(111 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical/biological testing of a catheter for sperm delivery. There is no mention of any computational or analytical functions, let alone AI/ML.
No
The device is used for the introduction of washed spermatozoa into the uterine cavity, which is a diagnostic or procedural function rather than a direct therapeutic intervention to treat a disease or condition. While it may be part of an fertility treatment, the device itself is not providing therapy.
No
The device is used for the introduction of washed spermatozoa into the uterine cavity, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components made of materials like polyvinyl chloride, ABS, and stainless steel, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the introduction of washed spermatozoa into the uterine cavity through the cervix." This is a procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into the uterus. It does not describe reagents, test strips, or equipment used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device itself (tensile strength, dimensions, sterility, biocompatibility, sperm survival with the device), not on the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
In summary, the Kitazato IUI Catheter is a medical device used for a therapeutic procedure (sperm delivery), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Product codes (comma separated list FDA assigned to the subject device)
MQF
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine cavity through the cervix.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- 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 =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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
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).
| Model | Product Code
Name | Catheter
Body | Center Core
Material | Catheter
Length | Outer
Diameter | Depth
mark | Stopper | Stylet
Cannula |
|-----------|--------------------------------------------------------------------|-----------------------|-------------------------|--------------------|-------------------|---------------|---------|-------------------|
| Type3 -v1 | Catheter with Outer
Stiffener Type with
Stylet Cannula | Polyvinylc
hloride | None | 18cm | 2.00mm /
6Fr | Yes | Yes | Yes |
| Type3 -v2 | Catheter with Outer
Stiffener Type
without Stylet
Cannula | Polyvinylc
hloride | None | 18cm | 2.00mm /
6Fr | Yes | Yes | No |
2
| Manufacturer | KITAZATO Medical Co., Ltd. | Irvine Scientific Sales Co., Inc. | Kitazato IUI Catheter
Comparison to Predicate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato IUI Catheter with
Outer Stiffener without Stylet
Cannula | Wallace Artificial Insemination
Catheter | |
| 510(k) Number | K131491 | K061679 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation
Number | 884.6110 | 884.6110 | Same |
| Regulation
Name | Assisted Reproduction
Catheter | Assisted Reproduction
Catheter | Same |
| Indications for
use: | Kitazato IUI Catheter with
Outer Stiffener with Stylet
Cannula, 18 cm, model
number Type 3-v1 is used for
the introduction of washed
spermatozoa into the uterine
cavity through the cervix. | The Wallace SIS/AI Catheter is
intended to be used in
artificial insemination
procedures intended for
insertion of the catheter and
introduction of washed
spermatozoa into the uterine
cavity. The Wallace SIS/AI
Catheter is also intended to
be used in Saline Infusion
Sonography (SIS), also known
as Saline Infusion
Sonohysterography (SIS) and
Saline Ultrasound Infusion
procedures in the detection
abnormalities within uterine
cavities. | Similar; both devices are
indicated for delivery of
washed spermatozoa to the
uterine cavity. The predicate
device is also indicated for
Saline Infusion Sonography
(SIS) which is not an
indication for the Kitazato IUI
Catheter. The Kitazato IUI
Catheter is not intended to
be used in SIS and Saline
Ultrasound Infusion
procedures, so there is no
additional safety or efficacy
concerns. |
| Overall Design | The Type 3-v1 device consists
of an 18 cm catheter with a
non-movable outer stiffening
component to provide added
rigidity. The catheter can be
used with an additional
included stylet catheter that
provides further rigidity if
needed. The catheter has a
smooth distal tip with two
side holes. The device
includes depth markings and a
movable depth stopper to aid
in assessing depth of
deployment into the uterus.
