(232 days)
Not Found
No
The device description and intended use clearly describe manual glass microtools used in ART procedures, with no mention of automated processes, software, or AI/ML capabilities. Performance studies focus on material properties and biological compatibility, not algorithmic performance.
No
The device, a set of microtools/pipettes, is used in Assisted Reproductive Technology (ART) laboratories to perform procedures such as ICSI, embryo biopsy, or assisted hatching. These procedures are diagnostic or facilitative steps in the process of achieving pregnancy, rather than directly treating a disease or condition within the patient. The tools manipulate gametes or embryos in vitro, which is an intermediate step in treatment, not the therapeutic outcome itself.
No
The device description clearly states that these are "assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos". They are tools used in procedures, not for diagnosis. While some types like the Biopsy Pipette are used to obtain samples for "preimplantation genetic diagnosis", the pipette itself is the tool for obtaining the sample, not the diagnostic device.
No
The device description explicitly states the microtools are made of glass capillary tubing and are physical instruments used in a laboratory setting. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device that is used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described microtools are used for physically manipulating human gametes (sperm and eggs) and embryos outside the body in a laboratory setting. They are tools for performing procedures like injection, holding, biopsy, and denuding.
- Intended Use: The intended use clearly states they are for "Assisted Reproductive Technology (ART) and Reproductive Medicine (RM)" and describes their specific roles in procedures like ICSI, biopsy, and assisted hatching. These are procedures performed on the gametes and embryos themselves, not tests performed on specimens derived from the human body for diagnostic purposes.
- Performance Studies: The performance studies focus on the sterility, endotoxin levels, and toxicity to mouse embryos, which are relevant to the safety and efficacy of the tools for handling gametes and embryos, not on the diagnostic accuracy of a test.
- Predicate Devices: The predicate devices listed are also described as micropipettes and microtools used in ART procedures, further supporting their classification as tools for manipulation rather than diagnostic devices.
While the procedures performed using these tools (like preimplantation genetic diagnosis on biopsied cells) might involve subsequent IVD testing, the microtools themselves are the instruments used to obtain the sample or perform the manipulation, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
MQH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory / IVF/Assisted Reproduction Technology (ART) laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
| Jieying
Laboratory Device | Predicate Device
Name | Predicate K
Reference | Applicant |
|---------------------------------------------|-----------------------------------------------------------|--------------------------|----------------------------------------|
| Injection pipette | Intracytoplasmic
Sperm Injection
Micropipets (ICSI) | K990847 | Humagen Fertility
Diagnostics, Inc. |
| Holding pipette | Holding Micropipets | K990847 | Humagen Fertility
Diagnostics, Inc. |
| Biopsy pipette | Blastomere Biopsy
Micropipet | K012811 | Humagen Fertility
Diagnostics, Inc. |
| Polar body biopsy
pipette | Polar Body Biopsy
Micropipet | K012811 | Humagen Fertility
Diagnostics, Inc. |
| Denuding pipette | Denuding
Micropipettes | K990847 | Humagen Fertility
Diagnostics, Inc. |
| Partial zona
dissection (PZD)
pipette | Partial Zona
Dissection (PZD)
pipette | K990847 | Humagen Fertility
Diagnostics, Inc. |
| Assisted hatching
(AH) pipette | Assisted Hatching
(AH) Micropipets | K990847 | Humagen Fertility
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.
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
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.
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