Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

K181770 · Cook Incorporated · LKF · Mar 29, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K181770
• Device Name: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
• Applicant: Cook Incorporated
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Mar 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended 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.

Device Story

Intrauterine Access Balloon (IAB) Catheter and Selective Salpingography (SSG) Catheter facilitate diagnostic imaging of female reproductive tract; IAB catheter delivers contrast medium to uterine cavity via dual-lumen polyurethane shaft with silicone balloon; IAB acts as access channel for secondary catheters (up to 6 Fr); SSG catheter (braided polyethylene) inserted through IAB to tubal ostium for targeted contrast injection; used during fluoroscopic procedures; operated by clinicians; output is visual contrast enhancement of uterus/fallopian tubes on fluoroscopy; aids assessment of tubal patency and structural anomalies; benefits include minimally invasive diagnostic visualization.

Clinical Evidence

Bench testing only. Testing included sterilization validation (ISO 11135-1), biocompatibility (ISO 10993-5, -10), package integrity (ASTM F1929, F88), and mechanical performance (tensile strength, lumen patency, balloon integrity/burst, torque response, kink radius, and dimensional verification).

Technological Characteristics

IAB: Polyurethane, acetal, polycarbonate, HDPE, vinyl, silicone; 9 Fr diameter, 23 cm length; dual-lumen with inflatable balloon. SSG: Braided polyethylene, stainless steel, rhenium-tungsten radiopaque band; 5.5 Fr diameter, 40 cm length. Both: Ethylene oxide sterilized, single-use, manual operation, non-powered.

Indications for Use

Indicated for patients undergoing hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Advanced Catheter for SHG and SIS (K123258)
• Fallopian Tube Catheterization Set (K171604)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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#### 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: [phone] x104034 Fax: [phone]

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.