The catheter is packaged in a
single barrier sterilization
pouch. A syringe is not
included in the products. | The Wallace SIS/AI device
consists of an 18 cm catheter
with a movable outer
stiffening component to
provide added rigidity. The
catheter has a smooth distal
tip with two side holes. The
device includes depth
markings to aid in assessing
depth of deployment into the
uterus. The catheter is
packaged in a single barrier
sterilization pouch. A syringe
is not included in the
products. | The predicate device
includes a movable outer
stiffening component or
what they refer to as the
Outer Sheath; this is slid over
the more flexible inner
catheter. This has the same
function as the Outer
Stiffener on the Kitazato IUI
Catheter. The overall design
of the subject and predicate
devices are similar, so there
is no additional safety or
efficacy concerns. |
| Sterile | Radiation | Ethylene Oxide (EO) | The predicate device is
sterilized utilizing EO and the
subject device with
Radiation. The Kitazato IUI |
| Manufacturer | KITAZATO Medical Co., Ltd. | Irvine Scientific Sales Co., Inc. | Kitazato IUI Catheter Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter with
Outer Stiffener, without Stylet
Cannula | Wallace Artificial Insemination
Catheter | |
| | | | Catheter is sterilized using a
validated method for
Radiation that does not
introduce any additional
safety or efficacy concerns. |
| Single-Use | Yes | Yes | Same |
| French Size | O.D. of Inner Catheter is 2 mm
(6 Fr) (the Inner Catheter
extends 4.5 cm beyond the
Outer Stiffener)
O.D. of Outer Stiffener is 2.5
mm (7.5 Fr) | Inner Catheter 16 gauge (1.29
mm) (the Inner Catheter
extends 5 cm beyond the
Outer Sheath) | Similar; the predicate device
inner catheter shaft has
similar diameters with the
predicate device being
slightly smaller. It is unclear
what the outer diameter of
the Wallace product is and
there is no information on
the company website. Based
on the size of the inner
catheter, the outer catheter
may be approximately 1.8 to
2 mm which is comparable to
the Kitazato IUI Catheter.
There is no additional safety
or efficacy concerns. |
| Length | 18 cm | 18 cm | Same |
| Depth Marks | Centimeter marks are located
at 5, 6, 7, 8 cm from tip on the
outer stiffer | 1 cm graduations on Outer
Catheter | Similar; the predicate device
has graduations along the
length of the catheter. The
Kitazato product has
markings included in the
range of the predicate device
for the area of application.
This does not add any safety
or efficacy concerns. |
| Tip | Closed and smoothly
rounded; two side holes end
type | Closed and smoothly
rounded; two side holes end
type | Same |
| Stylet | Yes | No | The additional stylet can be
used to add further rigidity
for the catheter to assist if
the uterine cervix is curved.
This does not impact the use
of the device and adds no
safety or efficacy concerns as
the functionality of the stylet
is commonly used with other
catheters to provide
additional rigidity. |
| Manufacturer | KITAZATO Medical Co., Ltd. | Irvine Scientific Sales Co., Inc. | Kitazato IUI Catheter Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter with
Outer Stiffener without Stylet
Cannula. | Wallace Artificial Insemination
Catheter | Kitazato IUI Catheter
Comparison to Predicate |
| Movable Depth
Stopper | 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. |
Table 5A Comparison of Characteristics – Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, Type 3-v1
:
.
3
.
