K Number

Device Name

INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER

Manufacturer

WASHINGTON REGULATORY SERVICES

Date Cleared

1999-05-27

(225 days)

Product Code

MQF,JJX

Regulation Number

884.6110

Type

Traditional

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

Intra-uterine transfer

1. Frydman Catheter 4.5, 5.5
1. Frydman Catheter 4.5 with 2 lumen and removable mandrel
1. Long Frydman Set
1. Frydman Set
1. Soft Frydman Set
1. Soft Frydman Set with madrel
1. TDT Set

Intra-fallopian transfer

1. Biset for GIFT
1. Gift Catheter
1. Oliver Set
1. Rinsing Valve for Oliver Set

Device Description

The Assisted Reproduction microtool devices have been down classified FR Vol. 63, No. 175 September 10, 1998. Effective date: October 13, 1998.

As found in the labeling/promotional material:
Frydman™ Catheter: Polyethylene catheter with a flexible end, internal diameter: 1.1mm, outer diameter: 1.6mm, and a distal opening.
Double Lumen Frydman™ Catheter 4.5: Polyethylene catheter, 17.5cm long, consisting of a central tube 2.1mm, stiffened in its proximal part on 13cm by a second polypropylene tube 2.6mm, with two hysterometric markings at 5.5 and 6.5 from the distal opening. The central tube is a double lumen tube: its lateral lumen is provided with a malleable mandrel, and its central lumen 1.1mm, is intended to contain embryo(s).
Soft Frydman™ Set (with or without mandrel): The set includes 2 catheters: Catheter Nº 1: Polypropylene introducer (with a blue adapter), Catheter Nº2 Polyurethane reimplantation catheter, Mandrel, 17.5 cm long, depending on the model.
Short Frydman™ Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter).
Long Frydman™ Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter).
T.D.T.TM Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer, Catheter No. 2 ultra-thin polyethylene reimplantation catheter.
BI SET™ for GIFT: The set includes 2 catheters: Catheter No. 1 introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter), Stainless steel trocar (with green adapter), 20 cm long. Two models are available: 1 transfer catheter, 2 transfer catheters.
Oliver Set MK II ™: The set includes: 1 polyamide, echogenic, introducer, 24 cm long, 1.9mm, 1.1mm, pre-curved at 45°, with an loive-shape tip fitted with a ground stainless steel ring, 1 metal mandrel, 27 cm long, 1mm, 1 polyethylene transfer catheter, 33 cm long, 1mm, 0.6mm.

Function of Device/Significant Physical Characteristics of Device: All devices are malleable, to allow a change in shape for the device; the mandrel is accluded to prevent the in-flow of bodily fluids when inserting into the crevix. All devices contain echolocater ultrasound markers.

AI/ML Overview

This document is a 510(k) summary for the Prodimed Intra-uterine, Intra-fallopian Transfer Assisted Reproduction Catheters. As such, it describes the device and its intended use but does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These types of details are typically found in more comprehensive study reports or clinical trial summaries, not in a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the given text.

Summary

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2 1999 EEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

K984604 Re:

Trade Name: Architect™ Estradiol MasterCheck Regulatory Class: I Product Code: JJX Dated: December 21, 1998 Received: December 28, 1998

න් ක්‍රිඩ් බැටි පිහිටි පිහිටි විශ්වය විය විසින් පිහිටි විසින් පිහිටි විසින් පිහිටි විසින් පිහිටි විසින් පිහිටි විසින් පිහිටි පිහිටි පිහිටි විසින් පිහිටි විසින් පිහිටි විසින්

Dear Ms. Platt:

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 (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 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 (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 the Flectronic Product .

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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 yours.

Steven Sutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of 6

Kag3604 March 3, 1999

510(K) Summary

PRODIMED Laboratories c/o Washington Regulatory Services Randolph L. Cooke 23 Welisewitz Road Ringoes. NJ 08551 609-466-0510 Fax 609-466-4443

2) DEVICE NAME:

Proprietary Names: Prodimed Intra-uterine, Intra-fallopian Transfer Assisted Reproduction Catheters

Intra-uterine transfer

1. Frydman Catheter 4.5, 5.5
1. Frydman Catheter 4.5 with 2 lumen and removable mandrel
1. Long Frydman Set
1. Frydman Set
1. Soft Frydman Set
1. Soft Frydman Set with madrel
1. TDT Set

Intra-fallopian transfer

1. Biset for GIFT
1. Gift Catheter
1. Oliver Set
1. Rinsing Valve for Oliver Set

Common Name: Assisted Reproduction Catheters

Classification Name: Assisted Reproduction catheters are classified as Class II at 21 CFR 884.6110. The product code is 85 MQF.

