(441 days)
Kitazato IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Kitazato IUI Catheters are sterile, single-use catheters for use in infusion of washed spermatozoa into the uterine cavity. Catheters are composed of a catheter shaft and a connector. The connector is connected to a syringe (not included with the catheter), and washed spermatozoa are aspirated through the tip of the catheter shaft connected to the syringe. During the insemination procedure, the shaft of catheter is introduced into the uterine cavity through the cervix, and then spermatozoa are injected into the uterine cavity. The Kitazato IUI Catheter has the following types; IUI Catheter with Stainless Steel Center Core Type and IUI Catheter without Stainless Steel Center Core Type.
The provided 510(k) summary for the Kitazato IUI Catheters outlines non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study proving performance against medical acceptance criteria. This type of filing (510(k)) aims to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to establish de novo medical performance standards through clinical trials or direct comparative effectiveness.
Therefore, the information requested for AI device studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable to this 510(k) submission, as it focuses on demonstrating equivalence through non-clinical bench testing.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Tensile Testing | Tensile strength to withstand 4.9N | Withstood 4.9N (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Dimensional Testing | Outer diameter and length according to specifications | Passed outer diameter and length according to specifications (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Endotoxin Testing | Endotoxin values conform to the value ≤20 EU/device | Endotoxin values conform to ≤20 EU/device (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Sterility Testing | No microbial growth | No microbial growth (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Human Sperm Survival Assay (HSSA) | ≥70% motility at 24 hours | ≥70% motility at 24 hours (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for each test. The summary indicates that "all the specifications have met the acceptance criteria," suggesting sufficient samples were tested for each non-clinical evaluation.
- Data Provenance: Not specified, but the tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (KITAZATO Medical Co., Ltd., Japan) or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission relies on objective non-clinical test results against defined physical, chemical, and biological specifications, not expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically associated with human interpretation of data (e.g., medical images) to establish ground truth for performance evaluation, which is not the case here.
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 is a medical device (catheter), not an AI-powered diagnostic or assistive technology. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. 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 technical specifications and industry standards for mechanical properties, dimensions, biocompatibility (endotoxin, HSSA), and sterility. For example, for endotoxin, the ground truth is a value of "≤20 EU/device."
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
{0}------------------------------------------------
510(k) Summary
For
NOV
Kitazato IUI Catheters – K112396
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 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (508) 838.9139 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Vincins, Vice President, QA Email: richard@emergogroup.com
3. Date Prepared
30 October 2012
4. Device Name
| Trade/Proprietary Name: | Kitazato IUI Catheter with Stainless Steel Center Core Type, 10cm, model number Type 1-v1Kitazato IUI Catheter with Stainless Steel Center Core Type, 7cm, model number Type 1-v2Kitazato IUI Catheter without Stainless Steel Center Core Type,10 cm, model number Type 2-v1Kitazato IUI Catheter without Stainless Steel Center Core Type,7 cm, model number Type 2-v2 |
|---|---|
| Common/Usual Name: | Kitazato Intrauterine Insemination (IUI) Catheter |
| Classification Name: | Assisted Reproduction Catheter |
| Classification Regulation: | 884.6110 |
| Classification Panel: | Obstetrics/Gynecology |
{1}------------------------------------------------
Product Code: MQF Device Class: =
5. Predicate Devices
Gynetics Medical Products N.V. – Smooze Model 4225 – K013501
6. Indication for Use
Kitazato IUI Catheters consist of the following versions:
- Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 .
- Kitazato IUI Catheter with Stainless Steel Core Type, 7 cm, model number Type 1-v2 .
- Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-. v 1
- . Kitazato IUI Catheter without Stainless Steel Core Type, 7 cm, model number Type 2v 2
Kitazato IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
7. Device Description
Kitazato IUI Catheters are sterile, single-use catheters for use in infusion of washed spermatozoa into the uterine cavity. Catheters are composed of a catheter shaft and a connector. The connector is connected to a syringe (not included with the catheter), and washed spermatozoa are aspirated through the tip of the catheter shaft connected to the syringe. During the insemination procedure, the shaft of catheter is introduced into the uterine cavity through the cervix, and then spermatozoa are injected into the uterine cavity.
The Kitazato IUI Catheter has the following types; IUI Catheter with Stainless Steel Center Core Type and IUI Catheter without Stainless Steel Center Core Type.
