Modified Novy Cornual Cannulation Set

K180552 · Cook Incorporated · MOV · Jul 12, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180552
• Device Name: Modified Novy Cornual Cannulation Set
• Applicant: Cook Incorporated
• Product Code: MOV · Obstetrics/Gynecology
• Decision Date: Jul 12, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation or contrast medium, in the evaluation of tubal patency.

Device Story

Device consists of introducing catheter, obturator, inner catheter with wire guide, endoscopic septum cap, and female Luer lock plugs. Used through operating channel of hysteroscope or uterine access device. Physician inserts catheter into proximal fallopian tube; introduces chromotubation solution or contrast medium. Enables visualization/evaluation of tubal patency. Used in clinical settings. Sterile, single-use device.

Clinical Evidence

Bench testing only. Testing included tensile testing of hub-to-shaft and tip-to-shaft joints, leak testing, dimensional compatibility, component compatibility, and biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993). Sterilization validation per ISO 11125:2014 and shelf-life/package integrity testing per ASTM F1980-02, F1886-09, F2096-11, and F88-09 were performed. All predetermined acceptance criteria were met.

Technological Characteristics

5.0 French introducing catheters (35cm or 40cm length). Materials: Nylon Torcon with bonded nonradiopaque tip. Sterile, single-use. Biocompatibility per ISO 10993. Shelf life validated per ASTM F1980-02. Package integrity per ASTM F1886-09, F2096-11, and F88-09.

Indications for Use

Indicated for patients undergoing evaluation of tubal patency via hysteroscopic or fluoroscopic selective catheterization and cannulation of the proximal fallopian tube(s).

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

• Novy Cornual Cannulation Set (K931476)

Submission Summary (Full Text)

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July 12, 2018

Cook Incorporated Naomi Funkhouser, MBA Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

Re: K180552

Trade/Device Name: Modified Novy Cornual Cannulation Set Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: MOV Dated: June 11, 2018 Received: June 12, 2018

Dear Naomi Funkhouser:

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. Iisting 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); 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.

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,

# Michael T. Bailey -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) K180552

#### Device Name

Modified Novy Cornual Cannulation Set

#### Indications for Use (Describe)

The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation or contrast medium, in the evaluation of tubal patency.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, bold, sans-serif font, stacked above the word "MEDICAL" in a smaller, white, sans-serif font. Both words are set against a solid red background. The logo is simple and clean, with a focus on the company name.

COOK INCORPORATED 750 DANIELS WAY PO BOX 489 GTON, IN 47402-0489 U.S.A. TOU FREE- 800-457-4500

## 510(k) SUMMARY - K180552

K180552 Page 1 of 3

## Modified Novy Cornual Cannulation Set Date Prepared: July 12, 2018

| Submitted By: | |
|-----------------------|-----------------------------------------------------|
| Applicant: | Cook Incorporated |
| Contact: | Naomi Funkhouser |
| | Rohini Patel |
| Applicant Address: | 750 Daniels Way |
| | P.O. Box 489 |
| | Bloomington, IN 47402 |
| Contact Phone Number: | [phone] x104371 |
| Contact Fax Number: | [phone] |
| Device Information: | |
| Trade Name: | Modified Novy Cornual Cannulation Set |
| Common Name: | Salpingography catheter |
| Regulation Name: | Obstetric-gynecologic specialized manual instrument |
| Regulation Number: | 21 CFR §884.4530 |

#### Device Description:

Product Code:

The Modified Novy Cornual Cannulation Sets consist of an introducing catheter, an obturator, and an inner catheter with wire guide, a blue endoscopic septum cap, and two female Luer lock plugs. With this submission, Cook intends to offer two Novy Sets with curved introducing catheters.

MOV (catheters, salpingography)

Introducing catheters are 5.0 French in size. The curved introducing catheters measuring 35 centimeters or 40 centimeters in length are manufactured with Nylon Torcon with a bonded Nonradiopaque tip. Both Novy Set are supplied sterile and intended for one-time use.

#### Indication for Use:

The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic or fluoroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation solution or contrast medium, in the evaluation of tubal patency.

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Image /page/4/Picture/0 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.

NIFIS WAY PO BOX ARS 1. IN 47402-0489 U.S.A. OU EPEE- 800.457.4500 OOKMEDICAL.COM

> K180552 Page 2 of 3

## Predicate Device:

The predicate device, the Novy Cornual Cannulation Set manufactured by Cook Incorporated (K931476), is a medical device set intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic or fluoroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation solution or contrast medium, in the evaluation of tubal patency. It is a group of sets including inner catheter with a wire guide, an introducing catheter, with obturator, and endoscopic cap, and female Luer lock caps. The predicate device was offered sterile for onetime use.

The predicate device has not been subject to a design related recall.

## Comparison to Predicate Device:

The proposed Modified Novy Cornual Cannulation Set as compared to the predicate device, Novy Cornual Cannulation Set (K931476) has the same intended use, are identical in terms of intended use, principles of operation, basic technological characteristics, and nearly identical in dimension and design.

Regarding technological characteristics, whereas the predicate submission is offered in many dimensions, in the curved and straight options, the Modified Novy Cornual Cannulation Set, subject of this submission, offers only two curved options and two-dimensional options. The material of the curved tip of the introducing catheter was modified from Torcon Polyethylene tubing to a Torcon Nylon tubing. The minor modifications to the dimension of the inner catheter and the material change of the curved introducing catheter do not raise different questions of safety and effectiveness.

#### Summary of Performance Testing:

The following tests were performed to demonstrate that the dimensional modification to the inner catheter and the material modification of the tip of the curved introducing catheter have met applicable design and performance requirements to support a determination of substantial equivalence.

- Tensile Test of the Hub to Shaft joint Verification that when subjected to maximum . load requirements, the hub to shaft joint satisfies the minimum load requirement. The predetermined acceptance criterion was met.

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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in white, and the word "MEDICAL" is in white and set against a red banner that is slightly darker than the background.

K180552 Page 3 of 3

- Tensile Test of the Tip to Shaft Joint Verification that when subjected to maximum . load requirements, the Tip to Shaft Joint satisfies the minimum load requirement. The predetermined acceptance criterion was met.
- . Leak Test – Verification that the hub to shaft joint is free from leaks. The predetermined acceptance criterion was met.
- . Dimensional Compatibility - Verification that the dimensions of the components of the Novy sets are clinically acceptable. The predetermined acceptance criteria were met.
- Component Compatibility Verification that the device components are compatible . with each other. The predetermined acceptance criteria were met.
- . Biocompatibility - Testing shows that the subject device sets with short term mucosal membrane contact are non-cytotoxic, non-sensitizing, and non-irritating. The following tests were performed:
- Cytotoxicity per ISO 10993-5:2009 o
- Sensitization per ISO 10993-10:2010 o
- Irritation per ISO 10993-10:2010 o
- Sterilization validation per ISO 11125:2014 ●
- Shelf life accelerated aging per ASTM F1980-02 to demonstrate that the subject . device maintains the mechanical specifications and its packaging maintains sterility (see bullet below) after three years of aging. In conformance to Cook requirements, the predetermined acceptance criterion was met.
- Package integrity per ASTM F1886-09 (visual inspection), ASTM F2096-11 . (bubble leak), and ASTM F88-09 (seal strength). In conformance to Cook requirements, the predetermined acceptance criteria were met.

In conclusion, the results of these tests support a determination of substantial equivalence of the Modified Novy Cornual Cannulation Set to the predicate Novy Cornual Cannulation Set.