K Number

Device Name

MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER

Manufacturer

A & A MEDICAL, INC.

Date Cleared

1997-10-10

(72 days)

Product Code

MFD

Regulation Number

884.5250

Intended Use

The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter is not intended for assisted reproduction procedures.

Device Description

The Mini Embryon IUI is a 5Fr Intrauterine Inseminator made of clear polyethylene, 18 cm in length, with an OD of 1.6 mm and an ID of 1.0 mm. A 5 cm distal segment with double side eyes and a rounded tip insures a very smooth entry with minimal disturbance to the endometrial bed. This is complemented with 11 cm of marked catheter shaft with 7 Fr in diameter for better and more secure handling. A proximal Luer Lock allows for connection with a syringe. It is to be supplied in two versions, Soft & Hard.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K905764, K921518, K954099, K932993, K910577, K884696

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a physical catheter and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No
The device facilitates the delivery of sperm but does not itself treat or cure a disease or condition, which is the primary characteristic of a therapeutic device.

Diagnostic

The device is an intrauterine insemination catheter designed to facilitate sperm delivery to the uterus and fallopian tubes, which is a therapeutic or procedural function, not a diagnostic one. Its purpose is to physically introduce sperm, not to detect, identify, or monitor a medical condition.

SaMD (Software as a Medical Device)

The device description clearly describes a physical catheter made of polyethylene with specific dimensions and features for intrauterine insemination, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Mini Embryon Intrauterine Insemination catheter is a physical device used to deliver sperm directly into the uterine cavity. It is a tool used in vivo (within the body) for a medical procedure, not a test performed in vitro (outside the body) on a sample.
Intended Use: The intended use clearly describes a procedure involving the physical insertion of the catheter into the body to facilitate sperm transport. It does not mention any testing or analysis of biological samples.

Therefore, based on the provided information, the Mini Embryon Intrauterine Insemination catheter is a medical device used for a therapeutic/procedural purpose, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Mini Embryon allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility

Product codes (comma separated list FDA assigned to the subject device)

85 MFD

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Uterine cavity, fallopian tubes, cervix

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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.

K905764, K921518, K954099, K932993, K910577, K884696

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

Regulation Number and Section

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).

Summary

OCT 1 0 1997 .81073

510(k) Summary As Required by 21 section 807.92 ( c )

A & A Medical, Inc. 1-Submitter Name: 4100 Nine McFarland Drive, suite B 2-Address: Alpharetta, GA 30004 (770) 343- 8400 3-Phone: (770) 343- 8985 4-Fax: 5-Contact Person: Adib Khoury 6-Date summary prepared: July 28th, 1997 7-Device Trade or Proprietary Name: Mini-Embryon Intra Uterine Insemination Catheter 8-Device Common or usual name: IUI catheter Intrauterine insemination cannula 9-Device Classification Name: 10-Substantial Equivalency is claimed against the following devices:

1-Seminor from Promedex Inc 2-Lifetek IUI Catheter from Lifetek Medical Inc 3-Select IUI from Select Medical Systems Inc 4-Intrauterine Insemination Catheter from Conceptus Inc 5-Edwards-Wallace Bourne-Hall from Marlow Surgical 6-Resubmitted Artificial Insemination Instrument set from Laboratoire ccd c/o Washington Regulatory Service

11-Description of the Device:

12-Intended use of the device:

K972823
.PL93

13-Safety and Effectiveness of the device:

Mini Embryon is safe and effective as other predicate devices cited above. This is better expressed in the tabulated comparison ( Paragraph 14 below )

14-Summary comparing technological characteristics with other predicate devices:

Please find below a tabulated comparison supporting that Mini Embryon is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached

P .S . Abbreviations used below: E=Equivalent, S=Similar, N/A= Not Applicable, DES=Description available, N/I=No Information available, 510(k)Summary available, 510(k)=510(k) available

				TECHNOLOGICAL							CHARACTERISTICS
		FDA file reference number	ATTACHMENTS INSIDE NOTIFICATION	Indications for use	Target population	Design	Materials	Performance	Sterility	Biocompatibility	Mechanical Safety	Chemical safety	Anatomical sites	Human factors	Energy used and/or delivered
Compatibility w/ environment & other devices	Where used	Standards met	Electrical safety	Thermal Safety	Radiation safety
1-Promedex, Inc SEMINOR	K905764	N/A	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
2-Lifetek Medical, Inc.
LIFETEK IUI CATHETER	K921518	N/A	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
3-Select Medical systems, Inc
SELECT IUI	K954099	510k sum	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
4-Conceptus, Inc. INTRAUTERINE
INSEMINATION CATHETER	K932993	510k sum	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
5-Marlow Surgical EDWARDS-
WALLACE BOURNE-HALL	K910577	510k	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
6-Laboratoire ccd c/o Washington
Regulatory Service RESUBMITTED
ARTIFICIAL INSEMINATION INSTRUMENT SET	K884696	N/A	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A

Image /page/2/Figure/2 description: This image is a flowchart outlining the 510(k) "Substantial Equivalence" Decision-Making Process. The flowchart starts with the question, "New Device is Compared to Marketed Device?" and proceeds through a series of questions with "yes" or "no" answers that lead to different outcomes. The final outcome is a determination of "Substantially Equivalent" or a need for more information.

A more Detailed version is also available in pdf version or found directly below.

End of Summary

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned above the text "DEPARTMENT OF HEALTH & ...", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 10 1997

Mr. Adib Khoury President A&A Medical, Inc. 4100 Nine McFarland Drive, Suite B Alpharetta, Georgia 30004-3386

Re: K972823

Mini-Embryon Intrauterine Insemination Catheter Dated: September 3, 1997 Received: September 4, 1997 Regulatory class: unclassified Product code: 85 MFD

Dear Mr. Khoury:

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 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). 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 (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 requirement, 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 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 regulation (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/dsmamain.html".

Sincerely yours

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure