Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number . Type 3-v1
. Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type 3-v2
Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Device Description

Kitazato IUI Catheter with Outer Stiffener Type with Stylet Cannula and without Stylet Cannula are recommended for uterine cervix with an anatomical curve because the catheter shaft can be easily manipulated. The Kitazato IUI Catheter is composed of an 18 cm catheter shaft that incorporates an outer stiffener component and a syringe connector. The distal tip of the catheter shaft is rounded and includes two side holes 3 mm from the tip of the catheter for sperm delivery. The catheter shaft also includes depth marker bands at 5, 6, 7, and 8 cm from the distal tip, and a movable stopper to aid in delivery of the device to the targeted depth.
The catheter is composed of a polyvinyl chloride shaft and an ABS connector. The Stylet Cannula of the Type 3-v1 version of the device is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. The spermatozoa can be introduced into the uterine cavity by the syringe that is connected to the stylet cannula with no need to remove the stylet cannula from the IUI Catheter. The syringe connector on both the catheter and stylet cannula has a 6% taper that is compatible with 6% taper connection syringe (note: syringe is not included with the catheter).

AI/ML Overview

The provided text is a 510(k) summary for the Kitazato IUI Catheter. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device. However, it does not include descriptions of acceptance criteria as typically understood in a medical device study (e.g., specific performance metrics like sensitivity, specificity, or accuracy compared to a benchmark). Instead, it discusses the device's technical specifications and the results of non-clinical (laboratory) tests to demonstrate that the device meets those specifications and is comparable to a predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission focused on substantial equivalence rather than a clinical performance study of an AI/algorithmic device. Instead, it lists the results of non-clinical tests against established specifications.

Test Category	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Mechanical Tensile	Established specification	Passed the established specification
Dimensional	Specifications for outer diameter and length	Passes outer diameter and length according to specifications
Endotoxin	≤ 20 EU/device	Endotoxin values conform to the value ≤20 EU/device
Sterility	No microbial growth	No microbial growth from sterility testing
Biocompatibility	Passed all testing (cytotoxicity, intracutaneous reactivity, sensitization)	Passed all testing for cytotoxicity, intracutaneous reactivity, and sensitization
Phthalates (DEHP) Release	According to specifications	Passed according to specifications
Human Sperm Survival Assay (HSSA)	≥ 70% motility at 24 hours	≥70% motility at 24 hours
Shelf Life	Established three (3) years	Established three (3) years

Relevant Study Information:

Sample size used for the test set and the data provenance:
- The document describes non-clinical testing (mechanical, dimensional, endotoxin, sterility, biocompatibility, phthalates release, human sperm survival assay, and shelf life). It does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of clinical data for algorithmic performance. Data provenance would be from manufacturing and laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document does not describe a study involving expert-established ground truth for an algorithmic device's performance. The "ground truth" for the non-clinical tests are the objective specifications and assay results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This document does not describe adjudication for a test set.
If a multi-reader multicase (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 is a medical device (catheter) and not an AI/algorithmic device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (catheter) and not an AI/algorithmic device. No standalone algorithm performance was assessed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on pre-defined engineering specifications, chemical/biological standards, and laboratory assay results. For example, sperm motility percentage is a direct measurement against a set threshold.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable. (See #8)

Summary

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510(k) Summary

For

Kitazato IUI Catheter – K131491

1. Submission Sponsor

KITAZATO Medical Co., Ltd. 2-15-12 Hongo, Bunkyou-ku Tokyo 113-0033 JAPAN Phone: +(81) 3-5800-6055 Fax: +(81) 3-5800-6056 Contact: Mari Yazaki, Quality Assurance Manager

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (508) 838.9139 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Vincins, Vice President, QA Email: project.management@emergogroup.com

Date Prepared

30 August 2013

4. Device Identification

Trade/Proprietary Name:	Kitazato IUI Catheter
Common/Usual Name:	Intrauterine Insemination (IUI) Catheter
Classification Name:	Assisted Reproduction Catheter
Classification Regulation:	884.6110
Product Code:	MQF
Device Class:	11
Classification Panel:	Obstetrics/Gynecology

5. Predicate Devices

Irvine Scientific Sales Co., Inc. - Wallace SIS/Al Catheter - K061679

SEP 1 1 2013

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6. Indication for Use

Kitazato IUI Catheter consist of the following versions:

Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number . Type 3-v1
. Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type 3-v2

Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

7. Device Description

The catheter is composed of a polyvinyl chloride shaft and an ABS connector. The Stylet Cannula of the Type 3-v1 version of the device is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. The spermatozoa can be introduced into the uterine cavity by the syringe that is connected to the stylet cannula with no need to remove the stylet cannula from the IUI Catheter. The syringe connector on both the catheter and stylet cannula has a 6% taper that is compatible with 6% taper connection syringe (note: syringe is not included with the catheter).