4
·
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 Catheter
Comparison to Predicate |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Kitazato IUI Catheter with
Outer Stiffener without Stylet
Cannula | Wallace Artificial Insemination
Catheter | |
| 510(k) Number | K131491 | K061679 | N/A |
| Product Code | MQF | MQF | Same |
| Regulation
Number1 | 884.6110 | 884.6110 | Same |
| Regulation
Name | Assisted Reproduction
Catheter | Assisted Reproduction
Catheter | Same |
| Indications for
use: | Kitazato IUI Catheter with
Outer Stiffener without Stylet
Cannula, 18 cm, model
number Type 3-v2 is used for
the introduction of washed
spermatozoa into the uterine
cavity through the cervix. | The Wallace SIS/AI Catheter is
intended to be used in
artificial insemination
procedures intended for
insertion of the catheter and
introduction of washed
spermatozoa into the uterine
cavity. The Wallace SIS/AI
Catheter is also intended to
be used in Saline Infusion
Sonography (SIS), also known
as Saline Infusion
Sonohysterography (SIS) and
Saline Ultrasound Infusion
procedures in the detection
abnormalities within uterine
cavities. | Similar; both devices are
indicated for delivery of
washed spermatozoa to the
uterine cavity. The predicate
device is also indicated for
Saline Infusion Sonography
(SIS) which is not an
indication for the Kitazato IUI
Catheter. The Kitazato IUI
Catheter is not intended to
be used in SIS and Saline
Ultrasound Infusion
procedures, so there is no
additional safety or efficacy
concerns. |
| Overall Design | The Type 3-v2 device consists
of an 18 cm catheter with a
non-movable outer stiffening
component to provide added
rigidity. The catheter has a
smooth distal tip with two
side holes. The device | The Wallace SIS/AI device
consists of an 18 cm catheter
with a movable outer
stiffening component to
provide added rigidity. The
catheter has a smooth distal
tip with two side holes. The | The predicate device
includes a movable outer
stiffening component or
what they refer to as the
Outer Sheath; this is slid over
the more flexible inner
catheter. This has the same |
| Manufacturer | KITAZATO Medical Co., Ltd. | Irvine Scientific Sales Co., Inc. | Kitazato IUI Catheter
Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter with
Outer Stiffener without Stylet
Cannula
includes depth markings and a
movable depth stopper to aid
in assessing depth of
deployment into the uterus.
The catheter is packaged in a
single barrier sterilization
pouch. A syringe is not
included in the products. | Wallace Artificial Insemination
Catheter
device includes depth
markings to aid in assessing
depth of deployment into the
uterus. The catheter is
packaged in a single barrier
sterilization pouch. A syringe
is not included in the
products. | function as the Outer
Stiffener on the Kitazato IUI
Catheter. The overall design
of the subject and predicate
devices are similar, so there
is no additional safety or
efficacy concerns. |
| Sterile | Radiation | Ethylene Oxide (EO) | The predicate device is
sterilized utilizing EO and the
subject device with
Radiation. The Kitazato IUI
Catheter is sterilized using a
validated method for
Radiation that does not
introduce any additional
safety or efficacy concerns. |
| Single-Use | Yes | Yes | Same |
| French Size | O.D. of Inner Catheter is 2 mm
(6 Fr) (the Inner Catheter
extends 4.5 cm beyond the
Outer Stiffener)
O.D. of Outer Stiffener is 2.5
mm (7.5 Fr) | Inner Catheter 16 gauge (1.29
mm) (the Inner Catheter
extends 5 cm beyond the
Outer Sheath) | Similar; the predicate device
inner catheter shaft has
similar diameters with the
predicate device being
slightly smaller. It is unclear
what the outer diameter of
the Wallace product is and
there is no information on
the company website. Based
on the size of the inner
catheter, the outer catheter
may be approximately 1.8 to
2 mm which is comparable to
the Kitazato IUI Catheter.
There is no additional safety
or efficacy concerns. |
| Length | 18 cm | 18 cm | Same |
| Depth Marks | Centimeter marks are located
at 5, 6, 7, 8 cm from tip on the
outer stiffer | 1cm graduations on Outer
Catheter | Similar; the predicate device
has graduations along the
length of the catheter. The
Kitazato product has
markings included in the
range of the predicate device
for the area of application.
This does not add any safety
or efficacy concerns. |
| Tip | Closed and smoothly
rounded; two side holes end | Closed and smoothly
rounded; two side holes end | Same |
| Manufacturer | KITAZATO Medical Co., Ltd. | Irvine Scientific Sales Co., Inc. | Kitazato IUI Catheter
Comparison to Predicate |
| Trade Name | Kitazato IUI Catheter with
Outer Stiffener without Stylet
Cannula | Wallace Artificial Insemination
Catheter | |
| Stylet | No | No | Same |
| Movable Depth
Stopper | 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. |
5
・
.
6
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
7
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.
8
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.
9
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
10
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