INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA

K102480 · Jieying Laboratory, Inc. · MQH · Apr 19, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K102480
• Device Name: INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
• Applicant: Jieying Laboratory, Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Apr 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Intended Use

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 Story

Glass capillary microtools used in IVF/ART laboratories; operated by embryologists/technicians. Pipettes facilitate micromanipulation of human gametes/embryos. Specific functions: injection (ICSI), holding (oocyte/embryo stabilization), biopsy (blastomere/polar body removal for genetic diagnosis), denuding (cumulus cell removal via enzymes), and assisted hatching (mechanical or chemical zona pellucida defect creation). Devices are gamma-radiated, single-use, and non-toxic. Clinical benefit: enables essential ART procedures for fertilization and genetic assessment.

Clinical Evidence

Bench testing only. Includes LAL (Limulus Amebocyte Lysate) endotoxin testing (limit <20 EU/device) and Mouse Embryo Assay (MEA) (passing criteria: >80% development to blastocyst stage after 96 hours). Sterility testing performed on aged samples.

Technological Characteristics

Glass capillary tubing; various beveled angles and sizes; gamma-radiated; non-toxic; single-use. No electronic or software components.

Indications for Use

Indicated for use in IVF/ART laboratories for micromanipulation, denuding, holding, or biopsy of human oocytes and embryos, including ICSI, assisted hatching, and preimplantation genetic diagnosis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Intracytoplasmic Sperm Injection (ICSI) Micropipets (K990847)
• Holding Micropipets (K990847)
• Blastomere Biopsy Micropipet (K012811)
• Polar Body Biopsy Micropipet (K012811)
• Denuding Micropipettes (K990847)
• Partial Zona Dissection (PZD) pipette (K990847)
• Assisted Hatching (AH) Micropipets (K990847)

Submission Summary (Full Text)

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APR 1 9 2011

5. 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: [phone]; Fax: [phone]; Website: www.jieyinglabs.com

SUMMARY

#### Jieying Laboratory Inc. Submitter's name: 982 Trans-Canada Address: Longueuil, Quebec Canada J4G 2M1 Phone: [phone] [phone] Fax number: Grace Holland Name of contact person: Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] 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)

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| Jieying<br>Laboratory Device | Predicate Device<br>Name | Predicate K<br>Reference | Applicant |
|---------------------------------------------|-----------------------------------------------------------|--------------------------|----------------------------------------|
| Injection pipette | Intracytoplasmic<br>Sperm Injection<br>Micropipets (ICSI) | K990847 | Humagen Fertility<br>Diagnostics, Inc. |
| Holding pipette | Holding Micropipets | K990847 | Humagen Fertility<br>Diagnostics, Inc. |
| Biopsy pipette | Blastomere Biopsy<br>Micropipet | K012811 | Humagen Fertility<br>Diagnostics, Inc. |
| Polar body biopsy<br>pipette | Polar Body Biopsy<br>Micropipet | K012811 | Humagen Fertility<br>Diagnostics, Inc. |
| Denuding pipette | Denuding<br>Micropipettes | K990847 | Humagen Fertility<br>Diagnostics, Inc. |
| Partial zona<br>dissection (PZD)<br>pipette | Partial Zona<br>Dissection (PZD)<br>pipette | K990847 | Humagen Fertility<br>Diagnostics, Inc. |
| Assisted hatching<br>(AH) pipette | Assisted Hatching<br>(AH) Micropipets | K990847 | Humagen Fertility<br>Diagnostics, Inc. |

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

Description of the device:

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.

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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

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

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.

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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

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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

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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 [phone] or [phone] 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

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#### 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

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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

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#### 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

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# 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

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# 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

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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

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#### 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