Model	Product CodeName	CatheterBody	Center CoreMaterial	CatheterLength	OuterDiameter	Depthmark	Stopper	StyletCannula
Type3 -v1	Catheter with OuterStiffener Type withStylet Cannula	Polyvinylchloride	None	18cm	2.00mm /6Fr	Yes	Yes	Yes
Type3 -v2	Catheter with OuterStiffener Typewithout StyletCannula	Polyvinylchloride	None	18cm	2.00mm /6Fr	Yes	Yes	No

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Manufacturer	KITAZATO Medical Co., Ltd.	Irvine Scientific Sales Co., Inc.	Kitazato IUI CatheterComparison to Predicate
Trade Name	Kitazato IUI Catheter withOuter Stiffener without StyletCannula	Wallace Artificial InseminationCatheter
510(k) Number	K131491	K061679	N/A
Product Code	MQF	MQF	Same
RegulationNumber	884.6110	884.6110	Same
RegulationName	Assisted ReproductionCatheter	Assisted ReproductionCatheter	Same
Indications foruse:	Kitazato IUI Catheter withOuter Stiffener with StyletCannula, 18 cm, modelnumber Type 3-v1 is used forthe introduction of washedspermatozoa into the uterinecavity through the cervix.	The Wallace SIS/AI Catheter isintended to be used inartificial inseminationprocedures intended forinsertion of the catheter andintroduction of washedspermatozoa into the uterinecavity. The Wallace SIS/AICatheter is also intended tobe used in Saline InfusionSonography (SIS), also knownas Saline InfusionSonohysterography (SIS) andSaline Ultrasound Infusionprocedures in the detectionabnormalities within uterinecavities.	Similar; both devices areindicated for delivery ofwashed spermatozoa to theuterine cavity. The predicatedevice is also indicated forSaline Infusion Sonography(SIS) which is not anindication for the Kitazato IUICatheter. The Kitazato IUICatheter is not intended tobe used in SIS and SalineUltrasound Infusionprocedures, so there is noadditional safety or efficacyconcerns.
Overall Design	The Type 3-v1 device consistsof an 18 cm catheter with anon-movable outer stiffeningcomponent to provide addedrigidity. The catheter can beused with an additionalincluded stylet catheter thatprovides further rigidity ifneeded. The catheter has asmooth distal tip with twoside holes. The deviceincludes depth markings and amovable depth stopper to aidin assessing depth ofdeployment into the uterus.The catheter is packaged in asingle barrier sterilizationpouch. A syringe is notincluded in the products.	The Wallace SIS/AI deviceconsists of an 18 cm catheterwith a movable outerstiffening component toprovide added rigidity. Thecatheter has a smooth distaltip with two side holes. Thedevice includes depthmarkings to aid in assessingdepth of deployment into theuterus. The catheter ispackaged in a single barriersterilization pouch. A syringeis not included in theproducts.	The predicate deviceincludes a movable outerstiffening component orwhat they refer to as theOuter Sheath; this is slid overthe more flexible innercatheter. This has the samefunction as the OuterStiffener on the Kitazato IUICatheter. The overall designof the subject and predicatedevices are similar, so thereis no additional safety orefficacy concerns.
Sterile	Radiation	Ethylene Oxide (EO)	The predicate device issterilized utilizing EO and thesubject device withRadiation. The Kitazato IUI
Manufacturer	KITAZATO Medical Co., Ltd.	Irvine Scientific Sales Co., Inc.	Kitazato IUI Catheter Comparison to Predicate
Trade Name	Kitazato IUI Catheter withOuter Stiffener, without StyletCannula	Wallace Artificial InseminationCatheter
			Catheter is sterilized using avalidated method forRadiation that does notintroduce any additionalsafety or efficacy concerns.
Single-Use	Yes	Yes	Same
French Size	O.D. of Inner Catheter is 2 mm(6 Fr) (the Inner Catheterextends 4.5 cm beyond theOuter Stiffener)O.D. of Outer Stiffener is 2.5mm (7.5 Fr)	Inner Catheter 16 gauge (1.29mm) (the Inner Catheterextends 5 cm beyond theOuter Sheath)	Similar; the predicate deviceinner catheter shaft hassimilar diameters with thepredicate device beingslightly smaller. It is unclearwhat the outer diameter ofthe Wallace product is andthere is no information onthe company website. Basedon the size of the innercatheter, the outer cathetermay be approximately 1.8 to2 mm which is comparable tothe Kitazato IUI Catheter.There is no additional safetyor efficacy concerns.
Length	18 cm	18 cm	Same
Depth Marks	Centimeter marks are locatedat 5, 6, 7, 8 cm from tip on theouter stiffer	1 cm graduations on OuterCatheter	Similar; the predicate devicehas graduations along thelength of the catheter. TheKitazato product hasmarkings included in therange of the predicate devicefor the area of application.This does not add any safetyor efficacy concerns.
Tip	Closed and smoothlyrounded; two side holes endtype	Closed and smoothlyrounded; two side holes endtype	Same
Stylet	Yes	No	The additional stylet can beused to add further rigidityfor the catheter to assist ifthe uterine cervix is curved.This does not impact the useof the device and adds nosafety or efficacy concerns asthe functionality of the styletis commonly used with othercatheters to provideadditional rigidity.
Manufacturer	KITAZATO Medical Co., Ltd.	Irvine Scientific Sales Co., Inc.	Kitazato IUI Catheter Comparison to Predicate
Trade Name	Kitazato IUI Catheter withOuter Stiffener without StyletCannula.	Wallace Artificial InseminationCatheter	Kitazato IUI CatheterComparison to Predicate
Movable DepthStopper	Yes	No	The movable depth stopperis used as a reference point;the physician measures thelength of uterus prior toinsertion of the catheter andutilizes the stopper as aguide. This does not impactthe use of the device andadds no safety or efficacyconcerns.