IDENTIFICATION: The Assisted Reproduction microtool devices have been down classified FR Vol. 63, No. 175 September 10, 1998. Effective date: October 13, 1998.

1. DESCRIPTION OF DEVICE: As found in the labeling/promotional material:

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Frydman™ Catheter

Polyethylene catheter with a flexible end, internal diameter: 1.1mm, outer diameter: 1.6mm, and a distal opening.

For the 4.5 model:

. Length of flexible end: 4.5cm
Total length: 17.5cm .
Two hysterometric markings at 5.5 and 6.5cm from the end .

For the 5.5 model:

Length of flexible end: 5.5cm .
Total length: 18.5cm .
Two hysterometric markings at 6.5 and 7.5cm from the end .

Double Lumen Frydman™ Catheter 4.5

Polyethylene catheter, 17.5cm long, consisting of a central tube 2.1mm, . stiffened in its proximal part on 13cm by a second polypropylene tube 2.6mm, with two hysterometric markings at 5.5 and 6.5 from the distal opening.
The central tube is a double lumen tube: its lateral lumen is provided with a ● malleable mandrel, and its central lumen 1.1mm, is intended to contain embryo(s).

Soft Frydman™ Set (with or without mandrel)

The set includes 2 catheters:

· Catheter Nº 1: Polypropylene introducer (with a blue adapter)
- · 14.5 cm long
- 2.2mm with positioning markings at 1, 2, 3, 4, 5, 6 and 7 cm from its distal . end
- with a movable sliding stopper .
Catheter Nº2 Polyurethane reimplantation catheter ●
- 23 cm long
- 1.53mm, 0.7mm .
- with markings spaced 1 cm apart in its lower part .
- . with a white adapter locked by a polyethylene cap
Mandrel, 17.5 cm long, depending on the model ●

Short Frydman™ Set (for difficult embryo transfer)

The set includes 2 catheters:

Catheter No. 1 polypropylene introducer (with an blue adapter) .
- · 14 cm long
- . 2.2mm, with positioning markings at 1, 2, 3, 4, 5, 6 and 7 cm from its distal end
- with a green mandrel and a movable sliding stopper .
Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter) .
- 21 cm long .
- . 1.6mm, 1.1mm

{4}------------------------------------------------

with a steel tube and 3 markings spaced 1 cm apart in its lower part .
Long Frydman™ Set (for difficult embryo transfer)

The set includes 2 catheters:

Catheter No. 1 polypropylene introducer (with an blue adapter) .
- 20 cm long .
- 2.2mm, with positioning markings at 1, 2, 3, 4, 5, 6 and 7 cm from its distal . end
- with a green mandrel and a movable sliding stopper .
Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter) .
- 25.5 cm long ●
- 1.6mm, 1.1mm .
- . with 1 marking its lower part

T.D.T.TM Set (for difficult embryo transfer)

The set includes 2 catheters:

Catheter No. 1 polypropylene introducer .
- 17.5 cm long, with a flexible tip of 4.5 cm long, and two hysterometric ● markings at 5.5 and 6.5 cm from this end
- It is provided with a plastic coated metal mandrel. Two models are . available: with transparent mandrel or green mandrel.
. Catheter No. 2 ultra-thin polyethylene reimplantation catheter
- 23.5 cm long, on a steel microtube, 1.0mm, 0.6mm, with a positioning ● mark at 2 cm from its lower part.

BI SET™ for GIFT

The set includes 2 catheters:

Catheter No. 1 introducer (with an blue adapter) .
- . 20 cm long
- with positioning markings at 1, 2, 3, 4, 5, 6 and 7 cm from its distal end . . with a green mandrel and a movable sliding stopper
Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter) ●
- 25.5 cm long .
- 1.6mm, 1.1mm ●
- with a steel tube and 1 marking at 2 cm from its lower part, with a movable . stopper and a graduated protective sheath
Stainless steel trocar (with green adapter), 20 cm long .
Two models are available:
- · 1 transfer catheter
- 2 transfer catheters .

Oliver Set MK II TM

The set includes:

1 polyamide, echogenic, introducer, 24 cm long, 1.9mm, 1.1mm, pre-curved . at 45°, with an loive-shape tip fitted with a ground stainless steel ring

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4 of 6

1 metal mandrel, 27 cm long, 1mm. The introduction of this mandrel in the . introducer allows to stiffen it and to insert it more easily.
1 polyethylene transfer catheter, 33 cm long, 1mm, 0.6mm. When this . catheter is inserted in the introducer, its end protudes on 6 cm from the inrtoducer tip.

It is provided with a positioning system (markings) that allows to transfer at a chosen distance from the olive.

