Daylily Single Use Sterile Embryo Transfer Catheters are sterile single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. All models of the Daylily Single Use Sterile Embryo Transfer Catheters consist of a transfer catheter and a guide catheter. Some device models (Type II and Type IV) also include a trial catheter.

The guide catheter is composed of a catheter shaft, connector, and a positioning ring (for certain Type III and IV variants). Guide catheters for some Type III and Type IV variants are also provided pre-curved. Guide catheters have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The transfer catheter is composed of a catheter shaft, connector, and a stainless-steel sleeve (for Type III and IV models). Transfer catheters have a rounded/blunt tip and marker bands at the proximal end of the catheter to aid in catheter placement. The transfer catheter is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) connected to the connector of the transfer catheter is used to deliver the embryos into the uterine cavity.

The trial catheter is an optional accessory for specific models (Types II and IV), composed of a catheter shaft, connector, and a polymer-coated stainless-steel core. Trial catheters have a rounded/blunt closed tip. The trial catheter is used to provide additional support during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

AI/ML Overview

The provided text describes the Daylily Single Use Sterile Embryo Transfer Catheters and reports on the non-clinical performance data to support its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Non-cytotoxic	Met: Device material found to be non-cytotoxic
	Non-sensitizing	Met: Device material found to be non-sensitizing
	Non-irritating	Met: Device material found to be non-irritating
Endotoxin	< 20 EU/device	Met: < 20 EU/device
Bench Performance (after accelerated aging)		All predetermined acceptance criteria were met.
Appearance	Not explicitly stated (visual inspection)	Met
Taper/Syringe compatibility	Not explicitly stated	Met
Dimensional analysis	Not explicitly stated	Met
Distance indication marker location and durability	Not explicitly stated	Met
Dislodgement of positioning ring	Not explicitly stated	Met
Tip drop when held horizontally	Not explicitly stated	Met
Bonding strength of device connections/bonds	Not explicitly stated	Met
Aspiration and leakage testing	Not explicitly stated	Met
Mouse Embryo Assay (MEA)	≥ 80% embryos developed to expanded blastocyst at 96 hours	Met: ≥ 80% embryos developed to expanded blastocyst at 96 hours
Sterilization Validation	Compliance with ISO 11135-1:2014, AAMI TIR 28:2016, ISO 10993-7:2008	Met: Studies performed per these standards
Package Integrity	Visual inspection, Bubble Leak (ASTM F2096-11), Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15)	Met: Testing performed per these standards
Transportation Simulation	Compliance with ASTM D4169-14	Met: Testing performed per this standard

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the numerical sample sizes for each test set (e.g., number of catheters tested for dimensional analysis, number of mice/embryos for MEA). It only mentions that "all predetermined acceptance criteria were met in the following tests."

The data provenance (e.g., country of origin, retrospective/prospective) is not provided. The manufacturer is Shanghai Horizon Medical Technology Co., Ltd. from China, suggesting the testing likely occurred in or was overseen by a facility associated with the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an embryo transfer catheter and the studies performed are non-clinical, primarily bench performance and biocompatibility tests. Therefore, it does not involve establishing ground truth from expert clinical interpretation (like in imaging AI devices). The "ground truth" for these tests are the defined acceptance criteria and standardized test procedures (e.g., ISO, ASTM standards, FDA guidance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human interpretation of data requiring adjudication. The tests are objective measurements against predefined specifications.

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

Not applicable. This device is a physical medical device (embryo transfer catheter), not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance studies are the predetermined acceptance criteria based on established industry standards and regulatory guidance. For example:

Biocompatibility: ISO 10993 series standards define acceptable biological responses.
Endotoxin: USP <85> and AAMI/ANSI ST72:2019 define acceptable endotoxin levels.
Mouse Embryo Assay (MEA): The 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" sets the specification for embryo development.
Other Bench Tests: Conformity to physical and functional specifications.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. Since there is no training set, this question is not relevant.