Table 5A Comparison of Characteristics – Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, Type 3-v1

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Table 5B Comparison of Characteristics – Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, Type 3-v2

Manufacturer	KITAZATO Medical Co., Ltd.	Irvine Scientific Sales Co., Inc.	Kitazato IUI CatheterComparison to Predicate
Trade Name	Kitazato IUI Catheter withOuter Stiffener without StyletCannula	Wallace Artificial InseminationCatheter
510(k) Number	K131491	K061679	N/A
Product Code	MQF	MQF	Same
RegulationNumber1	884.6110	884.6110	Same
RegulationName	Assisted ReproductionCatheter	Assisted ReproductionCatheter	Same
Indications foruse:	Kitazato IUI Catheter withOuter Stiffener without StyletCannula, 18 cm, modelnumber Type 3-v2 is used forthe introduction of washedspermatozoa into the uterinecavity through the cervix.	The Wallace SIS/AI Catheter isintended to be used inartificial inseminationprocedures intended forinsertion of the catheter andintroduction of washedspermatozoa into the uterinecavity. The Wallace SIS/AICatheter is also intended tobe used in Saline InfusionSonography (SIS), also knownas Saline InfusionSonohysterography (SIS) andSaline Ultrasound Infusionprocedures in the detectionabnormalities within uterinecavities.	Similar; both devices areindicated for delivery ofwashed spermatozoa to theuterine cavity. The predicatedevice is also indicated forSaline Infusion Sonography(SIS) which is not anindication for the Kitazato IUICatheter. The Kitazato IUICatheter is not intended tobe used in SIS and SalineUltrasound Infusionprocedures, so there is noadditional safety or efficacyconcerns.
Overall Design	The Type 3-v2 device consistsof an 18 cm catheter with anon-movable outer stiffeningcomponent to provide addedrigidity. The catheter has asmooth distal tip with twoside holes. The device	The Wallace SIS/AI deviceconsists of an 18 cm catheterwith a movable outerstiffening component toprovide added rigidity. Thecatheter has a smooth distaltip with two side holes. The	The predicate deviceincludes a movable outerstiffening component orwhat they refer to as theOuter Sheath; this is slid overthe more flexible innercatheter. This has the same
Manufacturer	KITAZATO Medical Co., Ltd.	Irvine Scientific Sales Co., Inc.	Kitazato IUI CatheterComparison to Predicate
Trade Name	Kitazato IUI Catheter withOuter Stiffener without StyletCannulaincludes depth markings and amovable depth stopper to aidin assessing depth ofdeployment into the uterus.The catheter is packaged in asingle barrier sterilizationpouch. A syringe is notincluded in the products.	Wallace Artificial InseminationCatheterdevice includes depthmarkings to aid in assessingdepth of deployment into theuterus. The catheter ispackaged in a single barriersterilization pouch. A syringeis not included in theproducts.	function as the OuterStiffener on the Kitazato IUICatheter. The overall designof the subject and predicatedevices are similar, so thereis no additional safety orefficacy concerns.
Sterile	Radiation	Ethylene Oxide (EO)	The predicate device issterilized utilizing EO and thesubject device withRadiation. The Kitazato IUICatheter is sterilized using avalidated method forRadiation that does notintroduce any additionalsafety or efficacy concerns.
Single-Use	Yes	Yes	Same
French Size	O.D. of Inner Catheter is 2 mm(6 Fr) (the Inner Catheterextends 4.5 cm beyond theOuter Stiffener)O.D. of Outer Stiffener is 2.5mm (7.5 Fr)	Inner Catheter 16 gauge (1.29mm) (the Inner Catheterextends 5 cm beyond theOuter Sheath)	Similar; the predicate deviceinner catheter shaft hassimilar diameters with thepredicate device beingslightly smaller. It is unclearwhat the outer diameter ofthe Wallace product is andthere is no information onthe company website. Basedon the size of the innercatheter, the outer cathetermay be approximately 1.8 to2 mm which is comparable tothe Kitazato IUI Catheter.There is no additional safetyor efficacy concerns.
Length	18 cm	18 cm	Same
Depth Marks	Centimeter marks are locatedat 5, 6, 7, 8 cm from tip on theouter stiffer	1cm graduations on OuterCatheter	Similar; the predicate devicehas graduations along thelength of the catheter. TheKitazato product hasmarkings included in therange of the predicate devicefor the area of application.This does not add any safetyor efficacy concerns.
Tip	Closed and smoothlyrounded; two side holes end	Closed and smoothlyrounded; two side holes end	Same
Manufacturer	KITAZATO Medical Co., Ltd.	Irvine Scientific Sales Co., Inc.	Kitazato IUI CatheterComparison to Predicate
Trade Name	Kitazato IUI Catheter withOuter Stiffener without StyletCannula	Wallace Artificial InseminationCatheter
Stylet	No	No	Same
Movable DepthStopper	Yes	No	The movable depth stopper is used as a reference point; the physician measures the length of uterus prior to insertion of the catheter and utilizes the stopper as a guide. This does not impact the use of the device and adds no safety or efficacy concerns.

