(89 days)
Not Found
No
The device description and intended use describe a simple mechanical catheter for insemination, with no mention of AI/ML or related concepts like image processing, data analysis, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is used for intrauterine artificial insemination procedures, which is a medical treatment.
No
The device is described as an 'Inseminator' used for intrauterine artificial insemination procedures, which is a therapeutic rather than diagnostic function. Its purpose is to introduce sperm into the uterus, not to identify or characterize medical conditions.
No
The device description clearly describes a physical, malleable catheter with a tip and a luer for syringe attachment, indicating it is a hardware device. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The 'Inseminator' is a device used to introduce a substance (washed sperm or semen) into the human body (the uterine cavity). It is a delivery device, not a device that analyzes a sample taken from the body.
- Intended Use: The intended use clearly states it's for "intrauterine artificial insemination procedures utilizing washed spermatozoa or semen." This is a procedure performed on the patient, not a test performed on a sample.
The description and intended use clearly indicate that this is a medical device used for a therapeutic/procedural purpose, not for diagnostic testing of a biological sample.
N/A
Intended Use / Indications for Use
For use during intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.
The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.
Product codes
85 MFD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
By a Physician
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
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.
Key Metrics
Not Found
Predicate Device(s)
K972245, K972823, K931630, K964848, K910317
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
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 Road
Orange, 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 is
Class 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.
-
- Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technologies.
- Uni-Sem™ Intrauterine Cannula for Artificial Insemination (K910317), Unimar / ર. CooperSurgical.
Product 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.
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.
1
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 Medical
Mini-Embryon
K972823 &
TomCat IUI
K972245 | Cook OB/GYN
Insemi-Cath
K931630 | Marlow Surgical
Wallace Artificial
Insemination
Catheter, K964848 | Unimar /
Cooper
Uni-Sem™
IUI
K910317 |
|-------------------|---------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------|
| 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
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the circle is a stylized eagle with three wavy lines extending from its head, representing health, services, and the human aspect of the department's mission.
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
3
SECTION 7 Page 1 of 1
510(k) Number (if known): K984306
Wallach Surgical's 'Inseminator' Device Name:
Indications For Use:
17
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
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96). --
vision Sign-Off)
Division of Reproductive, Abdominal, ENT,
nd Radiological Devices
510(k) Number K984306