(269 days)
Not Found
No
The description focuses on the physical characteristics and function of catheters for delivering contrast media, with no mention of AI or ML capabilities.
No.
The device is used for diagnostic purposes (delivery of contrast medium for examination and evaluation), not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used for "delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency" and for "fluoroscopic evaluation of tubal patency," both of which are diagnostic procedures. The "Device Description" also mentions facilitating access "during diagnostic procedures."
No
The device description clearly details physical components such as catheters, balloons, shafts, lumens, and syringes, indicating it is a hardware medical device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes. This examination is performed outside of the living body.
- Device Function: The described devices (Intrauterine Access Balloon Catheter and Selective Salpingography Catheter) are used in vivo (within the living body) to deliver contrast medium and facilitate imaging of the uterus and fallopian tubes. They are tools used during a diagnostic procedure (HSG and fluoroscopic evaluation), but they do not analyze biological specimens in vitro.
- Intended Use: The intended use clearly states delivery of contrast medium and access for imaging, not the analysis of biological samples.
- Device Description: The description focuses on the physical characteristics and function of the catheters for accessing and delivering substances within the body.
- Imaging Modality: The input imaging modality is fluoroscopy, which is an in vivo imaging technique.
The devices are instruments used to facilitate a diagnostic imaging procedure, but they are not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency.
The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.
The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media.
The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium.
Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic, Hysterosalpingography (HSG)
Anatomical Site
Uterus, Fallopian tubes, Tubal ostium
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)
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:
- Sterilization validation testing per ISO 11135-1:2014
- Ethylene oxide residual testing per ISO 10993-7:2008(R)2012
- Transportation simulation testing per ASTM D4169-16
- Package integrity testing after real-time aging to three years:
- Dye penetration testing per ASTM F1929-15
- Seal strength testing per ASTM F88/F88M-15
- Biocompatibility studies, as follows:
- Cytotoxicity testing per ISO 10993-5:2009
- Guinea pig maximization sensitization testing per ISO 10993-10:2010
- Intracutaneous irritation testing per ISO 10993-10:2010
- Bench Performance studies for the IAB Catheter before and after aging demonstrated that all predetermined acceptance criteria were met in the following tests and support a shelf-life of two years:
- Compatibility testing: The set components to be used together as stated in the instructions for use were tested for dimensional compatibility. The same testing was completed to assure the compatibility of the SSG Catheter with the IAB Catheter.
- Tensile testing: Tensile testing was completed for the different junctions of the device. Testing demonstrated that that the peak load value was greater than the predetermined acceptance criterion.
- Lumen patency: Lumen patency of the device was completed via injection of media. Testing demonstrated that the IAB Catheter lumen was patent and the predetermined acceptance criteria were met.
- Balloon leakage and integrity: The balloon was tested for leakage and integrity under the conditions of expected use. Testing demonstrated that the devices met the predetermined acceptance criteria for integrity and did not display leakage.
- Balloon burst: The balloon was tested for burst volume. Testing demonstrated that the predetermined acceptance criteria were met and the balloon burst above the labeled volume.
- Dimensional testing: Testing was completed to verify the devices critical dimensions (working length, length of side arm adapters, catheter outer diameter). Testing demonstrated that the acceptance criteria were met.
- Check-Flo valve leak reduction: The Check-Flo valve was tested to show a reduction in leakage under conditions of expected use. Testing demonstrated that the device met the predetermined acceptance criteria for leakage reduction.
- Bench Performance studies for the SSG Catheter before and after aging demonstrated that all predetermined acceptance criteria were met in the following tests and support a shelf-life of three years:
- The SSG Catheter was tested to assure dimensional compatibility with the IAB Catheter when used according to its intended use. Dimensional compatibility was also assessed to support use with 0.039 inch diameter wire guides.
- Tensile testing: Tensile testing was completed for the different junctions of the device. Testing demonstrated that that the peak load value was greater than the predetermined acceptance criteria.
- Lumen patency: Lumen patency of the device was completed via injection of media. Testing demonstrated that the SSG Catheter lumen was patent and the predetermined acceptance criteria were met.
