The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for use and intended to be used for obtaining female gametes/oocytes from the body.

Device Description

The Oocyte Retrieval Needle Set is used in In-Vitro Fertilization (IVF) procedures to obtain female gametes/oocytes from the body. It is a single-lumen needle of the proper length and diameter. Some physicians experienced in this procedure prefer a 17 ga x 35 cm needle which complies to the government specification GG-N-196. For convenience the needle is provided with PTFE connecting tubes and a silicone stopper.

AI/ML Overview

This 510(k) summary describes a medical device, not a software algorithm, therefore, some of the requested information regarding AI/ML device performance and testing is not applicable.

Here's the analysis of the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the "Oocyte Retrieval Needle Set" does not explicitly state quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, which are common for AI/ML devices. Instead, it focuses on biocompatibility and sterility/endotoxin levels for the physical device.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Materials are biocompatible with intended use.
	Passed tests for cytotoxicity and sensitization (short-term).
	Passed the mouse embryo assay (MEA).
Bacterial Endotoxin	Passed the bacterial endotoxin assay at a limit sensitivity of 9.6 EU/device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The testing described is for the physical device's biocompatibility and endotoxin levels, not for a software algorithm that would typically involve a "test set" of data. The "tests" here refer to laboratory assays performed on the device materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth, in the context of expert consensus, is typically established for diagnostic or prognostic AI/ML applications where human experts interpret medical images or data. For a physical medical device, "ground truth" is typically defined by standardized laboratory methods and regulatory guidelines.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among expert interpretations in diagnostic studies, which is not relevant for the biocompatibility and endotoxin testing of a physical device.

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

No. This study is for a physical medical device (an oocyte retrieval needle), not an AI/ML device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

No. This study is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's assessment is based on:

Standardized Biocompatibility Testing: Per ISO 10993, Part 1, for "external communicating device" for tissue contact.
Mouse Embryo Assay (MEA): A specific biological assay required for devices coming into contact with gametes/embryos.
Bacterial Endotoxin Assay: A standardized test to quantify endotoxin levels.

These are established laboratory and biological testing standards, rather than expert consensus on medical cases or pathology review.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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COMMON NAME:

510(k) Summary

K992308

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:	Oocyte Retrieval Needle Set

SUBSTANTIALLY EQUIVALENT TO:

The Oocyte Retrieval Needle Set is Class II and substantially equivalent, due to conformance with descriptions from CFR 884.6100 Assisted Reproduction Catheters (Procode 85 MQE) as described in the Final Rule in the Federal Register, Vol. 63. No. 175, Thursday, September 10, 1998, page 48436.

Assisted Reproduction Needle

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for use and intended to be used for obtaining female gametes/oocytes from the body.

SUMMARY of TESTING:

Based upon conventional biocompatibility testing (per blue book memorandum #G95-1 entitled: Use of International Standard ISO 10993: "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing," the materials of which the Oocyte Needle Set is fabricated are biocompatible with their intended use. Tests included those recommended for an "external communicating device" for tissue contact which have limited (short-term): 1) cytotoxicity, 2) sensitization. In addition, FDA has required the mouse embryo assay (MEA) for any device coming into contact with gametes and/or embryos. The Oocyte Needle Set passed the bacterial endotoxin assay at a limit sensitivity of 9.6 EU/device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

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

Re: K992308 Oocyte Retrieval Needle Set Dated: July 8, 1999 Received: July 9, 1999 Requiatory Class: II 21 CFR §884.6110/Procode: 85 MQE

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 vour 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 requlations 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 Regulation (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 device on our 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 requlation 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)	K992308
Device Name:	Doayte Retrieval Set.

Indications for Use:

The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for r he Broton modiour over obtaining female gametes/oocytes from the body.

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over -The-Counter Use _________
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(Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K992308
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Regulation Number and Section

§ 884.6100 Assisted reproduction needles.

(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).