Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.

AI/ML Overview

The provided text is for a 510(k) Premarket Notification for an Insemination Catheter. It explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics, no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Insemination Catheter are equivalent to those of the predicate devices."

Therefore, the following information cannot be extracted from the given document as no performance or safety study was conducted or provided:

A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance data is present.
Sample size used for the test set and the data provenance: No test set information is available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
Adjudication method for the test set: No adjudication method is described.
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, as this is a medical device, not an AI or imaging diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No standalone performance study was conducted.
The type of ground truth used: Not applicable, as no ground truth was established for performance testing.
The sample size for the training set: Not applicable, as no training set was used for a performance study.
How the ground truth for the training set was established: Not applicable, as no training set was used for a performance study.

In summary, the MedWorks Insemination Catheter's approval was based on demonstrating substantial equivalence to predicate devices through design and performance characteristics, without the need for new performance or safety studies involving acceptance criteria and clinical data.

Summary

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AUG 2 1 1998

MedWorks Corp. 510(k) Premarket Notification

July 24, 1998 Insemination Catheter

	510(k) Summary K982628
	P171
Trade Name:	MedWorks Insemination Catheter
Sponsor:	MedWorks Corp.2400 Crittenden DriveLouisville, KY 40217Registration #1530618
Device Generic Name:	Intrauterine Insemination Catheter
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Predicate Devices:	Roseff's Double Lumen Standard Intrauterine Insemination Catheter(K884696)Fertility Technologies, Inc.
	Mini-Embryon Intra Uterine Insemination Catheter (K972823)A&A Medical, Inc.
	Standard Intrauterine Insemination Catheter (K884696)CCD International
	Jansen-Anderson Insemination Set (K914150)Cook Ob/Gyn

Product Description:

Indications for Use:

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Safety and Performance:

Substantial equivalence for this device was based solely on design and performance characteristics, no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Insemination Catheter are equivalent to those of the predicate devices.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to currently marketed devices, the MedWorks Insemination Catheter has been shown to be safe and effective for its intended use.

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Image /page/1/Picture/0 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUM" around the left side of the seal. The right side of the seal has a symbol that looks like three curved lines stacked on top of each other. The seal appears to be from the Department of Health and Human Services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medworks Corporation c/o Ms. Pamela Papineau Delnhi Medical Device Consulting 50 Brewster Street Pawtucket, RI 02860

Re: K982628

Embryon® Intrauterine Insemination Devices and Stylet Dated: July 24, 1998 Received: July 28, 1998 Unclassified/Procode: 85 MFD

Dear Ms. Papineau:

AUG 2 1 1998

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 requirements, as set forth in the Quality System Regulation (OS) 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 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 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/cdrl/dsmaldsmamain.html".

Sincerely yours

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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Page

510(k) Number (if known):

Device Name: _MedWorks Insemination Catheter

Indications for Use:

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dober R. Silling

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

510(k) Number K982628

Prescription Use X OR (Per 21 CFR 801.109)

Over-the -Counter Use

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).