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.

AI/ML Overview

The provided text is a 510(k) summary for the "Mini-Embryon Intra Uterine Insemination Catheter." In this type of submission, the manufacturer is demonstrating that their new device is "substantially equivalent" to legally marketed predicate devices, rather than proving its safety and effectiveness through new clinical studies measuring specific performance metrics against pre-defined acceptance criteria.

Therefore, the sections of your request regarding acceptance criteria, specific study designs (like MRMC or standalone), sample sizes, and ground truth establishment are not directly applicable or explicitly detailed in this 510(k) summary. The document focuses on comparing the technological characteristics of the new device to existing predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific device performance metrics in the way a clinical study report would. Instead, it offers a "Summary comparing technological characteristics with other predicate devices." The acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device.

The table indicates that for various technological characteristics, the Mini-Embryon Catheter is deemed "Equivalent" (E) or "Similar" (S) to the six predicate devices.

Characteristic	Mini-Embryon vs Predicates
FDA file reference number	N/A
Attachments Inside Notification	E
Indications for use	E
Target population	E
Design	E
Materials	E
Performance	S
Sterility	S
Biocompatibility	N/A (Not Applicable)
Mechanical Safety	N/A (Not Applicable)
Chemical safety	E
Anatomical sites	E
Human factors	N/A (Not Applicable)
Energy used and/or delivered	S
Compatibility w/ environment & other devices	S
Where used	E
Standards met	E
Electrical safety	N/A (Not Applicable)
Thermal Safety	N/A (Not Applicable)
Radiation safety	N/A (Not Applicable)

Reported Device Performance:
The "Performance" characteristic is deemed "Similar" (S) to the predicate devices. The document does not elaborate on what specific performance aspects were compared or what the quantitative "similarity" entails beyond the general statement that it is "safe and effective as other predicate devices cited above."

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

Sample Size: Not applicable. This is not a study that involved a "test set" of patients or data in the traditional sense. The submission relies on a comparison of technical specifications and intended use against existing devices.
Data Provenance: Not applicable. There is no patient data or clinical data provenance discussed.

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

Not applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance.

4. Adjudication method for the test set:

Not applicable. There was no test set or adjudication process as typically performed in clinical trials or diagnostic accuracy studies.

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 is a medical device (catheter) submission, not an AI or diagnostic imaging device. No MRMC study was conducted or referenced.

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

Not applicable. This is a physical medical device. The concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The manufacturer is asserting that their new device shares sufficient technological characteristics and intended use with these predicates to be considered substantially equivalent. There is no new clinical "ground truth" generated from patient outcomes or pathology for the Mini-Embryon catheter in this submission.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for a physical medical catheter in this context.

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

Not applicable, as there is no training set.

Summary

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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:

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

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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 deliveredCompatibility 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, IncSELECT 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. INTRAUTERINEINSEMINATION 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 WashingtonRegulatory Service RESUBMITTEDARTIFICIAL 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

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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

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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

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<972823 510(k) Number (if known):

Device Name: MINI EMBRYON INTRAVERINE INSOMINATION CATHETER

Indications For Use:

The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the The Mini Embryon Intrautenine Insemmation catherer and works.
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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBORD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Q. Satting/

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).