Summary

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December 16, 2022

Shanghai Horizon Medical Technology Co., Ltd. % Zhixuan Zhang Senior Supervisor of Regulatory Affairs MicroPort Group Co., Ltd. 1601 ZhangDong Rd., ZJ Hi-Tech Park Pudong New District Shanghai, 201203 China

K220010 Re:
Trade/Device Name: Daylily Single Use Sterile Embryo Transfer Catheters (Type I (ETC-1018 S. ETC-1018 L. ETC-1024 S. ETC-1024 Ll. Type II IETC-2018 S. ETC-2018 L. ETC-2024 S, ETC-2024 L], Type III [ETC-3018 S, ETC-3018 L, ETC-3024 S, ETC-3024 L, ETC-3024 S-X, ETC-3024 L-X], and Type IV [ETC-4018 S, ETC-4018 L, ETC-4024 S, ETC-4024 L, ETC-4024 S-X, ETC-4024 L-X]) Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: November 14, 2022 Received: November 16, 2022

Dear Zhixuan Zhang:

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. 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 located 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.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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 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-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, Michael T. Bailey -S

For 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

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Indications for Use

510(k) Number (if known) K220010

Device Name

Daylily Single Use Sterile Embryo Transfer Catheters (Type I [ETC-1018 L, ETC-1024 S, ETC-1024 L, Type II [ETC-2018 S, ETC-2018 L, ETC-2024 L], Type III [ETC-3018 S, ETC-3018 L, ETC-3024 S, ETC-3024 L, ETC-3024 S-X, ETC-3024 L-X], and Type IV [ETC-4018 S, ETC-4018 L, ETC-4024 L, ETC-4024 S-X, ETC-4024 L-X])

Indications for Use (Describe)

Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K220010

SUBMITTER I.

Applicant:	Shanghai Horizon Medical Technology Co., Ltd.
Applicant Address:	Room 401, building 24, No. 1-28, 588 Tianxiong RdPudong New Area, Shanghai, P.R.China.Postcode: 201318.

Phone:	+86-21-38954600
Fax:	+86-21-50801305
Email:	BeiBei.Xing@microport.com
Contact Person:	Beibei Xing

Date Prepared: December 14, 2022

II. DEVICE

Trade Name:	Daylily Single Use Sterile Embryo Transfer Catheters (Type I [ETC-1018 S, ETC-1018 L, ETC-1024 S, ETC-1024 L], Type II [ETC-2018 S, ETC-2018 L, ETC-2024 S, ETC-2024 L], Type III [ETC-3018 S, ETC-3018 L, ETC-3024 S, ETC-3024 L, ETC-3024 S-X, ETC-3024 L-X], and Type IV [ETC-4018 S, ETC-4018 L, ETC-4024 S, ETC-4024 L, ETC-4024 S-X, ETC-4024 L-X])
Common Name:	Embryo Transfer Catheters
Regulation Name:	Assisted Reproduction Catheters
Regulation Number:	21 CFR 884.6110
Regulatory Class:	II
Product Code:	MQF (Catheter, Assisted Reproduction)

III. PREDICATE DEVICE

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets (K172051) manufactured by Cook Incorporated.

The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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catheter. Some device models (Type II and Type IV) also include a trial catheter.

Device configurations and specifications for the Daylily Single Use Sterile Embryo Transfer Catheters (Types I-IV) are shown below:

	Components
Model	Transfer catheter		Guide catheter		Trial catheter
	OuterDiameter(mm)/InnerDiameter(mm)	Length(cm)	OuterDiameter(mm)/InnerDiameter(mm)	Length(cm)	OuterDiameter(mm)	Length (cm)
Type I			2.35 mmOD/1.55-1.75 mm ID		N/A	N/A
Type II	0.95-1.50mmOD/0.55-0.75 mm ID	18-24 cm		12-17.3 cm	1.40 mm	15.3-20.6 cm
Type III					N/A	N/A
Type IV			2.35-2.50/1.55-1.90 ID		1.40 mm	15.3-20.6 cm

Table 1. Device configurations and models

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The Daylily Single Use Sterile Embryo Transfer Catheters are intended for single use only and sterilized by ethylene oxide. They have a three-year shelf life.

INDICATIONS FOR USE V.

Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

COMPARISON OF THE INTENDED USE AND TECHNOLOGICAL VI. CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES

The following table compares the Daylily Single Use Sterile Embryo Transfer Catheters to the predicate device.