- Torque response: The catheter was tested for adequate torque response. Acceptance criterion was determined by Cook's internal procedures. Testing demonstrated that the acceptance criterion was met.
- Radiopacity of marker band: Testing demonstrated that the subject device was determined to be radiopaque in a simulated clinical setting.
- Kink radius: A characterization study was completed to find the kink radius for the SSG Catheter tip. Testing adequately characterized the kink radius.
- Dimensional testing: Testing was completed to verify the SSG Catheter critical dimensions (working length, catheter outer diameter). Testing demonstrated that the acceptance criteria were met.
Key Results: The results of the performance testing described above demonstrates that the subject devices are as safe and effective as the predicate devices and supports a determination 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
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 29, 2019
Cook Incorporated Ian Herrman Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K181770
Trade/Device Name: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: February 27, 2019 Received: February 27, 2019
Dear Ian Herrman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 publish further announcements concerning your device in the Federal Register.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -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
2
Indications for Use
510(k) Number (if known) K181770
Device Name Intrauterine Access Balloon Catheter
Selective Salpingography Catheter
Indications for Use (Describe)
The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency.
The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K181770
Intrauterine Access Balloon Catheter Selective Salpingography Catheter Date Prepared: March 26, 2019
Submitted By:
Cook Incorporated Applicant: Contact: Ian Herrman, Rohini Patel Applicant Address: Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Device Information:
Trade Name:
- Common Name: Regulation Number: Regulation Name: Product Code: Device Classification:
Phone: (812) 335-3575 x104034 Fax: (812) 332-0281
Intrauterine Access Balloon Catheter Selective Salpingography Catheter Hysterosalpingography Catheters 21 CFR §884.4530 Obstetric-gynecologic specialized manual instrument LKF, Cannula, Manipulator/Injector, Uterine Class II
Predicate Devices:
The predicate device for the Intrauterine Access Balloon (IAB) Catheter is the Advanced Catheter for SHG and SIS cleared under K123258 by Catheter Research Inc.
The predicate device for the Selective Salpingography (SSG) Catheter is the Fallopian Tube Catheterization Set cleared under K171604 by Cook Incorporated.
Device Description:
The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.
The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media.
4
The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium.
Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.
Indications for Use:
Intrauterine Access Balloon Catheter:
The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6.0 French in diameter to access the uterine cavity for assessment of tubal patency.
Selective Salpingography Catheter:
The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.
Comparison to Predicate Devices:
IAB Catheter:
| Device
Characteristics | Subject Device
K181770 – IAB
Catheter | Predicate Device
K123258 – Advance
Catheter for HSG
and SIS | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Intrauterine
Access Balloon
Catheter is used for
delivery of contrast
medium into the
uterine cavity during
hysterosalpingography
(HSG) for
examination of the
uterus and fallopian
tubes, and evaluation
of tubal patency. The
catheter lumen accepts
catheters up to 6
French in diameter to
access the uterine | The intended use of "
the advance catheter
for HSG and SIS" is
for the delivery of
contrast media or
saline during
hysterosalpingogram
(HSG) and saline
infusion
sonogysterography
(SIS) into the female
reproductive tract for
examination of the
uterus and/or fallopian
tubes. | Different: The IAB
Catheter and the
predicate device are
intended for injection of
contrast media for HSG
to evaluate the female
reproductive tract. The
predicate device can also
be used for SIS
procedures, which the
subject device is not.
This difference
represents a more limited
use of the device for only
HSG procedures and
does not impact the |
| Device
Characteristics | Subject Device
K181770 – IAB
Catheter | Predicate Device
K123258 – Advance
Catheter for HSG
and SIS | Comparison |
| | cavity for assessment
of tubal patency. | The following are
some clinical
indications: suspected
polyps, fibroids,
adhesions, or
endometrial
thickening, and/or
selective evaluation of
fallopian tube patency. | overall intended use of
the device.
The IAB Catheter is also
indicated for introduction
of catheters used to
assess tubal patency
through its lumen. The
ability to pass a second
catheter through the IAB
Catheter does not
represent a new intended
use as the overall use is
the same (assessment of
patency/structural
anomalies in the uterus
and fallopian tubes). |
| General Design | Dual lumen catheter
with an inflatable
balloon at its distal tip
for sealing the cervix.
