Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff

K150927 · Coloplast A/S · OCY · May 27, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150927
• Device Name: Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
• Applicant: Coloplast A/S
• Product Code: OCY · Gastroenterology, Urology
• Decision Date: May 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourological procedures.

Device Story

Orchestra Hydrophilic Guidewire consists of a metallic core wire with a polymer coating and an outer hydrophilic coating. Used by clinicians during endourological procedures to facilitate the placement of other medical devices through the urinary tract. Supplied sterile and non-pyrogenic. The device functions as a mechanical guide to navigate the urinary tract anatomy. The current iteration features a modified hydrogel coating formulation designed for improved durability and reliability. Performance is verified through bench testing to ensure suitability for clinical use.

Clinical Evidence

Bench testing only. Testing evaluated the performance of the modified hydrophilic coating to ensure suitability for gastroenterology/urology use and confirmed that all product requirements and specifications were met.

Technological Characteristics

Metallic core wire with polymer coating; hydrophilic coating applied over a radiopaque polymer jacket. Supplied sterile and non-pyrogenic. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing endourologic procedures requiring the placement of devices through the urinary tract.

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

• Orchestra Hydrophilic Guidewire (K131072)

Reference Devices

• Merit Laureate Hydrophilic Guidewire

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Coloplast A/S LeeAnne Swiridow Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis. MN 55411

Re: K150927

Trade/Device Name: Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic Guidewire Angled Stiff, Orchestra Hydrophilic Guidewire Standard Straight Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCY Dated: March 31, 2015 Received: April 6, 2015

Dear LeeAnne Swiridow,

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. 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. You must comply

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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 (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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) K150927

#### Device Name

Orchestra® Hydrophilic guidewire standard angled, Orchestra® Hydrophilic guidewire straight stiff, Orchestra® Hydrophilic guidewire angled stiff, Orchestra® Hydrophilic guidewire standard straight, Orchestra® Hydrophilic guidewire straight stiff.

#### Indications for Use (Describe)

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

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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Image /page/3/Picture/0 description: The image shows the logo for Coloplast. The logo consists of a blue circle on the left side with horizontal lines across the top half. To the right of the circle is the word "Coloplast" in a bold, blue font.

Ostomy Care Jrology & Continence Care Wound & Skin Care

## 2. 510(k) SUMMARY

| 510(k) Owner's Name: | Coloplast A/S | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|
| Address: | Holtedam 1<br>3050 Humlebaek, Denmark | | |
| Phone/Fax/Email: | Office: | [phone] | |
| | Mobile: | [phone] | |
| | Fax: | [phone] | |
| | Email: | [e-mail] | |
| Name of Contact Person: | LeeAnne Swiridow<br>Sr. Regulatory Affairs Specialist | | |
| Address/Contact: | 1601 West River Road N<br>Minneapolis, MN 55411 | | |
| Date Prepared: | March 30th, 2015; revised May 27th, 2015 | | |
| Trade Name: | Orchestra® Hydrophilic guidewire standard angled<br>Orchestra® Hydrophilic guidewire straight stiff<br>Orchestra® Hydrophilic guidewire angled stiff<br>Orchestra® Hydrophilic guidewire standard straight<br>Orchestra® Hydrophilic guidewire straight stiff | | |
| Common Name: | Hydrophilic guidewire | | |
| Classification Name: | Endoscopic Guidewire, Gastroenterology-Urology | | |
| Product code: | OCY | | |

# Description of the Device:

The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

## Intended Use of the Device:

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourological procedures.

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Image /page/4/Picture/0 description: The image shows the logo for Coloplast. The logo consists of a blue circle on the left side with horizontal lines across the top half. To the right of the circle is the word "Coloplast" in a bold, blue font.

## Predicate Device:

The Orchestra® Hydrophilic Guidewire is substantially equivalent in performance, indication, design and materials to Orchestra® Hydrophilic Guidewire, cleared under Premarket notification # K131072.

## Summary and Conclusions from the Nonclinical Tests Submitted:

Merit modified the proportion of constituents in the hydrogel coating of Merit Laureate™ Hydrophilic Guidewire to improve the level of crosslinking. This change was made to improve the durability and reliability of the coating. Since all current product requirements and specifications were met when manufactured with the new coating change, this change does not alter the form, fit or function of the product (See Merit Product Change Notification in Appendix C).

Bench testing was also performed by Coloplast to evaluate performance of the modified hydrophilic coating to ensure the product is still suitable for gastroenterology/urology use.

### Conclusion

Based on the indications for use, design, technical characteristics, safety, and successfully completed performance testing, the Orchestra® Hydrophilic Guidewire is substantially equivalent to Orchestra® Hydrophilic Guidewire, cleared under Premarket notification # K131072.