Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART).

Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.

Device Description

The Denudation Pipettes are extruded polycarbonate capillary tubes that are pulled at one end to form a tapered tip. They have an outer diameter (OD) of 0.9mm at the proximal end and fit into an actuating device. All tips are approximately 90mm in length and depending on the size of the pipette have a volumetric capacity of 18.6-21.9µl.

The Denudation Pipettes are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:

80μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 210μm, 230μm, 250μm, 270μm, 290μm.

The Denudation Pipettes are radiation sterilized and provided in a sterile pouch, supplied in two packaging options. Each pouch contains 5 or 10 pipettes. All pipettes are intended for single use and disposable.

AI/ML Overview

This 510(k) clearance letter is for Denudation Pipettes, a Class II medical device used in assisted reproductive technologies. This type of device is an instrument and does not fit the typical format for AI/ML-enabled devices so I have focused on the relevant mechanical and biological performance characteristics.

Acceptance Criteria and Device Performance

There is no single study described that proves the device meets all acceptance criteria. Instead, a series of non-clinical performance tests were conducted.

Here's a table summarizing the acceptance criteria and the reported device performance for the Denudation Pipettes:

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria	Reported Device Performance	Comments
Biocompatibility/Embryo Safety	One-cell Mouse Embryo Assay (MEA)	≥ 80% embryos developed to expanded blastocyst at 96 hours	≥ 80% embryos developed to expanded blastocyst at 96 hours	Meets criteria. The subject device's MEA assessment time (96h) is shorter than the predicate (120h), but it's noted as the standard assessment time for this assay.
Material Toxicity	Endotoxin (LAL, USP<85>)	< 0.5 EU/device	< 0.05 EU/device	Exceeds criteria (better performance). The endotoxin specification is lower than the predicate (<20 EU/device).
Sterility	Sterilization Validation	Sterility Assurance Level (SAL) of 10⁻⁶	Sterile (10⁻⁶)	Meets criteria based on validation per ISO 11137-1:2006 and ISO 11137-2:2013.
Packaging Integrity	Visual test of package integrity	Pass (no compromise)	Not explicitly stated "Pass", but implies compliance through successful testing.	Tested per ASTM F1886/F1886M-16.
	Dye penetration	Pass (no leakage)	Not explicitly stated "Pass", but implies compliance through successful testing.	Tested per ASTM F1929-23.
	Seal strength testing	Pass (adequate seal strength)	Not explicitly stated "Pass", but implies compliance through successful testing.	Tested per ASTM F88/F88M-23.
Physical Dimensions	Distal Inner Diameter	Within specified range (80μm to 290μm)	80μm to 290μm	Meets criteria. The range of ID sizes is provided for the subject device.
	Proximal Outer Dimension	900 µm	900 µm	Meets criteria.
	Length	90 mm	90 mm	Meets criteria.
Shelf Life	Device Function at 36 months	Maintain all specified performance characteristics	Not explicitly stated "Pass", but implies compliance through successful testing.	Assessed via simulated transportation and accelerated aging, incorporating MEA, Endotoxin, and Dimension validation.
Appearance & Physical Property	Validation	Meets design specifications	Not explicitly stated "Pass", but implies compliance through successful testing.	General validation of appearance and physical properties.

Study Details for Acceptance Criteria

The document describes non-clinical performance testing rather than a single clinical study with patients. The testing focused on demonstrating the safety and effectiveness of the device's materials, manufacturing, and functionality.

2. Sample size used for the test set and the data provenance:

Mouse Embryo Assay (MEA): The sample size refers to the number of embryos used. The document does not specify the exact number of embryos tested, but it refers to the "2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices," which would dictate the appropriate sample size and methodology.
Endotoxin (LAL): The sample size would be the number of devices or extracts from devices tested. This is not explicitly stated.
Sterilization Validation: This involves testing biological indicators and dose mapping; sample sizes for these are defined by ISO 11137 standards.
Package Integrity and Shelf Life: Sample sizes would relate to the number of packages/devices tested at various time points and under different conditions. These are guided by the referenced ASTM standards.
Device Dimension Validation: This involves measuring a sample of manufactured pipettes; the sample size is not specified.
Data Provenance: This is not applicable in the usual sense (e.g., country of origin for clinical data) as these are non-clinical, laboratory-based tests conducted by the manufacturer or their designated testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable for this device and the presented non-clinical testing. Ground truth (e.g., disease presence) is not established by human experts in these types of performance tests. For MEA, the "ground truth" is whether an embryo develops into an expanded blastocyst, which is an observable biological outcome measured by trained laboratory personnel. For other tests, measurements are taken against defined specifications.

4. Adjudication method for the test set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies between human readers' interpretations of data (e.g., medical images). Here, the tests involve objective measurements (e.g., percentages, concentrations, physical dimensions) or standard pass/fail criteria according to established protocols.

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:

This question is not applicable as this device is a physical tool (pipette) and not an AI-enabled device designed to assist human readers (e.g., radiologists). Therefore, no MRMC study or AI assistance evaluation was performed.

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

This question is not applicable as this device is a physical tool and does not involve any algorithm or AI for standalone performance evaluation.