The catheter has two
connection lines, one
with a check valve for
balloon inflation and
another with a
stopcock for contrast
media infusion. The
same lumen used for
contrast medium
infusion can also be
used as an access port
for up to 6 Fr devices
used to assess tubal
patency. | Dual lumen catheter
with an inflatable
balloon at distal tip for
sealing the cervix. The
catheter has two
connection lines, one
with a stopcock for
balloon inflation and
another with a Leur
lock for contrast
media/saline infusion.
Device also has an
introduction sheath
that aids passage of the
HSG/SIS catheter into
the uterus. | Different: The predicate
includes an additional
introduction sheath to aid
in delivery of the
HSG/SIS catheter to the
uterine cavity. The
subject device does not
include an introduction
sheath, which is not
needed to access the
uterine cavity. This
difference does not raise
different S&E questions.
The subject device can
be used for passage of
dimensionally
compatible catheters into
the uterine cavity that are
used to assess tubal
patency, which is not a
feature of the predicate
device. This additional
use does not raise |
| Device
Characteristics | Subject Device
K181770 - IAB
Catheter | Predicate Device
K123258 – Advance
Catheter for HSG
and SIS | Comparison |
| Materials | Polyurethane
Acetal
Polycarbonate
HDPE
Vinyl tubing
Silicone | | |
| Catheter Length | 23 cm | Length unknown | Different: The length of
the predicate device is
not known. Differences
in length of devices do
not raise is different
questions of S&E. Note
that other cleared devices
have comparable lengths. |
| Catheter
Diameter | 9 Fr | 5 Fr and 7 Fr | Different: The subject
device has a larger
diameter than the
predicate device. This
difference does not raise
different questions of
S&E. Note that other
cleared devices have
comparable or larger
diameters. |
| Cervix Sealing
Balloon | Yes | Same | Same |
| Device
Characteristics | Subject Device
K181770 - SSG
Catheter | Predicate Device
K171604 – Fallopian
Tube Catheterization
Set | Comparison |
| Indications for
Use | The Selective
Salpingography
Catheter is intended
to be used through a
uterine access device
and positioned at the
tubal ostium for
injection of contrast
medium for
fluoroscopic
evaluation of tubal
patency. | The Fallopian Tube
Catheterization Set is
intended to be used
through a uterine
access device for
fluoroscopic selective
catheterization of the
proximal fallopian
tube(s) and injection of
contrast medium in the
evaluation of tubal
patency. | Different: The subject
and predicate indications
are comparable with the
exception that the subject
device is only used to
access the tubal ostium,
while the predicate can be
used for selective
catheterization of the
fallopian tubes. This
difference represents a
more limited use of the
subject device, but does
not impact the overall
intended use of the device
(assessment of tubal
patency). |
| General Design | Catheter with a
curved tip and a
radiopaque band for
visualization. It also
includes a Luer
connection for
installation of contrast
media.
A dimensionally
appropriate wire
guide may be used to
aid placement of the
catheter. | The predicate device
includes a Torque
Control Catheter, an
injection catheter, and
three wire guides.
The Torque Control
Catheter is comparable
to the subject device. It
consists of a catheter
with a curved tip and a
Luer connection for
installation of contrast
media. | Different: The predicate
device includes additional
components needed to
complete catheterization
of the proximal fallopian
tubes.
The design of the subject
device and the Torque
Control Catheter are
comparable and are both
used to access the tubal
ostium to assess tubal
patency. |
| Device
Characteristics | Subject Device
K181770 - SSG
Catheter | Predicate Device
K171604 – Fallopian
Tube Catheterization
Set | Comparison |
| | | | These differences do not
raise different questions
of S&E. |
| Materials | Polyethylene
Stainless Steel
Rhenium-tungsten
radiopaque band | Torque Control
Catheter:
Polyethylene
Stainless Steel | Different: Materials used
in the subject and
predicate devices are the
same except for the
marker band on the
subject device. This
difference does not raise
different questions of
S&E. |
| Catheter Length | 40 cm | 50 cm | Different: The predicate
is 10 cm longer than the
subject device. The
difference in length does
not raise different
questions of S&E as the
length of this catheter
only needs to be long
enough to pass through a
dimensionally acceptable
uterine access catheter
and have sufficient length
to reach the tubal ostium. |
| Catheter
Diameter | 5.5 Fr | Same | Same |
5
6
As shown above, the indications for use of the subject IAB Catheter is not identical to the predicate device; however, the differences do not represent a new intended use as both devices
7
are used to deliver contrast medium for the assessment of patency/structural anomalies in the uterus and fallopian tubes.
