Wilson-Cook Achalasia Balloon

K182895 · Wilson-Cook Medical, Inc. · PID · Jan 25, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K182895
• Device Name: Wilson-Cook Achalasia Balloon
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: PID · Gastroenterology, Urology
• Decision Date: Jan 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.

Device Story

Wilson-Cook Achalasia Balloon is a dilation catheter used by physicians to treat Achalasia. The device consists of a PET balloon attached to a 75 cm catheter with a Neuthane tip. It features three tantalum radiopaque bands for fluoroscopic visualization. The device is inserted into the esophagus; the balloon is inflated to 30 mm or 35 mm diameters to dilate the lower esophageal sphincter. The procedure is performed in a clinical setting under fluoroscopic guidance. The device is provided non-sterile and requires sterilization by the user. By mechanically dilating the sphincter, the device aims to improve esophageal function and patient symptoms.

Clinical Evidence

Bench testing only. Performance testing included balloon diameter/length, pressure verification, distensibility, tensile testing of joint components, dimensional verification, functional testing, and shelf-life testing. Biocompatibility testing was conducted per ISO 10993-1:2009.

Technological Characteristics

Materials: PET (balloon), Pebax (Y-junction), Neuthane (tip). Features: 75 cm catheter, 8 cm balloon length, 30/35 mm inflated diameters, tantalum radiopaque bands. Energy: Mechanical inflation (max 3.0 atm). Connectivity: None. Sterilization: Provided non-sterile (user-sterilized).

Indications for Use

Indicated for adult patients with Achalasia requiring dilation of the lower esophageal sphincter.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Rigiflex II Single Use Achalasia Balloon Dilator (K050232)

Submission Summary (Full Text)

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January 25, 2019

Wilson-Cook Medical, Inc. Theresa de Prat Regulatory Affairs Specialist II 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K182895

> Trade/Device Name: Wilson-Cook Achalasia Balloon Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PID Dated: October 22, 2018 Received: October 23, 2018

Dear Theresa de Prat:

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 mav, 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 avare 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 (QS) 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,

# Daniel G. Walter Jr -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) K182895

Device Name Wilson-Cook Achalasia Balloon

Indications for Use (Describe)

The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## K182895 Page 1 of 2

#### Submitted By:

| Submission: | Traditional 510(k) Premarket Notification |
|--------------------|--------------------------------------------|
| Applicant: | Wilson-Cook Medical, Inc. / Cook Endoscopy |
| Contact: | Theresa de Prat |
| Applicant Address: | Wilson-Cook Medical, Inc. / Cook Endoscopy |
| | 4900 Bethania Station Road |
| | Winston-Salem. North Carolina 27105 |

Contact Phone Number: [phone] Contact Fax Number: [phone]

#### Device Information

| Trade Name: | Wilson-Cook Achalasia Balloon |
|--------------------|---------------------------------------|
| Common Name: | Dilation Balloon |
| Regulation | |
| Description: | Gastrointestinal tube and accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Product Code: | PID |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |

#### Predicate Device

| Name: | Rigiflex II Single Use Achalasia Balloon Dilator |
|----------------|--------------------------------------------------|
| 510(k) Number: | K050232 |
| Date: | 03/11/2005 |

## Intended Use

The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.

#### Device Description

The subject dilation balloon consists of an PET balloon attached to a 75 cm that is secured to a white Pebax Y junction with two extension lines leading with a wire guide hub and an inflation hub. The catheter has four black ink markers on the catheter.

The dilation balloon is composed of PET, with a patient contacting length of 8 cm which can be inflated to a single size of 30 mm or 35 mm in diameter. The balloon has a 1.16" long tip made of white Neuthane. Three tantalum radiopaque bands are placed underneath the balloon to assist in fluoroscopic visualization of the balloon.

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| Model | Catheter | | Balloon | | | |
|---------------------------|------------------------------|-------------------------|---------------------------------|------------------------|--------------------------------------------|--------------------------------------------|
| Reorder<br>Part<br>Number | Catheter<br>Diameter<br>(FR) | Catheter Length<br>(cm) | Inflated<br>Balloon<br>Diameter | Balloon<br>Length (cm) | Recommended<br>Graduated<br>Pressure (PSI) | Recommended<br>Graduated<br>Pressure (atm) |
| WCAB-30 | 14.5 | 75 | 30mm<br>(90FR) | 8 | 45 | 3.0 |
| WCAB-35 | 14.5 | 75 | 35mm<br>(105FR) | 8 | 40 | 2.7 |

#### Comparison to Predicate Device

The subject device, the Wilson-Cook Achalasia Balloon, is substantially equivalent to the Rigiflex II Single-Use Achalasia Balloon Dilator (K050232) with respect to intended use, operating mechanism, technological characteristics.

Minor changes exist from the predicate Rigiflex II Single-Use Achalasia Balloon Dilator to the Wilson Cook Achalasia Balloon (subject device).

The subject device has a more specific intended use, different materials of construction, a shorter balloon patient contacting length, dimensional differences in catheter dimeter and length and provided non-sterile. The subject device has a maximum balloon inflation pressure of 3.0 atm while the predicate has a maximum inflation pressure of 1.36 atm. These minor differences do not raise new questions of safety or effectiveness.

## Summary of Non-Clinical Testing

The following performance testing was conducted to demonstrate performance of the subject device and confirmed that the subject device performs as intended.

- Balloon Diameter and Length ●
- Balloon Pressure Verification ●
- Distensibility
- Tensile Testing of Joint Components
- Dimensional Verification (catheter and balloon)
- Functional Testing ●
- Shelf Life Testing ●

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices- Evaluation and testing within risk management process.

#### Conclusion

Results from design validation and/or verification testing provide reasonable assurance that the modifications do not raise new questions of safety or effectiveness. Therefore, we believe the subject device to be substantially equivalent to the predicate.