TOM CAT F.L., TOM CAT S.L.

• K Number: K972245
• Device Name: TOM CAT F.L., TOM CAT S.L.
• Manufacturer: A & A MEDICAL, INC.
• Date Cleared: 1997-08-06 ( 51 days)
• Product Code: MFD
• Regulation Number: 884.5250
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: K984306

Intended Use

The TomCat 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

Device Description

The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device (TomCat IUI catheter). It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices, not a study proving the device meets specific acceptance criteria through clinical trials or performance metrics.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, and ground truth information) are not applicable or cannot be extracted from this type of document. The document focuses on comparing the technological characteristics of the TomCat IUI catheter to predicate devices.

Here's what can be extracted and a clear explanation of why certain information is not present:

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Description of Device Acceptance Criteria and Supporting Study

The provided document describes a 510(k) Pre-Market Notification (K972245) for the TomCat IUI catheter. The purpose of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to establish novel acceptance criteria proven through a specific clinical study with performance metrics in the way a new diagnostic algorithm might.

The "acceptance criteria" in this context are the characteristics and intended use that allow the device to be considered substantially equivalent to already approved devices. The "study" is the comparison presented in the 510(k) submission against those predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific numerical performance metrics (like sensitivity, specificity, accuracy), the "acceptance criteria" here are the characteristics of the device that are deemed similar or equivalent to predicate devices. The "reported device performance" is essentially the similarity demonstrated in the comparative table.

Characteristic	Acceptance Criteria (Equivalent/Similar to Predicate)	TomCat Performance (as claimed by applicant)
Indications for Use	Equivalent (E)	E (to listed predicates)
Target Population	Equivalent (E)	E (to listed predicates)
Design	Similar (S) or Equivalent (E)	S or E (to listed predicates)
Materials	Similar (S) or Equivalent (E)	S or E (to listed predicates)
Performance	Equivalent (E)	E (to listed predicates)
Sterility	Similar (S) or Equivalent (E)	S or E (to listed predicates)
Biocompatibility	Similar (S)	S (to listed predicates)
Mechanical Safety	Not Applicable (N/A) or Similar (S) / Equivalent (E)	N/A or S/E (to listed predicates)
Chemical Safety	Not Applicable (N/A)	N/A (to listed predicates)
Anatomical Sites	Not Applicable (N/A) or Equivalent (E)	N/A or E (to listed predicates)
Human Factors	Equivalent (E)	E (to listed predicates)
Energy Used/Delivered	Equivalent (E) or Not Applicable (N/A)	E or N/A (to listed predicates)
Compatibility w/ Environment	Not Applicable (N/A) or Similar (S)	N/A or S (to listed predicates)
Where Used	Similar (S) or Equivalent (E)	S or E (to listed predicates)
Standards Met	Equivalent (E)	E (to listed predicates)
Electrical Safety	Equivalent (E) or Not Applicable (N/A)	E or N/A (to listed predicates)
Thermal Safety	Not Applicable (N/A)	N/A (to listed predicates)
Radiation Safety	Not Applicable (N/A)	N/A (to listed predicates)

(Note: The table above synthesizes the claims made in the "Summary comparing technological characteristics with other predicate devices" found in the document. The specific entry for "TomCat Performance" is derived from the "E" or "S" markings in the predicate comparison table, indicating the applicant's claim of equivalence or similarity to established devices.)

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

• Not applicable. This document is a 510(k) pre-market notification, which relies on demonstrating substantial equivalence to existing legally marketed devices, rather than an independent clinical trial with a "test set" in the context of AI/diagnostic device performance studies. The comparison is based on the technical specifications and intended use of the new device against predicate devices.
• The data provenance is the applicant's comparison to established predicate devices, which are already marketed. This is not a "study" with a data set from a specific country or collected prospectively/retrospectively in the typical sense.

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 "test set" and thus no "ground truth" established by experts in the context of a new diagnostic algorithm's performance. The basis for approval is the comparison of the device's characteristics to already-approved predicate devices by the submitter, which is then reviewed by the FDA.

4. Adjudication method for the test set:

• Not applicable. As there is no test set or expert ground truth establishment described, no adjudication method would be detailed.

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 is a medical device for intrauterine insemination, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

• No. This device is an IUI catheter, a physical medical instrument. The concept of "standalone algorithm performance" does not apply.

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

• Not applicable. Ground truth generation for a diagnostic algorithm is not relevant to a 510(k) submission for a physical medical device demonstrating substantial equivalence. The "truth" in this context is that the predicate devices are legally marketed and considered safe and effective for their intended use.

8. The sample size for the training set:

• Not applicable. This submission does not involve a training set for an algorithm.

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

• Not applicable. This submission does not involve a training set or ground truth establishment in the context of algorithm development.

