The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

Device Description

The Embryo Glide™ Embryo Transfer Catheter and accessory stylet (ETC) is used during In-Vitro Fertilization (IVF) procedures to introduce embryo(s) into the female body. The embryo passes through the clear, 5 Fr polyurethane catheter, which is open on the end. The 5 Fr catheter is available in 18 cm and 23 cm lengths. Catheters have color-coded hubs to indicate different lengths. Each ETC comes with a 7 Fr sheath which provides a smooth passage into the uterus. An optional stylet (accessory) is available to aid in the initial placement of the 7 Fr sheath. Both the Embryo Transfer Catheter and stylet accessory (optional) are protected within a polypropylene sheath in a sterile, peel-able pouch.

AI/ML Overview

This submission (K992307) for the Embryo Glide™ Embryo Transfer Catheter and accessory stylet does not contain the kind of detailed information typically found in acceptance criteria and study results for performance claims of AI/ML-enabled medical devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices under the 21 CFR §884.6110 Assisted Reproduction Catheters (Procode 85 MQF) and conformance with general biocompatibility standards. The "Summary of Testing" section is brief and outlines general safety testing rather than performance metrics related to a specific clinical outcome or the analytical/clinical performance of an algorithm.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about a study evaluating AI/ML performance because that information is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not available. The document mentions biocompatibility testing (cytotoxicity, vaginal mucosal and dermal sensitization) and Mouse Embryo Assays as "testing," but it does not specify performance criteria (e.g., cell viability thresholds, irritation scores) or quantitative results from these tests. These are general safety tests, not performance tests in the context of an AI/ML algorithm.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML performance evaluation for this device. The biocompatibility tests would have their own sample sizes (e.g., number of animals for assays), but these are not for algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment for an AI/ML algorithm.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted diagnostic or interpretative devices, which this catheter is not.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. There is no algorithm.
7. The type of ground truth used: Not applicable for performance of an AI/ML algorithm. For biocompatibility, the "ground truth" would be the biological response observed in the assays (e.g., cell death, irritation).
8. The sample size for the training set: Not applicable. There is no AI/ML algorithm to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission pertains to a conventional medical device (an embryo transfer catheter) and focuses on demonstrating its safety and substantial equivalence to legally marketed predicate devices, not on the performance evaluation of an artificial intelligence or machine learning algorithm. The testing mentioned (biocompatibility and Mouse Embryo Assays) are standard safety tests for devices that come into contact with biological tissues and embryos, not performance studies for an AI/ML component.

Summary

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510(k) Summary

K992307

Submitted on behalf of:

	Company Name:	Lifetek Medical, Inc.
	Address:	732 Morningstar DrivePortage, WI 53901
	Telephone:	608-742-1188
by:	Elaine Duncan, M.S.M.E., RAC
	President, Paladin Medical, Inc.
	PO Box 560
	Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	July 8, 1999
TRADE NAME:	Embryo Glide™ Embryo Transfer Catheter and accessory stylet
COMMON NAME:	Assisted Reproduction Catheters

SUBSTANTIALLY EQUIVALENT TO:

The Embryo Clide™ Embryo Transfer Catheter and accessory stylet is Class II and substantially equivalent, due to conformance with descriptions from CFR 884.6110 Assisted Reproduction Catheters (Procode 85 MOF) as described in the Final Rule in the Federal Register, Vol. 63. No. 175, Thursday, September 10, 1998, page 48436.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF procedures to introduce embryo(s) into the female body.

SUMMARY of TESTING:

The Embryo Glide™ Embryo Transfer Catheter and accessory stylet has undergone biocompatibility testing according to the recommended methods within ISO 10993, which includes cytotoxicity testing, vaginal mucosal and dermal sensitization. In addition, Mouse Embryo Assays were conducted for the catheter and stylet accessory.

510(k) Submission: Embryo Glide™ Embryo Transfer Catheter & accessory stylet; Lifetek Medical, Inc.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.

SEP 1 4 1999

Lifetek Medical, Inc. c/o Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical®, Inc. and Requiatory Consultant to Lifetek Medical. Inc. P.O. Box 560 Stillwater, MN 55082-0560

Re: K992307

Embryo Glide™ Embryo Transfer Catheter and Accessorv Stylet Dated: July 8, 1999 Received: July 9, 1999 Requiatory Class: II 21 CFR $884.6110/Procode: 85 MQF

Dear Ms. Duncan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)	K992307
Device Name:	EMBRYO GLIDE EMBRYO TRANSFER CATHETER + ACCESSORY STYLET

Indications for Use:

The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992307

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510(k) Submission: Embryo Glide™ Embryo Transfer Catheter & accessory stylet; Lifetek Medical, Inc.

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).