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・

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8. Technological Characteristics

The indication for use and technology of the Kitazato IUI Catheter is substantially equivalent to the identified predicate devices.

9. Non-Clinical Testing

The catheter mechanical tensile testing, dimension testing, endotoxin testing, sterility testing and Human Sperm Survival Assay results support that all the specifications have met the acceptance criteria for the device.

Mechanical Tensile Testing: Tensile strength passed the established specification �
. Dimensional Testing: Passes outer diameter and length according to specifications
� Endotoxin Testing: Endotoxin values conform to the value ≤20 EU/device
Sterility Testing: No microbial growth from sterility testing .
Biocompatibility Testing: Passed all testing for cytotoxicity, intracutaneous reactivity, and sensitization
. Phthalates (DEHP) Release Testing: Passed according to specifications
Human Sperm Survival Assay: ≥70% motility at 24 hours ●
Shelf Life Testing: Established three (3) years .

The Kitazato IUI Catheter passed all testing and supports the claims of substantial equivalence and safe operation.

The Kitazato IUI Catheter complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate

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devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The substantial equivalence of the device is supported by the non-clinical testing. The validation testing of the device biocompatibility and HSSA testing was found to be acceptable and supports the claims of substantial equivalence.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that any differences between the Kitazato IUI Catheter and the predicate device do not raise any questions regarding its safety and effectiveness. The Kitazato IUI Catheter, as designed and manufactured, is substantially equivalent to the referenced predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

September 11, 2013

KITAZATO Medical Co., Ltd. % Richard A. Vincins, CBA, CQA, RAC Vice President, QA Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K131491

Trade/Device Name: Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula. 18 cm, model number Type 3-v 1 Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 Regulation Number: 21 CFR$ 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: July 12, 2013 Received: July 15, 2013

Dear Richard A. Vincins, CBA, CQA, RAC,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Richard A. Vincins. CBA. COA. RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131491

Device Name: Kitazato IUI Catheter

Indications for Use:

Kitazato IUI Catheter consist of the following versions:

Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number . Type 3-v1
Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model . number Type 3-v2

Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Herbert P. Lerner -S

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).