7. The type of ground truth used:

Quantitative Measurements: For most tests (Endotoxin, Dimensions, Seal Strength), the ground truth is established by objective, measurable values that must fall within predefined specifications.
Biological Outcome: For the Mouse Embryo Assay (MEA), the ground truth is the biological viability and development of mouse embryos to an expanded blastocyst stage. This is a recognized and standardized method for assessing the toxicity of materials coming into contact with gametes or embryos.
Compliance with Standards: For sterility, package integrity, and shelf life, the ground truth is compliance with the requirements and methodologies outlined in the referenced ISO and ASTM standards.

8. The sample size for the training set:

This question is not applicable. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as above.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 3, 2025

Guangzhou PINZHI Medical Device Co., Ltd.
℅ Jie Yang
Consultant
Chonconn Consulting Co., Ltd.
Room 504, Block C
No. 1029 Nanhai Avenue, Nanshan District
Shenzhen, Guangdong 518067
CHINA

Re: K250838
Trade/Device Name: Denudation Pipettes
Regulation Number: 21 CFR 884.6130
Regulation Name: Assisted Reproduction Microtools
Regulatory Class: II
Product Code: MQH
Received: June 3, 2025

Dear Jie Yang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K250838 - Jie Yang
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Page 3

K250838 - Jie Yang
Page 3

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250838

Device Name
Denudation Pipettes

Indications for Use (Describe)
Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART).

Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

K250838 Page 1 of 4

510(k) Owner	Guangzhou PINZHI Medical Device Co., Ltd.Room 405, 4th Floor, No.600-2 Guangshan 2nd Road, Fenghuang Street, Tianhe District,Guangzhou, P.R.ChinaPhone: (8620)85162357Email: ivfonly@ivfonly.comContact person: Hestia XuTitle: Technical Regulation Manager
Correspondent	Yang Jie, Consultant,Chonconn Consulting Co., Ltd.Room 504, Block C No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong 518067 CHNPhone: +86-755 33941160Email: yangjie@chonconn.com
Date Prepared	July 2, 2025

Product Information

Trade Name	Denudation Pipettes
Common Name	Assisted reproduction micropipette
Regulation Name	Assisted Reproduction Microtools
Regulation Number	884.6130
Regulatory Class	Class II
Product Code	MQH - Microtools, Assisted Reproduction (Pipettes)
Predicate Device	Research Instruments Ltd.EZ-Tip Vial of 20K161275The predicate device has not been subject to a design-related recall.

Device Description

The Denudation Pipettes are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:

80μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 210μm, 230μm, 250μm, 270μm, 290μm.

Page 6

K250838 Page 2 of 4

Indications for Use

COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below provides a comparison of the intended use and technological characteristics of the subject device and predicate device:

Characteristic	Subject deviceDenudation PipettesK250838	Predicate deviceEZ-Tip Vial of 20K161275	Comments
Indications for use	Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.	EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ Tips are not intended for biopsy of cells from oocytes or embryos.	Same
Materials	Polycarbonate	Polycarbonate	Same
Sterility	Sterile (10⁻⁶) Gamma Irradiated	Sterile (10⁻⁶) Gamma Irradiated	Same
Proximal Outer Dimension	900 µm	900 µm	Same

Page 7

K250838 Page 3 of 4

Distal Inner Diameter	Size range 80 µm to 290 µm	Size range 75 µm to 600 µm	DifferentThe subject device is within the cleared range of the predicate device. This difference does not raise different questions of safety or effectiveness.
Length	90mm	90mm	Same
Mouse Embryo Assay(MEA)	1-Cell MEA ≥80%Expanded blastocysts at 96 h	1-Cell MEA ≥80%expanded blastocysts at 120 h	DifferentThe Mouse Embryo Assay (MEA) assessment time is shorter for the subject device, but it is the standard assessment time for this assay. Therefore, this difference does not raise different questions of safety or effectiveness.
Endotoxin(LAL)	<0.5 EU/device	<20 EU/device	DifferentThe endotoxin specification for the subject device is lower than the predicate device. This difference does not raise different questions of safety or effectiveness.
Usage	Single Use	Single Use	Same

As shown in the table above, the subject and predicate devices have same indications for use statements and the intended uses of the predicate and subject devices are the same (i.e., denudation of oocytes and handling of oocytes and embryos during assisted reproduction technology procedures).

In regards to technological characteristics, the subject and predicate devices have similarities (e.g., material, length, diameter at the proximal end, sterilization method, etc.); however, as noted in the table above, technological differences were identified between the subject and predicate devices (e.g., distal end tip diameter and specifications for MEA and endotoxin testing). The technological differences between the subject and predicate device do not raise different questions of safety and effectiveness.

Page 8

K250838 Page 4 of 4

Non-Clinical Performance Testing

The following performance tests were performed in support of substantial equivalence:

Sterilization Validation per ISO 11137-1:2006 and ISO 11137-2:2013
Package Integrity Testing after Simulated transportation (ASTM D4169-23) & Accelerated aging (ASTM F 1980-21):
a. Visual test of package integrity (ASTM F1886/F1886M-16),
b. Dye penetration (ASTM F1929-23), and
c. Seal strength testing (ASTM F88/F88M-23)
Shelf Life testing assessing device function at Time 0 and at 36 months:
a. Simulated transportation (ASTM D4169-22)
b. Accelerated aging (ASTM F 1980-21)
c. One-cell mouse embryo assay (MEA): ≥ 80% embryos developed to expanded blastocyst at 96 hours per the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices.
d. Endotoxin (LAL, USP<85>): <0.05 EU/device
e. Device dimension validation
f. Appearance & Physical property validation

Conclusion

The results of the testing described above demonstrate that the Denudation Pipettes is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.