(51 days)
Not Found
Not Found
No
The device description and other sections do not mention AI, ML, or related concepts. The device appears to be a simple mechanical catheter.
Yes
The device is used to increase pregnancy rates in couples with unexplained infertility by facilitating sperm delivery, which is a therapeutic intervention.
No
The TomCat is described as an IUI catheter which is used to deliver sperm to the uterine cavity, not to diagnose a condition.
No
The device description explicitly states it is a "3 ½ french catheter with a length of 5 ½" made out of propylene," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed on the patient (introducing sperm into the uterine cavity) to facilitate pregnancy. This is a therapeutic or procedural use, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a catheter designed for physical insertion into the body. This is consistent with a medical device used in a procedure, not a reagent or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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
Product codes
85 MFD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine cavity and subsequently the fallopian tubes
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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 Device | |||||||||||||||||||||
| 2-The Rocket of London | |||||||||||||||||||||
| CSI Insemination Instrument | |||||||||||||||||||||
| and 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-ANDERSON | |||||||||||||||||||||
| INSEMINATION 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](https://510k.innolitics.com/search/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 INSEMINATION
CATHETER-8CM/18C | | | | | | | | | | | | | | | | | | | | | |
| 14-Conceptus, Inc. INTRAUTERINE
INSEMINATION 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-CATH
INSEMINATION 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 INTRAUTERINE
INSEMINATION 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 Washington
Regulatory Service RESUBMITTED
ARTIFICIAL 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 |
3
Table- Cont'd
4
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
5
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 (301) 594-4613. Additionally, for question 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.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
6
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