Comparison Item	Subject Device –K220010	Predicate Device –K172051	Comparison
Manufacturer	Shanghai HorizonMedical TechnologyCo., Ltd.	Cook Incorporated	Not applicable
Trade name	Daylily Single UseSterile Embryo TransferCatheters(Type I [ETC-1018 S,ETC-1018 L, ETC-1024S, ETC-1024 L], Type II[ETC-2018 S, ETC-2018 L, ETC-2024 S,ETC-2024 L], Type III[ETC-3018 S, ETC-3018 L, ETC-3024 S,ETC-3024 L, ETC-3024S-X, ETC-3024 L-X],and Type IV [ETC-4018S, ETC-4018 L, ETC-4024 S, ETC-4024 L,ETC-4024 S-X, ETC-4024 L-X])	Guardia™ AccessNano and Soft-TransEmbryo TransferCatheter Sets	Not applicable
Indications for Use	Daylily Single UseSterile Embryo TransferCatheters are used toplace in vitro fertilized	Used to place invitro fertilized (IVF)embryos into theuterine cavity.	Same

		Table 2. Intended use and technological characteristics comparison.

Comparison Item	Subject Device –K220010	Predicate Device –K172051	Comparison
	(IVF) embryos into theuterine cavity.
Dimension	Transfercatheter	OD 0.95-1.5 mm (2.85-4.5 Fr)Length 18-24 cm	OD 2.8-4.7 FrLength 19.1-24 cm	Different
	Guidecatheter	OD 2.35-2.5 mm (7.05-7.5 Fr)Length 12-17.3 cm	OD 5.5-8.1 FrLength 11.4-17.3 cm	Different
	Trialcatheter	OD 1.4mm (4.2 Fr)Length 15.3-20.6 cm	OD 4.0 FrLength 18 cm	Different
Material	Transfercatheter	Polyurethane,polycarbonate, stainlesssteel (with applicablevariants)	polyurethane,stainless steel	Different
	Guidecatheter	Polyether blockpolyamide, silicone(with applicablevariants)	Polyethylene,polymethylpentene,silicone	Different
	Trialcatheter	Polyether blockpolyamide, stainlesssteel	Polycarbonate,stainless steel,polyurethane	Different
Variants with pre-curvedguide catheter		Yes	Yes	Same
Variants with positioningrings/markers		Yes	Yes	Same
Depth markers oncatheters		Yes	Yes	Same
Sterility		Sterilized by ethyleneoxide	Sterilized byethylene oxide	Same
Single Use		Yes	Yes	Same
Shelf Life		3 years	3 years	Same
Mouse Embryo Assay		1-Cell MEA: ≥ 80%embryos developed toexpanded blastocyst at96 hours.	1-cell MEA ≥80%embryos developedto blastocyst in 96hours.	Similar
Endotoxin		< 20 EU/device	< 20 EU/device	Same

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The subject and predicate devices have identical indications for use statements and the same intended use. As shown in the table above, the subject and predicate device have many technological characteristics that are the same or similar. However, there are differences in dimensions and device materials. These differences do not raise

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different questions of safety and effectiveness.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

The following studies have been performed to support of the substantial equivalence to the predicate device:

Sterilization Validation testing per: .
- ISO 11135-1:2014 A
- A AAMI TIR 28:2016
- ISO 10993-7: 2008 A
Package Integrity testing:
- Visual inspection
- A Bubble Leak test per ASTM F2096-11
- Seal Strength testing per ASTM F88/ F88M-15
- A Dye Penetration test per ASTM F1929-15
Transportation Simulation testing per ASTM D4169-14 .
Biocompatibility studies conducted in accordance with the 2020 FDA guidance . document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. " Testing included the following assessments:
- Cytotoxicity per ISO 10993-5: 2009
- A Sensitization ISO 10993-10: 2010
- A Irritation per ISO 10993-10: 2010

Testing showed the device material to be non-cytotoxic, non-sensitizing, and nonirritating.

Endotoxin testing per USP <85> and AAMI/ANSI ST72:2019 Specification: <20 ● EU/device
Bench performance studies before and after accelerated aging to the equivalent of three-years of real-time aging in accordance with ASTM F1980-16 demonstrated that all predetermined acceptance criteria were met in the following tests:
- A Appearance
- A Taper/Syringe compatibility
- A Dimensional analysis
- Distance indication marker location and durability
- Dislodgement of positioning ring
- Tip drop when held horizontally
- Bonding strength of device connections/bonds
- Aspiration and leakage testing
- A Mouse Embryo Assay (MEA) per the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices: Specification - 1-Cell

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MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours.

VIII. CONCLUSIONS

The results of the testing described above demonstrate that the Daylily Single Use Sterile Embryo Transfer Catheters are as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.6110 Assisted reproduction catheters.

(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).