Function of Device/Significant Physical Characteristics of Device:

All devices are malleable, to allow a change in shape for the device; the mandrel is accluded to prevent the in-flow of bodily fluids when inserting into the crevix. All devices contain echolocater ultrasound markers.

The Frydman™ Catheter is used for embryo transfer when the permeability of the cervical canal is normal.

The Double Lumen Frydman™ Catheter 4.5 is used for embryo transfer with any permeability of the cervical canal.

The Soft Frydman™ Set, with or without a mandrel, is used for embryo transfer. The model with the mandrel may be used in the presence of a narrow or curved cervix that makes it difficult to introduce the model without the mandrel.

The Short Frydman™ Set is used for difficult embryo transfer. The set may be used in the presence of a narrow or curved cervix that makes it difficult to introduce a standard Frydman™ catheter.

The Long Frydman™ Set is also for difficult embryo transfer. The set may be used in the presence of a narrow or curved cervix that makes it difficult to introduce a standard Frydman™ catheter.

The T.D.T.TM Set is used for embryo transfer. The T.D.T.TM Set allows the reduction of the risk of setting in the crypts or occlusion by mucus that would impede the expulsion of the embryo.

The BI SET™ for GIFT is used for intrafallopian transfer of gametes via transparietal route under celioscopy.

The Oliver Set MK II ™ is used for intratubal transfer of gametes or zygotes via a transcervical approach.

Device Design/ Material Used/ Physical Properties:

Frydman Catheter:

Device Part Tube E212 Tube E321 Tube E320 Tube E342 Fitting
Material Used Polyethylene Polypropylene Polypropylene Polypropylene Polyethylene

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Frydman Set: Material Used Device Part Tube E212 Tube X092 Fitting Tube Fitting Tube E212 Tube 063 Plug Frydman Soft: Device Part Tube E212 Fitting Tube Fitting Tube E212 Tube 063 Plug TDT Set: Device Part Tube E241 Tube INOX Fitting Tube E212 Tube E321 Tube 320 Tube 342 Fitting Tube E212 Tube 063 Plug Oliver Set: Device Part

Tube E241

Polyethylene Stainless steel Polyethylene Polypropylene Polypropylene Polyethylene Metal Polypropylene Material Used Polyurethane Polyurethane Polypropylene Polypropylene Polyethylene Metal Polyethylene Material Used Polyethylene Stainless steel Butadiene styrene Polyethylene Polypropylene Polypropylene Polypropylene Polypropylene Polyethylene Metal Polyethylene

Material Used Polyethylene

{7}------------------------------------------------

cofle

Tube INOX Fitting

Stainless steel Butadiene styrene

Tube Fitting Polyamide Polyamide

5) STATEMENT OF INTENDED USED

These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

Intra-uterine transfer Frydman Catheter 4.5, 5.5 Frydman Catheter 4.5 with 2 lumen and removable mandrel Long Frydman Set Frydman Set Soft Frydman Set Soft Frydman Set with madrel TDT Set

Intra-fallopian transfer Biset for GIFT Gift Catheter Oliver Set Rinsing Valve for Oliver Set

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 1999

Mr. Randolph L. Cooke PRODIMED Laboratories c/o Washington Regulatory Services. Inc. 23 Welisewitz Road Ringoes, N.J. 08551

Re: K983604

Prodimed Intra-uterine, Intra-fallopian Transfer Assisted Reproduction Catheters Sets Dated: March 11, 1999 Received: March 15, 1999 Regulatory Class: II 21 CFR §884.6110/Procode: 85 MQF

Dear Mr. Cooke:

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/cdrh/dsma/dsmamain.html".

Sincerely yours,

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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510(k) NUMBER (IF KNOWN) K983604

DEVICE NAME: Prodimed Intra-uterine, Intra-fallopian Transfer Assisted Reproduction Catheters

INDICATIONS FOR USE:

These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

Intra-uterine transfer

1. Frydman Catheter 4.5, 5.5
1. Frydman Catheter 4.5 with 2 lumen and removable mandrel
1. Long Frydman Set
1. Frydman Set
1. Soft Frydman Set
1. Soft Frydman Set with madrel
1. TDT Set

Intra-fallopian transfer

1. Biset for GIFT
1. Gift Catheter
1. Oliver Set
1. Rinsing Valve for Oliver Set

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UsePer 21 CFE 801.109	OR	Over-The Counter-Use(Options Format 1-2-96)
----------------------------------------	------------------------------------------	-------------------------------------------------

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

510(k) Number	K983604
---------------	---------

000

Regulation Number and Section

§ 884.6110 Assisted reproduction catheters.

(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).