IUI Catheter with Stainless Steel Center Core Type: Catheters of this type consist of a catheter body and the connector. The rounded tip of the catheter shaft has a side hole used for aspiration and delivery of sperm. These catheters incorporate a stainless steel core in the center of the catheter shaft to provide rigidity to the catheter during device placement procedures. The connector has a 6% taper that allows it to be coupled with a standard syringe. One model is offered with the shaft of the catheter containing a depth mark and a stopper that aids in setting catheter insertion depth.
| Model | Trade Name | CatheterBody | CatheterLength | OuterDiameter | DepthMark | Stopper |
|---|---|---|---|---|---|---|
| Type1 -v1 | IUI Catheter with StainlessSteel Center Core Type | 12 Nylon | 10 cm | 1.65 mm / 5 Fr | Yes @7 cm | Yes |
| Type1 -v2 | IUI Catheter with StainlessSteel Center Core Type | 12 Nylon | 7 cm | 1.65 mm / 5 Fr | No | No |
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IUI Catheter without Stainless Steel Center Core Type: Catheters of this type consist of a catheter body and the connector. The rounded tip of the catheter shaft has a side hole used for aspiration and delivery of sperm. These catheters do not include a stainless steel center core in the body of the catheter. The connector has a 6% taper that allows it to be coupled with a standard syringe. One model is offered with the shaft of the catheter containing a depth mark and a stopper that aids in setting catheter insertion depth.
| Model | Trade Name | CatheterBody | CatheterLength | OuterDiameter | DepthMark | Stopper |
|---|---|---|---|---|---|---|
| Type2 -v1 | IUI Catheter withoutStainless Steel CenterCore Type | 12 Nylon | 10cm | 1.65 mm / 5 Fr | Yes @7 cm | Yes |
| Type2 -v2 | IUI Catheter withoutStainless Steel CenterCore Type | 12 Nylon | 7cm | 1.65 mm / 5 Fr | No | No |
Comparison Table - Kitazato IUI Catheter with Stainless Steel Center Core, 10 cm, Type 1-v1
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI CatheterComparison to Predicate |
|---|---|---|---|
| Trade Name | Kitazato IUI Catheter withStainless Steel Center Core | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | N/A |
| 510(k) Number | K112396 | K013501 | Same |
| Product Code | MQF | MQF | Same |
| RegulationNumber | 884.6110 | 884.6110 | Same |
| RegulationName | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications foruse: | The Kitazato IUI Catheter withStainless Steel Center Core isused for the introduction ofwashed spermatozoa into theuterine cavity through thecervix. | The Intra-Uterine InseminationCannula is to be used for intrauterine artificial inseminationprocedures utilizing washedspermatozoa. | Same |
| Overall Design | The device consists of Catheterwith Stainless Steel Center Core.The catheters are packaged in abarrier sterilization pouch/wrapping. A syringe is notincluded in the products. | The device consists of Catheterwithout Stainless Steel CenterCore. The catheters arepackaged in a barriersterilization pouch /wrapping. Asyringe is not included in theproducts. | There are slight differencesthat are discussed; thestainless steel core is to addrigidity for the catheter toassist if the uterine cervix iscurved. This does not impactthe use of the device andadds no safety or efficacyconcerns as the StainlessCenter Core is inside thecatheter similar to thefunction of a stylet that iscommonly used with invasivecatheters. |
| Sterile | Radiation | Radiation | Same |
| Single-Use | Yes | Yes | Same |
| French Size | 1.65 mm (5 Fr) | 2 mm (6 Fr) | These have similar size outerdiameter of catheter; thesize difference of 0.35 mm orone French size does not |
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI CatheterComparison to Predicate |
| Trade Name | Kitazato IUI Catheter withStainless Steel Center Core | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | |
| impact the use of the deviceand adds no safety orefficacy concerns. | |||
| Length | 10 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUIcatheter is within the rangeof the predicate device. |
| Depth Marks | Reference mark is located at 7cm from tip | No Depth Mark | The mark at 7 cm from thetip is used as a referencepoint; the physicianmeasures the length ofuterus prior to insertion ofthe catheter and the mark isused as a guide. This doesnot impact the use of thedevice and adds no safety orefficacy concerns. |
| Tip | Closed and smoothly rounded;one side hole end type | Closed and smoothly rounded;one side hole end type | Same |
| Stylet | No; inner stainless steel centercore | No | The stainless steel core is toadd rigidity for the catheterto assist if the uterine cervixis curved. This does notimpact the use of the deviceand adds no safety orefficacy concerns as theStainless Steel Center Core isinside the catheter similar tothe function of a stylet that iscommonly used with invasivecatheters. |
