SIALO BALLOON DILATATION CATHETER

K072749 · Sialo Technology, Ltd. · GCJ · May 14, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072749
• Device Name: SIALO BALLOON DILATATION CATHETER
• Applicant: Sialo Technology, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sialo Balloon dilatation catheter is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.

Device Story

Balloon dilatation catheter designed for salivary duct strictures; used under endoscopic or radiological guidance. Device provides mechanical dilatation of duct; facilitates endoscopic access for stone removal. Operated by qualified surgeons in clinical settings. Surgeon visualizes duct via endoscope or imaging; advances catheter; inflates balloon to dilate stricture. Output is physical expansion of ductal tissue; enables therapeutic intervention for salivary gland disease. Benefits include improved ductal patency and access for stone extraction.

Clinical Evidence

Bench testing only. Device subjected to safety, performance, and validation testing to ensure functional specifications and compliance with industry standards. Literature review provided regarding device use in other countries.

Technological Characteristics

Balloon dilatation catheter; intended for use through endoscopic working channels. Mechanical dilatation principle. No electronic components, software, or energy source described.

Indications for Use

Indicated for qualified surgeons treating patients with salivary gland diseases requiring ductal dilatation or endoscopic access for stone removal.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Salivary Duct Dilator (Cook Medical)
• KSEA Sialoendoscope and accessories (K012527)

Reference Devices

• Dilatation Catheter Ascend Balloon (K970041)

Submission Summary (Full Text)

{0}------------------------------------------------

K072749

Sialo Balloon Dilatation Catheter 510(k)

# MAY 1 4 2008

### 510(K) SUMMARY

## SIALOTECH DILATION BALLOON KIT AND ACCESSORIES

### 510(k) Number K_______________________________________________________________________________________________________________________________________________________________

.

"

| Applicant's Name: | Sialo Technologies Ltd.<br>Suite 220<br>11 Ben Gurion Boulevard<br>Ashkelon 78182<br>Israel<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ahava Stein/ Ofer Hornick<br>A. Stein - Regulatory Affairs Consulting<br>20 Hata'as St.<br>Kfar Saba 44425<br>Israel<br>Tel. [phone]<br>Fax. [phone]<br>e-mail: [e-mail] or [e-mail] |
| Date Prepared: | August 2007 |
| Trade Name: | Sialo Dilatation Balloon Catheter (for salivary duct) |
| Classification Name: | CFR Classification section 876.1500 (Product code GCJ) |
| Classification: | Class II medical Device |
| Predicate Device: | The Sialo Balloon Dilatation Catheter device is comparable to the<br>following predicate devices:<br>- The Salivary Duct Dilator (Class I 510(k) exempt device)<br>manufactured by Cook Medical. The salivary duct dilator is a<br>rigid rod with known diameter, which is inserted into the salivary<br>duct to create mechanical dilatation.<br>- The accessories of KSEA Sialoendoscope and accessories<br>(K012527) manufactured by Karl Storz Endoscopy. KSEA<br>Sialoendoscope is an endoscopic device with accessories intended<br>to treat salivary gland disease. |

{1}------------------------------------------------

(K970041) Dilatation Catheter Ascend™M Balloon - The manufactured by Cook Urological.

Sialo Balloon Dilatation Catheter is designed to allow dilatation of Device Description: the salivary duct under endoscopic or radiological guidance. Dilatation can be therapeutic by itself (for duct strictures), or provide endoscopic access for stone removal.

Intended Use / Indication for Use: The Sialo device is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.

Performance Standards: None.

The Sialo Balloon dilatation device has been subjected to extensive Test Data: safety, performance, and validation testing before release. Final testing of the Sialo device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards. Literature review describing device use in other countries is provided in Section 21 of this submission.

The Sialo Balloon dilatation device is similar to currently Substantial Equivalence: distributed endoscopic accessory devices intended for treatment of other strictures in other body cavities; and it is similar in intended use to the Cook salivary duct dilator. Dilatation balloon catheters are used through endoscopic working channels to dilate a variety of ducts/ tubes, such as dilatation balloons for the biliary duct, for the urinary tract, for the lacrimal duct, and for dilatation of blood vessels. All of the above features are similar to these features in the predicate devices.

The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices, is that the Sialo Balloon dilatation device is substantially equivalent in safety and efficacy to the predicate devices listed above.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 1 4 2008

Sialo Technologies Limited C/O Ms. Ahava Stein Regulatory Affairs Consultant A. Stein Regulatory Affairs Consulting 20 Hata'as St. Kfar Saba 44425 ISRAEL

Re: K072749

Trade/Device Name: Sialo Dilatation Balloon Catheter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: April 9, 2008 Received: April 17, 2008

Dear Ms. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 - Ms. Stein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chris

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K072749

Sialo Dilatation Balloon 510(k)

#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Sialo Dilatation Balloon Catheter

#### Intended Use Statement:

The Sialo Balloon dilatation catheter is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.

Prescription Use ﯿﮯ (Per 21 C.F.R. 801 Subpart D) C)

OR

Over-The-Counter Use (Optional Format Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Penna

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k072749