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Summary

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K 912245

00 - 0

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: June 9th, 1997

7-Device Trade or Proprietary Name: TomCat

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-Makler Insemination Device from Sefi-Medical Instruments

2-CSI Insemination Instrument and Sheath from Rocket of London

3-Oligospermis Cup from The Milex Products Inc

4-Cervical Cap from The Lamberts (Deleton) Limited

5-Seminor from Promedex Inc

6-Uni-Sem ( TM ) from Unimar Inc

7-Jansen-Anderson Insemination Set from Cook Ob/Gyn

8-Lifetek IUI Catheter from Lifetek Medical Inc

9-Insemi-Cath from Cook ()b/Gyn

10-Select IUI from Select Medical Systems Inc

11-Insemi-cath II from Cook Ob/Gyn

12-Genxcatheter from Gnx Intl. Inc

13-Wallace Artificial Insemination catheter- 8CM/18C M from Marlow Surgical Technologies Inc

14-Intrauterine Insemination Catheter from Conceptus Inc

15-Insemi-Cath Insemination catheter from Cook Ob/ Gyn

16-Edwards-Wallace Bourne-Hall from Marlow Surgical

• 17-Intrauterine Insemination and Sonohysterography catheter from Ackrad Laboratories
• 18-Resubmitted Artificial Insemination Instrument set from Laboratoire ccd c/o Washington Regulatory Service
• 19-Shepard Intrauterine Insemination catheter from Cook Ob/Gyn
• 20-Minispace ( TM ) IUI Catheter from Pharmacia Inc

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11-Description of the Device:

The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.

12-Intended use of the device:

The TomCat 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

13-Safety and Effectiveness of the device:

TomCat 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 TomCat is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached

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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		Indications for use	Target population	Design	Materials	Performance	Sterility	Biocompatibility	Mechanical Safety	Chemical safety	Anatomical sites	Human factors	Energy used and/or delivered	Compatibility wl environment & other devices	Where used	Standards met	Electrical safety	Thermal Safety	Radiation safety
1-Sefi-Medical Instruments	N/I	DES &AD COPY	E	E	S	S	E	S	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
Makler Insemination Device2-The Rocket of LondonCSI Insemination Instrumentand Sheath	N/I	DES	E	E	S	S	E	S	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
3-The Milex Products, Inc.Oligospermis Cup	N/I	DES	E	E	S	S	E	S	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
4-The Lamberts (Deleton)Limited Cervical Cap	N/I	DES	E	E	S	S	E	S	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
5-Promedex, Inc SEMINOR	K905764	N/I	E	E	E	E	E	E	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
6-Unimar, Inc. UNI-SEM(TM)	K910317	N/I	E	E	E	E	E	E	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
7-Cook Ob/Gyn JANSEN-ANDERSONINSEMINATION SET	K914150	510K	E	E	E	E	E	E	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
8-Lifetek Medical, Inc.	K921518	N/I	E	E	E	E	E	E	S	N/A	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A
9-Cook Ob/Gyn INSEMI-CATH	K870551	510k	E	E	S	S	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
10-Select Medical systems, Inc	K954099	510k cum	E	E	E	E	E	E	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
SELECT IUI
11-Cook Ob/Gyn INSEMI-CATH II	K954398	510k cum	E	E	S	S	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
12-Gnx Intl., Inc GENXCATHETER	K963031	N/A	E	E	E	E	E	E	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
13-Marlow Surgical Technologies, Inc	K964848	N/A	E	E	E	E	E	E	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
WALLACE ARTIFICIAL INSEMINATIONCATHETER-8CM/18C
14-Conceptus, Inc. INTRAUTERINEINSEMINATION CATHETER	K932993	510k cum	E	E	E	E	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
15-Cook Ob/Gyn INSEMI-CATHINSEMINATION CATHETER	K931630	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	N/A
16-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	N/A
17-Ackrad Laboratories INTRAUTERINEINSEMINATION AND SONOHYSTERO-GRAPHY CATHETER	K970492	N/A	S	E	S	S	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
18-Laboratoire ccd c/o WashingtonRegulatory Service RESUBMITTEDARTIFICIAL INSEMINATION INSTRU-MENT SET	K884696	N/A	E	E	E	E	E	E	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
19-Cook Ob/Gyn SHEPARD INTRA-UTERINE INSEMINATION CATHETER	K890301	N/A	E	E	S	S	E	S	S	N/A	N/A	E	E	N/A	S	E	E	N/A	N/A	N/A	N/A
20-Pharmacia, Inc. MINISPACE(TM)IUI CATHETER	K902171	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

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Table- Cont'd

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ATTACHMENT I

510(k) "Substantial Equivalence" Decision-Making Process (Overview)

Image /page/4/Figure/4 description: This image is a flowchart that describes the process of determining if a new device is substantially equivalent to a marketed device. The flowchart starts with the question "New Device is Compared to Marketed Device?" and proceeds through a series of questions about the device's intended use, technological characteristics, and performance information. The flowchart ends with a determination of "Substantially Equivalent" or a requirement 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/5/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, with three overlapping heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 1997

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

Re: K972245

ToraCat Intrauterine Insemination Catheter ... Dated: June 11, 1997 Received: June 16, 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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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. Issting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 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 vitry diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.ida.gov/odrh/dsmamain.html".

Sincerely vours.

William Yin

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

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JUL-30-97 WED - 2:01 PM

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).