The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.

Device Description

The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called 'The Inseminator' by Wallach Surgical Devices, Inc. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting new clinical study data.

Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from the provided text.

The document explicitly states:

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

The submission relies on a comparison of design, materials, sterilization, and intended use with existing predicate devices to demonstrate safety and effectiveness.

Here's what can be provided based on the available information:

1. A table of acceptance criteria and the reported device performance:

Since no performance data or specific acceptance criteria for performance were included in the submission beyond showing equivalence to predicate devices, this table cannot be fully populated as requested. The criteria for acceptance in this context refer to the characteristics being compared for substantial equivalence.

Acceptance Criteria (for Substantial Equivalence to Predicate Devices)	Reported Device (Wallach Surgical 'Inseminator')
Materials	polypropylene
Sterilization	EtO - SAL 10-6
Design	Equivalent to predicate devices
Target Population	Infertile Couples
Where Used	By a Physician

2. Sample size used for the test set and the data provenance: Not applicable. No test set data was provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment from experts was described for performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was described.

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 device is an intrauterine insemination catheter, not an AI-assisted diagnostic device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for performance was established within this submission; substantial equivalence was based on design and characteristic comparison to predicate devices.

8. The sample size for the training set: Not applicable. This device is not an AI-based system and does not have a training set in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission leverages the "substantial equivalence" pathway, which allows a new device to be marketed without new clinical trials if it can be shown to be as safe and effective as a legally marketed predicate device. The information provided focuses on demonstrating this equivalence through comparative tables of device characteristics, not through new performance studies.

Summary

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MARCH 1, 1999

K9843db

510(k) Premarket Notification Submittal 'The Inseminator' by Wallach Surgical Devices, Inc., SUMMARY CERTIFICATION page of SECTION 2

November 30, 1998 - Page 2 of 3

510(k) SUMMARY Safety and Effectiveness Information

Sponsor:	Wallach Surgical Devices, Inc.235 Edison RoadOrange, CT 06477
Registration #:	1219739
Contact:	Michael Malis
Phone:	203-799-2000 x114
Fax:	203-799-2002
Trade Name:	'The Inseminator'
Device Generic Name:	IUI Catheter
Classification Name:	Cannula, Intrauterine Insemination Device
Classification:	According to Section 513 of FDA, the device classification isClass II, under Product Code 85 MFD.

Predicate Devices to which we are claiming substantial equivalence:

TomCat Intrauterine Insemination Catheter (K972245), A & A Medical. 1.
Mini-Embryon Intrauterine Insemination Catheter (K972823), A & A Medical. 2.
Insemi-Cath (K931630), Cook OB/GYN. 3.
1. Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technologies.
Uni-Sem™ Intrauterine Cannula for Artificial Insemination (K910317), Unimar / ર. CooperSurgical.

Product Description:

Indications for Use:

For use during intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.

Contraindications:

The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.

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Safety and Performance:

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

	Wallach Surgical'Inseminator'K[this 510(k)]	A & A MedicalMini-EmbryonK972823 &TomCat IUIK972245	Cook OB/GYNInsemi-CathK931630	Marlow SurgicalWallace ArtificialInseminationCatheter, K964848	Unimar /CooperUni-Sem™IUIK910317
Materials	polypropylene	equivalent	similar	similar	similar
Sterilization	EtO - SAL 10-6	equivalent	similar	equivalent	similar
Design	Equivalent	equivalent	equivalent	equivalent	equivalent
Target Population	Infertile Couples	equivalent	equivalent	equivalent	equivalent
Where Used	By a Physician	equivalent	equivalent	equivalent	equivalent

SURSTANTIAL EQUIVALENCE CHART

Conclusion:

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

InsemSummary.doc

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ದಿರಿದ್ದರೆ MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Malis General Manager WALLACH Surgical Devices, Inc. 235 Edison Road Orange, CT 06477

Re: K984306

WALLACH Surgical's "Inseminator" (intrauterine artificial insemination catheter) Dated: November 30, 1998 Received: December 2, 1998 Regulatory Class: II Unclassified/Procode: 85 MFD

Dear Mr. Malis:

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 legally marketed predicate 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. 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 (QS) for Medical Devices: General requlation (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 requlation 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 does not affect any obligation you might have under sections 531 through 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 requlation (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/dsma/dsmamain.html".

Sincerely vours.

J.R. 10-21-48

Capt. Daniel G. Schultz, M.D. Acting 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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SECTION 7 Page 1 of 1

510(k) Number (if known): K984306

Wallach Surgical's 'Inseminator' Device Name:

Indications For Use:

The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.

The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) ~ procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109)

ﺎ ﺗﻜﺮﻳﻢ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96). --

vision Sign-Off)

Division of Reproductive, Abdominal, ENT,
nd Radiological Devices

510(k) Number K984306

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).