| Stopper | Yes | No | The stopper is used as areference point; thephysician 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 |
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter withStainless Steel Center Core | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | N/A |
| 510(k) Number | K112396 | K013501 | N/A |
| Product Code | MQF | MQF | Same |
| RegulationNumber | 884.6110 | 884.6110 | Same |
| RegulationName | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications foruse: | The Kitazato IUI Catheter withStainless Steel Center Core isused for the introduction ofwashed spermatozoa into theuterine cavity through thecervix. | The Intra-Uterine InseminationCannula is to be used for intrauterine artificial inseminationprocedures utilizing washedspermatozoa. | Same |
| Overall Design | The device consists of Catheterwith Stainless Steel Center Core.The catheters are packaged in abarrier sterilization pouch/wrapping. A syringe is notincluded in the products. | The device consists of Catheterwithout Stainless Steel CenterCore. The catheters arepackaged in a barriersterilization pouch /wrapping. Asyringe is not included in theproducts. | There are slight differencesthat are discussed; thestainless steel core is to addrigidity for the catheter toassist if the uterine cervix iscurved. This does not impactthe use of the device andadds no safety or efficacyconcerns as the StainlessSteel Center Core is insidethe catheter similar to thefunction of a stylet that iscommonly used with invasivecatheters. |
| Sterile | Radiation | Radiation | Same |
| Single-Use | Yes | Yes | Same |
| French Size | 1.65 mm (5 Fr) | 2 mm (6 Fr) | These have similar size outerdiameter of catheter; thesize difference of 0.35 mm orone French size does notimpact the use of the deviceand adds no safety orefficacy concerns. |
| Length | 7 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUIcatheter is within the rangeof the predicate device. |
| Depth Marks | No Depth Mark | No Depth Mark | Same |
| Tip | Closed and smoothly rounded;one side hole end type | Closed and smoothly rounded;one side hole end type | Same |
| Stylet | No; inner stainless steel centercore | No | The stainless steel core is toadd rigidity for the catheterto assist if the uterine cervixis curved. This does notimpact the use of the deviceand adds no safety orefficacy concerns as the |
{3}------------------------------------------------
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{4}------------------------------------------------
:
.
| Comparison Table – Kitazato IUI Catheter with Stainless Steel Center Core, 7 cm, Type 1-v2 | ||||
|---|---|---|---|---|
| -- | -------------------------------------------------------------------------------------------- | -- | -- | -- |
.
·
{5}------------------------------------------------
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI CatheterComparison to Predicate |
|---|---|---|---|
| Trade Name | Kitazato IUI Catheter withStainless Steel Center Core | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | |
| Stainless Steel Center Core isinside the catheter similar tothe function of a stylet that iscommonly used with invasivecatheters. | |||
| Stopper | No | No | Same |
Comparison Table – Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, Type 2-v1
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter Comparison to Predicate |
|---|---|---|---|
| Trade Name | Kitazato IUI Catheter withoutStainless Steel Center Core | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | N/A |
| 510(k) Number | K112396 | K013501 | Same |
| Product Code | MQF | MQF | Same |
| RegulationNumber | 884.6110 | 884.6110 | Same |
| RegulationName | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications foruse: | The Kitazato IUI Catheter is usedfor the introduction of washedspermatozoa into the uterinecavity through the cervix. | The Intra-Uterine InseminationCannula is to be used for intrauterine artificial inseminationprocedures utilizing washedspermatozoa | Same |
| Overall Design | The device consists of Catheterwithout Stainless Steel CenterCore. The catheters arepackaged in a barriersterilization pouch /wrapping. Asyringe is not included in theproducts. | The device consists of Catheterwithout Stainless Center Core.The catheters are packaged in abarrier sterilization pouch/wrapping. A syringe is notincluded in the products. | Same |
| Sterile | Radiation | Radiation | Same |
| Single-Use | Yes | Yes | Same |
| French Size | 1.65 mm (5 Fr) | 2 mm (6 Fr) | These have similar size outerdiameter of catheter; thesize difference of 0.35 mm orone French size does notimpact the use of the deviceand adds no safety orefficacy concerns. |
.