Regarding technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., dimensions, materials, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
SSG Catheter:
8
As shown above, the indications for use of the subject SSG Catheter is not identical to the predicate device; however, the differences do not represent a new intended use as both devices are used to deliver contrast medium for the assessment of patency of the fallopian tubes.
Regarding technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., dimensions, materials, additional components, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Performance Data:
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:
9
- . Sterilization validation testing per ISO 11135-1:2014
- Ethylene oxide residual testing per ISO 10993-7:2008(R)2012 .
- . Transportation simulation testing per ASTM D4169-16
- Package integrity testing after real-time aging to three years: ●
- o Dye penetration testing per ASTM F1929-15
- Seal strength testing per ASTM F88/F88M-15 o
- . Biocompatibility studies, as follows:
- o Cytotoxicity testing per ISO 10993-5:2009
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
- O Intracutaneous irritation testing per ISO 10993-10:2010
- Bench Performance studies for the IAB Catheter before and after aging demonstrated ● that all predetermined acceptance criteria were met in the following tests and support a shelf-life of two years:
- Compatibility testing The set components to be used together as stated in the o instructions for use were tested for dimensional compatibility. The same testing was completed to assure the compatibility of the SSG Catheter with the IAB Catheter.
- Tensile testing Tensile testing was completed for the different junctions of the O device. Testing demonstrated that that the peak load value was greater than the predetermined acceptance criterion.
- Lumen patency Lumen patency of the device was completed via injection of O media. Testing demonstrated that the IAB Catheter lumen was patent and the predetermined acceptance criteria were met.
- Balloon leakage and integrity The balloon was tested for leakage and integrity O under the conditions of expected use. Testing demonstrated that the devices met the predetermined acceptance criteria for integrity and did not display leakage.
- Balloon burst The balloon was tested for burst volume. Testing demonstrated O that the predetermined acceptance criteria were met and the balloon burst above the labeled volume.
- Dimensional testing Testing was completed to verify the devices critical O dimensions (working length, length of side arm adapters, catheter outer diameter). Testing demonstrated that the acceptance criteria were met.
- Check-Flo valve leak reduction The Check-Flo valve was tested to show a O reduction in leakage under conditions of expected use. Testing demonstrated that the device met the predetermined acceptance criteria for leakage reduction.
- Bench Performance studies for the SSG Catheter before and after aging demonstrated ● that all predetermined acceptance criteria were met in the following tests and support a shelf-life of three years:
- o The SSG Catheter was tested to assure dimensional compatibility with the IAB Catheter when used according to its intended use. Dimensional
10
compatibility was also assessed to support use with 0.039 inch diameter wire guides.
- Tensile testing Tensile testing was completed for the different junctions of o the device. Testing demonstrated that that the peak load value was greater than the predetermined acceptance criteria.
- Lumen patency Lumen patency of the device was completed via injection of o media. Testing demonstrated that the SSG Catheter lumen was patent and the predetermined acceptance criteria were met.
- Torque response The catheter was tested for adequate torque response. o Acceptance criterion was determined by Cook's internal procedures. Testing demonstrated that the acceptance criterion was met.
- Radiopacity of marker band Testing demonstrated that the subject device o was determined to be radiopaque in a simulated clinical setting.
- Kink radius A characterization study was completed to find the kink radius o for the SSG Catheter tip. Testing adequately characterized the kink radius.
- o Dimensional testing Testing was completed to verify the SSG Catheter critical dimensions (working length, catheter outer diameter). Testing demonstrated that the acceptance criteria were met.
Conclusion:
The results of the performance testing described above demonstrates that the subject devices are as safe and effective as the predicate devices and supports a determination of substantial equivalence.