(AH) Micropipets	K990847	Humagen FertilityDiagnostics, Inc.

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

Description of the device:

a. Injection pipette;
b. Holding pipette;
c. Biopsy pipette;
d. Polar body biopsy pipette;
e. Denuding pipette;
f. Partial zona dissection (PZD) pipette;
g. Assisted hatching (AH) pipette.

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

Indications:

The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows:

Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI)

Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy

Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation

Summary of the technological characteristics of our device compared to the predicate devices:

The Jieving Laboratory Devices have the same technological characteristics (i.e., testing, design, material, shapes and sizes) as the predicate devices.

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

LAL and MEA testing performed:

LAL (Limulus Amboycte Lysate) testing is performed on each batch of microtools. The level of endotoxin units must be less than 20 EU/device to be considered acceptable.

MEA (Mouse Embryo Assay) is cultured 1-cell zygotes together with the broken tip of the pipette for 96 hours in 37°C, 5% CO2 incubator. The product is considered non-toxic if the percentage of embryos developing to blastocyst stage is greater than 80%.

Sterility And Shelf-Life Evaluations:

Sterility testing was done on samples that were over two years of age. All test samples passed sterility testing. Shelf-Life has been set at two years.

The predicates and the Jieying Laboratory Inc. microtools were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Indications for Use Design Materials Safety Features Sterility Manufacturing Technique

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

APR 1 9 2011

Jieying Laboratory, Inc. c/o Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K102480

Trade Name: Micro-Manipulation Pipettes (Iniection Pipette, Holding Pipette, Biopsy Pipette, Polar Body Biopsy Pipette, Denuding Pipette, Partial Zona Dissection Pipette, Assisted Hatching Pipette) Regulation Number: 21 CFR §884.6130

Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: MQH Dated: April 5, 2011 Received: April 12, 2011

Dear Ms. Holland:

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 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 of medical device-related

{5}------------------------------------------------

Page 2

adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name: Injection Pipette

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI).

AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D). (21 CFR 801 Subpart C) . ..

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

ductive, Gastro-Renal, and

Page 1 of 1

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name: _ _ Holding Pipette

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy.

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) .. (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Keela Leni

Division Sign-Off) of Reproductive. Gastro-Renal, and gical Devices 510(k) Number

Page 1 of 1

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name: Biopsy Pipette

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s)

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard Keen

Division Sign-Off lon of Reproductive, Gastro-Renal, and Jrological Devices S10(k) Number

Page 1 of 1

{9}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name: Polar Body Biopsy Pipette

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s).

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Halad Remu

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102480

{10}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name: _________________________________________________________________________________________________________________________________________________________________ Denuding Pipette

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

--- words to the current word ---

Kobert Renner

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102480

{11}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name:

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically.

AND/OR Over-The-Counter Use × Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Hebert Plumer

(Division Sian-Off) on of Reproductive, Gastro-Renal, and

{12}------------------------------------------------

Indications for Use

510(k) Number (if known): K102480

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

signature

Division Sign-C roductive. Gastro-Renal, and

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.