•
{6}------------------------------------------------
| ManufacturerTrade Name | KITAZATO Medical Co., Ltd.Kitazato IUI Catheter withoutStainless Steel Center Core | Gynetics Medical Products NVIntra-Uterine Insemination andGIFT Catheters, Smooze #4225. | Kitazato IUI CatheterComparison to Predicate |
|---|---|---|---|
| Length | 10 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUIcatheter is within the rangeof the predicate device. |
| Depth Marks | Reference mark is located at 7cm from tip | No Depth Mark | The mark at 7 cm from thetip is used as a referencepoint; the physicianmeasures the length ofuterus prior to insertion ofthe catheter and the mark isused as a guide. This doesnot impact the use of thedevice and adds no safety orefficacy concerns. |
| Tip | Closed and smoothly rounded;one side hole end type | Closed and smoothly rounded;one side hole end type | Same |
| Stylet | No | No | Same |
| Stopper | Yes | No | The stopper is used as areference point; thephysician 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. |
Comparison Table – Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, Type 2-v2
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI CatheterComparison to Predicate |
|---|---|---|---|
| Trade Name | Kitazato IUI Catheter withoutStainless Steel Center Core | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | |
| 510(k) Number | K112396 | K013501 | N/A |
| Product Code | MQF | MQF | Same |
| RegulationNumber | 884.6110 | 884.6110 | Same |
| RegulationName | Assisted Reproduction Catheter | Assisted Reproduction Catheter | Same |
| Indications foruse: | The Kitazato IUI Catheter is usedfor the introduction of washedspermatozoa into the uterinecavity through the cervix. | The Intra-Uterine InseminationCannula is to be used for intrauterine artificial inseminationprocedures utilizing washedspermatozoa | Same |
| Overall Design | The device consists of Catheterwithout Stainless Steel CenterCore. The catheters arepackaged in a barriersterilization pouch /wrapping. Asyringe is not included in the | The device consists of Catheterwithout Stainless Center Core.The catheters are packaged in abarrier sterilization pouch/wrapping. A syringe is notincluded in the products. | Same |
·
{7}------------------------------------------------
| Manufacturer | KITAZATO Medical Co., Ltd. | Gynetics Medical Products NV | Kitazato IUI Catheter Comparison to Predicate |
|---|---|---|---|
| Trade Name | Kitazato IUI Catheter withoutStainless Steel Center Coreproducts. | Intra-Uterine Insemination andGIFT Catheters, Smooze #4225 | |
| Sterile | Radiation | Radiation | Same |
| Single-Use | Yes | Yes | Same |
| French Size | 1.65 mm (5 Fr) | 2 mm (6 Fr) | These have similar size outerdiameter of catheter; thesize difference of 0.35 mm orone French size does notimpact the use of the deviceand adds no safety orefficacy concerns. |
| Length | 7 cm | 7 cm, 14 cm, 20 cm | The length of the Kitazato IUIcatheter is within the rangeof the predicate device. |
| Depth Marks | No Depth Mark | No Depth Mark | Same |
| Tip | Closed and smoothly rounded;one side hole end type | Closed and smoothly rounded;one side hole end type | Same |
| Stylet | No | No | Same |
| Stopper | No | No | Same |
8. Technological Characteristics
The indication for use and technology of the Kitazato IUI Catheters 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 to withstand 4.9N
- . 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
- . Human Sperm Survival Assay: ≥70% motility at 24 hours
The Kitazato IUI Catheters passed all testing and supports the claims of substantial equivalence and safe operation.
The Kitazato IUI Catheters complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
{8}------------------------------------------------
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 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. Conclusion
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 Catheters and the predicate device do not raise any questions regarding its safety and effectiveness. The Kitazato IUI Catheters, as designed and manufactured, are substantially equivalent to the referenced predicate devices.
{9}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Date: November 2, 2012
KITAZATO Medical Co., Ltd. % Mr. Richard Vincins, CQA, CBA, RAC (US, EU) Vice President, QA Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701
Re: K112396
Trade/Device Name: Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 and 7 cm, model number Type 1-v2 Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-v1 and 7 cm, model number Type 2-v2 Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II
Product Code: MQF
Dated: October 22, 2012
Received: October 22, 2012
Dear Mr. Vincins:
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 for answer of 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 either 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 rublish further announcements concerning your device in the Federal Register.
{10}------------------------------------------------
Page 2 - Mr. Richard Vincins, CQA, CBA, RAC (US, EU)
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that I Drisean.teat your device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must or any 1 outlated and 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 Of it Fart 60 7), accember (21 CFR 803); good manufacturing practice requirements as set de recording systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 n you desire specific advisiboutFDA/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 note the regulation untiled, "Mischange 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 I ou may other baller generational 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
{11}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K112396
Device Name: Kitazato IUI Catheter
Indications for Use:
Kitazato IUI Catheters consist of the following versions:
- Kitazato IUI Catheter with Stainless Steel Core Type, 10 cm, model number Type 1-v1 .
- Kitazato IUI Catheter with Stainless Steel Core Type, 7 cm, model number Type 1-v2 .
- Kitazato IUI Catheter without Stainless Steel Core Type, 10 cm, model number Type 2-v1 .
- Kitazato IUI Catheter without Stainless Steel Core Type, 7 cm, model number Type 2-v2 .
Kitazato IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
(Part 21 CFR 801 Subpart D) Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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 CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Benjamin R. Fisher -S | |
|---|---|
| 2012.11.02 16:12:25-04'00' |
Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112396
§ 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).