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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<br>Characteristics | Subject Device<br>K181770 – IAB<br>Catheter | Predicate Device<br>K123258 – Advance<br>Catheter for HSG<br>and SIS | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Intrauterine<br>Access Balloon<br>Catheter is used for<br>delivery of contrast<br>medium into the<br>uterine cavity during<br>hysterosalpingography<br>(HSG) for<br>examination of the<br>uterus and fallopian<br>tubes, and evaluation<br>of tubal patency. The<br>catheter lumen accepts<br>catheters up to 6<br>French in diameter to<br>access the uterine | The intended use of "<br>the advance catheter<br>for HSG and SIS" is<br>for the delivery of<br>contrast media or<br>saline during<br>hysterosalpingogram<br>(HSG) and saline<br>infusion<br>sonogysterography<br>(SIS) into the female<br>reproductive tract for<br>examination of the<br>uterus and/or fallopian<br>tubes. | Different: The IAB<br>Catheter and the<br>predicate device are<br>intended for injection of<br>contrast media for HSG<br>to evaluate the female<br>reproductive tract. The<br>predicate device can also<br>be used for SIS<br>procedures, which the<br>subject device is not.<br>This difference<br>represents a more limited<br>use of the device for only<br>HSG procedures and<br>does not impact the |
| Device<br>Characteristics | Subject Device<br>K181770 – IAB<br>Catheter | Predicate Device<br>K123258 – Advance<br>Catheter for HSG<br>and SIS | Comparison |
| | cavity for assessment<br>of tubal patency. | The following are<br>some clinical<br>indications: suspected<br>polyps, fibroids,<br>adhesions, or<br>endometrial<br>thickening, and/or<br>selective evaluation of<br>fallopian tube patency. | overall intended use of<br>the device.<br><br>The IAB Catheter is also<br>indicated for introduction<br>of catheters used to<br>assess tubal patency<br>through its lumen. The<br>ability to pass a second<br>catheter through the IAB<br>Catheter does not<br>represent a new intended<br>use as the overall use is<br>the same (assessment of<br>patency/structural<br>anomalies in the uterus<br>and fallopian tubes). |
| General Design | Dual lumen catheter<br>with an inflatable<br>balloon at its distal tip<br>for sealing the cervix.<br>The catheter has two<br>connection lines, one<br>with a check valve for<br>balloon inflation and<br>another with a<br>stopcock for contrast<br>media infusion. The<br>same lumen used for<br>contrast medium<br>infusion can also be<br>used as an access port<br>for up to 6 Fr devices<br>used to assess tubal<br>patency. | Dual lumen catheter<br>with an inflatable<br>balloon at distal tip for<br>sealing the cervix. The<br>catheter has two<br>connection lines, one<br>with a stopcock for<br>balloon inflation and<br>another with a Leur<br>lock for contrast<br>media/saline infusion.<br>Device also has an<br>introduction sheath<br>that aids passage of the<br>HSG/SIS catheter into<br>the uterus. | Different: The predicate<br>includes an additional<br>introduction sheath to aid<br>in delivery of the<br>HSG/SIS catheter to the<br>uterine cavity. The<br>subject device does not<br>include an introduction<br>sheath, which is not<br>needed to access the<br>uterine cavity. This<br>difference does not raise<br>different S&E questions.<br><br>The subject device can<br>be used for passage of<br>dimensionally<br>compatible catheters into<br>the uterine cavity that are<br>used to assess tubal<br>patency, which is not a<br>feature of the predicate<br>device. This additional<br>use does not raise |
| Device<br>Characteristics | Subject Device<br>K181770 - IAB<br>Catheter | Predicate Device<br>K123258 – Advance<br>Catheter for HSG<br>and SIS | Comparison |
| Materials | Polyurethane<br>Acetal<br>Polycarbonate<br>HDPE<br>Vinyl tubing<br>Silicone | | |
| Catheter Length | 23 cm | Length unknown | Different: The length of<br>the predicate device is<br>not known. Differences<br>in length of devices do<br>not raise is different<br>questions of S&E. Note<br>that other cleared devices<br>have comparable lengths. |
| Catheter<br>Diameter | 9 Fr | 5 Fr and 7 Fr | Different: The subject<br>device has a larger<br>diameter than the<br>predicate device. This<br>difference does not raise<br>different questions of<br>S&E. Note that other<br>cleared devices have<br>comparable or larger<br>diameters. |
| Cervix Sealing<br>Balloon | Yes | Same | Same |
| Device<br>Characteristics | Subject Device<br>K181770 - SSG<br>Catheter | Predicate Device<br>K171604 – Fallopian<br>Tube Catheterization<br>Set | Comparison |
| Indications for<br>Use | The Selective<br>Salpingography<br>Catheter is intended<br>to be used through a<br>uterine access device<br>and positioned at the<br>tubal ostium for<br>injection of contrast<br>medium for<br>fluoroscopic<br>evaluation of tubal<br>patency. | The Fallopian Tube<br>Catheterization Set is<br>intended to be used<br>through a uterine<br>access device for<br>fluoroscopic selective<br>catheterization of the<br>proximal fallopian<br>tube(s) and injection of<br>contrast medium in the<br>evaluation of tubal<br>patency. | Different: The subject<br>and predicate indications<br>are comparable with the<br>exception that the subject<br>device is only used to<br>access the tubal ostium,<br>while the predicate can be<br>used for selective<br>catheterization of the<br>fallopian tubes. This<br>difference represents a<br>more limited use of the<br>subject device, but does<br>not impact the overall<br>intended use of the device<br>(assessment of tubal<br>patency). |
| General Design | Catheter with a<br>curved tip and a<br>radiopaque band for<br>visualization. It also<br>includes a Luer<br>connection for<br>installation of contrast<br>media.<br><br>A dimensionally<br>appropriate wire<br>guide may be used to<br>aid placement of the<br>catheter. | The predicate device<br>includes a Torque<br>Control Catheter, an<br>injection catheter, and<br>three wire guides.<br><br>The Torque Control<br>Catheter is comparable<br>to the subject device. It<br>consists of a catheter<br>with a curved tip and a<br>Luer connection for<br>installation of contrast<br>media. | Different: The predicate<br>device includes additional<br>components needed to<br>complete catheterization<br>of the proximal fallopian<br>tubes.<br><br>The design of the subject<br>device and the Torque<br>Control Catheter are<br>comparable and are both<br>used to access the tubal<br>ostium to assess tubal<br>patency. |
| Device<br>Characteristics | Subject Device<br>K181770 - SSG<br>Catheter | Predicate Device<br>K171604 – Fallopian<br>Tube Catheterization<br>Set | Comparison |
| | | | These differences do not<br>raise different questions<br>of S&E. |
| Materials | Polyethylene<br>Stainless Steel<br>Rhenium-tungsten<br>radiopaque band | Torque Control<br>Catheter:<br>Polyethylene<br>Stainless Steel | Different: Materials used<br>in the subject and<br>predicate devices are the<br>same except for the<br>marker band on the<br>subject device. This<br>difference does not raise<br>different questions of<br>S&E. |
| Catheter Length | 40 cm | 50 cm | Different: The predicate<br>is 10 cm longer than the<br>subject device. The<br>difference in length does<br>not raise different<br>questions of S&E as the<br>length of this catheter<br>only needs to be long<br>enough to pass through a<br>dimensionally acceptable<br>uterine access catheter<br>and have sufficient length<br>to reach the tubal ostium. |
| Catheter<br>Diameter | 5.5 Fr | Same | Same |

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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

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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:

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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:

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- . 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

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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.